A G I L I T Y. C O L L A B O R A T I O N . I N N O VA T I O N .

A N N U A L R E P O R T 2 0 2 0
2019–2020 International Board of Directors

ISPE OFFICERS ISPE DIRECTORS

Chair Vivianne J. Arencibia
Frances M. Zipp Independent Consultant
President and CEO Arencibia Quality Compliance Associates
Lachman Consultant Services, Inc
Gunter Baumgartner
Treasurer Senior Vice President, Head of Global Engineering
Joanne R. Barrick, RPh Takeda Pharmaceuticals International AG
Advisor, Global Validation
Eli Lilly and Company Scott W. Billman
Global Head of Engineering
Secretary Biogen
Jörg Zimmermann
Vice President, Vetter Development Service, Chris Chen, PhD
External Affairs CEO
Vetter Pharma-Fertigung WuXi Biologics (Shanghai) Co., Ltd.
GmbH & Co.
Ylva Ek
Past Chair Chief Quality Officer (CQO)
James A. Breen, Jr., PE KeyPlants AB
Vice President, Lead Biologics Expansion
Janssen Pharmaceuticals Lou W. Kennedy
CEO and Owner
Vice Chair Nephron Pharmaceuticals
Thomas B. Hartman
President and CEO Stephen C. Mahoney, JD
ISPE Executive Director, Global Quality & Compliance
Genentech, A Member of the Roche Group

INTERNATIONAL Christine M. V. Moore, PhD

YOUNG PROFESSIONALS Global Head and Executive Director, GRACS CMC Policy
REPRESENTATIVE Merck & Co, Inc.
LeAnna Pearson-Marcum Alice Redmond, PhD
Senior Project Manager Vice President, European Operations
PharmEng Technology CAI

Caroline Rocks, CEng

Senior Program Manager
AbbVie, Inc.
 WELCOME

AGILITY. COLLABORATION. INNOVATION

Normal life in many ways came to a halt in 2020 as a result of COVID-19. As a result,
the global pharmaceutical industry shifted into full speed. The Pharmaceutical Industry
accelerated discovery, development, and manufacturing at risk to meet the challenges
presented by the Pandemic. The men and women who develop, manufacture and
supply pharmaceuticals were also on the front lines, working to save lives and
overcome the crisis.

The pandemic, while horrific on so many fronts, also brought moments of great
challenge, opportunity and success on many fronts. The theme of this year’s Annual
Report captures the spirit of what came out of the determination and dedication
of ISPE Staff, Members and the pharmaceutical industry—greater Agility, greater
Thomas Hartman
Collaboration, and greater Innovation.
President & CEO
ISPE’s commitment to advancing the educational and technical proficiency of our ISPE
Members and the industry never faltered. We maintained our promise to provide
solutions to complex industry challenges through knowledge sharing, delivering
guidance, and by facilitating conversations on issues that will ultimately benefit
patients around the world.

Strides made in 2020 include:

• Transforming our in-person events into immersive digital experiences that allowed
our Members and industry to continue learning, knowledge-sharing, and networking
• Publishing five Guidance Documents, strengthening our library of technical
documents—considered the gold standard in our industry
• Launching the Eurasia Affiliate, growing our base of Affiliates and Chapters,
the backbone of ISPE
• Participating in the Department of the Air Force Acquisition COVID-19 Task
Force (DAF ACT) Initiative to Support Domestic Manufacturing of Active
Pharmaceutical Ingredients. The identified findings are applicable to all countries
with interest to improve the resiliency of their domestic supply of API’s for their
respective patient populations.

But we could not have done it without the efforts of our tireless volunteers, our
dedicated Members, and our worldwide ISPE staff.

We are looking forward to what 2021 holds for ISPE as we continue to facilitate neutral
environments for industry and regulators to engage in open dialog via our conference
platforms, explore the next frontier of the industry via Pharma 4.0™ and Facilities of
the Future, and launch programs to support the Workforce of the Future, Women in
Pharma®, and Global Knowledge Exchange initiatives sponsored by the ISPE Foundation.

The staff and leadership of ISPE are working hard to create the best professional
association possible for our industry. But we need your help to do it. We encourage all
Members to get more involved with YOUR Society in 2021. Volunteer for a committee,
contribute to creating a Guidance Document, or simply invest in the future by donating
to the ISPE Foundation.

Together, we will continue to strive for even greater Agility, Collaboration, and
Innovation in 2021 and for many years to come.
ANNUAL REPORT

01
 CELEBRATING 40 YEARS
ISPE: CELEBRATING 40 YEARS OF CONNECTING
PHARMACEUTICAL KNOWLEDGE
The International Society for Pharmaceutical Engineering (ISPE) was founded in 1980 by
a handful of people who believed the pharmaceutical industry needed an organization
that would deal with practical applications of science and technology for technical
professionals. The much-needed forum provided by ISPE began with a Membership of
engineers in North America. In time, ISPE Membership expanded beyond engineering to
include a broad representation from pharmaceutical professionals worldwide.

Flash-forward to 2020, and ISPE is a leading not-for-profit association serving its

17,000+ Members representing all scientific and technical areas of the pharmaceutical
manufacturing industry. ISPE remains committed to advancing its Members’ educational
and technical efficiency through forums for the exchange of ideas and practical
experience, and technical resources like ISPE Guidance Documents—considered the
gold standard in our industry. ISPE supports the international pharmaceutical industry
by leading multiple programs and critical areas of interest, including Drug Shortages
Initiative, Advancing Pharmaceutical Quality (APQ), Continuous Manufacturing, GAMP®,
Product Quality Lifecycle Implementation (PQLI)®, and Regulatory Quality Harmonization.

ISPE takes great pride in the impact we have made by educating and uniting regulators,
owner companies, service providers, and consultants to develop industry leading solutions.
We look forward to leading, collaborating, sharing, and breaking new ground in the years
to come.
ANNUAL REPORT

02
 REGULATORY AFFAIRS

ISPE is committed to fostering communications and interactions to advance common

interests among the pharmaceutical industry and regulatory agencies.

2020 IN REVIEW: REGULATORY AND QUALITY CONTENT AND INTERACTIONS

The shift to virtual conferences in 2020 allowed a greater ISPE delivered three days of customized training for
number of global regulators to participate in ISPE events as ANVISA assessors.
speakers, panelists, and attendees. Participation increased
to than more than 150 regulators from 20+ countries. ISPE launched the Advancing Pharmaceutical Quality
(APQ) Program with the publication of the first ISPE APQ
ISPE was selected as one of a limited number of Guide: Corrective Action and Preventive Action (CAPA)
organizations to provide feedback on the second System. The program seeks to improve the state of
targeted consultation for the EU GMP Guidelines Annex 1 pharmaceutical quality and ensure sustainable compliance.
revision, and on the PIC/S GMP Guide Annexes for ATMPs
and Biologics. ISPE member input was provided on those ISPE’s regulatory-focused volunteer groups - which
and seven other drafts released for consultation by global comprise more than 250 volunteers connected ISPE
Health Authorities. members to the latest regulatory developments by
delivering practical solutions delivered through ISPE
Numerous regulatory panel discussions were held at educational events and publications, including seven
ISPE conferences, with regulators answering questions webinars, six conference sessions, the 2020 Continuous
on topics such as Annex 1, digitization, practicalities of Manufacturing workshop, the 2020 Annual Meeting
harmonization, COVID-19 learnings, possibilities for using Regulatory and Quality track and Global Regulatory Town
distant assessment now and in the future, and the value Hall, five articles published in Pharmaceutical Engineering
of industry/regulatory interaction and collaboration for magazine, and seven other papers and blogs published
crises management. on the ISPE website.
ANNUAL REPORT

ISPE continues to work with a group of 11 other Lastly, ISPE launched the Regulatory Digest, a quarterly
associations identified as interested parties in newsletter dedicated to informing members, global
communication with the EMA on topics such as regulators, and the industry at large about ISPE’s
drug shortage prevention in context with COVID-19, activities related to regulatory and quality.
digitization, GMP for importers, EC GMP Guide Chapter
4 on Documentation/CSV Annex 11, GMP for IMPs
(Investigational Medicinal Products), audit management
03
in a changing environment, and more.
 ANNUAL MEETING AND CONFERENCES

GLOBAL REACH THROUGH VIRTUAL MEETINGS

The continued growth of technology enabled ISPE to have a global reach in the delivery
of educational programs through live and on-demand video conferencing with people
“The range of subjects and
scattered across the globe with a touch of a button. ISPE hosted 2 in-person and 7
the speakers engaged
virtual programs worldwide in 2020, working with 100+ volunteer leaders on program
provided broad and
development; showcasing 485 speakers; providing a platform for 90+ regulators
experience-based content.”
from global agencies; and providing conference educational opportunities for 3,200+
— ISPE Annual Meeting members and non-members across the industry.
Attendee
In addition to the traditional programs offered in North America and in Europe, we
expanded on opportunities to partner with our Chapters and Affiliates around the globe
that included our flagship annual events held virtually, and 7 topic-focused conferences,
workshops, and forums in North America, Europe, and Asia Pacific regions.

2020 HIGHLIGHTS ISPE ANNUAL MEETING & EXPO

The ISPE Annual Meeting featured keynote speakers from Sparks Therapeutics, CSL
Behring, GlaxoSmithKline, and FDA along with committee members, and speakers from
around the world, featuring 60+ education sessions in six different tracks. More than
250 industry and regulatory experts shared their expertise and vision for the future of
the industry, and networking opportunity with educational posters and exhibition hall
that provided further opportunities for delegates to network and gain insight into the
production approaches of other companies.

NORTH AMERICAN CONFERENCES

Other North American highlights included the Facilities of
the Future Conference held in San Francisco, CA 30 – 31
January and the Aseptic Conference, held in Bethesda,
Maryland 2 – 3 March, now in its 29th year.

ISPE’s 5th Biopharmaceutical Manufacturing Conference

(1 – 2 June) focused on innovation in facilities, production
methods and technologies that enable a competitive
and sustainable biopharmaceutical product supply for
the future. This conference included experts that are
developing, implementing, and operating advanced
supply chains providing high quality medicines to
global markets. Program presentations addressed
challenges of new modalities, process, operational and
facility innovations, and supply chain strategies bringing
reliability, efficiency, and modernization for today’s
2020 FOF conference. manufacturing and tomorrow’s new therapies. The conference featured views and
case studies by biopharmaceutical industry professionals, in additional to perspectives
from regulatory officials. Regulators provided insights on CMC approaches, and CGMP
developments for emerging technologies and individualized treatments.

Immediately following, 3 – 4 June, ISPE held the Continuous Manufacturing Workshop,

now a 2 day event. Interest in continuous manufacturing of pharmaceuticals had
exploded in the past few years, fueled by the recent regulatory approvals of the first
few drug products to be manufactured by this emerging technology. The 2020 ISPE
Continuous Manufacturing Workshop included industry practitioners, regulators and
ANNUAL REPORT

academics to discuss the recent successes and remaining challenges for continuous
manufacturing of small molecule drug substances and drug products. The workshop
provided an in-depth view of the manufacturing technologies and regulatory approaches
for successful development, implementation, and lifecycle management of continuous
manufacturing both for new molecules and for batch to continuous conversions.

04
 ANNUAL MEETING AND CONFERENCES

ISPE EUROPE ANNUAL CONFERENCE

At the 2020 ISPE Europe Annual Conference on 16–17 September, which was a virtual
conference, regulatory panel discussions included more than 20 regulators from eight
countries and the European Medicines Agency (EMA), Medicines and Healthcare “Highlights of the
Products Regulatory Agency (MHRA), Pharmaceutical Inspection Co-operation Scheme conference were the panel
discussions and the virtual
(PIC/S), European Directorate for the Quality of Medicines (EDQM), and World Health
plant tours. The regulatory
Organization (WHO). Highlights included panel discussions on Distant Assessments
panel discussions focused
During and After COVID-19, COVID-19 Challenges and Drug Shortages and COVID-19. on current and relevant
topics in the recent COVID
A regulatory panel discussed the topic of Distant Assessments on GMP and Inspection climate. The innovative
Reliance. Driven by digitalization, these assessments help the industry and regulators virtual plant tours
manage inspection challenges related to the COVID-19 pandemic. The panelists’ complimented a really
comments suggest that virtual inspection can work, but there are definite challenges strong programme.”
to the execution, including the need for common and harmonized processes and
technology. Additionally, there are concerns about how companies can create rapport —EUROPE ANNUAL
and build trust with regulators without face-to-face meetings. Despite the challenges, MEETING ATTENDEE
distant assessments seem to be worth pursuing as a way to support development of
new, innovative drugs or and avoid drug shortages for patients.

Further discussions focused on Learnings from COVID-19 and explored how the industry
and regulators are managing the challenges presented by COVID-19 and what can be
learned for the future. In summary, panelists liked a holistic approach, particularly that
overall quality requires full supply chain integration. Where there is good accessibility to
information, more flexibility could be imagined.

Virtual plant tour of ABEC.

ANNUAL REPORT

05
 ANNUAL MEETING AND CONFERENCES

2020 ISPE BIOTECHNOLOGY VIRTUAL CONFERENCE

The ISPE Europe Biotechnology Conference focused on how ATMPs, Aseptics and
Drug Products Meet Digitalisation. Biologics continue to develop to the most important
group of medical drugs in future and in October 2020, ISPE continued the series of
successful Biotechnology conferences with a virtual conference. Case studies featuring
new concepts to industrialisation, virtual plant tours to new, state-of-the-art facilities and
a workshop where current industry practise and new ways of operations were explored,
engaged our participants during this two-day event. The tracks focused on Quality and
Regulatory changes for ATMPs, Digitalisation and Pharma 4.0, Transfer of Manufacturing
Processes and Analytical Procedures between Facilities and ATMPs.

2020 ISPE PHARMA 4.0™ VIRTUAL CONFERENCE

At the 2020 ISPE Pharma 4.0™ Virtual Conference, 17–18 November 2020, 174 attendees
gathered online to discuss and learn about the progress of the pharma-specific industry
4.0 approach, In Europe the protected trademark is “ISPE Pharma 4.0”. Interactive case
studies and panel discussions ensured that participants stayed engaged and could
participate throughout the two days.

Certain conclusions were that the holistic approach to Pharma 4.0™ is crucial to
overcome the main implementation challenges. Whereas Pharma 4.0™ projects are often
seen as technological projects, thinking outside of silos is always key—it is necessary to
widen the plans, include competencies, involve organization, have strong sponsorship.

Panelists from the respective tracks highlighted that changes cannot be managed
by one function within an organization; there has to be a multi-functional approach.
Although the concept “digital transformation” may be easy to define, it can be difficult
to ensure everyone has the same understanding and expectations.

ASIA EVENTS
ISPE partnered with the Asia Pacific Affiliates on the 2020 ISPE Asia Pacific
Pharmaceutical Manufacturing Conference “Bracing for Impact: Best Practices for
Maintaining Pharmaceutical Supply Chain Continuity in a Complex and Dynamic
Environment”. The conference focused on helping attendees gain practical
understanding of current data integrity issues, and presentations included: regulatory
requirements and compliance; data integrity and enabling technologies; and data
integrity execution and a risk-based approach that encourages companies to align their
ANNUAL REPORT

data integrity strategies with regulatory priorities and industry-critical initiatives. It was
preceded by Executive Forum, giving delegates the unique opportunity to engage in
peer-to-peer problem solving through practical exercises and real-world case studies.

06
 FACILITY OF THE YEAR AWARDS

16TH ANNUAL ISPE FACILITY OF THE YEAR AWARDS

2020 WINNERS
EQUIPMENT INNOVATION SOCIAL IMPACT
F. Hoffmann-La Roche Ltd. GlaxoSmithKline
Project: Building 98 (B098) Project: Attachment Inhibitor Project
Location: Basel, Switzerland Location: Parma, Italy

FACILITY INTEGRATION United Therapeutics

Pfizer Inc. Project: Dinutuximab Dedicated Oncology
Project: Andover Clinical Manufacturing Facility Medical & Analytical Laboratory (DDOMAL)
Location: Andover, Massachusetts, USA Location: Silver Spring, Maryland, USA

FACILITY OF THE FUTURE OPERATIONAL EXCELLENCE

Sanofi Eli Lilly and Company
Project: Digitally-Enabled, Integrated Project: Lilly Innovation Development Center
Continuous Biomanufacturing Facility Location: Indianapolis, Indiana, USA
Location: Framingham, Massachusetts, USA
HONORABLE MENTION
PROCESS INNOVATION Boehringer Ingelheim Biopharmaceuticals
Janssen Pharmaceuticals China Ltd.
Project: Mirror 1: A Continuous Project: OASIS
Manufacturing Platform Location: Shanghai, China
Location: Beerse, Belgium
J&J, Janssen Pharmaceuticals, Inc.
PROJECT EXECUTION Project: Raritan CAR-T Clinical
Bristol Myers Squibb Manufacturing Facility
Project: Cruiserath Biologics Campus Location: Raritan, New Jersey, USA
Location: Cruiserath Campus, Tyrellstown,
Dublin 15, Ireland

2020 FACILITY OF THE YEAR AWARDS OVERALL WINNER

Sanofi
Project: Digitally-Enabled, Integrated Continuous Biomanufacturing Facility
Location: Framingham, Massachusetts, USA
Sanofi was awarded the 2020
Facility of the Year (FOYA) Overall
Winner at the 2020 Virtual FOYA
Banquet during ISPE’s 2020
Virtual Annual Meeting & Expo for
its Digitally Enabled Integrated
Continuous Biomanufacturing
Facility project in Framingham,
Massachusetts, USA.

Sanofi pushed the concepts of digitization to fully integrate process control, data collection,
and analytics and built a fully integrated bioprocessing facility that takes the application of
disposable process technology and flexible facility design to a new level. They used the best of
already proven technology and design and expanded the use to allow design and construction
ANNUAL REPORT

of a facility that enables continuous processing. Through an innovative collaboration with

equipment suppliers they were able to expand the use of single-use technology to include,
media and buffer preparation, upstream, downstream, and column packing. This combined with
a commitment to a ‘born lean’ design philosophy has created an industry factory 4.0 lighthouse.

07
ISPE MEMBERS WORLDWIDE

AFFILIATES BY REGION
Australasia Affiliate includes Australia,
New Zealand; D/A/CH Affiliate includes
Germany, Austria, Switzerland; Iberia
Affiliate includes Spain, Portugal; Eurasian
Economic Union Affiliate includes Russia,
Armenia, Belarus, Kazakhstan, Kyrgyzstan;
Nordic Affiliate includes Denmark, Finland,
Iceland, Norway, Sweden; United Kingdom
Affiliate includes England, Scotland, Wales.

CHAPTERS BY REGION
Boston Area Chapter includes Massachusetts,
Connecticut, Rhode Island, Maine, Vermont, New
Hampshire, Upstate New York; Carolina-South
Atlantic Chapter includes Alabama, Florida,
Georgia, North and South Carolina, Tennessee; AFFILIATE/CHAPTER
Chesapeake Bay Area Chapter includes area in and GROUP MEMBERS
around Baltimore, MD, Washington, DC, Northern
Argentina 58
Virginia; Delaware Valley Chapter includes Eastern
Australasia 227
Pennsylvania, Southern New Jersey, Delaware, part of Belgium 315
Maryland; Great Lakes Chapter includes Ohio, Indiana, Boston 1346
Illinois, Michigan, Wisconsin, Kentucky; Greater Los Angeles Brazil 130
Area Chapter includes Los Angeles, Orange, Ventura, and Canada 361
Riverside Counties; Midwest Chapter includes Missouri, Kansas, CASA 1003
Chesapeake 311
Iowa, Nebraska, Minnesota; New Jersey Chapter includes New
Czech/Slovakia 55
Jersey, New York, Northeastern Pennsylvania; Pacific Northwest Delaware 767
Chapter includes Washington, Oregon; Rocky Mountain Eurasian 80
Chapter includes Colorado, Utah; San Diego Chapter includes France 197
Southern California and north to Orange County; San Francisco/ D/A/CH 1105
Bay Area Chapter includes Northern California; South Central
Chapter includes Texas, Oklahoma, Louisiana.
 An association is nothing without its members, and ISPE closed out the year in 2020 with
nearly 18,000 members, continuing the growth pattern of the last several years. Even more
impressive—and indicative of our ability to accurately gauge and meet modern members’
needs worldwide—ISPE membership continued to grow during one of the most challenging
years in the history of our industry.

“I’ve been a member of

ISPE for a number of years
and am currently proud
to be the President of the
Australasian Affiliate. ISPE
has been an important
part of my career. Not only
does membership provide
access to an incredible
knowledge base through its
publications, training events
and communities of practice,
but more importantly it has
expanded my networking
opportunities globally,
improved my confidence,
and allowed me to meet
some awesome role models
and mentors.”

—Helen Atkinson,
Quality Professional

GROUP MEMBERS GROUP MEMBERS

COUNTRIES WITH MEMBERS
Great Lakes 605 New Jersey 685
Greater Los Angeles 378 Nordic 425
Iberia 182 Pacific Northwest 143
COUNTRIES WITHOUT MEMBERS
India 292 Philippines 140
Indonesia 272 Poland 94
Ireland 612 Rocky Mountain 275
Italy 485 San Diego 313
Japan 729 San Francisco 727
Korea 121 Singapore 274
Malaysia 367 South Central 155
Mexico 89 Thailand 275
Midwest 499 Turkey 136
Netherlands 221 UK 793
 PUBLICATIONS

PHARMACEUTICAL ENGINEERING® MAGAZINE:

FOCUS ON KEY CONTENT PRIORITIES
For 40 years, Pharmaceutical Engineering® (PE) has provided ISPE members with
information about trends and developments in the pharma industry. In 2020, PE
continued to expand the PE Online portion of the ISPE.org site with Online Exclusives
articles and continued the Open Access program for nonmember access to select
content. The six bi-monthly issues of PE featured articles on topics including biopharma/
cell and gene therapy, sustainability, aseptic, and the transition to digitalization.

January–February March–April

The pharmaceutical industry’s An array of sustainability

success is fueled by people, so topics were explored,
PE initiated a year-long series including real-world
of profiles of Industry Leaders, experiences, energy
a look at the lives and careers efficiency, and
of those who are changing the bioremediation of
face of the industry. pharmaceuticals.

May–June July–August

The introduction of ICH Q12, a The ISPE Aseptic Conference

transformational product provided a report on over
life-cycle management two decades of the ISPE
guideline, provided a wide Barrier Isolator Survey, which
scope of applicability across has tracked the application of
drug substances and barrier technology and
products, drug-device informed the industry of
combination products, and new molecular developments in aseptic.
entities and authorized products.

September–October November–December

Digitalization offers promise Cell and gene therapy

to transform the industry applications including
through capturing, analyzing, simulations for facility design,
and using data to support facilities for multiple cell
everything from R&D to drug therapy processes,
manufacture, supply chain oligonucleotide therapeutics
management, patient development, and more were
engagement, and quality assurance and explored in this annual revisit to fast-
control, among other objectives. developing approaches.
ANNUAL REPORT

10
 PUBLICATIONS

GUIDANCE DOCUMENTS
ISPE Guidance Documents, today acknowledged as the gold standard for the pharmaceutical
manufacturing industry’s technical content, have been offering practical answers to the
complex, dynamic challenges facing pharmaceutical operations and facilities around the
world since the first Guide, the ISPE Baseline® Guide: Volume 1 – Bulk Pharmaceutical
Chemicals, was published in 1996. In 2020, ISPE published five Guides, expanding our efforts
to meet the growing demands of industry for current best practices that meet and exceed
regulatory expectations. ISPE Guidance Documents continue to ensure a solid base for
training programs that inevitably spring from these expertly written Guides.

GUIDANCE DOCUMENTS PUBLISHED IN 2020

• ISPE Good Practice Guide: Critical Utilities GMP Compliance –
How to Be Compliant and Ready to Prove It
June 2020
• ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods,
and Controls
August 2020
• ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design
October 2020
• ISPE Advancing Pharmaceutical Quality Guide: Corrective Action
and Preventive Action (CAPA) System
November 2020
ANNUAL REPORT

• ISPE Good Practice Guide: Equipment Reliability

December 2020

11
 PROFESSIONAL DEVELOPMENT

A PASSION FOR EDUCATION, A COMMITMENT TO LIFELONG LEARNING

To excel, we must continue to grow, and in order to grow, we must continue to learn,
train, educate, and share. ISPE’s professional development and training programs
provide our members with a path forward, but we knew it was time to ensure and
expand access to the Society’s portfolio of training courses. So, in 2020, in response to
the COVID pandemic, ISPE accelerated it’s goal to move it’s professional development
into the virtual realm. Online Live training was successfully launched in March and
continued through the remainder of 2020.

There was also continued success in custom training. ISPE partnered with multiple
companies to provide the industry with educational courses that were specifically
tailored to individual needs.

Throughout the year, ISPE continued to lead the pharmaceutical community through
instruction of GAMP® practices to ensure the integrity of our data. We developed and
retained relationships with quality instructors who will continue to provide knowledge
and experience throughout our community.

ISPE TRAINING COURSES CONTINUE TO SUPPORT THE BUSINESS INITIATIVES OF COMPANIES

SUCH AS:
Abbott Laboratories Elan Corporation Health Canada Novo Nordisk
AbbVie Eli Lilly and Company Hikma Ortho-Clinical
Alkermes Emergent BioSolutions, Inc. Johnson & Johnson Diagnostics
Allergan, Inc. FDA Lonza Pfizer, Inc.
Amgen, Inc. F. Hoffmann-La Roche, Merck & Co., Inc. Regeneron
Astelllas Ltd. Mylan, Inc. Pharmaceuticals, Inc.
AstraZeneca Genentech, Inc. National Centers for Sanofi Pasteur
Bausch & Lomb, Inc. Genzyme Corp. Animal Health USDA Synthes, Inc.
Baxter BioScience Gilead Sciences, Inc. National Institutes of U.S. Department of
Manufacturing GlaxoSmithKline Health Veterans Affairs
Bayer CropScience AG H Lundbeck A/S Novartis International AG Ulma Packaging USFDA
W.L. Gore Associates

NORTH AMERICA TRAINING EUROPE TRAINING COURSES TAUGHT

OVER 400 TRAINED OVER 130 TRAINED OVER 25 COURSES

TRAINING WEB STATS

ANNUAL REPORT

1,615,139 926,864 3,704,753

SESSIONS USERS PAGEVIEWS
12
 FINANCES

THE BOTTOM LINE

ISPE completed another fiscally successful year on 31 December 2020. Despite
significant impacts on operations from COVID-19, positive operational and investment
performance combined to provide sufficient funding for ISPE’s continued improvements
in products, services, and information offered to Members and the Society. ISPE’s
auditors, Dearolf & Mereness LLP, conducted the 2020 audit and gave ISPE an
unqualified opinion, indicating that ISPE’s financial statements fairly represented the
organization’s financial position and were in accordance with generally accepted
accounting principles.

Assets and liabilities were in balance on 31 December 2020, at $10.7 million, which
equates to a decrease of approximately 13.4% over 2019 and was a direct result of the
impacts of COVID-19. Notwithstanding these challenges, ISPE continued to implement
new technology and improved business processes during the year. Overall operating
income and expense activities resulted in a gain of $160,000. Additionally, in 2020 the
ISPE Board approved strategic initiatives that resulted in an additional $577,000 of
expenses. These costs were partially offset by $239,000 in revenue from investments
and currency exchange activities. The combined operating, special initiatives, and
investing activities resulted in a change in net assets for the year ending 31 December
2020 of a negative $178,000.

To fund strategic initiatives in support of the Society’s mission, and to protect against
business disruptions such as COVID-19, ISPE holds funds in investment reserves. The
organization’s 2020 financial reserves gained $215,000 over 2019. While positive
investment returns are never guaranteed, ISPE’s investment portfolio is continually
monitored to ensure that appropriate levels of safeguards and risks are in place to take
full advantage of the market and to meet the long-term needs of the organization. ISPE
held financial reserves of over $6.8 million at year’s end.

Revenues from Membership, publications, meetings, and training were used to support
the ISPE Mission of connecting pharmaceutical knowledge to deliver manufacturing
and supply chain innovation, operational excellence and regulatory insights to enhance
industry efforts to develop, manufacture, and reliably deliver quality medicines to
patients. Additionally, ISPE staff is actively engaged in the development of new products,
programs, and Member benefits, as well as the pursuit of new business opportunities
that will support the mission, vision, and future needs of the organization.

ISPE leadership and management remain mindful of the changing US and World
economies, political and social environments, and their impacts on the Society.

Accordingly, the Society is prepared to modify the fiscal strategies of the organization in
order to meet these challenges and the ever changing needs of the Membership.

ANNUAL REPORT

13
 FINANCES

STATEMENT OF FINANCIAL POSITION STATEMENT OF ACTIVITIES

FOR THE YEAR ENDED DECEMBER 31, 2020 FOR THE YEAR ENDED DECEMBER 31, 2020
(With comparative financial information for 2019) (With comparative financial information for 2019)

ASSETS REVENUES
CURRENT ASSETS 2020 2019 PROGRAM REVENUES 2020 2019
Cash and Cash Equivalents $ 2,339,322 $ 4,021,763 Professional development $ 4,273,837 $ 8,795,727
Short-term investments - - Membership services 3,361,535 3,583,325
Accounts receivable 621,243 829,354 Guidance documents 2,048,895 1,760,669
Inventory of technical materials 32,746 34,626 Advertising fees 695,407 717,355
Prepaid Expenses 297,977 242,206 TOTAL PROGRAM REVENUES 10,379,674 14,857,076
TOTAL CURRENT ASSETS 3,291,288 5,127,949 OTHER
OTHER ASSETS Investment income 215,538 768,529
Property and equipment = net 567,411 720,151 Miscellaneous 813 14,318
Investments 6,758,611 6,526,026 TOTAL OTHER REVENUES 216,351 782,847
Deposits 65,272 51,890 TOTAL REVENUES 10,596,025 15,639,923
TOTAL OTHER ASSETS 7,391,294 7,298,067
TOTAL ASSETS $ 10,682,582 $ 12,426,016 EXPENSES
PROGRAM SERVICES
LIABILITIES AND NET ASSETS Professional development 4,120,872 7,508,983
CURRENT LIABILITIES Membership services 1,592,842 1,793,783
Accounts payable $ 523,158 $ 1,337,677 Guidance documents 865,281 808,205
Accrued expenses 264,916 462,324 Publications 527,277 619,106
Contract Liabilities 2,698,556 3,265,495 TOTAL PROGRAM SERVICES 7,106,272 10,730,077
TOTAL CURRENT LIABILITIES 3,486,630 5,065,496 Management and general 3,652,714 3,586,242
LONG-TERM LIABILITIES TOTAL FUNCTIONAL EXPENSES 10,758,986 14,316,319
Accrued rent 440,550 426,987
Unallocated payment to
TOTAL LIABILITIES 3,927,180 5,492,483 – 50,000
nonprofit organization
NET ASSETS TOTAL EXPENSES 10,758,986 14,366,319
Unrestricted 6,755,402 6,933,533 CHANGE IN NET ASSETS
(162,961) 1,273,604
TOTAL LIABILITIES AND NET ASSETS $ 10,682,582 $ 12,426,016 FROM OPERATIONS

NET CHANGE OF FOREIGN

(15,170) (75,235)
CURRENCY REMEASUREMENT
Change in net assets (178,131) 1,198,369
NET ASSETS—
6,933,533 5,760,209
BEGINNING OF YEAR, AS STATED

Change in Accounting Princiiple -

– (25,045)
Revenue Recognition

NET ASSETS—
6,933,533 5,735,164
BEGINNING OF YEAR, AS RESTATED

NET ASSETS—END OF YEAR $ 6,755,402 $ 6,933,533

ANNUAL REPORT

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ANNUAL REPORT

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 ISPE is committed to the advancement of the educational and technical
efficiency of its members through forums for the exchange of ideas and
practical experience.

We lead and facilitate the development of next-generation process

technologies and innovative technical solutions. On matters of regulation,
our focus is on those requirements that impact — or will impact — the
licensing of facilities, manufacturing processes and operations, and the
sustainability of the supply chain over the product lifecycle. ISPE provides a
neutral environment where our individual Members and experts belonging
to regulatory authorities can engage in open dialogue on issues that will
ultimately benefit patients around the world.

MISSION
ISPE is the global industry leader in connecting pharmaceutical knowledge
to deliver manufacturing and supply chain innovation, operational excellence
and regulatory insights to enhance industry efforts to develop, manufacture
and reliably deliver quality medicines to patients.

VISION
Provide solutions to complex pharmaceutical industry challenges through
manufacturing innovation, member and workforce development, technical,
regulatory, and compliance collaboration.

6110 Executive Blvd., Suite 600, North Bethesda, MD 20852 USA | +1-301-364-9201 | ispe.org