2019 IPI Winter Web Compressed

Volume 11 Issue 4
Peer Reviewed
Securing the Pharma Supply Chain

A Look Back at How We Got Here and Where We’re Going
An Overview of Speaker Programmes

and the Influence of HCP Compensation
How Pharma Companies Can Improve

Patient Engagement
Just the Right Dose

The Top Trends Shaping Drug Dosage Forms
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Contents
06 Editor’s Letter
REGULATORY & MARKETPLACE
08 The Impact of Regulation on Software Development
The increasing array of regulation surrounding medical

device design has as much impact on their software
DIRECTORS:
Martin Wright elements as the electronic and other physical components.
Mark A. Barker Manufacturers must be able to document every significant
action during the development process: where, when, how,
BUSINESS DEVELOPMENT: what, by whom and why each change was made. Gerhard
Thomas Kurse Kruger at Perforce Software discusses how the impact
[email protected]
of regulation on software development presents a huge
EDITORIAL: challenge in providing such evidence and one with which
Virginia Toteva many organisations struggle.
[email protected]
12 MDR Preparations: The Final Leg
DESIGN DIRECTOR:
Jana Sukenikova
Under the new EU Medical Device Regulations, due to go
www.fanahshapeless.com
live from May 2020, new medical device identification and
FINANCE DEPARTMENT: traceability measures will become compulsory. Bob Tilling
Martin Wright of Kallik explores the issues that compliance preparations
[email protected] have thrown up for manufacturers – particularly in relation
to global labelling management – and consider how firms
RESEARCH & CIRCULATION:
might now overcome these effectively so future waves of
Ana De Jesus
[email protected] regulatory changes aren’t as disruptive.
COVER IMAGE: DRUG DISCOVERY, DEVELOPMENT & DELIVERY

iStockphoto ©
14 An Overview of Speaker Programmes and the
PUBLISHED BY:
Influence of HCP Compensation
Pharma Publications
50 D, City Business Centre
London, SE16 2XB Speaker programmes remain key in boosting the adoption
United Kingdom of a drug. In recent years programmes have centred more
on education rather than promotion of a specific brand.
Tel: +44 (0)20 7237 2036 This shift can largely be attributed to the scrutiny focused
Fax: +44 (0)01 480 247 5316
on the relationships between doctors and life science
Email: [email protected]
companies. Todd Middleton at Cutting Edge Information
delves into how existing and developing regulations
All rights reserved. No part of this publication may be reproduced, surrounding healthcare provider (HCP) compensation
duplicated, stored in any retrieval system or transmitted in any form emphasise staying compliant when contracting medical
by any means without prior written permission of the Publishers. professionals for their services.
The next issue of IPI will be published in Spring 2020.
ISSN No.International Pharmaceutical Industry ISSN
CLINICAL & MEDICAL RESEARCH
1755-4578.
18 How Pharma Companies Can Improve Patient
The opinions and views expressed by the authors in this magazine Engagement
are not necessarily those of the Editor or the Publisher. Please note
that although care is taken in preparation of this publication, the
Engaging patients in medication management is not a
Editor and the Publisher are not responsible for opinions, views
and inaccuracies in the articles. Great care is taken with regards to
simple task and empowering patients to control complex
artwork supplied, the Publisher cannot be held responsible for any regimes is even more difficult without the right tools.
loss or damage incurred. This publication is protected by copyright. Omri Shor at Medisafe demonstrates that patients who
are more informed about their health condition(s) and are
2019 PHARMA PUBLICATIONS / Volume 11 issue 4 – Winter – 2019 involved in their treatment decisions demonstrate better
results through increased adherence rates and extended
persistency.
TECHNOLOGY
20 Data Inputs for Medical Intervention Valuations
It is well known that a positive net present value (NPV)

calculation on any product in development is a good
indication that upon market release, the financial return
www.ipimediaworld.com INTERNATIONAL PHARMACEUTICAL INDUSTRY 1

Contents
will exceed the cumulative life cycle costs of research, the traceability features and safety management of
development, market validation, market access, medical devices for sale within the EU. With less than
market release, manufacture and sales. Despite this eight months to go before the deadline, Volker Watzke at
market reality, rNPVs on projects and portfolios at the Domino Printing Sciences offers advice on how to become
start-up stage for healthcare-focused endeavours are compliant as quickly and efficiently as possible.
communicated either publicly or privately. Dr. Jonathan
Dando at Echino Ltd and Maximilian Lebmeier at Athena 34 A Patient-centric Journey Through the Pharma
Market Access Solutions Ltd examines how data being Supply Chain
used in rNPV calculations may be incorrect, creating
a disconnect between stakeholders with serious In the last decade we have seen a progressive trend
ramifications. across the pharmaceutical industry, with big block-buster
drugs gradually becoming less prevalent, as well as a
28 Lab of the Future – Getting the IT Foundation in shift towards smaller-volume therapies. Although this
Place Before the Hype Kicks In change has been necessitated by the discovery pipeline,
Stuart Needleman at Piramal Pharma Solution shows how
Many laboratories are currently embarking on a digital targeted therapies and personalised approaches have
journey and buzzwords such as artificial intelligence profound supply chain implications.
(AI), machine/deep learning (ML/DL), virtual/augmented
reality (VR/AR), internet of things (IoT), lab of the future 38 The New Technologies Shaping Aseptic Processing
(LoTF), and last but not least, data standardisation Techniques
with contributors like Allotrope foundation and SiLA,
are frequently mentioned in articles, white papers and The technology used in aseptic processing has seen
conferences. But the reality is that many laboratories are continuous improvement and innovation in recent years.
still highly paper-based. Stig Ragborg and Nadia Sara Adjal Aseptic processes involve hazards that must be properly
at the Life Sciences Advisory department in NNIT explain controlled to avoid consequences for patient safety.
why they are missing essential laboratory applications in Christian Dunne at ChargePoint Technology says that,
their IT landscape, thereby not harvesting the envisioned in response to this, the industry is seeing significant
benefits. developments in technology to prevent contamination
and ensure product sterility.
MANUFACTURING
42 Just the Right Dose: The Top Trends Shaping Drug
32 The EU MDR 2020: Deadline for Compliance Dosage Forms
The deadline for ensuring compliance with the European As new drug molecules in the pipeline become increasingly
Union’s Medical Device Regulations (EU MDR) is looming. complex and approved molecules are reformulated for
These new, stricter regulations are aimed at improving alternative routes of administration, the drug dosage
2 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

Contents
landscape is shifting significantly. Dr. Robert Lee at 64 Pharma Ocean Freight Enters New Waters (PART 2)
Lubrizol Life Science Health (LLS Health) discusses the
key trends influencing dosage forms in the industry. In this interview sequel, Alan Kennedy at Pharma TEAM-UP
answers questions from cold-chain expert David Bang
PACKAGING about the Poseidon ocean-freight model.
44 Role of Phase Change Materials for Safe 68 How Innovations in Temperature-controlled

Transportation of Pharmaceutical Goods Packaging are Helping Mitigate Cold Chain Risks
When Transporting Pharmaceuticals
Over 25% of pharmaceutical products are wasted every
year during transportation. Since seven out of 10 pharma With increasing regulatory requirements and compliance
products require temperature-controlled shipping, a within the cold chain to ensure the safe transportation of
compromised temperature-controlled chain has emerged pharmaceuticals and biologics, temperature-controlled
as one of the leading causes of this wastage. Geet Joshi, packaging manufacturers need to be at the forefront of
Nidhi Agrawal, Vikas Agrawal, Udit Mangal at Pluss industry innovation. Adam Tetz at Peli BioThermal explains
Advanced Technologies P. Ltd present the role of phase that the fact over half of the approved new drugs are
change materials and box design for transporting such going to be biologics or biosimilars, is proving another
temperature-sensitive goods. driver in the rising demand for tighter temperature control
requirements.
48 Leave No Manufacturer Behind
TALKING POINT
The upcoming deadlines for the EU Medical Device
Regulation (MDR) and EU In Vitro Diagnostic Regulation 74 Reimaging Temperature Monitoring Services
(IVDR) compliance do not solely affect medical device
manufacturers. Pharmaceutical companies producing IPI speaks with Jukkapekka Asikainen of Sensire about
either combination products or companion diagnostics its innovative temperature monitoring services
will also see their products undergo greater clinical
scrutiny as laid down in these new regulations. Elizma 76 How to Make Passive Pharma Packaging More
Parry at Maetrics gives informative and practical guidance Flexible, Cost-effective and Eco-friendly
to pharmaceutical manufacturers who are new to the
preparatory process and are required to obtain a CE mark IPI talks to Sven Rölle about time-saving cooling systems,
for their device. reusability and the future of individualised packaging.
52 New Technological Solutions to Strengthen and 79 The Greener Side of Pharma Logistics
Innovate Pharmaceutical Packaging to its Next Level
IPI speaks with Dr. Florian Seidenburg on the ecological
We are living in an age where busy and unhealthy lifestyles impact in the pharmaceutical supply chain.
have augmented the growth of diseases amongst every
age group. Even newborn babies have been the victims 81 Making Smart Equipment Decisions for a Secure
of chronic diseases. Akshita Pacholi from Allied Market Cold Chain
Research explains why pharmaceutical companies are
now strengthening their product packaging services to IPI speaks with Anthony Dellumo of Q Products about
meet the evolving needs of customers. passive thermal protection in pharma logistics.
56 Delving Deep into FMD
IPI speaks with Marietta Ulrich Horn & Werner Horn of

Securikett, on creating an integrated packaging solution
approach.
LOGISTICS & SUPPLY CHAIN MANAGEMENT
58 Securing the Pharma Supply Chain: A Look Back at

How We Got Here and Where We’re Going
The push for serialisation and traceability – assigning

unique identifiers to individual packs of medications
and being able to track them one by one or in
larger aggregations – in the pharmaceutical supply
chain continues in earnest. Glenn Abood at rfxcel
Corporationwork emphasises how taking stock at the
beginning of the New Year should inspire all of us to
renew our commitment to secure the pharma supply
chain, protect patients, and make the industry the
absolute best (and safest) it can be.

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Editor's Letter
2020 marks a new Watzke at Domino Printing Sciences change materials and box design
decade and, with a offers advice on how to become for transporting such temperature-
global population of compliant as quickly and efficiently sensitive goods. They talk about
7.8 billion people, the as possible. how new technology solutions are
pharmaceutical industry going to strengthen and innovate
plays a big part in the The big block-busters of the past pharmaceuticals packaging to the
present and future of are falling off the patent cliff and next level; we can only hope that
our planet. making way for a new patient-centric these will be sustainable and made
journey, which is also influencing how from recycled material.
There have been great leaps in the pharma supply chain is having
technology and drugs that we have to develop. Stuart Needleman at Following on from this, IPI talks to
seen invented, but I really hope Piramal Pharma Solution shows how Sven Rölle about time-saving cooling
that we can evolve even more and targeted therapies and personalised systems, reusability and the future of
that’s why there is a special focus approaches have profound supply individualised packaging and how this
in this journal on packaging and chain implications. is going to be more cost-effective
temperature-controlled shipment and eco-friendly.
(cool chain logistics). Did you know that 25% of
pharmaceutical products are wasted We look forward to seeing you
The global pharmaceutical every year during transportation, and at PharmaPack in Paris and the
packaging market size is expected to seven out of 10 pharma products Temperature Controlled Logistics
reach USD 158.24 billion by 2025, but require temperature-controlled Conference by IQPC in Germany.
with this there are also challenges shipping? Geet Joshi, Nidhi Agrawal,
we need to overcome. These include Vikas Agrawal and Udit Mangal at Lucy Robertshaw
the looming EU Medical Device Pluss Advanced Technologies P. Ltd Director, Lucy J.Robertshow
Regulations (EU MDR), and Volker explain the importance of phase Consulting
Members of the developing an appropriate temperature inputs from various experts in the
pharmaceutical supply and humidity monitoring programme cool chain management industry.
chain have various is essential to protect the quality of Read engaging interviews with
global regulatory environmentally-sensitive pharma- Jukkapekka Asikainen at Sensire,
re q u i re m e nt s t o ceutical products and to ensure Sven Rölle at Eutecma, Dr. Florian
meet while handling, patient safety. Medicines requiring Seidenburg at Ecocool and others.
storing, & distributing controlled-temperature storage
environmentally sen- conditions must be distributed in a I hope you enjoy the latest
sitive products. Their focus is to manner that ensures their quality will edition of the IPI, and I wish you
provide cold chain management not be adversely affected. all a Merry Christmas and a very
for temperature-sensitive pharma- Happy New Year.
ceuticals to ensure that the quality Our December 2019 issue of IPI
and efficacy of the product will is working closely with the TCL
not be compromised. Due to the Conference organised by IQPC. To
presence of multiple uncontrolled complement this event, IPI brings Virginia Toteva
variables in the distribution process, together a fascinating section, with Editorial Manager – IPI
Editorial Advisory Board

Bakhyt Sarymsakova, Head of Department of and Executive Vice President, Vienna School of Rick Turner, Senior Scientific Director, Quintiles
International Cooperation, National Research, Clinical Research Cardiac Safety Services & Affiliate Clinical
Center of MCH, Astana, Kazakhstan Associate Professor, University of Florida College
Jagdish Unni, Vice President – Beroe Risk and of Pharmacy
Catherine Lund, Vice Chairman, OnQ Consulting Industry Delivery Lead – Healthcare, Beroe Inc.
Robert Reekie, Snr. Executive Vice President
Deborah A. Komlos, Senior Medical & Regulatory Jeffrey Litwin, M.D., F.A.C.C. Executive Vice Operations, Europe, Asia-Pacific at PharmaNet
Writer, Thomson Reuters President and Chief Medical Officer of ERT Development Group
Diana L. Anderson, Ph.D president and CEO of D. Jeffrey W. Sherman, Chief Medical Officer and Sanjiv Kanwar, Managing Director, Polaris
Anderson & Company Senior Vice President, IDM Pharma BioPharma Consulting
Franz Buchholzer, Director Regulatory Operations Jim James DeSantihas, Chief Executive Officer, Stanley Tam, General Manager, Eurofins MEDINET
worldwide, PharmaNet development Group PharmaVigilant (Singapore, Shanghai)
Francis Crawley. Executive Director of the Good Mark Goldberg, Chief Operating Officer, PAREXEL Stefan Astrom, Founder and CEO of Astrom
Clinical Practice Alliance – Europe (GCPA) and a International Corporation Research International HB
World Health Organization (WHO) Expert in ethics
Maha Al-Farhan, Chair of the GCC Chapter of Steve Heath, Head of EMEA - Medidata Solutions,
Georg Mathis Founder and Managing Director, the ACRP Inc
Appletree AG
Patrice Hugo, Chief Scientific Officer, Clearstone T S Jaishankar, Managing Director, QUEST Life
Heinrich Klech, Professor of Medicine, CEO Central Laboratories Sciences

Regulatory & Marketplace
The Impact of Regulation on Software Development
compliance requirements for medical Beyond regulatory compliance,

The increasing array of regulation device firms are growing. there are two extremely important
surrounding medical device design reasons why better management over
has as much impact on their software
Plus, for many organisations who software development is needed: safety
elements as the electronic and other
physical components. Manufacturers have been manufacturing medical and security, which are typically the
must be able to document every devices before they became so main drivers for having compliance in
significant action during the software-centric, there has been a the first place. Software development
development process: where, when, learning curve. While designing and is where most vulnerabilities are
how, what, who and why each change testing physical components is not introduced, usually inadvertently, but
was made.
easy, it is well-trodden ground, with their implications can be catastrophic.
clearly understood processes within At the very least, they could cause a
It is a huge challenge to provide the engineering community. Software product to have a fault. At the other
such evidence and one with which development test and validation is end of the spectrum, they could lead
many organisations struggle. In a very different. Traditionally, software to complete product malfunction, or
recent survey carried out by Perforce developers tended to work in silos, even to allow a cybersecurity attack.
among medical device professionals separate to the rest of the business Various stories have hit the media in
worldwide, only 38 per cent were and focused more on creating brilliant the past couple of years about how
very confident – and 47 per cent code than ensuring compliance. That IoT-connected medical products can
somewhat confident – that they could is changing – out of necessity – but be taken over by remote hackers,
pass a surprise FDA audit. However, it can still introduce cultural barriers. including heart monitoring systems,
the challenge is not insurmountable, In addition, development teams are pacemakers and defibrillators.
given the right processes, techniques under huge pressure to bring products
and tools. More on that shortly, but to market faster, more cost-effectively, Breaking Down the Barriers
first, here is a quick overview of the and with more frequent release or In common with other industries,
regulations that affect medical device update cycles. medical device professionals are
software. embracing DevOps, literally a
Teams may be spread across portmanteau of ‘Development’ and
Some of these regulations are multiple sites and may use different ‘Operations’, whereby the traditional
US-based, others are European. systems and tools. They may work with cultural and process barriers between
Given the global nature of this market, external contributors, who may be from those two teams are broken down.
companies involved in medical device different, non-technical backgrounds. The result is that they can collaborate
development usually have to comply As well as software code, there are better, understand each other’s role
with them all. For instance, there are probably a variety of different file types and current status, understand the
several US FDA regulations applicable – such as CAD drawings, prototypes implication of their actions on other
to medical devices, including 21 CFR and so on – that need to be maintained. parts of the project, solve problems
Part 11. IEC 62304 which specifies Finally, there is the sheer scale of the faster, and so accelerate time-to-
lifecycle requirements for medical digital assets involved: terabytes of data market. DevOps depends on a variety
devices and medical device software. are becoming commonplace. All these of best practice steps, techniques and
It is a functional safety standard factors make keeping visibility and tools, and while there are numerous
derived from IEC 61508 and satisfies control over software development a instances of DevOps being done badly
the key requirements in the current tough job for even the most skilled and or in name only, equally there are some
Medical Devices Directive, due to be diligent project team. good experiences being shared.
replaced next year by the EU Medical
Device Regulation. ISO 14971 is the risk Alongside DevOps is the growth of
management standard for medical the Agile methodology and the two
devices. ISO13485 specifies the quality can – and often do – co-exist well.
management requirements for medical Compliance-driven markets have often
devices. Finally, there is next year’s been wary of Agile, which in its early
introduction of the Medical Device years was often quoted for its ‘minimal
Regulation (MDR) in the EU, replacing viable product’ delivery to market,
the Medical Devices Directive. The full but that is changing fast. Perforce’s
implication of the MDR on software is research across 2018 and 2019 found
something which most organisations that the medical device professionals
are still getting to grips with, but who had moved away from the most
regardless, the volume and variety of popular methodology – Stage-Gate

(a proprietary Waterfall-based vulnerabilities as early as possible of complex programming languages

method) – chose hybrid-Agile, which helps to prevent them escalating or such as C and C++, which while giving
combines elements of Agile with becoming harder to find at a later developers more scope for innovation,
more traditional methods. This could stage. This has productivity and cost can introduce more risk, because
be because when implemented well, benefits, too. there is more room for interpretation
it provides the best of both worlds: and therefore inadvertent errors.
the structure and control of more Given the vast amount of software For instance, a common problem is
traditional methodologies, together elements that need testing, and to overwriting memory buffer overflow,
with the flexibility and speed of reduce the risk of human error creeping and that can create a security
Agile. in, there is also a swing towards vulnerability that can be exploited at
automating test processes as much a later date.
Start Early as possible. Not only is this usually
It may sound obvious, but making welcomed by software developers Coding standards are sets of
sure that code is compliant, safe who do not want yet other task to rules that developers can follow,
and of high quality from the very proactively manage, it also opens confident that the code they are
beginning of a project can make a up testing to a wider audience who creating is safe, secure and meets
huge difference, but does not always have not received specialist training relevant regulatory compliance. In
happen. Comprehensive testing is in this area. Automated, continuous medical device development, one
essential, yet software tests – beyond testing means that projects can scale of the most commonly used coding
standard unit tests – have in the past up, without the due diligence of test standards is published by MISRA, a
been carried out at a later stage, processes turning into a bottleneck. collaboration between manufacturers,
usually by QA engineers or dedicated component suppliers and engineering
test managers. Now, that is changing, Coding Standards consultancies. Again, to prevent
with many software teams embracing Coding standards have become additional workload on the developer
‘shift left’, whereby developers take on commonplace in other safety-critical and reduce human error, coding
more testing tasks, plus ‘continuous markets, automotive being a notable standards are usually applied using a
testing’, where as its name suggests, example. Interest in their use is growing static analysis tool, which automatically
testing takes place at every stage of in medical device development too. inspects code in background mode
a project. The idea is simple: finding One of the main drivers is the use and flags up any issues.

Access Control types of files are involved in medical this is why more companies are
Another technique that helps keep device development projects, it is now adopting automation tools for
software development safe is important to have a version control these matrices, such as application
fine-grained access control. Users are system that supports them all. lifecycle management software, to
only given access to what they require reduce time, manual effort, and risk.
for their jobs. While this may sound Documenting Evidence The information gathered can then be
counter to the more collaborative While all of the tools and techniques exported as required into programs
working culture mentioned earlier, it described contribute towards such as Microsoft Office, to then
makes sound sense, compared to the more secure, safer and compliant generate documentation for regulators.
old-school approach where everybody software, all that has to be proven
was given access to everything. via documentation that is accessible Clearly, making sure that software
Controlling who has access to what to auditors and regulators. Creating is safe, secure and compliant is a
IP means that individuals are not a requirement traceability or trace multi-layered effort and is going to
exposed to risk, and should there be matrix is a common technique in require a lot of work. However, the
anyone with malicious intent on a design verification and validation volume of software in medical devices
team – for instance, to sell code – (V&V) and is often created using is only going to get larger and more
their opportunities are limited, or at popular office tools, such as word complex, so spending the time now to
the very least, easier to trace. processing and spreadsheets, which put in place the right steps means a
lend themselves well to external strong foundation for the future, one
Fine-grained access may be documentation. To prevent any that should not only keep regulators
possible to instigate quite simply, holes in the traceability process, it satisfied, but also help medical device
depending on the version control is important to create a matrix as firms stay competitive.
system at the heart of the development early as possible and to keep it up to
environment. Version control engines date. Given the scale and complexity
are a ubiquitous component of most of modern software development,
development projects, even relatively
small ones, and also create a single Gerhard
place to store code, large binary
files and digital assets. This enables
Krüger
everyone on a project to see the Gerhard Krüger is a Business Lead
development status at any one time, at Perforce Software. Since 2004
as well as have access to a historic Gerhard has been helping customers
record of who changed what, where, around the world implement
when and how. Sometimes referred Application Lifecycle Management
(ALM) and DevOps solutions. Gerhard
to as a ‘single source of truth’, this
is leveraging that experience in his role
makes it easy to roll back to a previous
as the Cloud Architect for Helix ALM.
version of the software (useful, when He holds numerous certifications,
dealing with a bug or other problem), including the Cisco Certified Network
to support compliance efforts, and to Professional Security (CCNP) and
engender a more collaborative working Certified ScrumMaster (CSM).
environment. As so many different

Patient-focused
drug delivery devices
Drug Delivery Devices

Innovative developments
Customized solutions
GMP customer IP manufacturing
www.nemera.net
[email protected]
Phone: +33 (0)4 74 94 06 54

MDR Preparations: The Final Leg
Typically, physical labels are created on ad-hoc manual processes for

Under the new EU Medical Device as templates and printed manually on ensuring that all ensuing output meets
Regulations, due to go live from May
the factory floor using data from ERP the new regulations consistently and
2020, new medical device identification
systems, while other customer-facing definitively.
and traceability measures will become
compulsory. Here, Kallik’s Bob Tilling
materials such as instructions for use
explores the issues that compliance (IFU) leaflets tend to come under the If the correct label is not fixed to the
preparations have thrown up for remit of separate teams, even external right product at the right time, products
manufacturers – particularly in relation design agencies in many cases. This will not have the required transparency
to global labelling management – disjointed approach does not lend as they move from factories, through
and consider how firms might now itself well to the kinds of controls the distribution, to the hospitals, doctors’
overcome these effectively so future EU is now imposing, which assume surgeries and pharmacies who supply
waves of regulatory changes aren’t as more systematic process coordination them, and the recipient patients.
disruptive. and content uniformity than that. Incidents like the PIP breast implant
scandal of 2009/2010, which triggered
From May 2020, new medical devices 2. Changes to Labelling Affect all of the new safety measures coming
sold in the EU must comply with the Everything through now, could still wreak havoc.
new Medical Device Regulation (MDR) The stringent new measures under This is what MDR is designed to avoid.
requirements, to improve product MDR/IVDR demand robust end-to-
traceability and patient safety. end product traceability, and that 3. Coordinated Control is Key
information is logged in a huge Manufacturers cannot hope to keep
Much has been written already central EU database, EUDAMED – a on top of product identification and
about the phasing in of MDR, and prerequisite for marketing medical traceability, or manage this with rigour
the in vitro device equivalent, IVDR, devices in European markets. This and efficiency, if they do not have
and how requirements and timelines in turn requires that products are clear visibility, control and systematic
apply to different categories of device. correctly labelled with specified safety coordination across everything
But how well have manufacturers information and symbols, and meet included on or with their products –
actually fared with the preparations requirements around electronic IFUs. through every channel, in every market.
for compliance? What lessons have So, devising a more defined strategy
they learnt? And what issues remain for enterprise labelling and artwork is In the final countdown to MDR
which, if addressed strategically, critical. compliance, there have been instances
could help them prepare better for of manufacturers panicking that the
next time the regulators drive through Device identification is a critical internal systems they have created to
new requirements? element in all of this. In the event of handle the new requirements are not
a safety scare and potential product up to the task. Although the responsible
1. Scoping Change: The Far Reaches recall, it is not enough for patients teams at these companies know what
of the Regulator and their medical consultants or they have to do, they have been unable
The first hard lesson medical device pharmacy outlets to know which type to overcome concerns about getting
manufacturers have had to get to grips of device has been affected. To limit the right labels out onto products and
with is just how demanding wholescale the damage, fear and hysteria, not to packaging – for instance, in scenarios
process change is, when regulators mention the cost to the manufacturer where manufacturing and distribution
are the instigators and deadlines for and the impact on their brand operations span locations in the Far
compliance are immovable. reputation, it is important that faulty East and US as well as Europe itself.
batches of product can be pinpointed
Up to now, compared to the and tracked down in the market, for It is finally dawning on these
adjacent pharmaceutical and biotech targeted remedial action. This in turn organisations that the only way to
sectors, the medical device industry depends on accurate, consistently ensure consistency and reliability is
has enjoyed more relaxed controls over reliable labelling. to have a single source of labelling
device identification and traceability, ‘truth’ that all market-facing product
and product lifecycle monitoring and Any change to labelling can threaten information and materials flow
reporting. This, added to the relative the quality and reliability of what’s from; one definitive place to update
size and scale of many of the firms issued, as even simple adjustments and check everything – which any
involved, has meant processes such can throw out the layout, leave a authorised team can access, anywhere
as global labelling management barcode partially missing, or obscure in the world, supported by appropriate
have not been seen as a board-level critical wording. So, it is imperative controls governing who can do what to
priority. that manufacturers aren’t still relying and with the content assets.

4. Process Harmonisation is Hard

Work, but Worth Striving For
Probably the biggest impact
MDR has had on medical device
manufacturers relates to the scale
of work involved. Many companies
drastically underestimated this, leaving
projects too late. Dispersed teams
and disjointed processes, as well as
inevitable duplication between content
sources such as translation databases
(for instance where these have existed
separately for label and IFU creation),
make for highly complex scenarios
that take time to unravel. That’s before
improvements can be implemented
to streamline and (where possible)
automate processes, such as change
management.
The danger where companies

have left MDR preparations until the
eleventh hour is that they are forced
by time pressures to do the minimum
required for compliance, even if that
is a costly workaround that doesn’t
deliver the quality control, compliance
confidence or process efficiencies the
manufacturer needs.
5. MDR Compliance is Not a One-off

Project applies for the most safety-sensitive – the industry and its products. Those
Another hard lesson is that regulatory Class III – devices; followed by Class II manufacturers that are seen to comply
disruptions are not a one-off event; or in 2023, then Class I items in May 2025. readily, even going the extra mile to
certainly they won’t be from now on. The UDI must appear in plain text give consumers the reassurances they
MDR will not be the only major global on all packaging parts of a product; need, will gain in market confidence
change to come the industry’s way, so be machine-readable; and include a around their brand. The desire for
companies that haven’t taken the time wealth of very specific information greater transparency, and consumer
to do things properly this time around under two different categories – a self-service (the ability to look up the
are likely to have to do it all again next device identifier (DI) and a production products prescribed to them), is not
time new requirements are introduced identifier (PI) – so there is a lot to get going to go away so the more that
– for example, product serialisation right in the coming months and years. manufacturers can do proactively to
on device labelling is likely to become satisfy this need, the better received
mandatory in the coming years. This is the first time in the medical their products will be.
device sector that changes to labels
Under MDR, everything from and IFUs have come at the same time, The immediate requirements of
bandages and crutches, to digital patient driving home to manufacturers just MDR are just part of this broader vision,
monitoring devices, contraceptive how inadequate some of their existing, and a sign of what’s to come.
implants, hearing aids and pacemakers, disconnected processes are. If they
will need to carry a unique device haven’t already, companies are likely to
identifier (UDI) on all of its labelling, review the extent of their inefficiencies
enabling rapid lookup in the event of and start working towards a common
an issue. approach to managing market-facing Bob
information, based on common
For the time being, manufacturers content and shared data, and more Tilling
marketing products in Europe only have joined-up ways of working. Bob Tilling is New Business
to provide UDI information to the EU Development Manager at Kallik, the
EUDAMED database, but starting from While the tasks that still remain may market-leading enterprise labelling
May 2021, unique product identifier sound onerous, it is worth companies company. www.kallik.com
codes/detailed product serialisation keeping in mind the bigger picture in all
information will have to appear on all of this, which is about ensuring patient Email: [email protected]
product labelling. The 2021 deadline safety and restoring public trust in

Drug Discovery, Development & Delivery
An Overview of Speaker Programmes and the Influence

of HCP Compensation
on a very local level – think hospital information across. Parties in charge of

Speaker programmes remain key in rounds – with 20 or fewer attendees. coordinating events now have the option
boosting the adoption of a drug. In recent In contrast, regional and international of going online, using webinars and video
years programmes have centred more
events may attract more than 100 chats to replace or supplement in-
on education rather than promotion of
a specific brand. This shift can largely attendees. Larger programmes often person events. Web-based engagements
be attributed to the scrutiny focused require a dedicated event space and provide convenience to HCPs in more
on the relationships between doctors the assistance of a third party. rural areas as well as those with
and life science companies. While this unorthodox schedules.
change has improved the healthcare Whereas speaker programmes
industry’s image, the compensation
traditionally take place in-person, While the content, frequency, medium
necessary to facilitate events has
drawn greater attention. Moreover,
modern speaker programmes also and size of speaker programmes depend
existing and developing regulations have alternative mediums for getting on a number of variables, the timing
surrounding healthcare provider (HCP)
compensation emphasise staying
compliant when contracting medical
professionals for their services.
What Do We Mean by ‘Speaker

Programmes’?
During the drug development and
commercialisation process, manufacturers
have opportunities to publicise their new
formulation or mechanism of action to
the greater medical community. One
option for accomplishing this goal
is funding and coordinating speaker
programmes. These events aim to engage
and inform HCPs about the value, risks
and usage of a drug. Speaking events
can also have a broader scope not as Figure 1: Company-Driven Medical Education Activity Start: Cumulative Percentage, by Product Type (2018)
closely tied to branded products.
The frequency of speaker programmes

in a product’s lifecycle varies a lot
depending on type. Large audience –
blockbuster – drugs typically warrant a
high number of speaking events because
of their wider need. Although less
common than in years prior, between 50
and 100 events per blockbuster product
are sponsored depending on market and
company size.
If a target patient population is

smaller, there will typically be fewer
speaker programmes – between 15
and 65 for a single product’s lifecycle.
The novelty of an orphan drug may,
however, increase that average.
Breakthrough developments can merit
more programmes for the purpose of
adequately educating practitioners.
Speaking engagements range widely Figure 2: Average Percentage of Marketing and Commercial Spend Allocated to Specific Activities, by Phase:
in size. Informal discussions can occur Launch Year to Second Year on Market (2015)

of when to initiate these programmes To further distance themselves according to factors associated with
is relatively standard. A Cutting Edge from any perceived influence, some speaker programmes. For instance, a
Information report from 2018 found companies use vendors to handle all keynote speaker will likely merit greater
that some surveyed companies start aspects of a programme. One way in compensation than non-keynote
working on speaker programmes as which this happens is independent speakers. An influential doctor will
early as Phase 3a. This work translates to medical education grants (IMEs). also garner higher payments than a
speaker recruitment, content evaluation, Coordination and content creation for less influential doctor. Geography,
searching for venues and a host of other IMEs are entirely vendors’ responsibility; company type and therapeutic area
activities. But as shown in Figure 1, the companies only provide financial are also key factors in tailoring speaker
majority of speaker programmes – in assistance. compensation.
this case, company-driven medical
education programmes – don’t begin Funding and organising non-branded Specialised vendors have even
in earnest until the registration/launch speaker programmes – company- emerged to help companies determine
phase.1 driven medical education events and acceptable HCP compensation levels.
IMEs – likely reduces the influence Some third parties now research
This was still the case in 20152. or bias that attending doctors may and develop payments for pharma
Another Cutting Edge Information show in their prescribing habits. But companies to implement and publish
report from that year shows a trend of this change only affects the content in government databases. A growing
increasing speaker programme funding and planning of speaking events. Life need for these types of vendors and
after launch year. As Figure 2 shows, science companies have also adjusted the adoption of fair market value
four per cent of survey participants’ how they compensate speakers for their (FMV) payments have become more
commercial and marketing spend went services. commonplace as more healthcare
to promotional speaker events during systems strive for transparency.
launch year. One and two years after The Question of Compensation
launch saw increases to 12% and 14% in Reimbursing a doctor for speaking at Payment Transparency Now and
the respective spend allocated to these an engagement or for training another Going Forward
engagements. speaker is a normal practice. Fiscal As mentioned, the Sunshine Act
remuneration is warranted if a physician was technically the first of its kind;
Shifting from Slightly Promotional to is taking time off from their current Australia has had rules prompting
Overtly Educational practice to provide a service. Before the pharma companies to disclose their
Despite the mention of commercial and enactment of the Physician Payments HCP payments since 20074. However,
marketing spend in Figure 2, speaker Sunshine Act, life science companies these regulations were developed and
programmes have become more could pay doctors whatever they deemed implemented by an industry body and not
educational than promotional in recent necessary for a particular engagement. by the Australian government. Medicines
years. Other avenues for HCPs and But this process was another perceived Australia acts as a representative for
pharma companies to engage have also avenue for companies to influence the Australian pharmaceutical industry
taken a less commercial tone. The shift prescribing habits. For example, a and introduced another version of the
took place largely because of scrutiny doctor might be prone to write more Sunshine Act in a revamped code of
over the perceived influence pharma prescriptions for a certain brand if they ethics in 2015.
companies have on doctors’ prescribing were paid at a higher than normal rate
habits. for speaking at an event. Trade group enforcement of
transparency is common in a number
New methods and language have Hypothetical and actual instances of of major markets. For instance, the
been introduced across the life sciences kickbacks tied to speaker programmes Japan Pharmaceutical Manufacturers
industry to emphasise the shift from were a large reason for the US’s Association (JPMA) released a revised
commercial to educational. Speaker implementation of the Sunshine Act version of its transparency guidelines in
programmes still provide value to in 2010. Technically the first of its 20185. Switzerland also has transparency
doctors and pharma, and these changes kind, this landmark piece of legislation rules created by an industry group.
help to ensure that speaking events requires pharma companies to disclose Science Industries Switzerland issued
remain part of the dynamic. Terms such in a public database the dollar amount its revised Pharma Cooperation Code in
as “company-driven”, “unaccredited”, or rendered for any service provided by 2013, which contained instructions on
“company-sponsored medical education an HCP3. This database – housed on a disclosing payments made to HCPs6.
event” have replaced “promotional CMS-run website – produced the first
engagement”. Centring a programme report on US pharma’s fiscal relationship Possibly the largest trade group in
on a brand or specific product doesn’t with doctors in 2014. healthcare, the European Federation
benefit today’s HCP. Instead, informing of Pharmaceutical Industries and
HCPs about new or emerging disease While companies still decide on Associations (EFPIA) represents pharma
states as well as larger trends within an HCP’s compensation amount, trade associations across the EU and
the healthcare landscape promotes making these payments public has the companies that operate within
greater engagement. It also diminishes made them adapt. To avoid Food and them. Because of its scope, the EFPIA’s
perceived influence over doctors’ Drug Administration (FDA) criticism, transparency code had a large impact
prescribing habits. companies have tailored their payments when implemented in 20157.

Federal “Sunshine” acts are developing focus, speaker programmes are still Cooperation Code 5-15 (2013).
outside the US as well. The Canadian key in bringing a product to market as https://en.scienceindustries.ch/
province of Ontario, for example, created well as engaging the greater medical involvement/pharma-code-and-
pharma-cooperation-code. Visited 20
its Health Care Payment Transparency community. Regulations governing
November 2019.
Act in 2017, but has yet to vote it into pharma transparency are impacting 7. European Federation of Pharmaceutical
action8. British Columbia has also speaker programmes more and more. Industries and Associations. The EFPIA
considered implementing its own Traditional factors associated with Disclosure Code: Your Questions
pharma transparency laws and is still speaker programmes – size, product type Answered, 3 (2015). https://www.efpia.
in the development stage. etc. – have become less influential as a eu/media/25183/the-efpia-disclosure-
code-your-questions-answered.pdf.
result. Compliance concerns stemming
Visited 20 November 2019.
The above examples of international from HCP remuneration have now taken 8. Government of Ontario. Health Sector
transparency laws contain several an equally, if not more, important place Payment Transparency Act (2017).
similarities. Most important, perhaps, when coordinating these events and https://www.ontario.ca/laws/statute/
is that all of these regulations require may continue to do so if transparency 17h25?_ga=2.241772162.1207382374.
documentation of payments followed by regulations become more common. 1519319126-1391897216.1519319126.
disclosure in a database. Some contrasts Visited 20 November 2019.
are apparent, though. Transparency codes REFERENCES
from multiple locations often contain
different thresholds and classifications 1. Cutting Edge Information. Coordinating
for what constitutes a payment, so the Company Driven Medical Education
Programs (2018) Todd
content of documentation varies by
2. Cutting Edge Information. Pharmaceutical
transparency code. Commercialization Profiles (2015) Middleton
3. US Congress. S.301 — 111th Congress
It is clear that the past ten years have (2009-2010). https://www.congress. Todd Middleton is a Sr. Data Analyst
seen huge growth in the commitment gov/bill/111th-congress/senate- at Cutting Edge Information, LLC.
to compensation transparency bill/301. Visited 20 November 2019. Located in Research Triangle Park,
between pharma and the countries in 4. Medicines Australia. Code of Conduct North Carolina, the company
Edition 18, 68-73(2015). https:// specialises in collecting and analysing
which they operate. Other major and
medicinesaustralia.com.au/wp- global FMV data to provide the most
emerging markets will likely follow their content/uploads/sites/52/2010/ accurate FMV rates on the market.
counterparts in this trend. And, if this 01/20150617-PUB-Code-Edition-18-
Todd has been an employee at
holds true, HCP compensation won’t be FINAL.pdf. Visited 20 November 2019.
Cutting Edge Information, LLC for
the last consideration when coordinating 5. Japan Pharmaceutical Manufacturers
Association. Transparency Guideline for the
two years. He attended the College
a speaker programme, but the first. of Charleston, where he acquired a
Relation between Corporate Activities and
Medical Institutions (2018). http://www. Bachelor of Science in international
Current pharmaceutical speaker business administration.
jpma.or.jp/english/policies_guidelines/pdf/
programmes have a considerably transparency_gl_intro_2018.pdf. Visited 20
educational tone with little mention of November 2019. Email: [email protected]
specific brands. Despite their educational 6. Science Industries Switzerland. Pharma

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Clinical and Medical Research
How Pharma Companies Can Improve Patient

Engagement
The patient journey consists of inefficiencies with the same begrudging

In today’s world, people are constantly the obvious check-points from early acceptance of previous generations.”
on the go and rushing from one place
education and awareness, to physician In fact, Dr Ron Rowes, chief medical
to another in between work, school and
taking care of their families. The art of interaction, appointment follow-ups officer of Prominence Health Plan,
multi-tasking has become a way of life, and reminders for continued care also recognised the challenge of
all of which is now dependent upon and medication adherence. If the meeting expectations of millennials
digital capabilities to make it possible. healthcare industry as a whole wants and said, “They’re used to reaching
However, what happens when a chronic to improve the patient experience, out when they need something, getting
condition is thrown into the mix, or
then the industry needs to prioritise instant gratification, moving on and
even the need to incorporate multiple
medications? Life doesn’t stop, and so
the other support incorporated into a only coming back when they have
the art of multi-tasking and managing patient’s routine to address challenges, the need again.” This is exactly where
one’s chronic condition intensifies. such as receiving the first prescription technology, especially mobile apps
Engaging patients in medication fill with insurance coverage or correctly and voice assistants, can be useful
management is not a simple task and administering an injection to stay on tools that help ensure patients feel
empowering patients to control complex course. In the US alone, medication supported throughout their journey.
regimes is even more difficult without
mismanagement is a $300 billion Millennials are not the only generation
the right tools. Patients who are more
informed about their health conditions problem that requires continual patient using technology to manage their
and more involved in their treatment support. patient journeys. According to American
decisions demonstrate better results Healthcare consumers have become Association of Retired Persons (AARP)
through increased adherence rates and more willing to turn to technology to research, seven out of 10 baby boomers
extended persistency. support their needs and even share own a smartphone. Baby boomers are
their data in order to improve their using technology to stay connected
How to Help Manage a Patient patient experience. The 2018 Deloitte with family and friends, and, in the
Journey Healthcare Consumer Survey analysed case of emergencies, this generation
There are several ways to empower trends of healthcare consumers and finds a peace of mind knowing they can
patients and support them across their willingness to engage and share receive assistance as fast as possible
their journey. As an industry, healthcare healthcare data, and according to the through a few clicks of their mobile
has pretty much failed to support and five-year study, by 2018, over 42% devices. Understanding how the baby
engage patients with modern-day of healthcare consumers surveyed boomer generation is using technology
expectations. A study conducted by GE reported that they would use technology can help healthcare companies design
Healthcare Partners found that “81 per for health improvement, which is up impactful online experiences that
cent of consumers are unsatisfied with from only 17% in 2013. Furthermore, support this generation’s healthcare
their healthcare experience – and the the study found that over 50% of journey needs. In the instance of
less they interact with the system, the patients managing chronic diseases medication adherence, adding features
happier they are.” For many patients, were willing to share their data with to applications that allow baby boomers
healthcare interactions may appear doctors to help provide better care and to invite friends and family into their
impersonal during a very sensitive time create alerts for themselves and family journey for support can significantly
of their life, especially when compared members if their health was in danger, improve the patient journey.
to a consumer’s other experiences. in addition to sharing healthcare data Furthermore, medication mana-
In most other industries, consumers with emergency services. gement users over the age of 65
have personalised experiences – from The healthcare industry must look to have higher engagement than their
ordering their daily coffee to online engage consumers in ways that meet counterparts under 65. Although those
banking through mobile applications. healthcare consumers’ expectations. For over the age of 65 juggle on average
But when consumers have to interact example, it’s important for healthcare 7.1 medications versus 4.5 medications
with healthcare, such as going to a providers and pharma to understand of those under 65, the baby boomers
doctor or speaking with a pharmacist, that the millennial generation, the report even higher adherence rates.
they may notice a significant lack of future generation aging into healthcare Given these statistics, it’s essential that
personalisation and convenience that needs, expects instant gratification. the entire health system recognises
they are used to receiving from other According to Kathy Hempstead, director the technology demands to provide
industries. Patients need support of insurance coverage for the Robert personalised journeys that are targeted
outside of their scheduled appointments Woods Johnson Foundation, “As more for each individual patient, in real time.
and therefore critical points of millennials interact with the healthcare
engagement and empowerment arise system, the industry will find itself Benefits of Digital Health Technology
during patients’ daily routines, which facing a more sophisticated and The emergence of digital health
are the moments of impact. demanding group that won’t stand for technology is impacting health

Clinical and Medical Research
outcomes. Digital health technology is to empower chronic disease patients patients with chronic complex
the convergence of computing power, across three complex therapeutic areas conditions is continual support and
connectivity, sensors, and software (cardiology, diabetes and thyroid). The personalised, targeted interventions.
used in healthcare that can be used pharmaceutical company wanted Digital drug companions provide
as a medical product, incorporated into to help patients better manage their continual support to patients through
a medical or pharmacologic product, conditions, particularly focusing on both therapeutically designed AI, and
used to develop a medical product, medication management, education a direct connection into care teams
used to study a medical product, or and convenient refill. at critical times. These programmes
used as a companion or adjunct to a The global pharmaceutical company deliver results but require real-world
medical product including diagnostics and their partner developed digital data to inform digital designs that
and therapeutics. With the evolution of programmes targeting diabetes, thyroid deliver personalisation and ultimately
technology in healthcare, the industry is and cardiovascular patients covering outcomes.
forced to open itself to alternative ways over 30 different brands across three Having a digital therapeutics solution
to treat or augment treatment with countries. Through these programmes, to accompany the drug used to be a
digital connectivity. Some examples patients received daily support ‘nice-to-have’. In the future, patients,
of the evolution of personalised and connectivity to their specific payors and providers will expect a
technology tools include wearables medication dosing and condition needs. digital solution to manage the patient
and using DNA sequencing to help Personalised medication reminders journey – and a digital therapeutics
physicians assess the likelihood of a provided transparency into complex companion is now the table stakes in
patient developing diseases, detecting dosing schedules which were shared 2020. Healthcare consumers expect
diseases earlies and intervening to with caregivers and later with HCPs. digital support to manage complexities,
minimise the impact. The customised programmes also especially when left to their own
Real-time data that interacts included condition-specific and/or devices to manage.
with patients in their everyday lives lifestyle content targeted to patients at
is another benefit of digital health appropriate phases of their treatment
technology. In today’s world, technology journey.
with customised programmes can The personalised content supported
provide pharma companies and health patients to make lifestyle and
systems with real-time data insights behavioural modifications and included
that allow these pharma companies disease and medication information,
or providers to intervene and help healthy lifestyle tips, caregiver support,
patients manage their complicated and trackers for measurements of
condition. Not only can technology several health indicators visible only
intervene at critical moments to to the patients. The customised digital
pre-empt an exacerbated condition but medication management programmes
monitoring and understanding medical provided patients with tremendous
behaviours also provides crucial pieces peace of mind and empowered them
of insight, such as dosage scheduling or to carry on with their daily routines.
reasons for skipping medications. This Within five months, customised
real-world data helps to inform better programmes achieved an average
support and education across the adherence of 83%, with 73% of
patient healthcare journey to ultimately patients rating their experience as very
deliver the desired outcomes. to extremely satisfied. Furthermore,
the results reinforce the benefits of
Personalised Programmes improving patient engagement and
Empowering Patients how it can positively impact health
Pharmaceutical companies are quickly outcomes.
evolving to create personalised support
for patients by powering data science The Future of Patient Engagement
Today we live in a world of technology Omri
and digital technologies capabilities. In
and strive towards personalisation Shor
fact, the Chief Digital Officer role and
in medicine. What’s needed to help
department is now more common and
working closely with companies to Omri is the CEO & co-founder
of Medisafe. He was inspired to
Adherence Lift of 8–20% in Just Five Months
support building a patient experience
create Medisafe after his diabetic
with the brand.
father accidentally double-dosed
In 2018, a top global pharmaceutical on insulin. Tapping into his
company that is committed to leveraging considerable entrepreneurship
innovative digital technologies that can experience, Omri successfully
support patients in their day-to-day grew Medisafe into the leading
activities, thus maximising treatment medication management platform
outcomes and reducing the burden with over 5 million users worldwide.
of the disease, prioritised the need

Technology
Data Inputs for Medical Intervention Valuations
inputs and their use in the published products and then using this to estimate
Abstract model. This article should be read in the value of the product. The maximum
Positive net present value (NPV)
conjunction with our previous article. reimbursable price and early-stage
calculation on any product in
development is a good indication that health economic models seem best
upon market release, the financial It is well known that a positive net suited when a product is already on
return will exceed the cumulative life present value (NPV) calculation on the market for one disease, and drug
cycle costs of research, development, any product in development is a good repositioning is being considered as a
market validation, market access, indication that upon market release, way to increase revenues, without high
market release, manufacture and sales the financial return will exceed the development cost and risk. For earlier-
and therefore potentially justify the
initial outlay; this is summarised as
cumulative life cycle costs of research, stage considerations, however, and
return on investment (ROI). development, market validation, market accounting for the perspective of either
access, market release, manufacture startup companies or early-stage R&D
Despite this market reality, rNPVs and sales and therefore potentially in larger companies, the calculation
on projects and portfolios at the justify the initial outlay; this is does not include previous risks and
startup stage for healthcare-focused summarised as return on investment costs.
endeavours are communicated either
(ROI). In healthcare and particularly
publicly or privately that greatly exceed
what is actually happening in the therapeutic intervention, development Regarding costing, there have been
marketplace, which suggests that the takes a long time of typically over 14 many studies performed since 1979
data being used in rNPV calculations years (FDA 2016; Stewart et al. 2018), on the costs of bringing a drug to
may be incorrect. and is costly (up to $2.6bn, (DiMasi et al. market (these studies have been neatly
2016)) which means that significant risk summarised in Mestre-Ferrandiz et al.
We previously reported the development has to be carried for a long duration 2012), however the costing indicated in
of a novel valuation model for medical
before knowing if the product was each referenced study did not include
intervention development in this journal
(Dando and Lebmeier 2019). worth the investment. current clinical data requirements of
review and reimbursement agencies,
This article expands on our previous Despite this market reality, rNPVs post-market release costs such as
article, providing more detail on data on projects and portfolios at the manufacturing, sales and general
inputs and their use in our previously startup stage for healthcare-focused expenses, and continued clinical trials,
published model. Here we describe
endeavours are communicated either all of which need to be paid for from
inputs derived from published literature,
especially probabilities, market size, publicly or privately that greatly exceed the drug revenues.
costs and risk – and success rates what is actually happening in the
including reimbursement by payers and marketplace, which suggests that the In recent years, several teams
their use to model rNPVs. data being used in rNPV calculations have reassessed the NPV estimation
may be incorrect, and there is a models: Svennebring and Wikberg
Our work highlights the necessity to disconnect between stakeholders, (2013) proposed extensions to the
identify the true value of the innovation
that has serious ramifications for when existing model that included constant
and the influencing factors that should
be taken during the whole development an early-stage company attempts to probability rates of finding a drug
cycle from discovery to market release, out-license its innovation to a larger candidate, a dynamic probability tree
and the risks associated with not doing organisation. for cumulative identification of new
this. candidates and that more than one
Methods compound can be selected for clinical
This article should be read in conjunction
The understood fallibilities of rNPV development. Real option-based
with our previous article.
calculations have led to the development valuations have also been proposed
Key words: Innovation management, of new valuation models, such as the which are founded more in managerial
valuation modelling, inverse modelling, headroom method that determines the flexibility and strategic value, while an
risk rates, reimbursement, return on maximum reimbursable price (Cosh effectuation model which integrates
investment 2007; Girling 2015; Markiewicz 2016), means, loss, partnerships and expecting
early-stage health economic models the unexpected can be used to identify
Introduction (Retel 2013; Brandes 2015; Miguel-Cases value differences between pipelines.
We previously reported the development 2015) which only study interventions
of a novel valuation model for medical ready for clinical trials or market launch, However, there are still several
intervention development in this or multi-criteria decision analysis underlying issues pertinent to
journal (Dando and Lebmeier 2019). (Thokala 2016; Middelkamp 2016) which generating an effective valuation:
This article expands on our previous is based on collecting feedback from Zizlavsky (2014) highlighted that one
article, providing more detail on data stakeholders based on hypothetical of the fundamental problems in NPV

Technology
approaches is that average probabilities There is also a lack of robust Research Question
of success or occurrence occur, when in peer-reviewed publications linking There is a certain level of ‘value over-
reality indication-specific probabilities pricing and reimbursement (P&R) optimism’ of early-stage innovations,
should be used. procedures outcomes such as health specifically those performed in
technology assessments (HTAs) with startup companies, based on the
While many authors (Rottgen 2018; the development stage values of incorrect perception that later-stage
Stewart et al. 2018) have indicated medical interventions using relative stakeholders, such as larger pharma-
that failure to include the total costs negative predictive value (rNPV) ceutical and biopharmaceutical
in their calculations can result in financial model valuation-based companies, are innovation stale, a
incorrect estimates. Fundamentally, the methods: yet the outcomes of the perspective also indicated in the rpNPV
issue is that full economic costing of P&R and HTAs define the terminal model (Walker et al. 2015). However, this
development is not used in early-stage market value of the intervention, is contradicted by reviewing pharma
value calculations. A risk-profiled NPV which by definition directly informs and biopharmaceutical company
model (rpNPV) did attempt to integrate the rNPV of the intervention in pipelines that perform valuations
in more market-related variables development at any given stage. that typically include all the pertinent
(Walker et al. 2015); this was the closest There is an emerging use of early market dynamics.
model that attempted to integrate health technology assessment
full economic costs. However, the (Ijzerman et al. 2017), which defines We wanted to know how and
model was using generic rather than ‘early HTA’ as assessment “of medical why this happens and also chose to
indication-specific variables, such as products just before and also at the reverse-model how up-to-date and
very long clinical trial phases, and did early stages of clinical use” and that complete market realities based on
not consider SAM and SOM (serviceable the outcomes can be used to manage publicly available sales revenues, when
accessible market [SAM] geography risk in technology portfolios and their integrated into the rNPV calculation,
differentiated market value) and market application. influence early valuation calculations
serviceable obtainable market (SOM
(percent of market penetrance that
can be achieved within a serviceable
accessible market)), as a function
of terminal market value related to
existing standards of care upon which
decisions to reimburse are made.
From our experience, many small

to medium companies in the field still
have incomplete perspectives of the full
market chain and pharma marketplace,
especially in the link between regulatory
approval and reimbursement and what
the priorities of larger entities are. The
general understanding is that the two
are synonymous, when in reality they
are not. Petersdorf and Kanavos (2015)
succinctly summarised this as follows:
“HTA agencies operate within a network
of other healthcare actors that, together,
determine whether a medicine is allowed
to enter a market, who receives the
medicine, and who pays for therapies.
Regulator bodies such as the European
Medicines Agency’s (EMA) Committee
for Medicinal Products for Human Use
are responsible for assessing drugs
on their efficacy and safety. Approval
is required from these agencies to
receive market authorisation. National or
regional bodies then negotiate with the
manufacturer (or the drug wholesaler)
on drug price, reimbursement status
(as in specifically for what based on
evidence-based medicine) and allocated
Stage specific rNPV calculations for the four modelled interventions, using generic success rates comparing
funding. HTA bodies inform these three abbreviated or full high and low costs, and indication specific success rates comparing abbreviated or
latter considerations.” full high and low costs

Technology
indications, modelling both biologics and

chemical entities. For cardiovascular
we modelled chemical entities for
hypertension and biologics for anti-
coagulants, while for endocrinology
we modelled chemical entities for
non-insulin drugs and biologics for
insulin-related drugs. Information on
market sizes was obtained from the
following sources. For each modelling
Clinical trial rates for CVD vs generic ROI: Phase III clinical trial success we elected to compare the lowest and
rates have increased, but this has not been reflected in the ROI
highest markets to provide the limits of
accounting for the various different regulatory perspective, clinical data valuation calculations.
data inputs. generated in one geographic block
or free trade area is not necessarily To model SOM values, we
This was enabled by two recent accepted in another, necessitating obtained information on the top ten
studies published in 2018 (Thomas further development costs (Van antihypertensive drugs being sold in
et al. n.d.; Wong, Siah and Lo 2018), Norman 2016). Each geographic area the United Kingdom from Statista
that has included indication-specific has its own specific health technology (Statista, 2018) and converted these
statistics and clinical success transition assessment requirement, with different figures into market penetrance values,
probabilities, based on the analysis of constraints. This means that the which were then used to calculate the
large sets of historical data, permitting intervention evaluation procedures various terminal values that should be
us to use as detailed and up-to-date during later-stage clinical validations inserted into the rNPV calculations.
data as possible. Success rates are are regulatorily different. Values ranged from 0.62% to 40% of
used for the probability adjustments the market share, and we modelled
in rNPV valuations (Villiger n.d.; Given that the ROI on drug terminal market values ranging from
Booth 2011; Booth 2014; Dillon 2015; development is below the WACC, the 1% to 100%. The same hypothetical
Drummond 2013), and based on our implication is that the market-related per cent market shares were used for
experiences from working throughout outcomes of P&R procedures and modelling in all other indications and
the value chain (Salas M. et al. 2009; HTAs play a critical role in defining if interventions described.
Larkin J. et al. 2015; Dando 2017; a health technology has any market
Dando & Weiss 2013) with the whole viability. Indeed, as Villiger and Bogdan Full Development Costs vs. Abbreviated
spectrum of stakeholders, we identified (2006) reported, “People want a drug Costs (High and Low Versions)
several key factors that needed to be to be valued to predict whether it will For development costs we used three
integrated into the calculation, which make money. However, valuation only different sources of information from
would possibly provide more realistic calculates the odds. The value tells you DiMasi (DiMasi et al. 2016), Booth (Booth
indicators of value. whether it is worthwhile to risk the bet 2011; Booth 2014) or Sertkaya (Sertkaya
and how much you should bet, but it et al. 2014). DiMasi’s estimates include
One key aspect was the link of does not tell you whether you are going the costs of failure (out of pocket
HTA-indicated benefits and perceived to win.” costs) therefore representing the high
terminal market values, which at cost threshold, although we did not
present seem to be based on total Market Size include capitalisation-related costs as
accessible market, i.e. the global market, To perform this study, we chose to focus there is still debate on this point, and
yet HTA decisions are geographically on cardiovascular and endocrinological capitalisation costs are entity-specific,
constrained. The importance, therefore,
is what the values that are reported in
market analyses correspond to, which
are: The total sales in the precise
geographic market where those sales
will occur based on clinical outputs on
a defined population.
Market values are typically reported

by indication or specific disease
application, which falls within the group
of diseases linked to the indication,
while total global market values are
reported with percentage by geographic
area. Geographic areas typically are the
USA, Europe and Asia-Pacific (APAC),
however for an HTA evaluation, and rNPV calculations for the four interventions using indication specific FEC high and low costs and phase
a medical intervention development specific cumulative progressive success rate.

Technology
while Sertkaya’s costs represent a more

critical path costing, and therefore
represent the lowest cost threshold.
Neither team provided information on
discovery or preclinical work, therefore
we combined these peer-reviewed
assessments with Booth’s professional
experience of discovery and preclinical
costs to generate two costing models:
low and high cost estimates in either
an abbreviated (historically used values)
or a full economic cost (FEC) value
including all costs. Additionally, the
preclinical development of biologics has
been reported to be 1.45 times higher
than for chemical entities, while clinical
translation costs are similar (Mestre-
Ferrandiz et al. 2012), which have also
been included in the input values.
For an effective assessment of the

HTA dossier, entities responsible for
reimbursement perform meta-analyses
and systematic reviews, in which,
providing the clinical trial has been
implemented correctly, the new
intervention is compared to the
existing standard of care. To be able
to prove that the new intervention is
comparable or better than the existing
standard of care, for major diseases,
large and well-designed Phase III trials
generating robust and meaningful data
for reimbursement decision-makers are
required to obtain reimbursement and
market access enabling sales.
To submit a reimbursement
dossier without sufficient, robust
and meaningful clinical evidence
leads to a very high risk of not getting
reimbursement, and two trials would
be the minimum. Assessment of
leading drugs on the market and their
clinical validation steps, this may still
be an underestimate. Successful
interventions launched globally have
revealed that typically more than
10 Phase III clinical trials in different
geographies are typically required
for sufficient clinical evidence to be
obtained.
There is the registration cost

and at the stage of market release,
there is also the manufacturing cost
of the intervention, which has two
components: the facility and the
actual therapeutic manufacture.
Manufacturing a biologic requires a
dedicated facility, costing on average
$350mn, without considering running SOM rNPVs for each market using real world data potential market share (numbers in millions of USD)

Technology
costs, while a chemical entity

manufacturing facility costs on average
$65mn. Actual manufacture of the
pre-launch phase has been estimated
to reach 30% of the costs of sales
(Basu et al. 2008); for the purpose of
generating the most optimistic possible
rNPV, we elected to use the lowest
possible value for manufacturing.
Higher downstream costs (scaled-

up manufacturing, continued clinical
studies) for the later stages were not
included for rNPV calculations, which
would have to be done on an intervention-
by-intervention basis depending on
the outcomes of the original clinical
trials and recommendations of the
reimbursing agencies.
Success Rates
We used information from the
latest publications (Wong, Siah & Lo
2018; Thomas, n.d.) reported in the
supplement to the article, which
contains 11 years of data from 2005 to
2015, related to multiple indications
and the success rate transitions from
Phase I to Phase III of the clinical trial.
We averaged all 11 years of success-
rate data by phase for cardiovascular or
endocrinological/metabolic indications
and used this as the ‘success rate’ for
the pertinent indication.
Results
Modelling the rNPVs
We first set out to determine the
impact on output valuations when
the full economic cost (FEC) or the
abbreviated cost of development were
used in the SAM. Using just the USA as
the SAM market example, the high costs
were compared to the low costs using
generic success rates for four potential
interventions; biologics treatment for
cardiac-related disease, biologics
treatment for diabetic-linked diseases,
chemical entity-based treatment
for cardiac-related disease, and
chemical-entity based treatment for
diabetic-linked diseases. As expected,
independent of the disease indication
or application, using FEC resulted in
a reduced rNPV value along the value
chain. On average and independent of
clinical phase, rNPVs were $49 million
dollars higher between abbreviated
low costs and FEC low costs, and
$71 million dollars higher between
abbreviated high costs and FEC high
SOM rNPV for each market with Dynamic Risk Rate application (values indicated in $mn) costs. The implication being clear that

Technology
whether your costs are critical-path we have researched these aspects Discussion
or encompassing total out of pocket, and reflected them against our own The rNPV outcomes obtained by
reducing costs will increase the rNPV. experience conducting and advising on using the full economic costs of the
When comparing phase by phase, rNPVs HTAs in these jurisdictions to inform development that would be incurred
for abbreviated costs were on average our analyses presented in this article. by either one stakeholder performing
$10.5 million higher for both Phases We especially considered robustness, everything in-house, or through
II and III compared to the FEC, while relevance and meaningfulness of the multiple stakeholders transferring
Phase 1 rNPVs for abbreviated costs underlying data as the overlapping the technology upstream to a more
were $36 million higher, implying that areas for HTA decision-making in our relevant stakeholder versus abbreviated
increasing the cost-effectiveness of work. For this we considered published costs were dramatic, and if based on
the early-stage R&D will have a greater sources as well as our own experience. using accepted ‘generic’ values go
impact on longer-term value. As the work we present in this article some way to explaining why the ROI
is a novel approach and has not been on drug development is so low. Drugs
When we integrated into the rNPV done before, we firmly believe this to reach the market where competing
calculations the latest indication- be a robust approach to this decision products drastically diminish the value
specific success rates, the impact analysis. of the innovation’s applicability. This
was more dramatic. At a Phase II level, was further impacted by geographic
using indication-specific success rates, Taking the perspective of an separation into SAMs and further still
on average a $180 million decrease in early-stage company, considering when the simulation included real world
rNPV was observed, while at the Phase moving forward one of its compounds market penetration of interventions, in
III level, the average decrease was in which alternative interventions would which there are multiple reimbursable
$507 million (averaging was performed represent the competing products with interventions available. This would
across indication and therapeutic different market shares, we modelled mean that all portfolios would need to
approach. The critical importance how the estimated ‘market penetrance be re-evaluated to assess true value,
and ramifications of this are further by percentage’ would further influence and then tied into the company’s
explored in the real-world modelling). the rNPV (It should be noted that the logistical capacities, implementation
100% value indicated in these tables approaches and strategies, and
As the FEC high and FEC low corresponds to the SAM value). Taking partnering possibilities to try to
corresponded to the total value chain into consideration that pre-Phase maximise value.
costs up to the first two years of market I would involve spending anything
release, and indication-specific success from $18 million to $250 million, it The use of a harmonised risk value
rates arguably provide a more accurate became clear that any intervention, inside the calculation would go a long
analysis, all subsequent simulations for whatever rationale, would need way to informing all stakeholders, and
were performed using these values, to obtain greater than 15% market while the IRR is standard, because its
comparing the USA and European share to be worthwhile, with the estimation is company-specific this can
markets. lower market share only potentially change significantly. We have proposed
making returns in the long term, with a one alternative; it is clearly more
The next simulation was to integrate potential to reposition the intervention realistic than existing risk rates when
in level of local market penetrance, or in alternative diseases in the same put into the context of real-world data
SOM. In healthcare interventions, SOM indication to increase revenue. This was but further modelling using as many
is determined by the existing standard the same for all disease/intervention different real-world examples, including
of care, the outcomes of the clinical type combinations. As rNPVs are from licensing deals, would inform the
trials, how convincing the clinical data additive, for early-stage entities utility of its application.
is compared to the null hypothesis and planning intervention development it
the potential pricing. Much of this forms also raises the strategic necessity of From the initial development of our
part of pricing and reimbursement internationalising as early as possible: model using the inputs and calculations
decision-making through procedures while it is tempting to establish foreign described here, we are constantly
like HTAs, which can therefore influence subsidiaries to access markets, this can updating the model and its inputs with
the pricing. HTAs are nowadays well be expensive, and for an early-stage further up-to-date data and product-
established not only in traditional HTA company, longer-term strategies of and company-specific information to
markets like the United Kingdom, but joint development and partnering reflect up-to-date market realities
also elsewhere like other European will potentially create future value providing true real-world valuations.
markets and in the United States, when a more local-based perspective
Canada and Asia, and it is gaining would not. It also addresses the Conclusion
further global momentum. Whilst importance of above regarding HTA’s The resulting necessity to identify the
processes and methods may differ and reimbursement decisions taken true value of the innovation and the
from one jurisdiction to another, the in trading blocks such as Europe, in influencing factors indicates several
basic principles of the data used being that one country may make a different approaches that should be taken
relevant and meaningful to decision- decision to another, irrespective of the during the whole development cycle.
makers and the value proposition being transferability of the HTA requirements, With an eye on the end goal and what
robust and able to be substantiated and market penetrance modelling is driving reimbursement, clinical
remains across jurisdictions. Therefore, needs to be performed in some detail. development programmes, especially

Technology
collaborations. Global Virtual Conference-

Business Management (1) p34-40.
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revenue generating medical interventions.
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drugs-dispensed-for-hypertension-and- http://www.avance.ch/newsletter/docs/

Technology
Lab of The Future – Getting the IT foundation in Place

Before the Hype Kicks In
management system (LIMS) throughout the years and have high

Many laboratories are currently • Scientific data management life cycle maintenance costs. Some
embarking on a digital journey
system (SDMS) laboratories need to consider
and buzzwords such as artificial
intelligence (AI), machine/deep • Chromatography data system replacing their legacy LIMS and
learning (ML/DL), virtual/augmented (CDS) ELN systems in order to lower the
reality (VR/AR), internet of things (IoT), • Laboratory execution system maintenance costs and enable new
lab of the future (LoTF), and last but (LES) features that are more aligned with
not least, data standardisation with their digital strategy (e.g. automated
contributors like Allotrope foundation
Depending on the type of laboratory workflows, integrations etc.).
and SiLA are frequently mentioned
in articles and white papers and at
and IT maturity, these applications • Some laboratories choose to
conferences. But the reality is that constitute a fundamental part of the postpone and delay application
many laboratories are still highly IT landscape in laboratories together upgrades, which increases the
paper-based. They are missing with the scientific instruments. complexity of the upgrade and
essential laboratory applications in makes it even more cumbersome.
their IT landscape and are working In recent years, the vision of a • Most laboratories consider
with their existing applications
unified platform accommodating the embarking on the cloud journey to
as “paper on glass” thereby not
harvesting the envisioned benefits. capabilities of multiple laboratory ensure scalability and accommodate
Furthermore, many laboratories are applications has grown2. Several increasing global dispersity, but
struggling with maintaining their highly application vendors are moving in are reluctant to do so due to data
customised legacy applications and that direction even though they clearly security considerations.
have not yet integrated applications are strongest within their original
and instruments to ensure smooth
application and domain area1. Build a Laboratory IT Architecture
data exchange and structured data
Vision & Strategy
capture.
Challenges with Laboratory In order to realise digital initiatives
Informatics and move towards LoTF, it is essential
Introduction to the Laboratory IT It can be highly cumbersome for scientists that laboratories scrutinise their
Landscape to navigate and access data as it is often current application landscape and
The nature of the IT landscape in buried within silo-based applications challenge the underlying architecture.
laboratories is rather complex, with and stand-alone instruments. It is Understanding the current architectural
multiple vendors providing both often said that it is easier for scientists setup and which gaps to close will
instruments and applications across to repeat an experiment than it is to provide the building blocks of the
different industries (biotechnology, locate data from a previous experiment. architecture roadmap.
pharmaceuticals, forensics, food & Many laboratories address this issue
beverage, oil & gas, cosmetics etc.). by introducing the FAIR principles into Do we have an architecture vision,
Laboratory informatics applications their IT architecture and application strategy and roadmap in place? The
have different, but often overlapping, landscape. architectural roadmap should tie
capabilities. In the pharmaceutical together with the overall vision of LoTF
and biotech industry, laboratory Some of the common challenges and link to the company’s business
informatics applications are used that laboratories are facing with strategy.
throughout research, development regard to their laboratory informatics
and manufacturing. There are different application landscape are: For example: if the business strategy
needs in the individual laboratories is focusing on increasing operational
within an organisation depending • Laboratories are not challenging the efficiency and/or cost reduction,
on whether you are working within architectures behind their current then the LoTF vision should focus
early R&D and drug discovery, which ELNs or LIMSs. This often results in on automation by establishing a
is considered less strictly regulated, a “gap” between the systems that laboratory IT architecture that supports
compared to working according are already implemented and the digitalisation of processes.
to GLP and GCLP in pre-clinical or digital strategy and vision of the
within GMP in manufacturing quality organisation1. Alternatively, if the business
control. Examples of central laboratory • Many laboratories have not strategy is focusing on increasing
applications are: established a laboratory IT innovation and developing new drug
architecture vision and strategy to candidates, the LoTF vision should
• Electronic laboratory notebook support their vision of LoTF. focus on establishing collaborative
(ELN) • Many legacy applications, especially lab communities and democratising
• Laboratory information LIMSs, have been heavily customised data. Therefore, the laboratory IT

THE AUTOMATION SOLUTION
MIKRON AUTOMATION IS YOUR PARTNER FOR

SCALABLE AND CUSTOMIZED ASSEMBLY
SYSTEMS – FROM THE FIRST IDEA TO THE
HIGHEST PERFORMANCE SOLUTIONS.

Technology
architecture should focus on moving standardised taxonomies in place implementation of any of the above
towards cloud solutions, including to ensure data quality? On which topics will not in itself generate value
global data lakes to enable advanced level should we standardise and for the laboratories. However, they
analytics to gain new insights. harmonise to enable search of are a prerequisite for embarking on
data across applications and the IT strategy focus areas below.
Getting the Foundation in Place instruments? How do we build our Implementing the following areas in
When defining a laboratory IT controlled vocabularies? Which the IT landscape will be the activities
architecture strategy, laboratories taxonomies and ontologies should generating tangible benefits for the
and their IT counterparts should in we use? Do we understand the laboratories:
our opinion consider the following differences between communication
fundamental areas: and data standards e.g. Allotrope • Application implementations
(ADF), SiLA, AnIML and where they and replacements: Which new
• Infrastructure: Does our current bring value? or should we build our applications are needed or which
infrastructure support the LoTF own standards? of the existing should be replaced
initiatives that we envision. according to our architectural
How do we enable seamless • Framework for implementing vision and strategy? How should
data exchange between globally and maintaining applications the new applications integrate to
dispersed business units and and instruments: Pharmaceutical our current IT landscape to fulfill
external CROs, where some are companies are spending a our vision of a fully digitalised
operating on-premise while others significant amount of their IT laboratory informatics platform?
are in the cloud? budget on establishing and
maintaining the validated state • Application integration: Which
• Data storage and archival: Do of GxP IT environments. How existing applications should be
we have a global data storage can we digitalise our compliance integrated? Should our ELN or LIMS
and archival solution in place, processes to ensure a more integrate to our CDS, data lake or
satisfying the storage, backup cost-effective and fast execution SDMS etc.? Which laboratories
and archiving requirements from of IT roadmap initiatives such are in scope and would benefit
the business? Should the systems as future IT implementations, from these integrations? What is
also accommodate GLP and GMP upgrades and integrations? Can the priority and sequence of the
retention rules and requirements? a test management system be integrations?
Have we made a clear distinction used to establish a framework • Instrument integration: Which
between data storage and data for application and instrument groups or categories of scientific
archiving and which solutions compliance? instruments should we integrate
should be used? Only SDMS or a to which applications? What is
data lake with SDMS capabilities Let the Hype Kick In for LoTF the plan of attack in terms of
or a combination? Do we have an The previously mentioned topics prioritisation and sequence?
established governance covering constitute the foundation to build Which types of integrations and
raw and meta data management? upon in order to establish a more technologies are preferred and how
complete laboratory IT landscape. will they be governed? How should
• Master Data Management (MDM): Establishing a strategy and a following we integrate instruments that are
Do we have multiple unharmonised currently stand-alone compared
data sources? How do we establish to those that are connected to
one golden data source where the designated laboratory networks
respective master data is exposed, or to the corporate network?
and master data consumers can
integrate to? How do we build • Advanced analytics: How can
the master data governance to we enable scientists to gain new
support this? knowledge from data? What new
knowledge are we targeting?
• Data standardisation, taxonomies How can we apply machine/deep
and ontologies: Do we have basic learning (ML/DL), data mining

Technology
(OCR): capturing handwriting the future needs will help you define
• Video and sound recording the ideal laboratory IT landscape.
of experimental procedures, It is important that you build an IT
physical results, images etc. strategy and roadmap for your journey
and define the sequence of what to
Executing a laboratory IT strategy implement or replace based on a
covering decisions on the above- strategic direction. In order to establish
mentioned topics will lead to a an IT landscape that enables your
roadmap containing a prioritised journey towards your vision of LoTF, it
sequence of initiatives. However, it is necessary to get the foundation in
can be necessary to show tangible place first.
results at an early stage in order to
ensure organisational sponsorship. REFERENCE
and predictive analytics and what This can be achieved by early
value will it generate? Should we implementation of certain initiatives 1. Shanler, Michael, Life Science’s Lab
apply semantic search after data Informatics Digital Criteria to Separate
(e.g. introduction of AI in specific areas
Vendor Leaders from Laggards, Gartner
have been captured or apply data or selected integrations) even though (2018)
standardisation at the point of the foundation is not yet fully in place 2. Shanler, Michael, Market Guide for
data entry? (e.g. data standardisation, master Laboratory Informatics, Gartner (2019)
data management, central archiving
• IoT: How can we build our IoT etc.). Changing the prioritisation by
network, for what purpose and accelerating specific initiatives must
what should be included e.g. be accommodated by the IT strategy
devices, wearables, sensors etc? to prevent:
The following use cases could be Stig
considered: • Unintended complexity in the IT Ragborg
architecture
• Proximity and exposure • Creation of unstandardised data Stig Ragborg is Manager of the
tracking • Other unforeseen outcomes Laboratory Informatics unit in the
• Real-time monitoring and leading to future rework Life Sciences Advisory department
alerting of instruments and in NNIT. He has worked in NNIT
equipment Furthermore, it is important to be for the past 15 years with a focus
• Predictive maintenance of aware that the roadmap will evolve on laboratory informatics advisory,
instruments and equipment and change as you move ahead. A system implementation and life cycle
• Tagging of reagents, revisit of the laboratory IT strategy and maintenance at pharmaceutical
companies. Today Stig is setting the
instruments, laboratory roadmap is necessary on an ongoing
direction of the laboratory informatics
consumables and personnel basis to ensure it reflects a changing
evolvement at NNIT.
environment.
• VR/AR/MR: How can we use these Email: [email protected]
new technologies to improve There are different IT needs across
our laboratory processes? The the laboratories in the value chain due
following use cases could be to the variety of scientific business
considered: processes. Historically, this has led
to a focus on the differences instead Nadia Sara
• Remote assistance to of the similarities between laboratory
Adjal
communicate with experts areas. Due to this mindset, there has
• Design of laboratory facilities been a lack of implementation of Nadia Sara Adjal is an Advanced
• Training of laboratory staff in cross-organisational global solutions Advisory Consultant within the
business processes and use and the associated benefits of a holistic Laboratory Informatics unit at the
of instruments view are rarely realised. The IT strategy Life Sciences Advisory department in
• Projection of work and roadmap should therefore on a NNIT. She has a background in applied
instructions and standard high level accommodate the needs chemistry and pharmaceutical design
operations procedures of all laboratories ranging from early & engineering and has hands-on
(SOPs) R&D to manufacturing QC, in order to experience working in drug discovery
• Design tools for molecular break down the traditional silo-based and R&D laboratories. She has for the
past four years worked with bridging
visualisation in medicinal mindset.
the gap between life sciences and IT
chemistry and drug discovery
with a focus on laboratory business
• Projection of material safety It can be wise to pull the brakes processes, laboratory informatics and
data sheets (MSDS) on current decoupled initiatives and scientific instruments.
• Capture and transfer of define where your laboratories should
analysis results be in the future and which needs the Email: [email protected]
• Optical character recognition IT landscape should cover. Assessing

Manufacturing
The EU MDR 2020: Deadline for Compliance
which fall under Class III and Class IIa/b At the time of writing, the technical
The deadline for ensuring compliance will need to have their UDI recorded, specification for EUDAMED is expected
with the European Union’s Medical indexed, and registered on a central to be released by the end of 2019. So
Device Regulations (EU MDR) is looming.
EU database called EUDAMED – the far, manufacturers have the benefit of
These new, stricter regulations are
aimed at improving the traceability European Database for Medical Devices. a technical bulletin, available from the
features and safety management of European Commission, which provides
medical devices for sale within the Manufacturers of Class III and Class information on how data should be
EU. With less than seven months to go IIa/b products will be responsible submitted. The technical bulletin is
before the deadline, the countdown is for sharing product data according addressed to the different needs of
on for medical device manufacturers to
to Annex VI Part B of the regulation. each manufacturer.
ensure they are compliant.
Manufacturers of Class I products will
Concerned about what the new also be required to collect and save Manufacturers will have appro-
regulations mean to you? In this article, product data but need only share this ximately 5–6 months from the release
Volker Watzke, EU Medical Device information if requested. of the technical specification of
Sector Manager at Domino Printing EUDAMED and the final date of
Sciences (Domino), offers advice on The introduction of the EU MDR registration. It is, therefore, advisable
how to become compliant as quickly
obligates medical device manufacturers to begin collecting data as soon as
and efficiently as possible.
to invest in technology to enable possible. Manufacturers will need to
the fast and accurate application of collect data on each product according
Recap: What is Required from traceability coding to products and to the Annex VI, Part B of the EU MDR,
the EU MDR? packaging at the individual item level. and begin preparing the data for
The EU MDR will come into force on 26th sharing on EUDAMED.
May 2020, replacing the EU’s current Failure to comply with these
Medical Device Directive (93/42/EEC) procedures may mean that devices As well as preparing all data in
and Directive on Active Implantable are withdrawn from sale, with device advance of the May 2020 deadline,
Medical Devices (90/385/EEC). manufacturers no longer able to supply manufacturers should ensure that they
their products to other EU Member have the right partners who support
As part of the new regulations, States. them through the process. To ensure
manufacturers of medical devices for that their devices comply with the new
sale within the EU must adhere to strict Where Are We Now? regulations, manufacturers should
guidelines to ensure their products Medical device manufacturers should speak to their code-issuing agency and
are safe to use. The regulations cover keep abreast of current developments notified bodies for advice.
all medical devices sold in the EU – as and when they arise, and speak to
everything from scalpels and needles authorities such as GS1, as well as At present, some large medical
to pacemakers, contact lenses, and notified bodies and trusted partners device manufacturers are utilising
prosthetic limbs. for advice and support. Conferences, up to 25% of their employee base
webinars and events can offer a wealth in bringing their procedures up to
From 26th May 2020, all medical of information on how best to manage standard. Small and medium-sized
devices will need to be assigned a unique your procedures and prepare for the manufacturers are unlikely to have the
device identification (UDI) code. Devices new regulations. capacity to dedicate so much of their

Manufacturing
workforce and should consider options should speak to one of the four newly Who Can Offer Further Advice and
for external support. accredited notified bodies for advice. Support?
With the deadline for ensuring
Issuing Agencies A Global Effect compliance with the EU MDR fast
In June 2019, GS1 became the first The EU MDR covers all items sold within approaching, manufacturers have
issuing agency for EU MDR-compliant the EU, but this does not mean that a strict timeframe to ensure that
codes, meaning that 2D GS1 DataMatrix only EU member states need to fulfil they have all affected areas of their
and GS1-128 codes can be used going the requirements. All manufacturers business covered, including product
forward. It is expected that other that wish to sell their product in the identification.
issuing agencies will follow suit, with EU need to ensure that they satisfy
potential for the use of HIBCC and the EU MDR requirements, or they may Manufacturers need to act now to
ICCBBA coding in the future. see their products removed from sale. ensure that they have the systems in
place to correctly identify and code
Notified Bodies Equally, manufacturers who are their medical devices in line with the
As part of existing EU Directives registered according to the EU MDR EU MDR. There are multiple aspects to
(90/385/EWG) and (93/42/EWG) should focus future attentions on take into consideration here, including
manufacturers audit and check their ensuring compliance in different product packaging requirements, as
products on a regular basis to ensure parts of the world where additional well as production volume and data
compliance. Notified bodies support legislation may be a factor. At present, management.
manufacturers in this process to the US, India, and South Korea are in
ensure that new and existing products the process of passing legislation on Partnering with a reliable coding
can be sold. Of the 57 notified bodies the identification of medical devices and marking supplier will ensure that
across Europe dealing with current and drugs, with further discussions manufacturers have access to the
legislation, only 38 have applied for currently in progress in Australia, industry knowledge required to choose
accreditation to the EU MDR. Brazil, Canada, China, Colombia, Japan, the most appropriate coding solution,
New Zealand, Russia, Saudi Arabia, and ultimately ensure UDI compliance.
At the time of writing, only four Singapore, and Turkey.
notified bodies had achieved the new
accreditation.
Manufacturers can decide which

notified body they choose for their Volker
products but should bear in mind Watzke
that some existing notified bodies
will no longer be available for Volker Watzke has a diploma in
assistance under the EU MDR. The industrial engineering and started his
new process of accreditation is career at Siemens in 2008. In 2010
significantly more challenging, and he joined Domino Printing Sciences
as such, around 20 notified bodies plc as a Regional Sales Manager in
Germany and became Life Sciences
have not applied.
Sales Manager on a strategic basis
shortly after. In his current role as EU
The sudden lack of notified Medical Devices Sector Development
bodies has become a bottleneck for Manager, Volker works closely with
manufacturers seeking accreditation key market players, focusing on
of their products and can be seen as a the legislations, applications, and
roadblock for innovation, as start-ups substrates concerning the medical
struggle to find support. Start-ups devices sector in Europe.
looking to register their products

Manufacturing
A Patient-centric Journey Through the Pharma

Supply Chain
for, and therefore, the user experience develop, manufacture and test new or
A Patient-centric Journey Through the in real-world settings is equally as improved drugs. Every dose decision
Pharma Supply Chain important as traditional therapeutic taken in development, choice of
In the last decade, we have seen efficacy – any therapy is fundamentally delivery vehicle, administration
a progressive trend across the
only as good as its correct and timely instructions and packaging all have a
pharmaceutical industry, with big
block-buster drugs gradually becoming use by patients. direct impact on the patient.
less prevalent and a shift towards
smaller-volume therapies, often for niche A third key development that has Patients represent the ultimate
patient cohorts. This trend has primarily brought the industry to the nexus beneficiaries of these services, and we
been driven by the fact that many of the of a new age is the tremendous must place their needs at the heart of
easier, less complex drugs have already
desire now coming from patients for the conversation. Understanding their
been made, with research now looking
at more complex compounds and
greater knowledge about their own needs – and building an organisation
orphan designations. But whilst this care, access to their own data, and that is dedicated to addressing them
change has been necessitated by the transparency in the therapies they – is the core of patient-centricity.
discovery pipeline, it has also brought receive. The engaged patient is taking This concept holds true regardless
about a new age of more targeted back control of their own treatments of whether the organisation is a
therapies, and in some cases, even and using a combination of apps, pharmaceutical company, biotech,
personalised approaches, and this has
remote healthcare access and the healthcare service provider, digital
profound supply chain implications.1 The
net result of these changes is that the
internet of connected things (IoT) patient engagement specialist, CRO
patient is becoming much more central to better manage their conditions – or even a contract development
to development as therapies target from simple tools for calorie counting partner.
smaller patient cohorts.2 through to complex devices that
monitor dose, response and lifestyle For CDMOs, this means a new
factors. mindset and culture for the organisation
Running parallel to this develop- defined by a fundamental objective
ment, we have seen the patient But the future of this concept is of reducing the burden of disease,
experience in clinical trials become an transferring it through all parts of the and how we approach developing
important consideration, with adaptive pharmaceutical supply chain and the and commercial drug substance and
trials and patient engagement and industry must move beyond working in product. At every level, the internal
retention tools becoming increasingly silos. However, we should take a step staff must transform their identity,
common.3 Originally this had the vision back to consider what it means to be shifting from self-identifying as a
of ensuring compliance and robust patient-centric before exploring the manufacturing company to thinking
data in trial design, but the industry implications of this shifting approach. and acting like a service company. Of
has shifted quickly up the value chain course, the company will still produce
so that patient, healthcare provider A recent study published by products, and it must remain driven
and sponsor can have access to vital Astra Zeneca yielded a collaborative to deliver for its customers. But the
information through a mixture of definition of patient-centricity as emphasis shifts from what those
patient-selected devices, and eCOA “putting the patient first in an open and products are in and of themselves, to
tools.4 sustained engagement of the patient what the products m for patients.
to respectfully and compassionately Only by adapting this sentiment as
Accelerating this development was achieve the best experience and an ethos can an organisation become
the enactment of the 21st Century outcome for that person and their truly patient-centric.
Cures Act – which has placed an family.”5 This definition does not
acute emphasis on patient-centric solely come from industry, but was At a practical level, this means
development, personalised medicine driven by direct consent from the end we need to deliver new engagement
and increasing utility of real-world users themselves – the patients. It schemes throughout the workforce
evidence. Understandably, patient- is important to note this distinction: so that employees understand the
centricity has also gained considerable in order to be truly patient-centric importance of what they do, and how
traction in adherence for commercial in thought and deed, one must hear their efforts have a real-world impact
products and we have seen great directly from the patient. on patients. So, for example, at the
strides made by both packaging and project initiation stage, teams should
delivery device manufacturers. The So with this definition in mind, we be briefed on the therapy area, patient
patient here is rightly now viewed explore the potential impact on the population and the impact of the
as the direct customer innovator CDMOs that support the industry’s drug. Then to empower employees
companies are designing products efforts by efficiently helping discover, to meet the people the product will

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INDUSTRY 35
Manufacturing
help, patients are brought in through The definition of patient-centricity, manufacturer’s reputation for quality.
customers to share their journey about as defined by the aforementioned Astra So what started as a trend out of the
how the drug has helped them. Zeneca stu dy, requires pharma to ‘put internet that was breaking down the
the patient into your working standards’. traditional silos of medical information
One key initiative that has been This means ensuring that the patient has now shifted to a focus of life cycle
pioneered to deliver true patient- first approach also extends into how we impact of medicines. This trend has
centricity is the creation of patient as an industry react to helping patients been accentuated by many of the
awareness councils across global get access to the therapies they need. FDA infringements seen in the last
sites. These new bodies comprise few years, and a growing awareness
cross-functional executives and In the future, we will see more of the role that outsourcing plays in the
employees, and they act as the examples of CDMOs manufacturing patient supply chain. So whilst scandals
patients’ advocates and ambassadors drugs to treat extremely rare diseases, like adulterated heparin undoubtedly
for patient-centricity through as they will back up their patient- cast a long shadow on the industry, the
development and commercialisation. centric credentials with a commitment move towards full patient transparency
Their role is exploring in detail the to doing the right thing by patients, in the supply chain is shining a new
impact of manufacturing choices, even in cases of little or low profit. light on good manufacturing practice
development criteria and approaches Similarly, putting in place patient- (excuse the pun). In the future, it may
on the patient. Moving into the future, centric cultures within the workforce become greatly more common for
they will have an extremely important at CDMOs. So, for example, when licence-holders to share and celebrate
role to play in every project, and are the FDA recently approached our the manufacturing records of CDMO
tasked with creating, managing and customers to increase production of partners. An early example of this
monitoring the best practices for a generic injectable drug used in the type of trend can be seen with the
applying patient-centricity to the treatment of a variety of cancers – due recent serialisation initiatives in both
entire organisation. Ultimately, the goal to issues with another manufacturer Europe and the United States. These
is to drive patient-centricity from the – we immediately stepped up are already delivering much greater
bench to the plant. production. Adapting the site for trust, and it is translating through to
higher volumes, the team worked the patient as there is greater visibility
This concept is extended to after additional shifts to accommodate the on every drug’s journey - it can be
visits and increasingly we will see extra batches that were required to fill tracked moving between manufacturer,
‘patient profiles’ being brought into the the gap. So, patient-centricity is not distribution channel and all the way to
CDMO space – which are essentially just about tangible factors, but also pharmacy.7
daily maps of the patient’s experience recognising that the responsibilities
to better inform the drug development we have extend beyond the delivery of What the patient will want to see is
process. It’s a key part of the team’s pharmaceuticals, and we have a duty the best possible regulatory standards
discussions with patients, as we want to adapt to the wider conditions facing are adhered to, but also that their
to get a closer picture of the patient. At our patients. therapies are made with partners that
present, these types of initiatives only look to go beyond these standards using
run in commercial drugs, but it won’t Drug Discovery approaches that included PAT, QbD and
be too far in the future to see this type Another area that, even just a few continuous processing. Undoubtedly,
of scheme delineated into early phases years ago would have seemed the future will see patients taking an
of development. Moving forwards, this unlikely, is the growth of patient increasingly active interest in exactly
will also mean creating new guidance and charity organisations directly how, when and where their vital
– developed with advocacy groups, funding discovery programmes of therapies are discovered, developed
ethics & compliance, as well as legal biotechs and early-stage researchers. and manufactured.
– for employees on how to interact Understandably, these groups have
with patient groups. The challenge is to an acute focus on patient-centricity, Environmental Footprint
accept that this approach takes time, and in the future, they may take a We are not there just yet, but the next
because it is a change in culture and in more active role in the supervision of natural evolution of this trend will be for
the ‘way we work’ running through the outsourcing with the goal of delivering the patient to be assured that not only
business, even into the manufacturing the greatest cost benefits and, more are their therapies safe and effective,
teams. importantly, partners that offer the but they have also been made with
investigational new drug the best minimal environmental impact in mind,
In other parts of the industry we possible chance of success. from reducing the number of process
have seen patient advocacy training steps and hazardous chemicals to
groups created – e.g. Sanford Transparency the safe disposal of waste products.
Research Institute introduced the Running parallel to the patient- It does not take one to look too far
Patient Advocacy Certificate Training centric approach we are taking, there into the future for us to envisage the
[PACT] course – and our hope is that is the trend globally of the ‘informed use of some kind of environmental
the industry will embrace these to patient’ – people want far greater certification to be placed upon
ensure it has the right culture and depth of information than before, CDMOs that could translate through
philosophy to achieve true patient- and not just on clinical trials data and to patient packaging. Certainly, in
centricity.6 side-effects, but also running into the devices and packaging, the industry is

Manufacturing
already heavily advanced on its journey patients we serve globally. Questions Patient-centricity-Moving-from-a-
towards extrapolating not only its no one thinks to ask today (e.g. ‘how nice-to-have-to-best-practice
immediate environmental challenges, are my drugs manufactured’, ‘what is 4. http://www.appliedclinicaltrialsonline.
com/four-pillars-achieve-patient-
but the full life cycle impact.8 the supply chain process’ and even
centricity?pageID=2
‘its environmental footprint’) will be 5. Defining patient centricity with
Conclusion key parts of the supply chain and patients for patients and caregivers:
The implications for pharma of patient- patient engagement package in just a a collaborative endeavor.” BMJ Innov:
centricity have been well documented, few years’ time. This is the future we first published as 10.1136/bmjinnov-
but what is under-appreciated is the envisage, one in which, above all else, 2016-000157 on 24 March 2017.
we recognise the responsibility we 6. http://www.pharmexec.com/
new significance it will bring to bear
what-does-patient-centricity-look
on the CDMO sector – especially bear should be solely to patients. We
7. https://pharmafield.co.uk/in_depth/
with the new types of drugs coming are at the nexus of a new age, whereby developing-product-and-patient-
through the pipeline. So rather than patient-centricity will become the centric-services/
being fundamentally a b2b-facing integral philosophy around which we 8. https://www.pharmapackeurope.com/
proposition, increasingly, contract design all services, even technical visit/news-and-updates/pharmapack-
service providers will view the patient approaches – from implementing report-predicts-diversification-
innovation-leading-rise-licensing
as the end consumer – and never ‘just dosage form and delivery, packaging
someone we simply sell to’. This will and logistics right through to meeting
be a relationship built upon mutual regulatory standards and good
understanding and partnership. manufacturing practice.
The pharmaceutical supply chain
is increasingly opening up and REFERENCES Stuart
the patient must be placed at the
1. http://www.pharmexec.com/supply-
Needleman
centre of industry efforts. Increased
chain-what-price-patient-centricity
transparency and a new age of Stuart Needleman, Chief Commercial
2. http://www.pharmtech.com/
dialogue between manufacturers will patient-centric-drug-development- Officer, Piramal Pharma Solutions.
increase trust, help us achieve better comes-age Patient-centricity: The New Nexus
efficacy rates and, most importantly, 3. https://www.outsourcing- for CDMOs.
develop better medicines for the pharma.com/Article/2018/09/18/

Manufacturing
The New Technologies Shaping Aseptic Processing

Techniques
In addition to the developing as humidity, oxygen, temperature or

Introduction regulatory landscape, drugs that are positive or negative pressure.3
The technology used in aseptic targeted to meet the specific needs of
processing has seen continuous a small group of patients are becoming Restricted access barrier systems
improvement and innovation in recent
increasingly popular. This creates the (RABS) are also commonly used in
years. For many manufacturers, the
need for a robust containment strategy need for an increased amount of small sterile manufacturing environments.
is becoming increasingly multifaceted batch products. In the production There are several elements that must
as they are required to work with of sterile goods, equipment must be in place to have a fully functioning
small-batch novel therapies. The be cleaned, decontaminated and RABS. These include: properly designed
industry is now seeing more stringent sterilised between batches to prevent equipment; management oversight; a
regulatory requirements around sterile contamination of the following batch. quality system; proper surrounding
manufacturing coming into play, with
This has the potential to delay the room design to maintain ISO 5 in the
renewed emphasis on assurance and
controls, including leveraging the best manufacturer’s start-up and shut-down critical zone; gowning practice; training;
available technologies and conducting process if not handled correctly. initial high-level disinfection with
thorough, science-based risk sporicidal agent and standard operating
assessments of processes1. Aseptic Current Cleanroom Technologies procedures (SOPs) for rare interventions
processes involve hazards that must If not managed correctly, sterile including disinfection, appropriate line
be properly controlled to avoid manufacturing environments are clearance and the documentation of
consequences to patient safety;
open to many sources of potential the event.4
in response to this, the industry is
seeing significant developments in contamination, which are potential
technology to prevent contamination hazards during the manufacture This technology has seen wider use
and ensure product sterility. of sterile drugs. If microorganisms, in recent years, as it can offer operators
particles or endotoxins enter the the opportunity to interact with the
working area, patient safety could products as necessary while still
Aseptic Processing Technology ultimately be put at risk. Operators providing a barrier between workers
Market Landscape are one of the main sources of and processing lines, thus reducing
As it stands, the global advanced contaminants in the cleanroom contamination risks. In addition,
aseptic processing equipment market environment, simply due to the many RABS incorporates high-efficiency
is set to reach a CAGR of 3.8% between microbes and bacteria carried by the particulate air (HEPA) filtered airflow,
2017 and 20242. This can be attributed average human. which can significantly reduce the
to the evolving requirements of sterile “probability of a non-sterile unit”
product manufacturing, and the move In addition to humans, potential (PNSU). RABS technology has been
by containment technology experts sources of contamination include the found to yield similar PNSU data to the
to further innovate to ensure these raw materials used, the environment use of isolator technology, and it can
requirements are met. and equipment. The need to ensure also create operational flexibility as
the safe and sterile transfer of APIs and RABS can be opened to allow process
There is growing industry formulation ingredients during aseptic intervention while isolators must
awareness around the potential for processing has driven the development remain closed during operation.
contamination in manufacturing of multiple technologies, such as
environments, including the risk of isolators. Isolators can be employed in Challenges of Current Technologies
batch, and potentially sole patient cleanroom environments to minimise While both isolators and RABS are
sample loss if a product is contami the risks from contaminants by highly beneficial to ensuring product
nated. providing an airtight barrier around the sterility, both technologies also
aseptic processing line. have their disadvantages. It can be
There are currently stringent difficult to transfer materials in and
regulations in place for aseptic Isolators were first used for aseptic out of the chamber when isolators
processing procedures. For example, filling of drug product in the mid to are used, meaning a docking isolator
GMP guidelines require cleanroom late 1980s. Operators access the may need to be coupled and the
areas for the manufacture of sterile enclosure using gloves and half-suits interior may need to be sterilised
products to be classified according to perform interventions, which before materials are transferred.
to the required characteristics of the allows for complete separation of Moreover, isolators have much
environment. These environments operator and product. Current isolator slower start-up times in comparison
must meet rigorous classifications in design incorporates unidirectional to RABS, where product changeovers
accordance with ISO14644 in order to airflow into the chambers and can are often much more efficient and
be categorised as grade A, B, C or D. provide a specific environment such easier to manage.

RABS, however, provide lower integrity chambers,
meaning the closed solution provided is less robust than
that of isolators. Additionally, RABS generally rely on
manual cleaning processes, unlike isolators which can be
decontaminated through an automated process, allowing
for high-level bio-decontamination. The cleaning process
for a RABS system is more complicated than in a traditional
sterile area. This is because all product or process contact
parts within a RABS are sterilised or steamed-in-place
(SIP) prior to use and if doors are opened, cleaning and line
clearance must occur per procedures. In addition, glove
handling and assembly at the glove ports in RABS are more
complicated procedures because of sterility requirements
and the need to continuously test glove integrity, adding
additional steps to the process.
These disadvantages pose significant challenges for the

industry, especially as the demand for aseptic processing
continues to grow. Because of this, pharmaceutical
manufacturers are looking to new technologies to lower
costs, improve efficiencies, and reduce the risk of costly
and potentially dangerous product contamination. In many
cases, these technologies work alongside isolators and
RABS set-ups, allowing firms to integrate them into their
aseptic processing lines rather than investing a significant
amount of money into overhauling their processes.
The Prevalence of New Technologies

The industry is increasingly implementing single-use
technologies and systems in response to these challenges.
Disposable technologies are being widely embraced
by the industry thanks to the boost in efficiency and
the ease of use that disposable parts can provide. For
example, split butterfly valves (SBVs) provide containment
when transferring product from one machine or vessel
to another and minimise the levels of dust emitted
to exterior surfaces and the surrounding environment
before, during and after transfer.
Made up of an active half and passive half, SBV

technology enables a product to be transferred from one
container, process vessel, isolator or RABS to another
without compromising sterility. Many manufacturers
are finding that an SBV approach can provide a more
practical option in achieving assurance of product sterility,
as an alternative to more traditional barrier techniques.
SBV technology also decreases reliance on cleanroom
environments and can offer increased sterility assurance
and improved ergonomics.
In use, the active half of the SBV will be attached to

the receiving vessel, with the passive half attached to the
discharging drug container or flexible bag. A single plate
is created when the two halves of the disc are brought
together. This allows product to flow on the interior
surface of each half. When the passive and active halves
are detached, the external face remains clean and can be
safely exposed to the process environment.
Additionally, SBVs can allow decontamination to take

place in a closed environment, as an opening is created
between the discs when the valve is sealed, enabling a

Manufacturing
decontaminating gas to be flushed of sensitive products while in transit,

through. Chemical indicators are then as currently this is often met with
used to validate the process and solutions such as fibre or plastic drums
confirm full coverage of the enclosure with flexible liners. This often poses
is attained, followed by biological substantial challenges when it comes
indicators to ensure a 6-log reduction to filling, sealing, handling and emptying
(which is equivalent to a 99.9999% these packages.
reduction in bacterial spores) has been
successfully accomplished. Utilising the SUP approach, the
industry can now provide a method
SBVs now exist with a disposable of contained powder transfer within
passive half of the valve, known as facility A (drug supply) and can also be
a single use passive (SUP). This is used as a product’s primary packaging
designed so that it can be opened and container closure for transportation
once docked with the active unit. This to facility B (drug product formulation).
technology forms a complete hybrid In fact, this package can be used as a
system and ensures that new single use common method of transfer into the
products are compatible with existing process line in facility B, saving on the
SBV systems in the field. Because these additional risk and time-consuming
products are disposable, this eliminates task of sub dispensing on site.
the need for cleaning and sterilising the
passive half of the system and allows Final Thought
for increased productivity. Advances in the industry have seen
companies pushing to innovate to
Broadly, single-use equipment ensure their offerings are competitive
can avoid high water and energy while remaining compliant with
consumption as cleaning processes regulations. While current technologies
and the need for copious amounts of like isolators and RABS can offer
water for injection are circumvented. substantial benefits, there are still
Steam sterilisation is replaced by improvements to be made.
pre-sterilisation of equipment;
removing clean-in-place processes can Sterile products require specific
allow firms to create an aseptic system manufacturing and handling processes
that is more closed, which reduces to ensure sterility, with patients
contamination risks. potentially at risk if these requirements
are not met. We are seeing an influx
As well as single-use technologies, of innovative new technologies such
new smart technologies are expected as disposable single-use technologies,
to flourish given the importance of multi-location solutions, and smart
ensuring sterility during drug product technologies in response to this.
manufacturing. For example, firms can Manufacturers are continuing to
provide operators with vital equipment implement these new technologies
performance data through installing due to the benefits they offer, with
wireless monitoring technology like the reduced costs and downtime key Christian
VERIFI SMART monitoring solution onto elements of this offering, and it’s Dunne
an SBV. This can provide maintenance, likely that this will continue as sterile
health and safety and compliance teams products increasingly form a major part Christian Dunne is the Global Head
with the necessary information to be of the drug development pipeline and of Sterile Solutions at ChargePoint
able to make informed decisions to regulations. Technology for the AseptiSafe®range
proactively manage their maintenance of products for sterile containment.
programmes. He works on the advancement
REFERENCES
of ChargePoint Technology's split
Pharmaceutical companies are butterfly valve technology, designed to
1. https://www.pharmaceuticalonline.
also utilising multiple manufacturing handle highly potent/sterile powders
com/doc/keys-to-aseptic-processing-
and small-scale components, where
locations – often, the development, improvement-efficiency-0001
product and operator protection
manufacturing and packaging of 2. https://www.marketsandmarkets.com/
Market-Reports/aseptic-processing-
are paramount. While working
products is wholly outsourced. As on many aseptic applications,
market-53206289.html
more drug products are moved Christian integrated several different
3. https://getd.libs.uga.edu/pdfs/burton_
between facilities, transportation shannon_l_201605_ms.pdf bio-decontamination systems and
between countries is often involved. 4. https://a3p.org/wp-content/ has an in-depth understanding of
Manufacturers are now looking to uploads/2015/03/article_ their performance and application.
technologies that ensure the integrity regulatory_2015_RABS-definition.pdf

expect + + more
More precision. More consistency. More control.

IMA draws on its extensive expertise to provide the most advanced solutions
for DPI processing and assembly.
Direct weight control performed in line on each single capsule or device before and after filling.
Absence of mechanical powder compression for improved airway intake.
Accurate micro-dosing and automatic feedback and adjustment.
Highly flexible and precise inhaler assembly.
All of this is more than any other production equipment can achieve today.
Much more than filling. Fulfilling your requirements.
inhalation.ima.it
Visit us at
Drug Delivery to the Lungs (DDL 2019)
Edinburgh, Scotland
December 11-13, 2019

Manufacturing
Just the Right Dose: The Top Trends Shaping Drug

Dosage Forms
As new drug molecules in the pipeline

become increasingly complex and
approved molecules are reformulated
for alternative routes of administration,
the drug dosage landscape is shifting
significantly. Dr Robert Lee, president,
CDMO Division, Lubrizol Life Science
Health (LLS Health) discusses the key
trends influencing dosage forms in the
industry:
1. The 505(b)(2) Pathway to maximise these technologies’ 3. More Convenience

A significant proportion of the innovation effectiveness in a formulation requires Development of combined, implantable
in drug dosage form work is being driven expertise and experience. Taking an polymeric dosage forms has been
by the Food and Drug Administration’s orthogonal approach and being open a growth area since it was first
(FDA) 505(b)(2) pathway. A 505(b)(2) to a variety of methods in the early demonstrated that the release rates
sponsor can use clinical data produced stages of development is also advisable and therapeutic delivery of drugs
by other companies to seek FDA rather than leaning too far towards one could be controlled with highly refined
approval without performing all the approach. polymers. One of their great advantages
work required with a traditional new is they can be designed to achieve
drug application (NDA). This is a clear A clear target product profile (TPP) various sustained drug release rates and
advantage for developers that saves that describes the end drug product is profiles in line with the requirements of
valuable time and money. This strategy the foundation of good development a given patient population.
also significantly lowers risk since the practice. A profile should include
API being developed has already been route of administration, dose, form Drug-eluting devices (DEDs) also
used in a marketed product. factor, pH, particle size distribution, provide other advantages over
etc. Once the TPP is understood and conventional dosage forms: a localised,
As a result, many existing drug the physicochemical characteristics of more targeted delivery, lower dosage
products are being reformulated to the active are identified, suitable drug requirements, and most importantly,
create new, improved dosage forms, delivery technologies that may achieve greater patient compliance and
treat different indications, enable the TPP can be deployed. When these convenience.
new dosing regimens, and achieve technologies are ineffective, creating
new routes of administration via the proprietary technologies to help achieve Implantable DEDs are considered
pathway. This is carried out using the objectives can also be explored. combination products comprising “two
advanced formulation technologies
to improve existing commercial drugs
for new routes of administration or
longer-acting dosing regimens that have
much better rates of bioavailability and
patient compliance.
2. Complex Molecules
As more complex and insoluble
molecules have entered the pipeline
bioavailability has become a more
prevalent formulation challenge. In the
past, simply putting a molecule into a
tablet may have been effective, but this
is no longer the case. Today’s molecules
require more complex and advanced
drug delivery technologies that address
insoluble compounds.
It is possible to increase bioavailability

through specialist technologies, but

Manufacturing
or more regulated components, i.e., drug/

device, biologic/device, drug/biologic, or
drug/device/biologic, that are physically,
chemically, or otherwise combined or
mixed and produced as a single entity.”
DED developers today have a range

of materials and modelling techniques
available that improve the efficiency and
success rate of creating these products.
Through careful selection of excipients,
device design, and processing methods,
DED developers can optimise delivery
of their specific drug. As polymer
selection and device design continue to
improve with customised chemistries
and advanced modelling, DEDs will
continue to grow in use. medicines and reformulate them in of drug dosage forms can give
ways that place a greater emphasis pharmaceutical companies access
4. Patient-centricity on patient-centricity. This is leading to the expertise and technologies
It is critically important to take a patient- to innovations such as long-acting to select the best dosage form for
centric approach to drug delivery. If a injectables that require a lower dosing each application. CDMO expertise is
patient does not like the dosage form regimen or improving the bioavailability particularly critical for non-conventional
then they are unlikely to take the drug, of a drug so it can be delivered via an dosage forms, such as nasal and
leading to negative therapeutic outcomes. alternative, more convenient route of ophthalmic, and implantable devices
Dosage forms should appeal to, not repel, administration. and depots, which have additional
the target audience. So, for paediatric complexity and regulatory issues for
medicines, for example, this means 5. Regulation drug developers to consider.
creating palatable, oral liquid forms that More complex dosage forms, such
negate the need for large tablets. as long-acting injectables or DEDs,
require a very thorough understanding
Similarly, parenteral dosage forms of the manufacturing processes
are often unpopular and in certain cases involved to carry out the necessary
may be possible to avoid. The nasal regulatory characterisation and Rob
route of administration is a growing analytical work. Standard methods
Lee
alternative for therapies targeting the to measure the dissolution and
central nervous systems, thanks to its elution profile of complex products, Dr. Lee is responsible for product
ability to bypass the blood-brain barrier. for example, will not always work and development. Before joining LLS
It offers great potential for drugs that specialised expertise is required to Health, Rob held senior management
treat conditions like migraines, allergies, ensure that such work is completed positions at Novavax, Inc., Lyotropic
and epilepsy. correctly. Therapeutics, Inc., and Imcor
Pharmaceutical Co. He holds BSs
The 505(b)(2) pathway is leading drug Working with an outsourcing partner in Biology and Chemistry from the
innovators to rethink existing market for the formulation and development University of Washington and a PhD
in Physical Bioorganic Chemistry
from the University of California,
Santa Barbara. Rob has published
articles in numerous peer-reviewed
journals and three book chapters
plus holds 11 issued patents and 14
provisional or PCT patent applications.
He has over 23 years of experience
in pharmaceutical research and
development of both therapeutic
drugs and diagnostic imaging agents.
Rob maintains strong academic ties,
including an appointment as Adjunct
Associate Professor of Pharmaceutical
Chemistry at the University of Kansas
in 1992, and serving as a reviewer
for both the International Journal
of Pharmaceutics and Journal of
Pharmaceutical Sciences.

Packaging
Role of Phase Change Materials for Safe

Transportation of Pharmaceutical Goods
result in damaged products putting • High latent heat energy storage

Over 25% of vaccines reach their lives of patients at risk. All is not that capacity.
destination degraded because of bad though. Recent innovations and
incorrect shipping. 30% of scrapped
technological advancements have PCMs were developed to meet the
pharmaceuticals can be attributed
to logistic issues alone. 20% of made it much easier to mitigate such ever-increasing energy needs in the
temp-sensitive products are damaged risks today. field of cooling and heating, including
during transport due to broken cold in pharmaceutical product shipments.
chain. Shelf life of the sensitive medicinal We will discuss the role of one such Today, specific PCMs between the
products is short and demands innovation- phase change materials, range of -35°C to +89°C exist for
temperature control. As per WHO,
or PCMs as they are commonly maintaining precise temperatures. This
precise temperature conditions has to
be specified on the every product. The
called, using an experimental box helps maintaining the integrity of the
labels and precautionary statements design. PCMs are suited to meet the temperature-sensitive products. Some
range from “store under normal storage specific temperature requirements. of the advantages of PCMs over regular
conditions (15 to 25oC)”, “store between Several organizations have explored, water/ice pouches are:
2 and 8 °C (under refrigeration, no implemented and commended the
freezing)”, “store below 8 °C (under kind of problems PCMs could solve for • Help maintain the product integrity-
refrigeration)”, “store between -5
the industry. Today, all major pharma PCM used for maintaining 15–25°C
and -20 °C (in a freezer)” to “store
below -18 °C (in a deep freezer)”. The
packaging companies are focusing temperature is different (has
products therefore require speedy and on improving the packaging design different melting temperature)
temperature controlled delivery of the and performance by incorporating than the one used for maintaining
products. Any temperature fluctuations different kinds PCMs suiting different 2–8°C temperature or for frozen
can make the product unstable and requirements. Choice of right PCM, (-20°C) products.
unfit to use. Products travel from hot insulation and packaging has become • Allow for reduced packet size,
and humid to cold and dry climate.
the most important parameter while weight and volume
Simply boxing the pharmaceutical
products does not help solve this designing a temperature-controlled • Drive costs lower- with high energy
problem. Moreover, temperature tracing transportation box. Companies like PCMs lower cost insulation can
up to last mile delivery is not a usually Pelican Biothermal, Sonoco Thermo- also deliver adequate performance.
followed practice.. This raises questions safe, Vaqtec and PLUSS (India) are Make uch simplified packaging
on reliability of tertiary packaging used all focussed on delivering right simpler- reduces thawing steps
and whether it can really sustain temperature, universal packing, and
temperature abuse on outside during the
compact size using PCMs and VIPs Material of Construction
transportation. The paper presents the
role of Phase Change Materials and a box (Vaccum Insulation Panel). An insulated box was constructed
design for transporting such temperature with thermal resistance in the
sensitive goods. The box maintains the What are PCMs and why are they range 2–3 m2K/W. Payload box to
temperature inside the payload box used? accommodate the pharmaceutical
within range throughout its journey; from Phase Change Materials (PCMs) goods was also constructed with an
the manufacturer’s pick up point to the are passive thermal energy storage insulation material with low thermal
end customer.
materials, meaning they can maintain resistance in the range of 0.3 – 0.6
temperature without any external m2K/W. Phase change material (PCM)
Introduction power supply. This is achieved by with phase change temperature of
Over 25% of pharmaceutical products energy involved in change of phase 01oC, 22oC and -23oC was chosen to
are wasted every year during the from solid to liquid or vice versa. The maintain the box temperature in the
transportation. Since seven out of ten most commonly used PCM is water/ice range of 2-8oC, 15–25oC and -15 to
pharma products require temperature- (gel). However, its efficacy as PCM has -25oC, respectively. PCM combinations
controlled shipping, compromised always been in question. Melting at 0°C for each range of temperature is
temperature-controlled chain has (32°F), use of water is mostly imprecise shown in Table 1.
emerged as one of the leading causes of for pharmaceutical products and adds
Temperature PCM1 PCM2
this wastage. The products, therefore, to the risk of freezing the vaccines. Range (°C) Phase change Phase change
require speedy and temperature- Three major factors that qualify a PCM temperature temperature
controlled delivery of the products2. (°C) (°C)
The reality, however, is pharmaceutical • Consistency in performance over 2-8 1 5
supply chain is quite complex and a substantial number of cycles 15-25 22 -
fragmented. There are multiple stake • Constant temperature -15 to -25 -23 -
holders and intermediaries through maintenance during release and Table 1: PCM used for different temperature range
the entire process; a single miss can absorption of energy of PCM

Packaging
To ensure that the temperature Methodology

does not go below the desired range, a To check the accuracy of the box, it was tested under two conditions:
second PCM is aligned along the walls
of the payload box. PCM properties of
all the PCMs used in the transportation
boxes is shown in Table 2. Aligning the
second PCM along with the first PCM is
termed as cascaded effect. Presence
of second PCM ensures that the extra
energy stored by the first PCM does
not go waste and also ensures that
the pharmaceutical products are not
affected by the subzero temperature.
Secondly, frozen PCMs does not need
any conditioning time. PCM materials
used in the boxes are water based or
biodegradable products which does
not affect the environment in the long
run.
PCM Phase Change Latent Heat Density
Temperature Range (°C) (kJ/kg) g/cc
HS01 2-8 340 0.99 Figure 1: Exploded view of the transportation box
HS22 15-25 185 1.54
HS23N (-20)-(-25) 290 1.2 Exposure temp Exposure time Movement from Hyderabad
OM05 5-10 250 0.9
(°C) (hours)
Table 2: PCM properties
5 10 Reefer truck (from freight forwarder to shipper)
To ensure the longevity of the 25 4 Shipper
box up to two to three uses and to 5 10 Reefer truck to airport
protect the pharmaceutical products 35 2 Airport unloading before it reaches CFE
from condensate of the frozen PCM 5 12 CFE
pouches, appropriate packaging was 45 4 Del. tarmac
chosen. Pharmaceutical products 5 10 In-flight
are first enclosed in their individual 40 3 Unloading during transit, tarmac (Istanbul)
packaging as produced by the 5 10 CFE
manufacturer. The payload box is made 40 3 Loading during transit; tarmac (Istanbul)
of an insulating material (polyurethane 5 10 In-flight
foam, expanded polystyrene or vacuum 30 3 Destination unloading, tarmac (US)
insulated panels). The packaged 25 15 Destination airport
pharmaceutical products go into the 5 8 Reefer truck
payload box. Each PCM pouch used to 30 2 Unloading at destination warehouse
maintain the temperature of the box
Table 3: Temperature profile for real-time testing
is enclosed in a corrugated box to give
the whole assembly a rigid structure. temperature and time data as per next 120 hours is shown in Figure 2.
An exploded view of one such box is Table 3. The box was then placed 2. Real-time testing. The box was again
shown in Figure 1. inside the chamber. loaded with HS01 and OM05. HS01
was frozen before assembling the
Special care was taken in this design Complete testing and data box. OM05 was lined along the walls
to make the product user-friendly. The recording is enabled with real-time of the payload box. The payload
box assembly is similar to stacking data monitoring. This enables the box was loaded with medicines.
a carton over carton. This reduces user to monitor the status of the box The temperature-controlled
the chances of error at the freight throughout the transportation. chamber (used as an ambient)
forwarder. was programmed according to
Experimental Results the profile shown in Table 3. The
1. An optimum temperature of testing complete assembly was placed in
was determined from Table 3. To 1. A transportation box was loaded the chamber. The performance of
do this, the temperature profiles in with HS01 and OM05. HS01 was the box over the next 120 hours is
Table 3 were analysed. As a worst frozen before assembling the box. shown in Figure 3.
case scenario, the box was placed OM05 was lined along the walls
at an averaged-out temperature of the payload box. The payload Conclusions
throughout the experiments. box was loaded with medicines. Pharmaceutical products and other
2. Real-time testing. To do this, The complete assembly was temperature sensitive goods need
the temperature-controlled placed in an ambient 32oC. The utmost precision in storage and
chamber was programmed with performance of the box over the transportation. PCM technology is

Packaging
Nidhi
Agrawal
Nidhi is a post-graduate in Organic
Chemistry from St. Stephens College,
Delhi University (2005) and was awarded
the best student of the year and
prestigious ‘Science Meritorious’ award
during her studies. She is currently
Figure 2: Performance of 2–8 degree box when placed at an ambient 32oC
working at Pluss Advanced Technologies
and leads a team that has created several
Phase Change Materials.
Vikas
Agarwal
Vikas Agarwal comes with a background in
Chemical Engineering from Indian Institute
Figure 3: Real-time testing of Technology (IIT), Varanasi. He brings a
vast experience dealing with Phase Change
a boon to such products. However, https://www.sensire.com/blog/
Material based Cold Chain Solutions in the
appropriate assembly and packaging is pharmaceuticals-cold-chain. [Accessed
Pharmaceutical and Logistic industry.
equally important. Poor design can lead 06 November 2019].
3. N. Dorset, "dorsetccg.nhs.uk," [Online].
to compromised performance and/or Email: [email protected]
Available: https://www.dorsetccg.nhs.uk/.
higher cost. Unnecessary and unplanned [Accessed 08 November 2019].
packaging can lead to extra weight of 4. R. J. L. R. O. R. H. H. D. M. G. A. Quick JS,
the box leading to extra freight charges. Managing Drug Supply, West Hartford:
Extra or less amount of PCM can also Kumarian Press, 1997.
Geet
drastically affect the performance of 5. P. l. IQ, "Pharma logistics IQ," [Online].
the box. This transportation box is a Available: https://www.pharmalogisticsiq. Joshi
com/packaging-shipping-systems/articles/
result of exhaustive optimization of
guide-to-temperature-controlled- Geet post-graduated in Chemical
right quantity of PCM and packaging.
logistics. [Accessed 08 November 2019]. Engineering from BITS Pilani. He is
Optimized deadweight reduces freight 6. Shipabco, "Shipabco.com," November an active researcher in the field of
cost. 2018. [Online]. Available: https://www. temperature-controlled packaging and
shipabco.com/the-rules-for-shipping- shipping solutions and has developed a
The results can be extrapolated pharmaceuticals-you-need-to-know/. wide range of thermal packaging solutions.
to develop pallet shippers. For [Accessed 08 November 2019].
pallet shippers, back up hours can 7. "http://www.emballiso.com.sg/product. Email: [email protected]
html," Emballiso, [Online]. Available:
go upto five days providing a great
http://www.emballiso.com.sg. [Accessed
bulk shipping option at controlled 10 November 2019].
temperature. The solution can be 8. "https://pelicanbiothermal.com/thermal-
beneficial and economical for the packaging/reusable-parcel," Pelican
pharmaceutical logistics. The wastage Biothermal, [Online]. Available: https://
Udit
of medicines and vaccines can be pelicanbiothermal.com. [Accessed 10 Mangal
curbed to a large extent reinforcing November 2019].
our commitment of providing quality 9. "https://intelsius.com/products/ Udit is a Biotechnologist with a
temperature-controlled-packaging/," management degree from Management
healthcare and ensuring well-being of
Intelsius, [Online]. Available: https://intelsius. Development Institute (MDI), Gurgaon.
every individual. com. [Accessed 10 November 2019]. He has over 10 years of experience across
10. "https://www.va-q-tec.com/en/ functions including product development,
REFERENCES technology/," Va-q-tec, [Online]. Available: product management, sales and marketing
https://www.va-q-tec.com/en. [Accessed in the Healthcare and Life Sciences
1. "apps.who.int," [Online]. Available: 10 November 2019]. industry. Currently, he leads the healthcare
https://apps.who.int/medicinedocs/ 11. Softbox, "https://www.softboxsystems. division at Pluss Advanced Technologies.
en/d/Jh1813e/3.3.8.html. [Accessed 08 com/thermal-covers/," Softbox systems,
November 2019]. [Online]. Available: https://www.softbox Email: [email protected]
2. "www.sensire.com," [Online]. Available: systems.com. [Accessed 10 November 2019].

Volume 9 Issue 1 INSIGHT /
Volume 9 Issue 1 - Spring - 2017
International Pharmaceutical Industry

Supporting the industry through communication
Peer Reviewed
KNOWLEDGE /
FORESIGHT
IPI – International Pharmaceutical Industry
MALDI Mass Spectrometry in Drug Discovery

Gaining A Deeper Understanding
SUPER PUBLICATIONS
Three Ways to Mitigate the Risk of
Late-Stage Failure in CNS Drug Development
Data
The Foundation of Clinical Trials
Temperature Management
Keep Your Cool
FOR SUPER PHARMACEUTICALS
IPI
Peer Reviewed, IPI looks into the best
practice in outsourcing management
for the Pharmaceutical and Bio
Pharmaceutical industry.
JCS
Peer Reviewed, JCS provides you
with the best practice guidelines for
conducting global Clinical Trials. JCS
is the specialist journal providing you
with relevant articles which will help
you to navigate emerging markets.
www.jforcs.com
Volume 4 Issue 1
Volume 4 - Issue 1
Supporting the Development of Veterinary Drugs, Veterinary Devices & Animal Feed PEER REVIEWED
Applying Game Theory to One Health

Modelling Veterinary Healthcare Delivery
International Animal Health Journal - Supporting the Development of Veterinary Drugs, Veterinary Devices & Animal Feed
Mastitis due to Mycoplasma bovis

Insights
Pet Obesity
Prevention is Better than Cure
Leadership Skills of
Extraordinarily Successful Executives
www.animalhealthmedia.com
Official Supporting
Associations - Sponsor Companies -
www.animalhealthmedia.com
11_IAHJ_February2017.indd 1 25/02/2017 13:37:17
IAHJ IBI
Peer Reviewed, IAHJ looks into the Peer reviewed, IBI provides the biopharmaceutical industry with
entire outsourcing management of the practical advice on managing bioprocessing and technology,
Veterinary Drug, Veterinary Devices & upstream and downstream processing, manufacturing,
Animal Food Development Industry. regulations, formulation, scale-up/technology transfer, drug
www.animalhealthmedia.com delivery, analytical testing and more.
www.biopharmaceuticalmedia.com
INTERNATIONAL PHARMACEUTICAL INDUSTRY 47
Packaging
Leave No Manufacturer Behind
part a result of the recognition that

The upcoming deadlines for EU Medical combination products are becoming
Device Regulation (MDR) and EU In
increasingly complex, making the
Vitro Diagnostic Regulation (IVDR)
compliance do not solely affect medical need for tighter regulation and control
device manufacturers. Pharmaceutical an absolute must. From here on out,
companies producing either combination ancillary device components will be
products or companion diagnostics will dealt with equally careful examination
also see their products undergo greater as purely medical device products.
clinical scrutiny as laid down in these
new regulations. This article offers
informative and practical guidance to Article 117
pharmaceutical manufacturers who are For products regulated as medicinal
new to the preparatory process required products, Article 117 states that the
to obtain a CE mark for their device. metered dose inhalers which function marketing authorisation dossier
With the regulations coming into effect as prefilled drug delivery systems, submitted by pharmaceutical
in May 2020 (EU MDR) and May 2022 as well as bone cements containing companies should include proof of
(EU IVDR), time is of the essence for conformity of the device. Proof of
antibiotic, root canal fillers containing
businesses wishing to continue trading conformity can be presented in one
medicinal substances with ancillary
their products on the EU market. of two forms:
action and intrauterine contraceptives
containing copper or silver – the list • results of the conformity
While the new regulations principally goes on. Confusion may arise when assessment of the device part,
target medical device manufacturers, manufacturers package together more in accordance with the relevant
pharmaceutical companies than one component, but which are general safety and performance
manufacturing products with a medical not necessarily dependent on each requirements of Annex I of
the MDR, contained in the
device component would be wrong to other at the point of use. For instance, manufacturer’s EU declaration
assume that they are exempt from syringes packaged with vaccines do not of conformity;
the unprecedented upheaval and constitute a combination product, as • or the relevant certificate issued
the tightening of supervision taking it is possible to use a syringe to deliver by a notified body allowing the
place across the European regulatory other drugs just as another syringe may manufacturer to affix a CE
landscape. With the global combination be suitable to administer the target marking to the medical device.
product market size expected to drug. Assessing a product’s intended
If the conformity assessment is
reach $177.7bn by 2024,1 coupled with purpose and principal mode of action missing, and requires the involvement
increasing technological innovation helps to understand why certain of a notified body, the applicant must
in the medical device market, it has products are regulated as two separate be able to provide an opinion issued
become essential to strengthen safety products rather than as a combination by a notified body designated under
and efficacy. Accordingly, the new EU product. the MDR for the type of device. This
MDR updates the requirements for opinion should demonstrate the
conformity of the device part with
combination products to address the In the European Union, combination
the relevant requirements of Annex I
regulatory gap that existed under the products are either regulated as of the MDR.
previous directives and to establish medicinal products or medical devices,
regulatory harmonisation for these depending on which component has
products. the ancillary function. As such, the EU In preparing their clinical evaluation
MDR will particularly impact ancillary reports (CER), pharmaceutical
Combination Products Must medical devices that are used to companies will most likely be
Play by the Rules administer medicinal products, for missing some of the required data
Combination products can be this represents a big change than for to demonstrate the clinical safety,
composed of any combination of an those already regulated as medical performance and clinical benefit of
ancillary drug, a device or biologically devices. The products in which the their device components. If this is the
active product. Examples of device serves as the applicator of the case, it may be necessary to carry out
combination products are drug-eluting integral drug component are currently new studies and clinical evaluation –
stents and medicated dressings, where regulated as a medicinal product under particularly for manufacturers of legacy
the medicinal component contained the EU Medicinal Product Directive devices, given that historical market
within the device coating has an 201/83/EC (MPD) but will now also fall clearance does not apply under the
ancillary purpose to the medical device under Article 117 of the EU MDR, which EU MDR. With such studies costing
claims. Other types of combination serves as an amendment to Annex I time and money, businesses should
products are insulin injector pens and of the EU MPD. This adjustment is in begin assessing which data they are

Packaging
missing to submit a complete report. are to truly understand the urgency should note that products holding a
It is important not to underestimate of getting an early start with their CE mark under the current Medical
the time it takes to complete a CER, preparations. Today, there are only Device Directive 93/41/EEC can claim
particularly for companies that are eight notified bodies available to a two-year extension so long as no
writing one for the first time and who review technical documentation changes are made to the products.
do not have CER authors available under the EU MDR. It is expected that Failing to achieve compliance within
in-house or other internal expertise. this number will rise before the end the deadline means a total removal
of the year, but regardless, companies of any non-compliant products from
will need to join a waiting line to the market. Such an outcome would
Clinical Evaluation Reports must
demonstrate that:
have their documentation reviewed. not only limit market access to the
Device-regulated products will also affected business but would also
• the device achieves its intended require a consultation between the negatively impact their company
performance; notified body and a national CA or reputation, as well as potentially
• the known and foreseeable risks, the European Medicines Agency patient treatment if no alternative is
and any adverse events, are (EMA), to assess the ancillary drug available. Pharmaceutical businesses
minimised and acceptable when
function, which may further prolong are encouraged to get ahead of the
weighed against the benefits of
the device’s intended use; the approval process. game and begin their preparatory
• any claims made about the compliance procedures as soon as
device’s performance, safety and Inevitably, it will be a lengthier possible, to avoid such unwanted
clinical benefit are supported by procedure under these circumstances consequences.
suitable evidence. and manufacturers should be prepared
for likely delays. By submitting their Companion diagnostics must go
clinical evaluation reports in a by the book
Learning the art of interpreting the
timely manner, manufacturers are Companion diagnostics are IVD
regulation, applying that knowledge
at least minimising, to the best of devices which help improve the
and developing the compliance
their capacity, the duration of the safety and efficacy of a medicinal
documentation are all things that
compliance procedure on their product by determining which
medical device manufacturing
side. With significant challenges patients would most benefit from
companies have invested much time,
to overcome and a high demand treatment, and which may experience
resources and energy into, to ensure
for notified bodies, pharmaceutical adverse effects from it. These kinds
effective regulatory compliance.
companies unfamiliar with the of devices will fall under the scope of
Pharmaceutical companies
regulatory system for medical the EU IVDR. The IVDR establishes a
investing proper resources into this
devices may wish to partner with new risk-based classification system
process will be the ones to reap
third-party specialists to facilitate which labels products according to
the long-term benefits, as having
the process and alleviate the weight risk – with Class A presenting the
accessible, up-to-date clinical data
on the shoulders of European notified lowest risk and Class D presenting the
will be crucial for the maintenance of
bodies. highest risk. Lower risk devices will
clinical records and for post-market
be assessed on a sampling basis by
surveillance activities in the future.
The deadlines for EU MDR and IVDR notified bodies, which may make their
As compliance is an ongoing activity
compliance are May 2020 and 2022 progression into the EU market faster
that lasts throughout the lifecycle of
respectively, however manufacturers than with the higher risk devices that
a device, businesses are furthermore
encouraged to incorporate a device
compliance process into their
operations as soon as possible.
Reaching out to a notified body to

get the ancillary device component
certified will be a new venture for
many manufacturers of combination
products. Previously, pharmaceutical
manufacturers of combination
products and companion diagnostics
were solely required to liaise with a
national Competent Authority (CA).
Now, pharmaceutical companies
will need to gather clinical data and
liaise with a notified body to obtain
a CE mark for the device component.
Pharmaceutical companies should
immediately be made aware of
the current shortage of designated
notified bodies in Europe if they

Packaging
documentation, manufacturers
should begin researching which
organizations will be available to
review the documentation for their
specific products area. In doing so,
manufactures can only help reduce
the inevitably long process by gaining
a place at the front of the queue.
U n d e r t h e n ew Eu ro p e a n
regulations, combination products
and companion diagnostics will be
subjected to more stringent clinical
scrutiny. Medical device manufacturers
are most likely informed about the
ins and outs of the new EU MDR and
IVDR regulations, but pharmaceutical
companies may not be as aware of the
new requirements. Their unfamiliarity
with the entire process means they
are likely to require more time for
each step. Given the overdemand
for notified bodies in the regulatory
arena, getting an early start can be
the crucial step away from product
market freeze to full compliance
and market access. Pharmaceutical
companies must take the issue of
compliance seriously and allow for
first require assessment. Companion worse, shortage of notified bodies; extra time and resources to get to the
diagnostics will be considered Class currently only two notified bodies finish line, or else face the negative
C under the IVDR and will receive a have been designated under the consequences of missing the cut-off
higher level of clinical scrutiny and EU IVDR. There are also far fewer point. Proactive organisations who
may require more time before being notified bodies awaiting designation take the long view when it comes
placed on the market. in comparison with the EU MDR. to combination products will be
Making matters worse, the IVDR With a limited number of notified well prepared to create sustainable
is experiencing a similar, if not much bodies presently available to review regulatory compliance that drives
their business.
REFERENCES
1. Drug Device Combination Product

Market Worth $177.7 Billion By 2024,
Grand View Research, May 2018
Elizma
Parry
Elizma Parry, Director, Global
Clinical Practice at Maetrics, brings
over 25 years of experience to the
Maetrics team, providing clients
with expert counsel in the clinical
practice environment. Before joining
Maetrics, Elizma occupied a shared
acting role as the head of a Europe-
based notified body. She has also
developed and presented training
courses across the UK and USA.

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Packaging
New Technological Solutions to Strengthen and

Innovate Pharmaceutical Packaging to its Next Level
stages of packaging. The primary packaging aims to strengthen the

We are living in an age where busy and stage includes the material that security of the pharmaceutical
unhealthy lifestyle has augmented the
envelops and has a direct effect on products throughout the supply chain.
growth of diseases amongst every age
group. Other than age groups, even the product’s shelf life such as vials The procedure aims to save the drug
newborn babies have been the victims and ampoules, IV containers, and from adulteration and ensures product
of chronic diseases. The pharmaceutical prefilled syringes. On the other hand, safety through the intended shelf life.
companies are now strengthening their the secondary packaging stage groups Furthermore, the packaging contains
services to meet the evolving needs of the primary packages together, such one or more barriers to enter. Moreover,
customers. However, one of the major as shipping containers, carton boxes, the packaging presents visible evidence
concerns of pharmaceuticals is product
and injection trays. Later comes the to customers, if tampering occurs.
packaging.
tertiary packaging system that is used
to handle the bulk and shipping such as Novel Laser Coding Technology:
Packaging is essential for brand container, edge protectors, and barrel. Laser coding technology has advanced
identity and customers’ trust- For these stages, several technologies the packaging system to the next level.
worthiness. However, when it is are used in pharmaceutical packaging. The innovative laser coding system
about pharmaceuticals packaging, enables glass containers to be coded
certain essentials are required to Packaging Technologies Commonly at the glass syringe manufacturer and
be taken care of. One of the various Used in Pharma: allows tracking from production to
fundamentals of pharmaceuticals end customer. The technology offers
packaging is the containment of the Blow Fill Seal (BFS): a reliable track and trace system,
product. Containment strengthens the Over the past few decades, BFS and a reduced risk of syringes and
packaging to hold the contents, protect has become predominant in the batches being mixed up. On the other
the environment’s operator from high pharmaceutical packaging industry. hand, laser coding technology proves
toxicity and product reaction, and Various medicine regulatory agencies to be effective for counterfeiters.
prevent diffusion of dust, gasses, and including the US Food and Drug Furthermore, laser coding technology
vapours. The packaging should be strong Administration (FDA) considered BFS offers a documentation tool that
enough to protect the product against to be one of the greatest forms for provides information about each
all external odds such as moisture, processing aseptic. In this procedure, a container such as fill date, expire date,
biological contamination, mechanical container is formed, filled, and sealed in and place of production. On the other
damage, and adulteration. Furthermore, a sterile, enclosed part of the machine. hand, the marked matrix code allows
the packaging is an essential source Moreover, the process is continuous the indexing of data regarding individual
of presenting information via labels for without any human involvement. The products such as production line,
the consumers. Moreover, customers process is used to produce aseptically dosage, batch, and drug specification.
look for better convenience while using sterile pharmaceuticals including
the products. ophthalmic, respiratory solutions, and Whatever type of packaging,
wound care products. quality maintenance is the topmost
With several advancements and concern for packaging companies and
new innovations in pharmaceutical Induction Cap-sealing Technology: manufacturers. There is no denial that
packaging, companies are expected This packaging technology is used to the advanced packaging procedures
to witness significant growth. generate airtight and hermetic seals have proved effective in securing
According to research by Allied Market on the top of the containers. The the product from adulteration and
research, the global pharmaceutical technology follows a principle that the counterfeiters. However, integrating
packaging market would witness the conductive material such as aluminum serialisation has strengthened
highest growth rate of 6.27% from 2016 foil heats up when it gets in contact packaging technologies. The service of
to 2022. Rising product advancements, with a high-frequency magnetic field. tracking and tracing the product has
innovative manufacturing procedures The procedure is commonly used for also strengthened the transparency
for sustainable and eco-friendly cap-sealing after the container gets between providers and end-users. On
packaging solutions, rising R&D filled. the other hand, the increased demand
investments, and emerging markets for sensitive medicines has led the
of generic drug and drug delivery are Tamper-evident Pharmaceutical companies to prepare the medicines
some of the trends driving the market Packaging: sooner with increased shelf life,
to grow. Security is vital for pharma products. stability, and secured packaging.
The brand name and fame are
To reinforce the packaging, a dependent on its privacy and security. With this concern, a company
pharma product goes through three Tamper-evident pharmaceutical named Aptar CSP Technologies has

Packaging
stepped forward with the launch of The newly collaborated companies Taking this into account, various
Xcelerate development services. The will expand their ready-to-use companies have stepped forward
pharma companies are looking forward combinations. West Pharmaceutical to bring innovative and efficient
to easing the use of medicine with Services, a solution provider for packaging services. The new
ready-to-use drugs. Recently, West injectable drug administration and a packaging solution has been
Pharmaceutical Services and SCHOTT primary packaging solution provider, launched to enhance both the
entered into a packaging partnership have merged to combine the SCHOTT packaging and distribution of
to expand West’s ready pack system. iQ platform with West’s Ready Pack temperature-based pharmaceutical
Moreover, packaging involves the System. Furthermore, the companies products. Recently, a temperature-
stability of the quality of the drug together will introduce a combination based packaging and logistic
throughout the distribution channel. of West’s components with adaptive company, CSafe Global introduced
However, certain drugs require a proper high-quality RTU glass vials by the AcuTemp Plus Series of solutions
temperature to maintain their optimal SCHOTT. Likewise, the companies for temperature-controlled shipping
significance. Approaching a solution will evolve to include other ready-to- needs of pharmaceuticals, clinical
for such medicines, a company called use combination products on a small trials, and emerging cells and gene
CSafe Global has recently launched its quantity basis. therapies. Furthermore, with an
AcuTemp Plus Series for temperature- enlarged portfolio, the new AcuTemp
based medicines. Following are the The companies announced their Plus Series will also meet the rising
activities in detail: agreement at the CPHL Worldwide demand and customer prospects for
conference and shared plans to expand quality, temperature performance,
Aptar CSP Technologies Launched West’s ready-pack -system to involve and system robustness required for
Xcelerate Development Services to SCHOTT glass offerings such as vial cell and gene therapies.
Optimise Active Packaging: formats, ready-to-use cartridges, and
The new technology will expedite pre-fillable glass syringes. The vice The high-performance ThermoCor
the packaging process for sensitive president and general manager at Vacuum Insulated Panels (VIP) have
medicines. Aptar CSP Technology, West, Mike Schaefers, stated that the been used to design the AcuTemp
a material science and advanced company understands and appreciates Plus Series of the packaging solution.
packaging service provider, recently the need to provide ready-to-use, The VIP provides end-to-end control
introduced its Xcelerate development high-quality, sterile packaging products of internal payload temperatures.
services to optimise active packaging in small volumes for both clinical and Furthermore, the range offers multiple
development procedures with expert developmental phases. He further temperatures and size configuration
insights and increased speed-to- added that their partnership with profiles along with various integrated
market. The packaging service is SCHOTT now offers their customers track and trace choices. Moreover,
designed to detect moisture and high-quality glass containment the AcuTemp Plus Series is powered
oxygen sensitivity in drug products options with Ready Pack System. On with an end-to-end service setup
through stability studies. Furthermore, the other hand, the vice president at with REPAQ, CSafe’s reuse and retest
it determines certain environmental SCHOTT Pharmaceutical Systems, programme.
conditions such as relative humidity, Fabian Stöcker, signified that the easy
temperature, and oxygen levels of the and fast access of ready-to-use vials The CEO of the company, Patrick
product and then forms a theoretical and components provides flexibility in Schafer, stated that the company
package design. Moreover, the the drug development and production is pleased to expand its cold chain
company’s vice president of business process and improves the user’s safety packaging for the cell and gene
development, Craig Voellmicke, as well. Later he said that both the therapy market. He further added
signified that their complete solution of companies have partnered to provide that they have focused on R&D to
material science and active packaging a risk-free containment solution that advance their solutions for meeting the
solutions, and the newly introduced meets with the regulations across the requirements of the highly in-demand
Xcelerate developments services, world. medicinal products. Furthermore,
provide enhanced stability, prolonged the new AcuTemp Plus Series shows
shelf-life, and accelerated time-to- The companies have tested the impressive results with temperature
market for sensitive medicines. Further, combination of SCHOTT’s high-quality performances.
he added that the combination provides ISO vials with high-end sterilised seals
effective drug protection and ease of and stoppers by West. Expanding this Pharmaceutical Packaging Conserves
adoption. concept for other primary packaging the Veracity of the Drugs:
containers including ready-to-use There is no denying that the pharma-
West Pharmaceutical Services and syringes and cartridges will benefit ceutical industry is witnessing massive
SCHOTT Packaging Solutions to Merge: their customers as well. competitions amongst companies
The advancements going through the for developing and marketing of the
packaging companies have influenced CSafe Global to Enlarge their Packaging drugs. Moreover, the achievement of
the contracting between pharmaceutical Portfolio with the Launch of AcuTemp the pharmaceutical industry will only
companies and packaging companies Plus Series: be achieved when the packaging meets
to strengthen both their services and Several pharmaceutical products the requirement of its customers
product security. have temperature-controlled needs. without compromising the standard

Packaging
and quality of the product. Precise governmental regulations have urged the production of the same drugs.
packaging ensures the distribution increasing competition amongst the However, perfect packaging not only
of the product at an optimal state packaging companies to uphold the improves safety but also increases
and saves the product from harmful highest medical standards. the ascendancy of the drug. Packaging
environmental conditions such as light adds value to the product, prevents
and moisture. Apart from this, labelling the product counterfeiting, and simplifies its use
is a crucial part of pharmaceutical for consumers. In addition, it increases
From research to the marketing packaging as it presents the necessary the brand’s significance, increases
of the product, packaging plays an information. However, pharmaceutical customer’s preference and offers
important role. Packaging protects companies have been through profitability. Moreover, with safe and
the drugs from physical, chemical, astonishing advancements. Moreover, reliable packaging, pharma companies
and biological damages and improves packaging companies have adopted ensure the benefits reach toward their
the adherence of the medication. the latest technologies to improvise customers.
Moreover, technological developments drug packaging. On the other hand,
have advanced pharmaceutical they have followed the trend of
packaging such as state-of-the-art passing contracts with the packaging
technology that guides the users industries. Furthermore, the demand
regarding useful information such for packaging of delicate medicines has Akshita
as proper amount, timings, and led packaging companies to expand
conditions of the dosage. Conversely, their packaging portfolio, providing Pacholi
the integration of tracking and several options to pharmaceutical
Akshita has a Masters degree in
tracing technology in pharmaceutical companies.
English Literature and presently
packaging not only fuelled the
is working as a content writer
trust of its customers but also The packaging companies serve as with Allied Market Research.
increased the transparency between a guard that protects the product and She loves reading, writing short
the manufacturer and customers, maintains its factual characteristics. Most stories, poems, and blogs. She is
throughout the distribution chain. importantly, packaging strengthens a selective sports’ admirer and is
Furthermore, the rising demand for brand preference. Mostly, pharma- curious to learn new things.
sensitive medications and certain ceutical companies compete due to

Packaging
Delving Deep into FMD

An Interview with Marietta Ulrich-Horn and Werner Horn of Securikett
on Creating an Integrated Packaging Solution
Q. With the rise of digital automation It is of key importance Since the FMD and other global
and technological proliferation, there to us that we maintain regulations require unique codes and
is a greater need than ever to offer a our patients’ safety and batch and expiration dates, these
one-stop shop for both physical and rule out any substandard transparent and translucent labels
digital product security, to create drugs in the market. Not work very well, to be placed just on
an integrated packaging solution only are patients with low income top of any such information, both on
approach in the pharma sector. affected by these ‘falsified drugs’, varnished and unvarnished surfaces. In
Can you tell IPI as to how you use a but it also has an impact on online particular the so called “VOID” effect,
‘one-stop shop’ framework to meet shoppers browsing the web for displaying a lock-sign, the word “OPEN”
the growing demand for a digitalised cheaper alternatives. Not to mention or text in any language or alphabet, has
pharmaceutical product packaging that illegal medicines have already become a favourite among many of our
market? penetrated the official supply chain customers.
in Europe, which gave the stimulus
The term ‘physical for the Falsified Medicines Regulation In 2019 we opened an innovative new
and digital security’ in (FMD) by the EU. adhesive coating line at our premises in
pharma means secure Austria. This line has further improved
tamper-evidence that Our secure seals, with their the performance and workability of
is connected to a single customised, specific void effects, are these seals.
item identification via a printed unique used not only for tamper verification,
identifier code. Why should customers but also as a means against copying. Q. Known as the ‘smart packaging
use secure tamper-evident packaging, These labels would be very difficult to evolution’, pharma has seen its raw
you might ask? Well, put simply, if a reproduce, in particular the translucent materials, primary, secondary and
simple seal without any protection shades, which can be placed over text tertiary packaging undergo a self-trans-
against copying or cloning is used, any and the unique identifier, without formation to reduce cost, unburden the
fraudster could make a replica of that obstructing readability. So far, we did logistic chain and increase invisibility.
package, reprint the code, and sell it not encounter any useful copies in the With the compilation of individual
as an original. To deter fraudulence, market. smart packaging functionalities in the
Securikett has created secure tamper- market, how can companies capture
evident sealing labels, and in addition Q. Since the Falsified Medicines value from the smart packaging
offers the unique identifiers and Directive entered into force in evolution to transform supply chains,
related services. For example, a unique February 2019, the primary objective product integrity and customer
identifier, created by the CODIKETT® of the directive was to prevent experience?
system, can be activated for various counterfeit medicines from entering
uses in a heavily digitised era. These the legal supply chain throughout Smart packaging typically
physical and digital product security the EU, leading to the manufacturing requires an unpredictable
systems have a variety of functions and of FMD-compliant pharmaceutical unique identifier (UID). In
the same code can also “talk” to users, packaging products. What measures is the world of IOT each device
for information and communication, Securikett undertaking to ensure that has its ID (MAC address),
whilst remaining compliant to the their products are using the application which enables it to communicate with
Falsified Medicines Directive (FMD). of tamper verification features, that others.
do not compromise the readability of
Q. Maintaining the right product statutory information? For packaging to become smart,
security strategy in the pharma usually a printed code or an integrated
sector can often be thwarted by the Long before the FMD was RFID or NFC chip is required, which
counterfeit pharmaceutical packaging first published in 2011, we carries the UID. Even the identifier,
market which creates ‘imitation had started to develop prescribed by the FMD in the form
packaging products’ that are of poorer a toolbox of transparent of a simple data matrix code, can be
quality and do not meet the stipulated and translucent security used as a starting point for individual
safety standards. How does Securikett seals. These labels are of a technical smart packaging functionalities. Thus,
use anti-counterfeit packaging to not nature and thus in many countries are this code becomes multifunctional –
only prevent brand imitation but also not considered as part of the print we call it the “code in code” approach.
enable brand protection and create and other packaging features. Our It can then be used for track and
ease for customers to distinguish customers appreciate this, as quite trace throughout the supply chain,
between original and counterfeit often they do not have to re-register consumer communication, or to check
products? their packaging. out for parallel trading.

Packaging
It is also important to protect that Indeed, when it gets to cartons, while avoiding a mix of plastic
code against code-cloning by other “safety first”, environmental and paper.
means of security. This can be done aspects often have come
physically in the print of the code second in the past, or At Securikett, innovation is key.
itself, in the packaging or by the secure have been disregarded in There will be more solutions ahead of
tamper-evident seal. Other means pharmaceutical packaging. And then, us, as the consideration of long-term
against code cloning are digital, such after “safety” came “convenience”. It sustainability has gathered momentum
as establishing safe user entry points is not easy to get these aligned with over the last few months. Innovation will
for the scanning process. “environmental sustainability”. lead to improvements but regardless,
patients’ safety should still be
Today at Securikett, we not only Being providers of labels and seals, considered.
print codes as QR or Datamatrix, we we look at the particular waste recovery
also store the unique identifier in process of each type of packaging,
an NFC (near field communication) together with the seals. These waste
chip, to address users directly and collections and treatments today
easily. Our secure cloud solution unfortunately differ from country to Werner
CODIKETT® offers many features to country, or even region to region.
use codes within and beyond legal Horn
requirements. As sealing labels typically are small,
Werner studied economics
the amount of material is comparatively and holds an Executive MBA.
Q. The drive for sustainable packaging little, as compared to other packaging As co-founder and CEO, he is
innovation has become increasingly components. Seals can replace a larger particularly responsible for the
apparent, as more packaging cellophane wrapper to guarantee a international sales organisation
companies are expected to be product’s integrity. of Securikett, a company offering
transparent with business practices, a wide range of smart packaging
especially with the impact they have However, self-adhesive sealing solutions: complex security labels for
physical product protection, and the
on the environment. With a thin labels are supplied on a liner, which digital cloud solution CODIKETT®
line between ‘safe and sustainable’ should be recovered by collection. for consumer communication and
packaging solutions in the pharma And recently, we have introduced our track & trace in global applications.
sector, how can companies create innovative linerless translucent “VOID” Today Werner’s expertise includes
safety-compliant products that tapes. Linerless paper-based “VOID” encompassing knowledge of
match their customer’s needs, whilst tapes to seal shipping cartons are on product security, supply chain
integrity and consultancy in
addressing environmental concerns at our R&D road map. They would enable
risk management related to
the same time? tamper-evident taping of shipping counterfeiting and illicit trade.
Dr. Marietta
Ulrich-Horn
Marietta holds a PhD in philosophy
and an Executive MBA. She
is co-founder and CEO of
Securikett where she leads the
R & D department. Marietta has
been delegated by the Austrian
Standards Institute to actively
contribute to the emergence
of international standards on
authentication, traceability by UIDs
(unique identifiers), tax bands and
tamper-evidence. She was project
leader of ISO 22381:2018 “Security
and resilience – Authenticity,
integrity and trust for products
and documents – Guidelines for
establishing interoperability among
object identification systems to
deter counterfeiting and illicit
trade”. Marietta also contributed to
shaping ISO 21976:2018 “Packaging
– Tamper verification features for
medicinal product packaging”.

Logistics & Supply Chain Management
Securing the Pharma Supply Chain: A Look Back at

How We Got Here and Where We’re Going
the drugs for sale on the internet are supply chains complies with the laws
As we begin 2020, the push for fake, principal among them ‘lifestyle on the books?
serialisation and traceability – assigning
medicines’ such as Viagra and Cialis.
unique identifiers to individual packs
of medications and being able to There is large-scale counterfeiting of The answer is serialisation
track them one by one or in larger antimalarials and antibiotics, and there’s and traceability. And that’s why
aggregations – in the pharmaceutical been an uptick in fake cardiovascular governments around the world have
supply chain continues in earnest. New and cancer medicines. In February of begun mandating it, with the goals of
global regulatory changes are due this last year, for example, the WHO issued increasing awareness of fakes, purging
year, and manufacturers, distributors,
a global warning about counterfeit them from markets, and being able to
and all other industry stakeholders
should be working to lock down their
Iclusig, a drug used to treat two types trace drugs back through the supply
supply chain operations, not only for of leukaemia in adults. The fakes did chain to a legitimate manufacturer.
the sake of compliance, but to continue not include the active ingredient;
the fight against counterfeit drugs. instead, they contained paracetamol Serialisation as the Law of the Land
(acetaminophen). The IQVIA report I referenced earlier
Achieving serialisation, let alone said the US pharma market reached
end-to-end supply chain traceability, Deaths attributed to falsified $485 billion in 2018, a 5.2% jump over
requires several things of manufacturers. medicines top 1 million annually; some 2017. It further predicted that pharma
First, they must understand why estimate that 250,000 children die every spending in America would reach
unit-level identification and tracking is year from taking fake drugs intended $625–655 billion in 2023, a 4–7%
so critical; only then will the full scope to treat malaria and pneumonia. Most compound annual growth rate over
of their value become clear. Next, they deaths occur in countries where this five-year period.
must keep abreast of the worldwide demand for drugs is high, but the supply
regulatory landscape, including new chain isn’t secured by government The growth has obviously been
and pending laws, timetables for regulation and industry oversight and tremendous. Just seven years ago,
enactment, and delays, both anticipated quality control. in 2013, the US market was valued at
and unanticipated. Last, they must be $332 billion. It was in November of
prepared to address challenges as There’s consensus that most that pivotal year that the Congress
the pharma industry evolves and the counterfeit and substandard enacted the Drug Quality and Security
demands on its supply chain become medicines are manufactured in China Act (DQSA), Title II of which is the Drug
ever more stringent. and India. The truth, however, is that Supply Chain Security Act (DSCSA).
they can come from anywhere. And This legislation amounted to formal
Let’s take a closer look at each of though it’s important to acknowledge government acknowledgement that
these. Serialisation is here to stay, so and address where bad actors are America’s ever-growing pharma market
taking stock at the beginning of the working, when tests of fake drugs needed sweeping change to help
New Year should inspire all of us to reveal fentanyl, arsenic, printer ink, protect consumers from counterfeit,
renew our commitment to secure the paint, and other deadly ‘ingredients’, stolen, contaminated, or otherwise
pharma supply chain, protect patients, the pharma industry must batten harmful drugs.
and make the industry the absolute down its own hatches, starting with
best (and safest) it can be. its supply chain, and deal with this The DSCSA is a 10-year plan to build
global issue. an interoperable electronic system to
Why Serialisation is Important identify and trace the distribution of
According to a January 2019 report Although reputable manufacturers drugs in the United States. It’s also
from the IQVIA Institute for Human and their trading partners strive to do designed to help detect and remove
Data Science, the global market for good work, ingrain precautions in their potentially dangerous drugs from
pharmaceuticals will reach $1.5 trillion processes and operations, and aim to the supply chain. Its first phases
in 2023. That’s a staggering number, serve the public health, how can they dealt with manufacturers, then
but it probably doesn’t surprise you. be sure everything entering their supply expanded to downstream trading
What might give you pause, however, chains is legitimate? How can they be partners, the ultimate goal being
is the extent to which falsified and sure what’s happening before, during, unit-level serialisation and end-to-end
substandard medical products continue and after production – from ingredients traceability in a digital pharma supply
to proliferate in our markets and the to delivery to end users –remains chain by 2023.
breadth of the damage they’re doing. unsullied?
Progress has been good. In 2019
The World Health Organization How can they demonstrate to Update: Barcode Readability for DSCSA
(WHO) reports that 50 per cent of regulators that every node of their 2023 Interoperability, GS1 reported

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to go on a tour of this amazing space in 360 degrees.

impressive results with ‘The Big Three,’ minimum, a GTIN, an expiry date, and serialisation and end-to-end traceability
AmerisourceBergen, McKesson, and the batch/lot number. This information is new to most industries, including
Cardinal Health – especially when must also be printed on labels. All pharma. And when you’re blazing
compared with tests in 2017 and 2018. transactions for drug packages must trails, you should expect challenges.
AmerisourceBergen scanned 1545 be reported to a national Drug Track & By amassing knowledge and being
packages from 270 manufacturers, and Trace System, and all manufacturers prepared for challenges in three key
71.9% had a readable 2D barcode with licensed by the Saudi Food and Drug areas – regulations, data quality, and
all four DSCSA-required data elements Authority must acquire a Global emerging technologies – you’ll be better
(up from 7.2% and 20.4% in 2017 and Location Number (GLN). able to shape the supply chain through
2018, respectively). Of the 16,314 which your products travel.
packages from 477 manufacturers In Brazil, the sixth-largest pharma
McKesson scanned, 71% had a readable market in the world, the Brazilian Navigating Regulations
2D barcode with the required data Health Regulatory Agency (ANVISA) has Governments have created laws
elements (20.8% in 2018 and 6.5% in been working on a National Medicine such as the FMD and DSCSA to
2017). Cardinal Health scanned 19,444 Control System (SNCM). As in the EU combat substandard and counterfeit
2D and linear barcodes on 7996 cases and US, every product must have a 2D drugs and protect consumers. But
from 177 manufacturers; of these 78.7% barcode with four data points. The next just as we should expect public
with 2D barcodes and 73.3% with linear major milestone is in October 2020, sector involvement in something as
barcodes had all four data elements when manufacturers must be able to important as the drug supply chain,
(up from 15.1% in 2018). serialise one-third of their products. we should be prepared for ‘hiccups’
in their processes. As we’ve seen,
In the EU, where IQVIA reported that Russia, by far, will have the world’s deadlines and requirements change,
the pharma market reached $182 billion strictest serialisation requirements. and guidance can be confusing.
in 2019 and would jump to $195–225 If implemented as planned, the
billion by 2023 (a 1–4% compound regulations will require all medications, Through all this, however, one
annual growth rate over five years), including over-the-counter medications, mantra applies: Always be preparing.
the European Parliament and Council to be serialised and traceable. This is a Regardless of what regulations say,
released the Falsified Medicines major departure from the global status you must always be working toward
Directive (FMD) in 2011. Unlike the quo. However, as recently as August an optimised, flexible, and secure
DSCSA’s phased approach, FMD went of last year, the country announced supply chain. It’s an expensive
into full effect all at once in February changes to the law, the most significant journey; manufacturers have to
2019. Its goal is essentially identical, of which cut the length of the crypto invest in hardware (equipment) and
however: improving patient safety code required on all medicine packaging software (serialisation and traceability
by mandating market authorisation from 88 to 44 characters. The decree solutions), keep updated, and make
holders and manufacturers to put also changed options for including sure everything is interoperable and
a system in place that will prevent batch numbers and expiry dates in 2D connected. Distributors have to have
falsified medicines from entering the barcodes and updated guidance on edge systems that can read barcodes
legal supply chain. That system is tamper-proof packaging. and connect with their solution
the European Medicines Verification providers. But this is the price of doing
System (EMVS), which should As these examples make clear, business.
guarantee every drug’s authenticity via serialisation is a global movement,
an end-to-end verification. with more and more countries Getting Serious about Data Quality
accepting responsibility for eliminating It’s impossible to overstate the
The EMVS verifies unit-level substandard and counterfeit drugs importance of accurate data in the
serialisation using four data elements through a regulated, interconnected pharmaceutical supply chain for the
similar to those mandated by the US digital supply chain. The not-so- purposes of patient safety, serialisation,
legislation. In addition to a lot number subtle subtext for manufacturers is traceability, and compliance. Without
and expiry date, every unit must have that companies won’t do business accurate data, your products might
a Global Trade Identification Number with you if you’re not being proactive not reach your customers, or they
(GTIN) and a randomised serial number. about entrenching serialisation and might fail to meet global market
(Serial numbers in the US do not have traceability in your supply chain requirements. Without accurate data,
to be randomised.) operations. This is why it’s important to you jeopardise pharmacovigilance,
follow the global regulatory scene and including combating falsified
So, the EU and United States have keep up to speed on where technology medicines. High-quality data is
established strong precedent for supply is taking the pharma industry. Which also the foundation for analytics
chain security through serialisation brings us to our last point: Being and data-driven technologies such
and traceability. Now, other countries prepared for challenges. as artificial intelligence (AI) and
are following suit, chief among them blockchain. If the data is bad, then
Russia, Saudi Arabia, and Brazil. Saudi Facing the Future: Will You Be the output from these systems will
regulations, for example, stipulate that Ready? at best be suspect and can affect
all drugs must be marked with a GS1 In the grand scheme of things, a all manufacturing and supply chain
data matrix barcode that contains, at digital supply chain with unit-level activities.

such as being able to predict demand

for products and identify supply chain
bottlenecks. For AI to deliver on its
promise, however, it needs a lot of
high-quality data. As serialisation
systems originated as a response to
meet government mandates, a single
company may not have access to
enough data. Though some vendors
have access to a broader set of data,
be sure to understand their data
privacy policies — your company’s data
may become part of their data mining
efforts.
So, learn the pros and cons. Allow

yourself time to assess your current
Invest the resources to understand supply chain serialisation solution, it’s and future needs. Don’t, however,
data quality standards and embrace all too easy to jump on the bandwagon be passive. Proactively seek solution
the people and technologies that before you have the information you providers that will explain things clearly
ensure everything comes together need to make the right decisions. and can demonstrate that they’ll
in your supply chain. All of these Three emerging technologies illustrate prioritise your best interests. Ask about
elements have to work in concert for my point: the internet of things (IoT), pilot programmes or other ways you
your products to reach their markets blockchain, and AI. Each undoubtedly can minimise risk while putting the
safely and on time. has benefits you might want to technology through its paces.
consider; whether they’re right for you
Understanding the Value of is another matter. Final Thoughts
Serialisation Serialisation and traceability are
Serialisation is the future – indeed, IoT collects real-time information rightfully at the industry forefront as
the now – of global compliance, and from outside the walls of your we move into the 2020s. To secure
you’ll be out of business if you don’t organisation. For pharma, this is often the pharma supply chain, work with
adapt. Still, some wonder, beyond associated with cold-chain monitoring. reliable companies who can survey
compliance, what can serialisation do Among other things, IoT devices can the regulatory landscape and keep you
for me? There’s a one-word answer: provide real-time alerts if temperatures compliant, even as governments change
data. approach harmful levels, if a high-value their schedules and expectations.
shipment deviates from a prescribed Choose solution providers who will
Data is integral to pharma, and route, or if a sealed shipment has been advise on technology clearly and
serialisation yields the kinds of opened. But because they can transmit earnestly, can show the full scope of
powerful granular data that will data every few seconds, you must be the value it brings, and will position you
advance and improve the industry. ready to handle massive amounts of for success no matter what challenges
For example, when all your products data. arise. But most important, don’t wait to
are serialised, you can monitor and take the long view: focus on securing
maintain a safe inventory, ensuring Blockchain, the technology behind your products and supply chain now.
patients always have drugs while Bitcoin that promises a ‘world
eliminating overstocks. Furthermore, without middlemen’, has generated
as data analytics become the most a lot of buzz. For use in supply
important factor in determining how chains, it holds vendors and partners
drugs are developed, tested, marketed, accountable for their actions, and can Glenn
and delivered, rich supply chain data make management more efficient
will guide where your company goes by reducing inconsistencies and
Abood
and help future-proof your operations. uncertainties. Still, leading researcher Glenn Abood is the founder and
Serialisation also helps make Gartner reported in October 2019 that CEO of rfxcel. He was compelled to
high-quality data readily available, a ‘most enterprise blockchain projects start the company in 2003 when he
benefit that cannot be overstated as are stuck in experimentation mode’ and realized consumers couldn’t check
the industry faces new demands and ‘blockchain technologies are still five the authenticity of their prescription
considers adopting new technologies. to 10 years away from transformational drugs. Since then, he has overseen
the development of leading-edge
impact’.
serialization and track and trace
Cultivating the Right Attitude about solutions that are at work across
Emerging Technologies AI offers the capacity to use a variety of industries, including
The allure of new technology is computer systems to discern new pharma, food and beverage,
compelling. It can be overwhelming. information companies can use in government, and consumer goods.
From the phone in your hand to a virtually any aspect of their operations,

Pharma Ocean Freight Enters New Waters – Part 2
very well with other studies that have but historically it could have been
Doesn’t a lot of pharma already travel been carried out. For example, figures faster. Firstly, it doesn’t help that
by sea? from the WHO indicate that the use of pharmaceuticals account for just a tiny
Indeed a high proportion of pharma
ocean freight can reduce the cost of proportion of temperature-sensitive
is, and always has been, dispatched
by sea. At least when measured on a vaccines transportation by up to 80%. and an even tinier proportion of ocean
volume basis. But it’s mainly the easy In fact, the WHO has figures showing freight traffic (around 0.1%). It’s hard to
stuff, mostly non-cold-chain logistics. that an ocean reefer that is just 10% get away from the fact a shipping line
This business is of a highly competitive full can still be around half the cost of can earn nearly as much from shipping
nature and the shipments are usually the equivalent airfreight. a reefer full of relatively low-value
no more than general freight standard. citrus fruit as it does from shipping a
This is not Poseidon’s market. The stark
I presume these are direct savings. reefer-load of high-value medicines.
reality is that pharma shippers spend
about eight times as much on air freight Are there any indirect costs or Why would a carrier want to take the
as they spend on ocean freight. This savings to be considered? risk? And there are a lot of reasons
suggests that the scope for cost savings At Poseidon, we have seen that why pharma companies recoil from
through converting more sea freight to sometimes a bit more needs to be sea freight, including a basic managerial
air freight is huge. spent to provide a ‘bullet-proof’ inertia that is fuelled by misinformation,
freight solution. But, at the same time misunderstanding and fear of change.
If sea freight is cheap, reliable and there is little doubt that the synergies, Another major factor relates to the
sustainable, do we need air? efficiencies and innovations that outsourcing of logistics to 3PLs who,
Ocean freight is a much more reliable come out of the Poseidon team-based quite simply, make more money out of
and stable delivery mode for most approach will more than compensate air freight. But the biggest reason why
pharmaceuticals. But at the moment, for these costs. This is certainly the ocean freight is not the default mode
air freight is often the ‘shipping default experience of other integrated supply of transport for cold-chain pharma is
mode’ by pharma companies. They are chains, whose participants have often down to poor logistics planning. Good
comfortable with air freight and air been surprised by the scope and scale logistics planning seems to be pretty
freight needs less planning. However, of collaborative efficiencies. So we obvious, but the pharma industry really
it is enormously more expensive than can expect the 70%+ levels of average seems to struggle with this.
sea freight. And it is dramatically less savings to be maintained.
reliable, mainly on account of the And it should be realised that,
number of hand-offs involved and the But that’s just the start. Although until the formation of Poseidon, there
fact that the product can be exposed the up-front financial costs of sending has been no representative body
to widely varying ambient environments pharma by ocean freight are typically pushing and protecting the interests
during a journey. Air freight should around 30% of the cost of sending the of sea freight. Pharma ocean freight
only be used where a shipment is: a. equivalent ocean freight by air, this is does not have a central body such
extremely time-sensitive, b. needed actually just the tip of the cost-saving as IATA pushing its agenda. As air
urgently, c. such a small volume that iceberg. At the end of the day it is the freight increasingly mobilises to
it wouldn’t make sense to ship it 'door-to-door' and 'whole-life' costs protect its lucrative pharma business
otherwise, or d. not served by a viable that really matter. And this means with projects such as the IATA CEIV
ocean lane. This does not spell the end taking into account the consequential Certification scheme, ocean freight is
for air freight. Far from it. An optimum costs of poor cold-chain management. going to struggle to sustain its recent
solution for many situations will be a For example, in practice, the overall momentum unless it becomes better
multi-modal one and in other cases, cost of a typical temperature violation organised and co-ordinated. Ocean
air freight will be always be readily is not the cost of ruined or impaired freight needs to discard its ‘low-value’
available for back-up and emergency product (mainly due to 'stability budget’ image and get ready to handle complex,
purposes. dispensations) but the cost of the highly sensitive biologics.
associated reporting, root cause analysis
Tell me more about ocean freight and CAPA. The cost of these mandatory Is Poseidon doing anything to combat
cost savings. obligations has been reported to range poor logistics planning?
A recent analysis by Poseidon of the from $3000 to $10,000 for every single It certainly is. As I said, poor planning
primary cost savings from switching excursion; a figure that translates into is at the root of the entire problem.
from air freight to sea freight showed $multi-billions at an industry level. Because, although the pharmaceutical
that most pharmacos that have made market is totally dependent on having
a reasonably sizeable transition are Big savings; why is the trend from air the right product in the right place at
enjoying average overall cost savings of to sea not faster? the right time, the drug manufacturers
just over 70%. This figure of 70% tallies It is a rapidly accelerating shift now have generally concluded that logistics

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is not a core function or business towards biologic medicines gains freight on a tonne/km basis. Road
strength. This has meant that logistics momentum. transport is also extremely poor as
is being outsourced to third parties we all know. Transitioning pharma
which has served to reinforce a strong The problem is not that the transportation away from air freight
silo mentality. And despite what you technology doesn’t exist to ensure towards more environmentally-benign
might hear from air freight vendors, the safe transportation of pharma modes is something that can be done
a big proportion of the pharma that products, it’s more about resistance relatively quickly.
is currently being sent by air is not to change and the fact that a sizeable
particularly time-sensitive (although industry has sprung up that makes Poseidon has undertaken some
some pharma products, of course, do money out of the status quo. I am large-scale field pilots. Tell me more
have short therapeutic lifespans); it of the opinion that this scale of about these.
simply ends up skywards because of detriment is completely untenable for Poseidon is nearing completion of a
poor planning. an industry producing life-preserving series of large-scale pilot studies, both
medicines and, for this reason, field and static, that taken together,
It’s not that pharma manufacturers Poseidon is adopting a ‘duplex‘ form one of the largest pharma
don’t have data or don’t plan. Of course approach to product protection. This ocean freight exercises of its type
they do. The issue is more about the uses a rigorously tested combination ever undertaken. The result is that
failure to share the information – of active protection (refrigerated we have an unrivalled set of data for
demand data, production data etc. reefer) and passive redundancy this type of shipment. These ‘proof-of-
– that is needed for efficient logistics (thermal packaging) to provide a concept’ field trials have involved the
planning. This internal information fault-tolerant thermal management rigorous monitoring, door-to-door, of
hoarding mirrors the lack of data sharing system. This inbuilt resilience of this multiple refrigerated container-loads
that bedevils the external logistics ‘belt & braces’ system together with containing different product types.
process. Problems and inefficiencies an end-to-end product surveillance These have been very demanding
always occur at the interfaces, the system makes ‘zero excursions’ a intercontinental shipments conducted
points where two departments or practical proposition. The benefits of during both summer and winter
two companies come together. This which in terms of reduced whole-life seasons. Different reefer types, thermal
is where communications break down costs, reductions in investigative packaging solutions, data logging and
and responsibilities become blurred; a operations, increased product safety geo-positioning devices have all been
recipe for sub-optimal performance, if and overall peace of mind, will be put to the test and the routes were
not disaster. The Poseidon collaboration immense. specially selected and configured to
model is explicitly designed to break introduce as much stress and rigour
down these invisible barriers and we How important are the sustainability into the tests as possible. Multiple
are working with our IT partners to benefits of sea freight? transport modes including ocean,
develop a digital logistics platform that The sustainability of freight is an inland waterway, rail and road, were
positively incentivises good planning. elephant in the room and the question included along with transhipments and
When logistics buyers can visibly see of the relative eco-damage of different enforced reefer powerdowns. A very
the effects of bad planning on their transport modes is a huge, and rapidly thorough programme.
bottom line, you can be sure they escalating, issue. The time has now
will start to work in a more organised arrived (just look at all the alarming Can we see the results?
manner. Good planning is not just news reports) when this large mammal The Poseidon pilot reports are not in
about having data, it’s about the right in the corner cannot be ignored any the public domain but are available,
people having the right data, in the longer. The fact is that air freight is more free of charge, to pharmaceutical
right place, at the right time. than fifty times more environmentally manufacturers that join the Poseidon
damaging than the equivalent sea network.
How can Poseidon offer ‘zero
excursions’?
Estimates of the losses attributable
to temperature excursions are stated
in the billions of dollars, with some
sources reckoning that around 4% of
pharmaceuticals do not arrive at their
destination in usable condition as a
result of temperature degradation.
Whatever the exact figure, the
losses are huge. For any high-tech
business sector these losses would
be unacceptable, but for the quality-
conscious and safety-driven pharma
sector they are nothing short of
disastrous. These are figures that I
believe could escalate as the trend

How does the Poseidon model sit to ocean freight for smaller pharma
with digitalisation? producers. We have an LCL pilot
The realities of global pharma freight project currently underway and we are
movement with its hugely fragmented working closely on this with a number
composition, regional infrastructure of Poseidon pharma companies. Alan
limitations, tight regulatory oversight Kennedy
and reliance on human interventions Where is Poseidon at in introducing
means that pharma logistics will not commercial ocean freight services? Are With extensive cross-sector
lend itself easily to lowest-common- these imminent or still a long way off? experience, Alan is focused on
denominator digital logistics based The answer to this is “neither”. The bringing best-collaboration practice
on algorithmic intelligence and theme of our 2019 Annual Poseidon to pharma-logistics. He is a supply
arms-length "digital forwarding". Forum which took place recently at chain consultant specialising in
the Port of Antwerp was “Materialising supply chain dynamics and is founder
Instead, the onset of digitalisation is
and Executive Director of Pharma
going to create a critical role for a new the Vision”. Our goal is to introduce
TEAM-UP, a non-profit initiative with
breed of forwarder in buyer-driven our first commercial services in 2020
the goal of fostering closer supply chain
niche markets such as pharma; a after we have completed our pilot integration. He is one of the principal
role in which strategic partnerships, projects and finished our programme architects behind the Poseidon
customisation, added-value, agility/ of preparations. program, which has been conceived to
flexibility, quality, know-how and radically transform the transportation
a seamless end-to-end focus will What next? Air freight? of pharmaceutical products by sea.
form the path to real business Indeed, there are many Poseidon This is being achieved through the
sustainability. participants that would welcome the application of contemporary supply
Poseidon programme being expanded, chain best-practice and structured,
Notwithstanding the power of or augmented, by an air freight service multi-party collaboration. He has
that operates in a similar manner. served on many industry committees
digitalisation, it is vital that forwarders,
and working parties including the Main
big and small, embrace not just new This would undoubtedly be in the
Development Committee of the UK
technologies, but new business models best interests of the pharmaceutical
Government-sponsored “Integrated
like Poseidon that add value, create shipper, who is more interested in Collaborative Working Toolkit" where
differentiation and have the potential safely transporting its products than he chaired its Integrated Supply Chain
for a transformative effect on the shoring up redundant freight modes. Working Group and originated its
market. Without this, the new digital Integrated Supply Chain Workbooks.
age will end up as nothing more than a But for the foreseeable future, He regularly presents on this topic and
race to the bottom. In fact, it will be a Poseidon will continue to push ocean has authored numerous papers.
race where the first casualty is quality freight as the preferred long-haul
transportation mode for medicines. Email: [email protected]
(read "patient safety") and the second
casualty is profit (read "survival"). I must, however, make it abundantly
clear that this is not a ‘daggers at
Zero temperature excursions. Is this dawn’ contest between air freight
a realistic goal? and sea freight. There will always be a
Absolutely yes. We already have healthy demand for pharmaceuticals
David
the technology to deliver effective to be transported by air, whether it’s Bang
cold-chain management at an for emergency needs, because of
affordable cost. The repeated failure genuine product time-sensitivity or David has held various leadership
of the industry to maintain the thermal simply because there are no viable sea positions in the healthcare logistics
industry. In 2005 he co-founded
integrity of the cold chain is more routes available. However, on account
LifeConEx, a joint venture between
about cultural issues than technical of its cost, its inherent risks and its
DHL and Lufthansa for bio-pharma
issues. The Poseidon field pilot studies extremely high carbon footprint, air logistics. In 2006 he became the CEO
have been actively collecting the robust freight should never be seen as the and went on to grow the start-up
data to verify its claims in this respect default mode for pharma products. into a globally recognized provider
and there is no doubt whatsoever that of temperature-managed logistics
the Poseidon’s ‘goal zero’ is a realistic Final comments? solutions with a half billion-dollar
target. The Poseidon programme will not only revenue from 100+ stations in 65
serve to accelerate modal shift; it will countries. David has served on the
Will you be providing groupage cause the industry to question the Board of Rx-360 and since March
services? validity of the logistics status quo at 2019 has been a Member of the
A key objective of the Poseidon the present time. Poseidon is not just Board at MaxQ Research, a leader
in revolutionary shipping systems
programme is the provision of a about modal shift, it’s about fitness
for sensitive biologics. David is also
GDP-compliant LCL (Less than for purpose, efficiency, transparency
Global VP Strategic Development at
Container Load) service that will and, above all, safety. With so much Hellmann Worldwide Logistics.
provide shippers with greater booking to be done, Poseidon will be pushing
flexibility, improved risk dispersal and the pharma cold-chain boundaries for Email: [email protected]
lower cost. It will also provide access some time to come.

How Innovations in Temperature-controlled

Packaging are Helping Mitigate Cold Chain Risks
when Transporting Pharmaceuticals
the TCP industry when transporting a pharmaceutical prerequisite. When
With increasing regulatory requirements time- and temperature-sensitive transporting high-value pharma payloads
and compliance within cold chain
biologics/biosimilars. end-to-end, especially in more remote
to ensure the safe transportation
of pharmaceuticals and biologics,
regions, ensuring TCP meets industry
temperature-controlled packaging It’s widely accepted the cold chain compliance standards is vital.
manufacturers need to be at the industry infrastructure within Europe,
forefront of industry innovation. the US and some parts of Asia is Another area where compliance
proficient when it comes to regulatory can be compromised is the use of
compliance; emerging markets posing temperature-controlled vehicles
With the significant rise of biologics greater challenges include Russia, (TCV). As the name suggests, a TCV
and biosimilars within the industry, China, India and Brazil. is a road transport vehicle such as a
any minor temperature excursion van, truck or articulated trailer whose
during the cold chain journey can have The increased need for last-mile cargo compartment is maintained at a
costly consequences for patients and pharmaceutical transportation is temperature different (lower or higher)
pharmaceutical companies alike. another growing trend within pharma, from that of the external ambient
which requires stringent compliance conditions. The environment inside
The fact over half of approved throughout the cold chain process to the cargo compartment may be either
new drugs are going to be biologics ensure the protection of high-value, chilled or cooled by a roof-mounted
or biosimilars is proving another temperature-sensitive pharma payload refrigeration unit. In addition, the
driver in the rising demand for tighter end-to-end on its journey from the vehicle body is usually insulated for
temperature control requirements. manufacturing facility to the patient’s additional security.
Innovation in temperature-controlled hands.
packaging (TCP) is increasingly vital This means that companies could
within the cold chain process. An increase in the call for bespoke ship pharmaceutical product using
drug shipments means there is a the minimum of protective packaging,
This is in direct response to the greater challenge to ensure thermal relying on the vehicle’s refrigeration
pharmaceutical industry’s rising stability for smaller sample shipments system to keep product to the correct
requirement to protect more of throughout the entire supply chain. temperature. The downside is that
the drugs with strict temperature if the vehicle’s refrigeration system
controlled ranges, due to the drugs Industry innovations are also fails, or isn’t regularly checked or
being based on biological compounds required in response to the rise globally maintained to ensure compliance, or
which required strict temperature of agencies and organisations producing the load is subject to lengthy customs
controls, rather than chemical, which specific in-country guidelines and inspections, then there’s a strong
have less efficacy than biologics, but regulations the drug companies are likelihood of a temperature excursion.
less strict temperature requirements. required to support and be prepared This excursion could compromise an
for. entire load, which could be worth many
This provides the industry with even millions of pounds. With TCP, it’s only
greater challenges, including: These increasing regulations are one payload at risk if the packaging fails
driving the need for TCP manufacturers or there is human error introducing the
• Emerging markets and globalisation to respond with more pioneering temperature excursion.
• Increasing call for more advanced passive packaging systems alongside
TCP systems demonstrating industry innovation Industry Innovation
• Drive for technologies to support that critically meets the necessary The temperature-controlled packaging
new generation of cold chain regulatory compliance being called for industry is constantly seeing the
pharma shippers from region to region. introduction of innovative, newer
• Innovative TCP solutions highly technologies to successfully serve the
engineered to ensure compliance The TCP industry is also governed pharmaceutical sector.
and meet regulatory requirements by stringent GMP (Good Manufacturing
within the industry Practice) standards. This includes increasing imple-
mentation of more advanced phase
More complex distribution lanes, Standards bodies, including change materials (PCM) and vacuum
with emerging markets, geographies, the International Organization for insulated panels (VIPs) for insulation
increasing regulatory compliance Standardization (ISO), are in place to purposes to maintain temperature
conditions and remote region locations ensure packaging is fit for purpose, while throughout the pharma cold chain
are just some of the challenges facing being safe and reliable, understandably, process.

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These older technologies, such as

water-based ones, required seasonal
packaging components, sometimes
covering all four seasons, which in turn
required seasonal instructions, which
drives the need for further training and
additional warehouse personnel.
Performance improvements and

cost savings can be made and passed
on through the supply chain process
by reducing processes required and
subsequent training.
A further industry development is

the advent of pioneering tools that
allow TCP companies to improve
These newer technologies are There is also a significant advantage packaging performance. Technical tools
instrumental in avoiding temperature to being able to have conditioning or that aid with performance modelling
excursions during transportation, which packaging protocols in place for year are helping revolutionise the TCP
could render the pharmaceuticals round use rather than modified from industry landscape.
unstable, causing them to lose efficacy. season to season.
These testing techniques included
Other notable innovations include Industry innovations help create software, which allows companies to
advanced TCP that feature ‘hibernation’ simpler packaging processes, which is develop a temperature profile easily,
capabilities. So, should a customs as integral as maintaining temperature which they might want to test against
delay occur in the cold chain, these to the payload area. a specific shipping lane.
new-generation packaging systems
can be placed in a refrigerated area One of the main risks in cold chain Currently the industry is moving
and this suspends or stops the loss of is temperature excursions, and human towards these newer technologies,
cold energy retained by the cold chain error during the initial packaging looking at tools to assist in the
shipper. process is the main cause of these management of more modern PCMs,
excursions. which are more technologically
Many of the newer systems are advanced over managing traditional
available in a variety of volumes and In the industry of drug distribution water-based systems.
covering different temperature ranges and biological sample transportation,
offering sustained supply chain stability. the growing trend is a move towards A number of TCP manufacturers
more advanced VIPs and PCMs instead offer comprehensive thermal testing
Emerging technologies are also of utilising the more traditional, and qualification processes, using
allowing pharma companies to utilise water-based systems. a number of different techniques,
shipping systems with a reduced which vary according to the stress the
number of components incorporated There has been a notable decline in shipment will be put under. The testing
in the packaging process and coolants the use of older coolant technologies, process includes calculations and
used in the thermal packaging. which utilise water. estimates, as well as simulation using
specialist environmental chambers
followed by a live shipment to prove
any assumptions.
The laboratory test simulation

allows the customer to test exactly
how the TCP will perform over
various durations and under variable
conditions. For instance, testing can
be carried out for full load or partial
loads, with temperature probes located
in key places within the payload space
to ensure every part of the TCP is
tested thoroughly. This allows the
laboratory to test the true performance
of the shipper, as the thermal mass
will be greater when the TCP is fully
loaded. It is important that product is

Manufacturing & Recycling of thermal packaging Europe - USA
Thermal Blankets for the temperature

protection of ambient pharmaceuticals in
airfreight (+15°C +25°C) / (+59°F +77°F)
- High temperature protection in HOT and COLD

- Very light weight + water resistant
- Tailor made for Euro pallets / Block / Airplane pallets
- Protocols and S.O.P.’s available
Qualifications & Validations

- Ambients (+15°C/+25°C) in stress test 8% products mass
- Qualification tests according to EN-12546-2
- Tarmac summer profile tests (+46°C) during 6 hours
- Tarmac winter profile tests (-15°C) during 6 hours
- Solar power tests + Greenhouse effect qualification
Ecological notes
- UNIQUE = Recyclable due to non-laminated composition
- Re-use of recycled compounds = LOW Ecological footprint
- Recycle machines in Temax manufacturing plants
Also used in REEFER container transports

for unplugged temperature protection TEMAX – BIO BASED thermal blankets
Temax BIO thermal Polyethylene foils made from sugar cane
KRAUTZ - TEMAX Group - BIO CO2 = no impact on global warming

- HQ and manufacturing Belgium – Europe - 25kgCO2 reduction per transported pallet
- Logistics Center QA Belgium – Europe - Manufacturing & recycling at Temax plant
- Warehouse Chicago – USA - Recycling + Re-use = Low Ecological Footprint
- Website www.krautz.org - BIO certified by DIN
- Email [email protected]
NEW - European Logistics Center and Quality Assurance - Control of thermal packaging for Pharmaceuticals
3740m² warehousing - ISO-9001:2015 certified – Global QA clearance
TemaxPharma+ warehouse Customer dedicated storage + QA Temax fleet / 11 trucks-trailers

tested under these conditions so the

customer can select not only the best
performing TCP, but also the one which
gives the most consistent performance,
irrespective of product payload.
Testing techniques are carried out

by ISTA-compliant certified thermal
testing laboratories, using calibrated
environmental chambers. This
equipment allows the full journey
of the TCP to be mapped. Extremes
of temperature, for instance as
low as minus 85°C to high ambient
temperatures, using incubators, can
be simulated.
Dedicated engineering teams utilise

multi-physics technology to produce Although single-use packaging ways to guarantee multiple reuse
virtual prototypes used to qualify cold still serves a purpose, particularly packages are fully qualified, remaining
chain packaging performance in a when it comes to more difficult to fit for purpose after multiple uses.
variety of ambient profiles. This can control or challenging lanes, when the
be to industry standard profiles, or to retrievable infrastructure is in place, Convincing pharmaceutical firms
specific, custom thermal validation reusable, which is on the rise, can of the importance of having the fit for
specified by the pharma / clinical trials prove a more cost-effective option purpose cold chain shipping systems,
supplier. per trip. as part of their overall operations and
budget considerations, is an ongoing
It is essential that cold chain Reusable technology is becoming challenge.
packaging options, whether they are more and more accepted because it
pre-qualified shippers or custom- can really drive down costs per use. It comes down to helping clinical
designed shippers, are compliant with The packaging industry is working companies better understand the true
global industry standards such as the hard to try and change preconceived cost of impact of moving to newer
International Safe Transit Association perceptions about reuse and its technologies and what impact that can
(ISTA), International Air Transport reliability. have for their operations. Ultimately
Association (IATA), United Nations (UN) ensuring stability in the supply chain
and World Health Organisation (WHO). To best serve the pharmaceutical is critical within the pharmaceuticals
industry’s rigid requirements, TCP industry, where patient safety and
Temperature ready indicators fitted manufacturers must continue to efficacy are an absolute priority.
on PCM panels, which display when strive to set and surpass standards,
they are ready for use and packing, are creating shipping solutions best placed
also new to the sector, further aiding to meet the evolving, exacting pharma
the protection process in cold chain. protocols.
Adam
Future trends will see the increase Future developments will involve
in the use of reusable packaging. industry standards, which demonstrate Tetz
Adam Tetz is the Director of
Worldwide Marketing at Peli
BioThermal and has over 25 years
of marketing experience. Prior to
Peli BioThermal, Tetz held positions
in product management and
marketing communication across
a variety of industries, including
medical software, financial soft-
ware, information services and
professional consulting services.
He holds an MBA in Marketing from
the University of Saint Thomas
and a BA in Advertising from the
University of Minnesota.

Reimagining Temperature Monitoring Services

IPI speaks with Jukkapekka Asikainen of Sensire about Inovative
Temperature Monitoring
Q. For over ten years Sensire has the whole chain in real time. This is That means lane, equipment and
reimagined full-service solutions that where we monitoring companies come packaging validations in transportation,
help customers from the outset, with in. and mapping and monitoring storages,
its innovative temperature monitoring warehouses and other cold equipment
services such as TempNet Cloud, We provide actionable data in a where the medications are stored. With
which uses an application programme timely manner, so that the logistics wireless monitoring equipment, all this
interface system (API). Can you tell us companies are able to address issues is now extremely easy to do.
how Sensire has developed patented before they become hazardous to the
technology with the cold chain sector samples or medications in their care. And going past just mapping and
in mind and what the benefits of using validation, and into automatic real-time
‘real-time monitoring solutions’ are? Preventing excursions then monitoring we can start directing
eliminates the need for costly processes to prevent excursions and
With our latest solutions and time-consuming temperature the subsequent degradation and waste.
we recognised that the validation inspections on arrival. Still, A way of thinking about real-time
market lacked a centralised if something were to happen, detailed, monitoring is then to see it as ongoing,
method for gathering and automatically-created reports on continuous validation of all logistics
combining end-to-end transportation and storage conditions processes.
cold chain data. This directly impacted can shorten the receiving inspections
product safety and quality. considerably. Q. With the augmentation of wireless
technologies used to enhance cold
To solve this, we came up with a So, efficiency can be improved by chain monitoring solutions, you can
solution that combines technology, the double offer of real-time prevention save on monitoring costs and prevent
software development and APIs and management by exception that waste, protecting the environment
that offers real-time visibility and professional temperature monitoring along the way. Can you tell IPI how
automating manual tasks. companies can offer. generating an electronic audit trail
of all your monitoring activities is not
With real-time visibility, our customer Q. One of the easiest ways for only more ecological than traditional
can better ensure efficient quality and pharmaceutical manufacturers, monitoring solutions but also allows
safety processes. With the addition third-party logistics providers and you to spend less time reporting on
of a mobile app for guiding employee retailers to up their revenue and regulatory compliance and leverages
processes we support effective, timely improve customer satisfaction is the gathered data to improve
and above all correct processes and to make sure that pharmaceuticals processes through predictive cloud
corrective actions. This enables our never get wasted because of incorrect analytics?
customers to not only correct problems handling and conditions. However
but to prevent them altogether. traditional temperature loggers Many organisations are
only help you weed out the wasted getting rid of paper in order
Q. Although good practice regulations products after the temperature to create less of a burden
and guidelines have been designed excursions have happened. Because on the environment. So,
to support effective temperature a patient cannot be allowed to receive it’s only natural to make
monitoring in the pharma cold degraded pharmaceuticals, how that same move in logistics operations.
chain, around a third of cold chain can pharmaceutical companies and Digitalising also provides an equal or
pharmaceuticals are put at risk by manufacturers support the imple- even better audit trail as the binders
temperature excursion annually. How mentation of GXP (Good Practices and paper archives used to, because
can cold chain monitoring companies and Regulations) to prevent this from it facilitates faster reporting.
prevent temperature excursions in happening?
clinical sample logistics and improve Another major benefit of digital
temperature validation efficiency at Much of GxP regulation is archives is that drilling down to root
the same time? about risk. So, the best causes is much easier. This can be
way a pharma company further simplified with the addition of
The companies handling can support implementing predictive analytics that can help in
the logistics need to good practices is by being catching potentially wasteful processes
know where and when the diligent in their risk assessments. That and problem hotspots.
excursions happen to be means digging deep into the process
able to prevent them. That to find out where possible problems Better processes in turn will help
means they need to be able to monitor happen. decrease product waste, inspection

costs for excursions and ultimately

logistics costs as well.
With regard to our SaaS model and

reusable wireless technology, we’re
also solving the environmental load
that many disposable monitoring
methods are causing today.
Q. Software as a Service (SaaS) is a

method of software delivery that allows
data to be accessed from any device,
which enables software vendors to
utilise data integration to understand
the customer in the cold chain sector.
Therefore, how can the deployment
of SaaS type solutions allow current
technology adopted by suppliers and
customers to not only improve their
visibility and transparency throughout
the cold supply chain but also
create a significantly early return on
investment?
That's a great question

– SaaS provides better
visibility because its
technology set-up is
extremely light, requiring
very little customer staff input to get past few years. How can the pharma ship that much, freeing up capacity by
operable. supply chain managers – both eliminating product shipments needed
domestic and global – address the to substitute for wasted or quarantined
Faster setup equals faster process rising costs, get better at projecting products.
visibility, which facilitates earlier future capacity needs and work with
problem identification and highlights logistic providers more effectively?
improvement possibilities. And the
possibility to integrate existing systems One of the best ways to cut
helps utilise legacy systems more costs and predict capacity
efficiently and get more value out of needs is to address Jukkapekka
those as well. excursion in the logistics Asikainen
chain. Let me elaborate:
As for the early ROI, in a full-service Jukkapekka (Jp) Asikainen is the
SaaS model, such as Sensire’s, the initial One source of inefficiency in pharma founder and CEO at Sensire Ltd.
investment is lower than in traditional logistics is the long inspection cycles He is a leading expert on the cold
payment models, and there are no when an excursion has happened, supply chain and an accomplished
hidden costs. With recognised savings which ties up logistics capacity from innovator of market-leading
from process improvements and waste warehouses in the form of quarantine wireless monitoring solutions for
reductions, we can calculate ROI to until inspections are ready and may pharmaceutical logistics, healthcare
around three to 12 months, of course require substitute products to be services, and processing and
depending on what the customer is shipped. manufacturing operations.
looking for and how agile they are in
refining their processes. With complete end-to-end data Jp is a highly successful serial
entrepreneur and has over 30
records, inspections can be carried out
years in executive management,
Q. In 2018 the market for the pharma more efficiently, freeing up capacity
marketing and sales. As a
cold chain logistics sector was in storage by shortening quarantine long-time specialist on environ-
estimated to be worth $318 billion, times. mental monitoring systems, Jp
with the sales volume of temperature- is exceedingly experienced at
controlled products growing at twice Of course, eliminating the excursions providing customers with real-life
the rate of pharma overall. Although the in the first place with real-time data solutions to real-world challenges.
pharma market is economically viable, and immediate corrections will allow
global transportation and packaging the SC manager to consider only how Email: [email protected]
costs have risen dramatically in the much actual products are used and

How to Make Passive Pharma Packaging More Flexible,

Cost-effective and Eco-friendly
IPI talks to Sven Rölle About Modular Cooling Systems...
Q. Since 2008 Eutecma GmbH has
dedicated itself to the development,
production and sales of passive
cooling systems for transport and
logistics, arguably revolutionising
the pharma-technical innovations
landscape. Could you tell us why
eutecma has challenged standard
solutions and offered alternatives in
cold chain logistics?
We are always at our best

when customers give
us tricky problems that
seem impossible to solve
at first glance. That has
”One size fits all”: The universally usable passive energy storage units ICECATCH© from eutecma fit in every
driven what we do here from the very size of PROTECT box and every type of temperature zone.
beginning. “Is there a temperature-
stable, reliable cold storage element in that is?” Posing this question was our passive energy storage units are
cold chain logistics that doesn’t require eureka moment, the cell from which available for all PROTECT box sizes
any additional buffer elements, spacers the intelligent PROTECT solutions from eutecma in three formats. There
or foam materials – and on top of that, emerged. They offer a temperature- is a cooling element that is suitable
can simplify our internal packaging stable home for 120 hours for sensitive for every temperature range. And
processes?” We were asked this pharmaceutical, healthcare, lab since pharmaceutical companies,
question eleven years ago by a globally diagnostics and biotechnological wholesalers and shippers only need
renowned pharmaceutical corporation. products – without any need for extra to schedule, store, precondition and
Our answer: the patented ICECATCH© energy and in all pharma-relevant package with one cooling format per
Solid Insulated, a water-based passive production areas, meaning ambient (+15 temperature range, storage costs go
cold storage unit with an integrated °C to +25 °C), cold (+2 °C to +8 °C) and down, handling becomes simpler and
hydrophobic insulation layer. As the frozen (<-20 °C) situations. work processes are streamlined. The
only such product on the market, modularity of the eutecma packaging
the ICECATCH© Solid Insulated has Q. Cooling systems for temperature- solutions is achieved by a unique
remained one of a kind to this day. In sensitive products such as pharma- stacking system that was introduced in
combination with a fluid space and ceutical products always require a 2013 for the first time for the PROTECT
a hard foam coolant retainer, which more dynamic supply chain that is pallet shipper and has been an integral
ensures controlled retention thanks to above all safe but also cost-effective. part of all our boxes ever since. And as
a vacuum process used in production, How does eutecma address this the filling requirements grow, so do the
it cleverly takes advantage of physical challenge? What exactly is so unique boxes in height, making them able to
processes. To date it has been used in eutecma cooling systems? accommodate various volumes. Since
millions of times and has set new both “genes” fit so perfectly, the end
standards for cold chain logistics. In If the eutecma system result is a very temperature-stable
2009, however, there were no signs possessed a DNA, two cooling system with the benefit of a
that the ICECATCH© Solid Insulated genes would probably be high degree of security.
would ever achieve such sales numbers responsible for its unique
because we started noticing these features: flexibility and Q. What is so special about this
new cool bricks kept running into the modularity. Whatever advantages our stacking system? How does it
problem that they didn’t fit well into a customers and their supply chain impact the packing process and the
number of the commercially available experience are based on these two subsequent transport?
cool boxes on the market. We were kind characteristics. Flexibility is the result
of missing the key to unlock the door. So of the uniform format of the cool Modularity and its
we asked ourselves: “Why don’t we just and warm bricks. They are always: advantages are most
develop a system packaging that uses one size fits all. Be it ambient, cold or impressive in the supply
always the same cool bricks format frozen logistics, be it a mini delivery chain when using the
regardless of volume and regardless of 4 litres or an XL delivery of 1600 PROTECT XL-pallet shipper
of size – ICECATCH© Solid Insulated, litres – the form stable ICECATCH©- we launched in 2018. Thanks to the

passive energy storage elements into the that cooling does not cool down the
slots and close the lid. Not only does the product space below +2 °C and secondly,
combination of flexibility and modularity the storage unit transfers the melted
afford the customer the highest degree coolant to the fluid space very slowly −
of security but also freedom. Because at the desired cooling temperature of ±0
maybe one day 961 litres are being °C. It then flows around the insulating
shipped off and on the following day: layer. During the phase change from solid
1588 litres. Plus: If every delivery that to liquid, the so-called phase transition,
leaves storage is optimised for volume, there is a considerable amount of
transport costs will drop precipitously. stored energy. At the same time, the
And that is more than just the icing on cool brick possesses an extremely
the cake. high heat absorption capacity thanks
to the frozen coolant in the core. Both
Q. eutecma is at the forefront of factors are responsible for maintaining
advanced cooling solutions, creating a product space temperature of +2 °C
cooling elements such as the to +8 °C – for a period of up to 120
ICECATCH® Solid cool brick for the hours. GDP also requires reproducible
With the PROTECT XL-Pallet Shipper, the transport transport of temperature-sensitive test results. Our intelligent cooling box
packaging specialist eutecma has developed a products. Can you explain how design fulfills this requirement. The
qualified, GDP-compliant passive cooling system
that sets new standards in cost reduction, process
eutecma ensures that all products frame features lateral slots into which
optimization and reusability. follow Good Distribution Practice you simply slide the cool bricks – they
(GDP) and how you ensure the then remain secured there for the
stacking system, the incoming volume-
maintenance of the cold supply chain entire transport. This ensures a uniform
optimised boxes can be dropped off,
of pharmaceuticals meets cold chain temperature distribution during the
transported and put in intermediate
compliance? entire transport. Nothing can slide out
storage within the in-house traffic
system in a space-saving fashion – of place. The design of the ICECATCH©
GDP guidelines require Solid Insulated in combination with the
either prior to their initial use or on the separation of cooling
their return transport. In the first step design of the PROTECT boxes guarantee
materials and the trans- full compliance with GDP guidelines.
of the packing process, the forklift driver ported product. ICECATCH©
can place the euro pallet loaded with And so the result – a reliable system
Solid Insulated’s compliance which is more than the sum of its parts,
the good directly onto the base plate with this regulation is exemplary
which makes transferring or repacking the cool bricks and the box.
because it is unique in directly
the goods from a shelf into the box integrating a hydrophobic insulation
unnecessary. In the second step, the Q. Here at IPI we are keen to champion
layer and thus rendering any buffer
storage worker builds the box up to the eco-friendly and sustainable businesses
material completely obsolete. As soon
desired height by stacking up one, two, in the pharmaceutical industry and
as the -18 °C cooling element starts
three, four or five stacking frames on are delighted to see that eutecma has
thawing during transportation on
top of each other – depending on the curated reusable packaging solutions
account of the ambient temperature,
volume needed. This is where eutecma such as ‘Protect System Packaging’.
the insulation layer starts manifesting
cooling boxes really demonstrate their Outlined as customised, product-
its double advantage: firstly, it ensures
superiority, because building up the box specific systems for every ‘consumer’s
doesn’t require a contortionist to do the needs’, can you tell us more about how
job. The L-shaped frame elements are reusable packaging solutions can save
designed to stand solidly on their own. costs, avoid waste and improve our
This means one worker instead of the carbon footprint? How do developing
usual two is enough to assemble the individualised packaging systems
PROTECT XL-pallet shipper in just a few help eutecma reach zero solid waste
minutes time – quickly and easily. That targets?
has a substantial impact on labour costs.
Thanks to the clearly visible markings in As a guest at a hotel,
the EPS itself, the worker can identify more and more people
immediately which part goes where, use towels more than
thus ruling out any assembly mishaps. once. Why, we wondered
And so the simplicity of the packing recently, shouldn’t this
process helps to substantially reduce also apply to PROTECT cold packaging
any mistakes. After the box has been and ICECATCH © passive energy
filled with product and stacked up, it storage units? In reality this idea has
can be left in the ambient, cold or frozen already been implemented, as we
storage section until a dispatch order is The innovative design of the PROTECT XL-Pallet had already been noticing for some
triggered. In a last step, the warehouse Shipper builds upon three success factors: an easy- time that our customers or even our
to-load base plate, self-standing frame elements in
worker has only one thing left to do: to various heights and uniform cool brick formats for customer’s customers were already
slip the correct number of ICECATCH© all temperature ranges. re-using eutecma systems. Basically,

there is nothing that would contradict to be limited. Could eutecma explain

multiple use since the eutecma system what ‘digital cargo’ is and how you see
packaging consists of EPS/Airpop – a it transforming the pharma ‘cool chain
very age-resistant material – and is sector’?
designed to be very robust, as is the
composite foil used in the ICECATCH© As the manufacturer and
passive energy storage units. The real developer of intelligent
question, however, is: when is it the passive cooling systems,
right time to change out a towel at we focus on the section of
a hotel? Meaning when to swap out the supply chain that deals
the packaging or the cool bricks? We with the transport of temperature-
provide the correct answer to that in sensitive freight. Be it pharmaceutical
our instructional video “Reusability products, food or durable goods,
Guidelines”, a concise, in-depth look one discernible mega trend is the
Lighter, more secure, more efficient and more
at the topic of “re-usable packaging environment-friendly than conventional cooling
customisation of products and here
solutions in temperature-controlled bricks: the ICECATCH© Solid Insulated from eutecma. we also see great opportunities in
logistics”. The first good news: provided our business. When today goods are
a handful of quality criteria are met, Q. Increasingly, climate chambers shipped from A to B, it happens in a
eutecma packaging and passive energy are being used by advanced cooling static system. But consider a future
storage bricks can be re-used without solution brands to simulate and where each and every shipment is
any problems – and not only once or document dynamic temperature not seen just as a representative of an
twice but multiple times. The life cycle profiles and the relative humidity individual case in a given process? But is
of our products does not end upon of the goods to be transported at a highly customised shipment subject to
leaving our customer’s supply chain. ambient temperatures between individual factors and thus requiring an
Our customers’ customers can also -80°C and +80°C. Can eutecma individual set-up? This would optimise
continue to use our eutecma system tell us how climate chambers use product security and virtually rule out
packaging and ICECATCH© passive ‘transport calendars’ to calculate the any temperature outliers with the
energy storage units without any outside temperatures of hundreds ensuing delivery losses and economic
worries, as long as the quality criteria are of transport connections and how damage. As regards patient safety and a
being met. This compounds the positive this creates system packaging which “well-lubricated” supply chain, realising
effects of re-usable packaging solutions will withstand even the toughest this vision would be metaphorically
for the pharmaceutical, healthcare, conditions? the philosopher’s stone. Here a great
lab diagnostics and biotechnological potential lies dormant and we here at
industry many times over – with We have invested in eutecma are about to tap into it.
benefits for the environment and value three in-house climate
creation. But the good news doesn’t chambers where our own
stop there either: We are planning on product developments
converting the EPS from discarded or individually developed
boxes into EPS base granulate which packaging solutions are stress tested
Sven
then can be formed into new boxes. to qualify them for our customers. In
And another important innovation, this this process, we work with empirical Rölle
time a digital first, is going to help us to data from the German Weather
Service that is entered into a transport Sven Rölle, after positions in
shrink our product’s CO2 footprint. As of
several packaging companies,
the first quarter of 2020, every eutecma calendar, which we then use to
is an eutecma employee of the
box will bear a QR code. An app will compute the ambient temperature first hour and contributed to
tell the users which kind of box they situations of hundreds of transport many milestones in eutecma’s
are dealing with and how, for example, connections. We always assume a history. With a degree in
to pick-and-pack it for the presumed worst-case scenario when testing in business and management, the
lanes and presumed loads. This app the climate chamber for the benefit Head of Sales feels the pulse
and the instructional video will enable of having an extra security buffer. of many global players in the
every user – no matter where they are Rupture pressure, burst pressure and pharmaceutical industry. With
on the planet – to re-use the packaging drop test measurements ensure that a finely-developed sense for
and passive energy storage units until the system packaging will withstand intelligent solutions driven by
they reach the point when the quality even the toughest conditions. We “outside-the-box” thinking,
see the climate chamber test as a
he and his team push the
criteria are no longer met. And even
development of new, ground-
then, this is not the end because if valuable add-on that is designed to
breaking cooling systems and
only one sudden-death criterion is not give eutecma customers an extra layer the services that come with
met – for example a damaged corner of security. them. eutecma was founded in
element – you don’t have to replace 2008 as a spin-off from ideapro
the entire system but only the defective Q. The term ‘digital cargo’ has become gmbh, a company specializing
element. This is a huge leap on the way a buzzword in the digital logistics in chemo-technical innovations.
towards realising a zero-waste vision. industry, but public knowledge seems

The Greener Side of Pharma Logistics

IPI Speaks with Dr. Florian Seidenburg on the Ecological impact in
Pharmaceutical Supply Chain
Q. From the outset, it was clear Q. With an increasing customer demand Q. One of your main products is thermal
that ECOCOOL was revered for its for reliable service, flexibility and short blankets. Can you tell us a little bit
innovative packaging and insulation delivery times in the pharmaceutical, more about your products, what they
concepts, having been awarded the transport, and logistics industries, cooling achieve and why your products stand
Bremerhavener Gründerpreis (Bremer- packaging companies can struggle to out in a saturated market?
haven Founder's prize) in 1999, a keep up with the influx of consumers
remarkable feat considering it was who require personalised packaging Indeed, thermal blankets
founded by economics graduate solutions. How does ECOCOOL’s are one of our main
Heinrich Siedenburg and engineering production facilities ensure that they product ranges. In the
graduate Ulf C. Abbes in the same are always prepared to respond to the pharmaceutical supply
year. Can you tell IPI more about how specific needs of their customers? chain, they are mainly used
the Bremerhaven prize supported the to protect the sensitive loads during
founders with the implementation We take pride in stating transport interfaces, especially during
of their promising business ideas in that all our products are the dreaded “tarmac-time” in air-
the cooling packaging and packaging 100% made in Germany in freight. We offer four different ranges
components sphere? our Bremerhaven-based (ECO-LIGHT, ECO-SAFE, ECO-SAFE+
factory. Even though most and ECO-SAFE++). While all four
The Bremerhaven Founder’s of our processes are quite labour- solutions offer a reflective outer
prize gave the then infant intensive, we feel that being close to our surface, they differ in terms of thermal
start-up the necessary customers in central Europe is the key to protection. In particular, I would like
financial backing to pay for being able to live up to their demanding to point out the ECO-SAFE+ model,
costly development outlays schedules. We are also building very which uniquely combines a thermal
and get through the first difficult years. close relationships with our customers, blanket with thermal mass through
Considering that it mainly consisted of which helps us to understand their our WaterBlankets. These long sleeves
€100.000 funding, it enabled ECOCOOL requirements and their needs. That filled with water-based gel add a
to grow without any VC or other external being said, we do serve global customers significant amount of thermal mass to
financial backers. and ship worldwide. the outside of the sensitive and mostly

lightweight products. This way, the A qualification of a shipper box We believe that cool
thermal protection can be drastically consists of four steps (DQ, IQ, OQ, PQ) chain solutions must
improved and temperature excursions which all technical equipment in the become greener in the
further minimised in an extremely pharmaceutical supply chain must be future. Therefore, we are
cost-effective way. The efficacy of this subject to. In the case of insulated going to launch a 100%
solution has been confirmed by content subjeted boxes, the most important biodegradable 2°–8°C shipper box,
customers over and over again. part of this qualification process is entirely made from recycled paper and
the OQ and PQ steps. OQ stands are pulp. This solution drastically reduces
Q. The EU directive ‘Good Distribution operational qualification and basically the use of plastics and can be recycled
Practice (GDP) states that pharma- consists of several tests of the thermal via the paper stream, hence reducing
ceutical products such as medicines performance of the box in a controlled, the environmental impact of cool chain
need to be transported ‘according to lab environment. Having demonstrated packaging dramatically. A first prototype
storage conditions’, in order to not only in this step that the box can maintain will be on display during the IQPC Cool
ensure that there is more security in the the required temperature range over the Chain Europe Event in Düsseldorf.
drug distribution chain but to also make desired runtime, the customer needs
the pharmaceutical transport chain safer to perform the so-called performance Q. The pharmaceutical packaging
too. As wholesale distributors must qualification. This qualification step industry has come a long way since the
legally obtain a wholesale distribution consists of various shipments during 19th century, with modern technology
authorisation, can you tell us more about throughout the year in order to assess shaping pharmaceutical logistics
how products such as your Pharmboxes if the lab results carry over to the real through computer-based solutions.
(2–8 °C) are GDP compliant? world. If the preceding OQ has been Can you tell IPI what role AI and AR
designed with demanding temperature have to play in the smart packaging of
Technically, temp-chain profiles, the PQ usually shows no pharmaceuticals.
packaging cannot be unwanted surprises.
GDP compliant. They As we are also a distributor
are a tool to make the Q. Ecological considerations are of temperature data
distribution process of our becoming more and more important loggers, we need to keep
customers GDP compliant, by helping as many pharmaceutical customers a very keen eye on those
to eliminate temperature excursions. are looking for ways to reduce their developments. There has
Another requirement for cool-chain ecological footprint. How does been a surge of new and fascinating
shipper boxes is (pre-)qualification. ECOCOOL cope with this challenge? solutions in this area with exciting
possibilities for the users, such as
real-time temperature monitoring,
real-time geo localisation or highly
automated processes through Bluetooth
or near field connectivity. We offer a
wide range of temperature data loggers
and individually help customers to find
the correct device for their needs.
Dr. Florian
Siedenburg
Dr. Florian Siedenburg is the
general manager of ECOCOOL
GmbH, located in Bremerhaven,
Germany. Dr. Florian Siedenburg
graduated in 2006 in Economics
and obtained his doctoral degree in
Econometrics in 2010. He entered
the family-owned business in 2013.
ECOCOOL GmbH was founded in
1999. ECOCOOL specialises in the
development and distribution of
insulating packaging. As of today,
thermal blankets and other passive
packaging for pharmaceutical
air-freight constitute the core
business of ECOCOOL.

Making Smart Equipment Decisions for a Secure Cold Chain

IPI Speaks with Anthony Dellumo of Q Products about Passive Thermal
Protection in Pharma Logistics

Q. To maintain temperature-sensitive on product specifications, mode of Speaking from our own
products within the manufacturer’s transportation, shipping lane(s), and so experience in hosting the
required temperature range, the thermal forth. For example, QProducts & Services Cold Chain Council event
packaging industry must use passive PalletQuilt® solution can range from a twice a year in Chicago, it
thermal energy storage materials single reflective cover with various seems to stem from the idea
(PCMs) during all transportation phases, levels of insulation, to our PalletQuilt of “thought leadership”. When we speak
from manufacturer to end user. With Kit thermal shipper that includes with those who attend from around the
QProducts and Services specialising bottom wrap, bottom pad and gel globe, who work in some of the largest
in cold chain shipping solutions, sleeves surrounding the entire payload. and smallest transportation networks,
how do you use thermal packaging A transportation team can increase it’s amazing to hear how collaboration
to help protect valuable cargo from efficiency in time, cost and customer and the sharing of challenges and
temperature spikes that would render service by making smart equipment solutions can be very empowering to
your commodities worthless upon decisions while also maintaining product all of us who touch cold chain logistics
arrival? integrity and a secure cold chain. in some way. To take a step away from
the sales and marketing of your typical
From our own experience Q. The public’s appetite for the cold conference or tradeshow really allows
in helping manufacturers chain sector, has meant that events room for conversation about the topics
protect their product in such as the ‘Cold Chain Council’ have and concerns that affect the industry
transit, the use of phase sprung up across the world, with currently and in the coming years.
change materials (PCMs), topics such as ‘preparation readiness We highly recommend attending your
while an effective barrier against in the supply chain’ and the booming nearest “non-conference”, whether in
unwanted thermal energy, is often a ‘food and beverage industry’s impact person or digitally on the web.
practice that is broadly implemented on cold chain’ educating the masses
rather than utilised within a specific on cold supply chain logistics in Q. In today’s accelerated global
set of shipping parameters that call for the pharmaceutical and food and market, quick supply is a prerequisite
an added layer of protection. In offering beverage industry. How can pharma’s for successful business, especially in
a holistic set of solutions to a shipper, participation at events like Cold Chain the cold chain sector where high-tech
we tend to suggest the adaptation of Council have a positive impact on the insulation is needed to maintain
variable levels of protection based cold chain sector as a whole? temperature throughout the supply

chain. After all, the speed of delivery

brings more reliability and decreases
the risk of damage, ensuring that cargo
security is of the upmost importance.
Can you tell IPI why there has been
an increase in logistic and supply
chain services using global air freight
services and how this enables global
reach, validation and performance and
qualification of their thermal covers?
From a cold chain security

standpoint, air freight has a
lot to offer in ways of saving
time. When your freight is
moving quickly, it has less
time to become compromised by the
two biggest threats to a secure cold
chain – temperature and tampering. historical weather analysis can show inform on executing the use of passive
From a thermal protection standpoint, the cost savings potential of virtually temperature protection, including
the most vulnerable period for air cargo any shipping lane when best shipping Technical Report no. 72, co-authored by
is the tarmac and while this may only practices can be augmented by the QProducts & Services Vice President
be a few hours, the exposure can be forecasted risk analysis. Whether that of Technical Services, Pete Mirabella.
extreme when combatting the radiant, be fifteen days or fifteen weeks into the The report details the validation
conductive and convective influence of future, having the ability to plan how you processes for the design, performance,
sun, wind and pavement. However, this is are shipping your temperature-sensitive operational qualification, etc; as well
also prime use case for passive thermal cargo ahead of time can eliminate paying as a basic knowledge of some of the
protection in the way of a reflective for temperature-controlled freight thermal dynamics that take place
and/or insulated cover, depending on when you don’t need it. Alternatively, in and around an insulated system
the level of protection required for the passive thermal protection would then when exposed to different types of
environment the cargo is subjected to be implemented to protect cargo on heat transfer. As manufacturers and
while awaiting loading into the aircraft. approved lanes during low-risk periods shippers become more knowledgeable
of time. The more reliable and flexible and experienced, they will be able to
Q. Considering climate change, your passive solutions are, the more plug in the data from their product
companies need to minimise their reliable and flexible your transportation specifications and formulate the proper
impact on the environment, with network can be. level of passive protection needed, and
sustainable and eco-friendly measures when and where to utilise it in order
in place to reduce their collective Q. With strict regulations from to achieve a more efficient cold chain
carbon footprint. From addressing governing organisations globally, the supply network. Thanks to advanced
the loss of trust in global corporations validity of passive thermal solutions thermal simulation software, it is also
in the cold chain sector to ensuring comes under great scrutiny from now possible to run simulated testing
that transparency is the new norm, a quality assurance standpoint. to validate a passive solution to a
it’s vital to not let sustainability Therefore, how should companies certain extent.
become just another buzzword in the execute temperature testing and
pharmaceutical logistics space. Can validation protocols with subsequent
you tell IPI how ‘greening the logistics’ technical reports on the operational
introduces sustainability opportunities and performance qualifications of
when thermal packaging comes into their full line of products in line with
play? cold chain supply chain and logistics
Anthony
regulations? Dellumo
In the conversation of
greening logistics as As passive thermal Anthony Dellumo is Marketing
it relates to thermal protection becomes more Manager and a product specialist
protection, the biggest widely accepted by quality for QProducts & Services, global
supplier of thermal packaging
target is indeed CO2 assurance groups globally,
solutions and the electronic cargo
emissions. While cleaner fuels and there has been a need
security system, Power In-Lock®.
electric engines are a step in the for a very detailed outline of best Anthony has 8+ years’ experience in
right direction, the real battle remains practices in implementing passive qualification and implementation
passive vs. active protection. With the protection solutions. For example, of thermal solutions in the global
advancements in shipping lane risk the Parental Drug Association (PDA) supply chain and developed
analysis coming to fruition, i.e. Riskpulse, has several published, expert written QProducts’ marketing platform.
historical shipping data compared to guidelines that can help educate and

9
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News
Lynparza Recommended by FDA Further, in pooled data a high of doses a “health lottery” for needy
Advisory Committee for 1st-line proportion of patients with Haemophilia patients.
Maintenance Treatment of Germline A who were treated, both with and
BRCA-mutated Metastatic Pancreatic without inhibitors, achieved zero Adamas MS Drug Shows Worse-than-
Cancer treated bleeds. This continued to expected Trial Results
AstraZeneca and MSD Inc., Kenilworth, increase over time, from 70.8% in week A drug designed to help patients with
NJ, US (MSD: known as Merck & 1 to 24 to 88.6% in weeks 73-96, the multiple sclerosis (MS) failed to hit
Co., Inc. inside the US and Canada) company revealed. several targets in a late-stage trial.
announced that the US Food and Drug
Administration (FDA) Oncologic Drugs It is “vital” that people with Adamas Pharmaceuticals tested how
Advisory Committee (ODAC) voted 7 to haemophilia A in Scotland have access well different doses of the medication,
5 to recommend Lynparza (olaparib) as to the “latest, innovative treatments,” Gocovri, helped MS patients walk.
a 1st-line maintenance monotherapy for explained Dan Farthing-Sykes, chief Although a higher dose of the treatment
patients with germline BRCA-mutated executive officer of Haemophilia improved walking speed compared to a
(gBRCAm) metastatic adenocarcinoma Scotland. placebo, it failed to help with the trial’s
of the pancreas (pancreatic cancer), secondary walking goals.
whose disease has not progressed Haemophilia A is an inherited,
following 1st-line platinum-based serious disorder in which a person’s Gocovri has already been approved
chemotherapy. blood does not clot properly, in severe to treat side-effects associated with a
cases leading to uncontrolled and Parkinson’s drug. The news that it didn’t
In August 2019, the FDA accepted often spontaneous bleeding. There is perform as well as the company had
the supplemental New Drug Application currently no cure for the disorder, but hoped for in the MS trial sent shares
(sNDA) for Lynparza for this indication prophylaxis with factor VIII has been for Adamas plummeting by 45 percent.
with Priority Review and set a recognised as the preferred treatment The company said it will now assess its
Prescription Drug User Fee Act (PDUFA) approach to help prevent and reduce continued investment in Gocovri as an
date for the fourth quarter of 2019. the frequency of bleeds. MS treatment.
The sNDA submission was based on Novartis Announces Plan to Give Away BHP Opens New Irish Testing Facility
the positive results from the Phase III Doses of World’s Most Expensive Drug for Pharma and Medtech
POLO trial published in The New England Next year, Novartis will give away up to A new laboratory in Ireland is the first
Journal of Medicine and presented at 100 doses of its gene therapy for spinal to offer a complete elemental impurity
the 2019 American Society of Clinical muscular atrophy (SMA), which sells for testing service for the pharma and
Oncology Annual Meeting. The results $2.1 million per patient. medtech sectors.
showed a statistically significant and
clinically meaningful improvement in The Swiss drugmaker said that The facility was opened by the testing
progression-free survival and reduced it created the plan specifically to provider BHP Laboratories following
the risk of disease progression or death target patients in countries where significant investment by the company
by 47% based on a hazard ratio of 0.53 the treatment, Zolgensma, is not yet into its facilities over the last 12 months.
(p=0.0038). Lynparza nearly doubled the approved. Zolgensma was OK’d by the
time patients with gBRCAm metastatic FDA in the U.S. last May and has since The new facility was officially opened
pancreatic cancer lived without disease raked in $175 million in sales. by Pat Breen, TD, minister for Trade,
progression or death to a median of 7.4 Employment, Business, EU Digital
months vs. 3.8 months on placebo. SMA impacts about 1 in 10,000 Single Market and Data Protection.
babies, and can lead to severe physical
Scotland Gives Roche’s Haemophilia A disabilities and death. In some countries The investment by BHP will enable
Drug the Go-ahead awaiting approval for Zolgensma, the company to meet existing client
NHS Scotland has approved families have turned to crowd-funding needs and to expand into UK and
the reimbursement of Hemlibra to come up with a way to pay for the European markets.
(emicizumab), Roche’s severe congenital treatment, which can completely cure
haemophilia A treatment for patients the condition if given before the onset Commenting on the investment and
without factor VIII inhibitors. of symptoms. expansion, Dervla Purcell, laboratory
manager at BHP Laboratories said: “Our
The drug, which is developed by Biogen’s Spinraza has also been customers within the pharmaceutical
Roche’s Chugai Pharma subdivision, can approved to treat SMA and Roche is and medical device industries are
be self-administered by injection under expected to have a SMA treatment regulated by very strict quality control
the skin at multiple dosing options (once cleared for use in 2020. requirements and want to work with
weekly, every two weeks, or every four accredited and approved laboratories.
weeks). In clinical trials, Hemlibra dosed A health advocacy group called They also want to reduce lead times
once-weekly or every two weeks led to TreatSMA said that although it for testing. Our investment comes on
a statistically significant and clinically supported Novartis’ efforts to improve the back of significant growth in the
meaningful reduction in treated bleeds access to Zolgensma, it called its number of customers looking for our
compared to on-demand treatment. program to give away a certain number services in the past few years.”

News
“The new cleanroom sample preparation traditional outreach through sales of millions of dollars and years on
facility along with the ICP instruments representatives declines, it is difficult protracted litigation, and instead will
complement our existing in-house to catch and hold provider attention. provide billions of dollars and critical
techniques, such as GCMS, LCMS and That’s why it’s critical to make every resources to communities across the
HPLC, and allows us to offer a complete interaction matter. country trying to cope with the opioid
testing package to clients where time crisis. We will continue to work with
and compliance are critical,” she said. Performance-Driven Medical state attorneys general and other
Education™ (PDME) is an integrated plaintiff representatives to finalize and
The American Diabetes Association approach designed to elevate brand implement this agreement as quickly
Collaborates with eHealthcare Solutions value. It focuses on education first, as possible.”
for Digital Advertising Representation then on harmonizing medical education
eHealthcare Solutions (EHS) is thrilled and promotional communications. It Purdue Pharma spent $250 million
to announce a multi-year collaboration unites science, storytelling, behavioral on legal fees and costs to defend their
with the American Diabetes Association science, and neuromarketing to amplify case this year alone, officials say. They
(ADA), the nation’s leading voluntary the power of your brand. PDME is said that the cost of this battle made
health organization fighting to bend the an education-first idea that applies bankruptcy inevitable.
curve on the diabetes epidemic, whose marketing principles to medical
noble mission is to prevent and cure education and vice versa. Alzheimer's Drug Candidates Reverse
diabetes, as well as to improve the lives Broader Aging, Study Shows
of all people affected by diabetes. Purdue Pharma Files for Bankruptcy as In mouse models of Alzheimer's disease,
Part of Opioid Litigation Settlement the investigational drug candidates
EHS will be the ADA’s sole After long negotiations, Purdue known as CMS121 and J147 improve
digital representation firm sourcing Pharma, the pharmaceutical company memory and slow the degeneration of
pharmaceutical and medical device that produces the opioid painkiller brain cells. Now, Salk researchers have
advertising for the ADA’s medical journals OxyContin, filed for bankruptcy shown how these compounds can
and Diabetes Forecast magazine, the on Sunday, after being accused of also slow aging in healthy older mice,
leading health and wellness magazine contributing to the opioid crisis that has blocking the damage to brain cells
in the diabetes space which delivers killed over 70,000 people in 2017 alone. that normally occurs during aging and
expert content involving food, fitness, Purdue Pharma announced on Monday restoring the levels of specific molecules
weight loss, medications, monitoring in a statement that a preliminary to those seen in younger brains.
and other information which improves agreement has been reached on the US
the lives of people with diabetes. opioid litigation settlement. This falls The research, published last month
under Chapter 11 of the US bankruptcy in the journal eLife, suggests that the
The ADA is a highly prestigious code. The settlement is estimated to drug candidates may be useful for
organization, and according to R.J. provide $10 billion to address over treating a broader array of conditions
Lewis, CEO of EHS, “EHS is honored, 2,000 lawsuits filed by state, local and and points out a new pathway that links
humbled and proud to be selected as Native American governments. normal aging to Alzheimer's disease.
the ADA’s partner for digital advertising
representation and execution. We look On Tuesday a judge gave a way for "This study further validated
forward to improving physician and OxyContin to stay in business while these two compounds not only as
HCP audience capabilities, growing Purdue Pharma pursues its bankruptcy Alzheimer's drug candidates but also
high impact sponsorship programs, and protection and settlement. as potentially more widely useful for
expanding the ADA’s native consumer their anti-aging effects," says Pamela
advertising base.” Steve Miller, chairman of Purdue’s Maher, a senior staff scientist at Salk
board of directors said, “this settlement and a co-corresponding author of the
5 Actions that Maximize the Impact framework avoids wasting hundreds new paper.
of Promotional Medical Education
Initiatives
Successful promotional medical
education (Promo MedEd) programs
engage, enlighten, and ultimately shift
the behaviors of healthcare providers.
These programs are successful because
they are part of a strategic plan with
clear, measurable educational and
behavioral objectives. This coordinated
series of face-to-face and nonpersonal
activities is designed to move providers
into action.
As medical information proliferates,

marketing channels multiply, and

Advertisers Index
Page 83 19th Annual temperature Control and logistics
IFC Abzena Ltd.
Page 61 Changi Airport Group
Page 85 CPhI South East Asia
Page 63 Dokasch Temperature Solutions GmbH
Page 65 Ecocool
Page 3 Emirates Skycargo
Page 69 Eutecma
Page 59 Finnair Cargo
Page 17 Gerresheimer AG
Page 41 IMA ITALY
Page 71 Krautz Temax
Page 29 Mikron Automation
Page 11 Nemera
Page 51 Nipro Group
Page 84 Pharmapack
Page 47 Pharma Publications
Page 35 Phillips Medisize
IBC Q Products
Page 5 Schott AG
Page 53 Securikett
Page 73 Sensire
Page 7 Tashkent International Healthcare
BC Turkish Cargo
Page 9 & 37 Valsteam ADCA ENG
Page 39 Woolcool
I hope this journal guides you progressively,

through the maze of activities and changes
taking place in the pharmaceutical industry
IPI is also now active on social media.

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Keeping Your
Cold Chain Secure.
visit us at
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We manufacture thermal protection

and cargo security solutions for
all modes of transportation. Visit us >
Qsales.com
INTERNATIONAL PHARMACEUTICAL INDUSTRY 89
THE WORLD'S HEALTH
IS IN THE SAFE HANDS
OF TURKISH CARGO
As the cargo airline that flies to more countries than any other, we carry all your
health and wellness needs, from pharmaceuticals to medical supplies without
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Volume 11 Issue 4

Securing the Pharma Supply Chain

An Overview of Speaker Programmes

How Pharma Companies Can Improve

Just the Right Dose

Antibody Development Conjugation Technologies Payload Development

POC & Route Design GMP Manufacturing Extensive Bioassay &

WORLD ADC AWARDS 2018

REGULATORY & MARKETPLACE

08 The Impact of Regulation on Software Development

The increasing array of regulation surrounding medical

COVER IMAGE: DRUG DISCOVERY, DEVELOPMENT & DELIVERY

20 Data Inputs for Medical Intervention Valuations

It is well known that a positive net present value (NPV)

www.ipimediaworld.com INTERNATIONAL PHARMACEUTICAL INDUSTRY 1

2 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

44 Role of Phase Change Materials for Safe 68 How Innovations in Temperature-controlled

56 Delving Deep into FMD

IPI speaks with Marietta Ulrich Horn & Werner Horn of

LOGISTICS & SUPPLY CHAIN MANAGEMENT

58 Securing the Pharma Supply Chain: A Look Back at

The push for serialisation and traceability – assigning

4 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

PERFECTION MADE FOR PEOPLE.

SCHOTT EVERIC™. Next-generation vials.

SCHOTT AG, Pharmaceutical Systems, www.schott.com/pharma

Editorial Advisory Board

6 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

The Impact of Regulation on Software Development

compliance requirements for medical Beyond regulatory compliance,

8 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

(a proprietary Waterfall-based vulnerabilities as early as possible of complex programming languages

www.ipimediaworld.com INTERNATIONAL PHARMACEUTICAL INDUSTRY 9

10 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

Drug Delivery Devices

www.ipimediaworld.com INTERNATIONAL PHARMACEUTICAL INDUSTRY 11

MDR Preparations: The Final Leg

Typically, physical labels are created on ad-hoc manual processes for

12 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

4. Process Harmonisation is Hard

The danger where companies

5. MDR Compliance is Not a One-off

www.ipimediaworld.com INTERNATIONAL PHARMACEUTICAL INDUSTRY 13

An Overview of Speaker Programmes and the Influence

on a very local level – think hospital information across. Parties in charge of

What Do We Mean by ‘Speaker

The frequency of speaker programmes

If a target patient population is

14 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

www.ipimediaworld.com INTERNATIONAL PHARMACEUTICAL INDUSTRY 15

16 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

Ferbuary 5– 6, 2020 | Paris, France

Visit us at Hall 7.2 | Booth B 60/64

How Pharma Companies Can Improve Patient

The patient journey consists of inefficiencies with the same begrudging

18 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

www.ipimediaworld.com INTERNATIONAL PHARMACEUTICAL INDUSTRY 19

Data Inputs for Medical Intervention Valuations

20 INTERNATIONAL PHARMACEUTICAL INDUSTRY Winter 2019 Volume 11 Issue 4

From our experience, many small