Pre-Launch

Planning:
Priming Your Pharmaceutical Brand
For Profit And Success

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 Executive ​To deliver on the high hopes of
Pharmaceutical brand launches,
companies must engage in

Summary comprehensive pre-launch

planning

Eularis ©2014 www.eularis.com 2

Executive Summary

A product’s shaping, positioning, In today’s environment, Pharmaceutical companies find themselves in a bind. Until recently, if drugs
made over $500 Million in annual revenue within 3 to 5 years of launch, they were considered
sales uptake and market hugely successful. They were a support to an extensive company portfolio and a component of
performance, with proper greater company profit.

marketing focus and support, However, things have changed. The standards for a successful drug have become much higher and
can translate to the elusive much more dangerous. With so many revenue-producing drugs going off patent, companies are
facing large holes in their balance sheets and sales that are increasingly slow.
blockbuster
Plus, with the stakes high and available funds low, pipelines are drying up. Add to this the closer
scrutiny of safety issues, the rise of Generics, slower physician acceptance and adoption of new
therapies, and the Pharma Industry is in trouble.

More and more, companies are expecting marketers to be instrumental at the key moment of
launch, and marketers are under extreme pressure. To deliver on the high hopes of Pharmaceutical
brand launch, companies must engage in comprehensive pre-launch planning.

In this report we analyze why launch is increasingly important, the issues involved in pre-launch
planning, including key organizational strategies, marketing tactics, regulatory considerations, global
issues, and methods for ensuring the most effective plans.

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 Brand Launches In ​To understand why brand
launches are increasingly

Today’s Pharma
seen as a salvation for
Pharma companies, we
must fully understand how

Environment
we got here in the first
place

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Brand Launches In Today’s Pharma Environment

As a salve to the painful To understand why brand launches are growing

in importance and increasingly seen as a
INCREASED COMPETITION

situation we find ourselves in, salvation for Pharma companies, we must fully A drug launched in 1965 could enjoy several
many savvy Pharma companies understand how we got here in the first place: decades’ worth of exclusive market
domination. However, companies are looking
are seizing upon a potential SLUGGISH R&D to each other to discover their peers’ solutions
solution in powerful brand Spending on research and development has
and secrets to R&D success, and are producing
remarkably similar products. Drugs launched
launches steadily increased in the last decade but, at the in the last few years have mere months before
same time, productivity has dropped competition shows up. And, of course, there
dramatically. While companies throw more are Generics.
money at the R&D department, the prices
required to bring a new product to market and The Generics Industry captured 14% of the
to see it through FDA approval have global HealthCare market in 2004, with overall
skyrocketed. The total monies required to bring revenues of $58 Billion. Since then, the
a new chemical entity to market is now numbers have only increased. With a
estimated at an average of U.S. $879 Million. As competitor boasting equal product quality and
a result, R&D has become sluggish, with fewer safety, but reduced prices, Big Pharma is
products in and out of development, and the finding it hard to compete.
Industry’s pipelines have dried up.
As a result of these key factors, companies are
STAGNANT ROI growing more aware of the need to have a
consistent stream of new and better
The cost to bring drugs to market is increasing Pharmaceutical products if they want future
more and more, but the return on this R&D growth that can be sustained over time.
investment is in decline. From 2001 to 2005, Market success is gauged by a company’s
only 3 out of 10 new drugs generated enough ability to introduce new drugs quickly and
sales to repay R&D investment. triumphantly, and to maximize sales through
stellar marketing, promotion and positioning.
Only by making the best and biggest splash
possible, and doing it again and again, can
companies thrive.
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 Pre-Launch ​Launch success is integral
to a brand’s overall success,

Planning and to the company’s

continuing viability

-- The Early Stages

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Pre-Launch Planning -- The Early Stages

By ensuring a proper launch A successful launch is not simply about the moment of launch. To leverage launch into a business-
sustaining product, and to fully capitalize on the efforts put into development, launch must be
that establishes a brand, that exquisitely planned.
creates awareness and need What makes for a successful launch? Early planning. Thoroughness. Analytics. A willingness to learn.
before sales begin, that drives it The attitudes and working behaviors that prime a company to think creatively, plan effectively and
to peak sales and effectively engender success. A study by Best Practices LLC of 20 blockbuster products from 15 companies can
help us summarize these key organizational best practices when it comes to creating optimal
meets initial and new launches:
competition, a brand can avoid  A successful launch comes after launch planning that spans over multiple years.
crises that often occur during a  A successful launch requires major multi-tasking and collaboration. The marketing team, for
successful launches, must coordinate highly disparate activities over a long time period and
product’s lifecycle synchronize across departments, thought leaders, spread-out facilities and global enterprises.
 A successful launch requires the integration of marketing and R&D. Successful companies
recognize these departments have different priorities and tactics but the same goals. Marketers
want to build market share and influence customers, while R&D wants to ensure drug efficacy
and quick entry to the market. Together, they want a successful launch, and using cross-
functional teams and other integration methods will enable that.
 A successful launch requires meticulous resource allocation through analytics. Marketers need
to time and allot resources early, consistently and comprehensively throughout the launch cycle.
Resources include people, dollars and time, and they must be assigned appropriately to build
big launches for high-potential products.
 A successful launch effectively leverages thought leaders. Advisory panels and conferences are
already common, but often occur too late in the game to influence development. Thought
leader insights should be gathered prior to the establishment of clinical development protocols,
enabling product development to be shaped to match market needs.
 A successful launch utilizes broad market research and analytics. In order to differentiate and
deliver the value necessary for a big splash, marketers have to understand market dynamics
and ensure clinical development is attached to market needs.
 A successful launch builds on sales force support. Is the sales team convinced? Do they
understand and have strategies for leveraging the value propositions of the new product? Are
they ready from Day 1? Creating and maintaining buy-in from the sales team is absolutely critical
for launch success.
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Pre-Launch Planning -- The Early Stages

Overall, the pre-launch planning framework must set up business practices that enable hard decisions to be made and tactics undertaken. Just as
important is early planning for marketing during the launch and after. Time is critical when it comes to launches; a product must have an exact, well-
informed, strong plan that can be implemented immediately upon approval. Marketing, then, should be considered even while drugs are still in the
development and research phases.

Marketers should undertake efforts to understand their burgeoning product, find an ideal market position and get ready for the long haul, all in the early
stages of product creation. Key marketing activities in these early planning stages include:

Market Analysis:
Long before that product is complete and ready for sale, you need a deep understanding of your product and how it’s going to fit into the market. That
means understanding the current market, including the disease area, target customers and target audiences, needs of patients and physicians in this
area, current treatment approaches, key opinion leader ideas and views, and trends involving patient access and reimbursement.

Gauging the Competition:

A part of knowing your market is knowing the competition that already exists now and that which is likely to develop before and after launch. How does
your product relate to what already exists? What additional benefits will you provide?

Planning Clinical Trials:

The decisions you make about clinical trials for your new product will directly inform the type of positioning and branding you undertake. Overall,
products that present significant lifecycle opportunities can often forgo competitive positioning and the need to engage in competitive clinical trials. For
drugs in critical and serious conditions, however, the comparison could directly affect positioning and eventual sales.

Preliminary Positioning:
Pharma companies know that physicians have limited time to grasp and internalize product messages. That’s why early work at developing the best
positioning will pay off upon product launch.

With all of these planning activities in the early pre-launch stages, the product is primed and increasingly ready as launch nears.

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 Pre-launch ​Companies must consider
regulatory issues at all

Planning stages of a product’s

lifecycle

-- Regulatory Planning

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Pre-launch Planning -- Regulatory Planning

Time is critical when it comes to Companies must consider regulatory issues at all stages of a product’s lifecycle. However, most of
the effort placed into regulatory considerations is late in the lifecycle, defending patents against
launches and a product must Generic challenges.
have an exact, well informed, By investing more attention and energy into initial regulatory approval, and obtaining that approval
strong plan that can be as quickly, efficiently and comprehensively as possible, far greater value can be earned over a
implemented immediately upon product’s life.

approval Every day that a new product has on the market increases sales; every day a product launch can be
hastened can boost these returns and market penetration.

In the last few decades, the costs of putting a new medication on the market have increased
dramatically.

Additionally, the official requirements set by reviewing institutions have become more severe.

As result, the time required for a company to enter a new drug on the market has lengthened
significantly. Although a patent monopoly theoretically provides for 20 years, in practice, it usually
lasts only 10 years. Even more recent data suggests it is now down to an average of 8 years.

Specific legal regulations for patented drugs in the U.S. and EU, including the Hatch-Waxman Act,
the Roche-Bolar Provision and the Supplementary Protection Certificate (SPC), increasingly favor
less exclusivity and more competition, especially from Generics. To maximize patent protection, the
pre-launch team must focus on getting regulatory approval quickly.

Several regulatory means exist through which companies can look to accelerate market arrival.

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Pre-launch Planning -- Regulatory Planning

Priority Review:-

In the U.S., the FDA offers an abbreviated priority review process for specific products that can demonstrate a key point: they serve a specific and notable
unmet medical need. Between 2001 and 2005, more than 40% of new U.S. drug approvals were completed through this priority review procedure.

Orphan Drugs:-

These programs in the U.S. and EU offer market exclusivity for the drugs for rare diseases, but this period is offered only to the drug that receives market
approval first. Applications for these orphan drugs are given greater levels of support and feedback from regulators, meaning approvals are accelerated.
Market exclusivity periods vary but, generally, average 5 years following initial approval. Drugs meeting these standards in the U.S. between 2001 and 2005
received a period of market dominance ranging from 3 to 7 years.

European Named Patient Programs:-

These programs are similar to the U.S. programs of compassionate use, with a key difference. When a patient has a serious illness that does not have an
approved drug available, drugs that have shown promise in clinical trials, but are not yet fully FDA approved, can be authorized for use.

In Europe, these unlicensed drugs can be reimbursed, granting Pharma companies an opportunity to generate revenue while development is still in
progress. These programs can quickly create loyal physician adopters, physicians who will act as references for other physicians when the drug is formally
approved.

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 Pre-launch ​Preliminary positioning
done early in the pre-

Planning
launch period is about
determining the early ideas
concerning differentiation
-- The Later Stages

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Pre-launch Planning -- The Later Stages

Demonstrating a product’s From the early pre-launch planning framework, through initial marketing and into regulatory review,
a concerted company effort helps lay the groundwork for product success. As launch grows closer,
value through science - through it’s time to focus these efforts into clear next steps.
data on efficacy and safety, and Preliminary positioning done early in the pre-launch period is about determining the early ideas
through competitive advantages about differentiation. Demonstrating a product’s value through Science, through data on efficacy
- is the focus and safety and through competitive advantages, is the focus.

As regulatory approval grows closer and launch becomes imminent, differentiation must expand.
Companies need to determine ways to demonstrate value, not just through effect but also through
services, the product design and how the new drug will be more convenient, helpful, useful and
necessary for consumers.

In the later stages of pre-launch, marketers must take on this task through key activities:

COMMERCIALIZATION AND PROMOTION

What is it that customers truly value? The market research conducted in the early stages of pre-
launch can go a long way towards pinpointing this. What’s needed as marketing develops is to
boldly translate this definition of value into the new product.

Focusing on achieving meaningful differentiation allows physicians to see how a product can fit
into clinical practice and patients to see how the product can benefit them. It allows payers to
better and more appropriately evaluate the product in terms of reimbursement and
requirements.

Overall, differentiation through promotional means of awareness campaigns, eDetailing and

direct-to-consumer advertising can set the stage for a successful launch, with physician and
patients craving the product and formulary acceptance smoothing the way.

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Pre-launch Planning -- The Later Stages

GLOBAL LAUNCH

Planning a global launch is about coordination and timing a new product launch across multiple markets. Early launches in follow-on markets help drive
the initial splash as well as the product lifecycle. Where to start? Drugs are traditionally launched in the U.S. first. Approval to launch time is fastest in the
U.S. However, to stretch a launch across the globe requires more than timing. Branding is ever more important in the global marketplace. The brand
name serves as a tool for recognition and an instant association for customers of specific product attributes. Global brands, those available in the U.S.
and EU under one name, made up over 50% of all new drugs between 2001 and 2005.

LAUNCH PARTNERSHIPS

Companies with deep pockets, extensive sales and marketing resources, and global reach are the companies that tend to create the biggest and most
successful launches. But what about the companies that don’t have endless resources? Marketers and the C-Suite are increasingly recognizing this
quandary and considering the strategic move of creating a launch partnership. By relying on an experienced and established launcher of new products,
companies can play to their strengths and enlist an expert for areas of uncertainty. Partnering strategies can involve a mix of licensing and contract sales
agreements.

A final key consideration in this phase of pre-launch planning is lifecycle management. Maximizing the profitability of a product over its lifetime only works
if it’s a lifelong strategy and not a last-minute effort to thwart competition. Ways to do this effectively in the pre-launch period include strategies we’ve
discussed, like accelerating approval.

But how can you sustain a lifecycle management focus, through the prolonged pre-launch period and through the product’s life? Some experts suggest a
dedicated lifecycle management team, ensuring that activities will not be swept to the side during the various stages of a brand’s life.

Also, by looking to other consumer-oriented industries, and some innovative practices in Pharma, we can come up with some key ingredients of successful
lifecycle management.

Establishing this approach to lifecycle management during the pre-launch period will better prepare the team for its continued work over the long term.

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Pre-launch Planning -- The Later Stages

Be Proactive:- Start early, plan ahead and prepare for any and all scenarios that will arise during a product’s lifecycle.

Organize:- Set up the cross-functional teams that will enable a comprehensive perspective and approach, whether or not these are official Lifecycle
Management teams. Establish clear ownership and accountability for key actions as well as defined lines of authority. Most importantly, the team must
include members that have the actual power and skills to drive action forward and make any necessary changes.

Franchise:- Make plans for your specific product but also consider the possibilities for further expanding into the therapeutic area. A therapy franchise
dominates this area through complementary products and can be accomplished through solo efforts or licensing partnerships.

Expand:- Plan for current uses of the product, but also never stop thinking about the future uses and areas to expand into.

Reformulate:- Choose the best form of delivery that makes sense in today’s environment, but set the groundwork for new innovations. Scientists are
advancing the art of formulation every day, so keep aware and keep focus on newer, patient-friendly methods of administration. Reformulation down the
line is an important way of expanding a drug’s usefulness and audience.

Protect:- Through the pre-launch period, the focus should be on speeding the product to approval to leverage the amount of patent exclusivity. During a
product’s lifecycle, the team must study all regulatory trends and methods of maintaining patent protection. Prolonging the time before Generic
competition is an essential means of protecting the time and energy put into drug production.

Switch:- Think a successful OTC switch will be just the key for protection years down the line? Not without extensive planning that reaches back into the
pre-launch period. Some experts contend the switch should be planned while the drug is still in clinical trials, and at a minimum of 7 or 8 years before
action.

Shut Down:- Think you shouldn’t even consider the end of the line when you’re in pre-launch? Think again. Exit strategies should be planned and plotted.
Far too often a product is allowed to limp along in its latter years, consuming valuable organizational and financial resources. Consider the long-term and
the potential scenarios for actively managing the end-of-life phase, and pinpoint the cut-off point for when the product no longer delivers value.

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 Secret Weapon ​What factors will positively
affect launch and drive

For Pre-Launch market penetration? What

should companies watch
out for that could derail

Planning years of planning?

Eularis ©2014 www.eularis.com 16

Secret Weapon For Pre-Launch Planning

Analytics models can provide No matter how much you plan ahead, new drug
development is inherently risky in today’s
However, conducting such a complex array of
strategic and tactical preparations can be
the insight on what drives your environment. The potential to spend a large extremely challenging and mistakes can be
target consumers and can help amount of time and money without appropriate
return or necessary success is large. Thorough,
costly.

predict actual launch results long-range pre-launch planning goes a long way Throughout the multiple phases of pre-launch
towards increasing the odds for success. But planning, sophisticated analytics, like the
sometimes it’s not enough. Eularis Analytics System, can help you answer
key questions, supporting your process and
Increasingly, Pharma managers and marketers removing the dangerous uncertainty that can
need a way to assess the potential for a new doom your product. Taken together, analytics
product, and the likelihood of success upon throughout pre-launch can help companies:
launch. What factors will positively affect launch
and drive market penetration? What should  Quantify the potential impact from each
companies watch out for that could derail years marketing activity before launch with
of planning? specific allocations;
 Evaluate which messages will have the most
The best way to plan is with the support of impact on actual prescribing;
comprehensive market evaluation, modeling,  Reveal how, when and where to spend your
forecasting and simulations that help marketing budget for the best results;
decision making before and during launch.  Forecast brand performance at launch
Analytics models can provide the insight on what based on the current situation;
drives your target consumers and help predict  Provide a ‘What If’ forecast showing the
actual launch results. impact of any specific marketing changes.

Why Analytics? Think of the stakes. As we’ve Through every phase of pre-launch, analytics
demonstrated in this report, launch is a critical can provide the powerful predictions and
time for any Pharmaceutical or Biotech product. planning aids that result in optimal launch:

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Secret Weapon For Pre-Launch Planning

Early Pre-launch Planning can help you answer questions about key market drivers, competitor strengths and weaknesses, positioning and price points,
and optimal resource allocations. Analytics in this stage can answer these questions:

 What are the key market drivers for your therapeutic category?
 What are the strengths of your competitors and what weaknesses are possible to exploit?
 What is the best way to segment the market for maximum sales?
 How should you position the brand for maximum financial impact?
 What price point will get maximum sales?
 What are your optimal allocations for maximum growth?
 How can you allocate sales and marketing budgets across activities at launch?
 How do you divide your budgets for optimal market share and sales gain?

Regulatory Planning can help you answer questions about the effect of clinical trial data, market share with clinical trial results and regulatory approval.
Analytics at this stage can answer these questions:

 What is the commercial potential of your brand with your current clinical trial data? How about with additional clinical trial data?
 If you stop clinical trials now, what will be the launch market share?
 If you do further clinical trials, will your launch market share be impacted?
 How can you speed up regulatory approval?

Late Stage Pre-launch Planning can help you answer questions about key messages to drive brand growth, effective positioning, potential impact from
marketing activities, global launch timing and market share predictions. Analytics at this stage can answer these questions:

 How can you grow patient demand without being able to market the drug?
 What messages will drive brand growth most?
 Will your planned messages give you maximum growth?
 Have you positioned the brand to capture maximum launch market share?
 How can you quantify the potential impact from each activity before implementation?
 What are your optimal sales and marketing activities?
 What is the commercial potential of your market category in a specific country?
 Which country should you launch in first?
 How should you roll out a global launch?
 How can you predict the brand launch market share and sales potential?
 How much market share should you expect to have at launch versus your competition?

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Secret Weapon For Pre-Launch Planning

To see the power of analytics in pre-launch planning, consider the case study of Reyataz (atazanavir), a direct acting Antiviral initially indicated for the
treatment of HIV. Reyataz conducted analytics at 3 time periods pre-launch to understand optimal clinical trial data, optimal positioning and brand
potential, market drivers, messages and ideal budget allocation, in order to be prepared for a rapid launch and rapid uptake.

The drug was first approved in the U.S. through priority review on the 20th of June 2003, and received a centralized EU approval 8½ months later. Reyataz
had market exclusivity in the U.S. through to 6 July 2007. The drug achieved sales of $248 Million in its first full year on the market, Q3 2003 to Q2 2004.
Reyataz’ initial market growth has been driven by its positioning as an equivalent therapy to class leader efavirenz and old standard nelfinavir. Reyataz
(atazanavir) generated global sales of $931 Million in 2006, a year-on-year increase of 33.8%.

Viread, another new HIV therapy first launched in October 2001, had no head-to-head trial data and suffered from disappointing sales. Reyataz’ quarterly
sales surpassed those of Viread in Q4 2005, despite being launched 7 quarters later. The results speak for themselves in the sales figures seen in the next
figure.

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Secret Weapon For Pre-Launch Planning

In another case of analytics aiding pre-launch planning, AstraZeneca decided to conduct pre-launch analytics for their product, Nexium. This included an
examination of the core messages having most impact for the category and the promotional activities having most impact on physicians’ behavior when
prescribing. The brand team conducted the Eularis Analytics in several time periods prior to launch and, thereafter, at 6 monthly intervals. In conducting
these analytics in time periods pre-launch, the brand team was able to understand the vulnerabilities of its competitors and position itself in the best
possible way. The team also understood the core brand market share potential based on its own clinical trial results, which were input into the System. It
was then able to focus on positioning messages with potential to give most marked increase in market share and plan its marketing effort to match the
areas recommended by the analytics for maximum growth. As a result, the brand had a 3.3% market share at launch and a strong growth pattern as shown
below. This is an example of an excellent profile of the brand just after launch, after using Eularis’ Analytics System to determine vulnerabilities in
competitor drugs prior to launch of the brand.

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Secret Weapon For Pre-Launch Planning

Between launch and 6 months, the activity was tweaked to incorporate the findings from the analytics at launch and adjustments were made to the
marketing effort to areas the Eularis Analytics recommended would provide maximum growth. AstraZeneca trained reps to do detail with the emphasis
shown in the Eularis Analytics and the budget was allocated according to the budget mix recommended by the System. The picture of the brand at 6
months post-launch can be seen in the following graph.

Market share had grown to 10.3% and it was still on track for rapid growth and, yet, AstraZeneca continued to use the Eularis Analytics System to grow the
brand further. Market share came in at 3.3% within 1 month post-launch and had more than tripled very quickly to 10.3% by month 6 by following the
System’s recommendations. It was rerun every 6 months to ensure new market environment and validated perception factors against the competitors
were constantly taken into account for continuous refinement and growth in market share. The brand continues to be a market leader in this category and
the team has consistently used the Eularis Analytics since pre-launch in that market.

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 ​Pharma companies are
recognizing the profound

Conclusion power of marketing to

boost new products and
support business today as
well as tomorrow

Eularis ©2014 www.eularis.com 22

Conclusion

While the pressure for launching The environment for Big Pharma today is tough. However, while the pressure for launching new
products is higher than it has ever been, and marketers are tasked to create magic from thin air, new
new products is higher than it strategies and tactics are available to plan effectively and plot for profit.
has ever been and marketers What should effective pre-launch planning involve for a successful launch and a product that will
are tasked to create magic from sustain company success?
thin air, new strategies and A planning framework involving organizational changes, clear thinking and preparatory actions; initial
tactics are available to plan marketing plans that thoroughly inventory the market, competition and clinical trial landscape, and
effectively and plot for profit create preliminary positioning; regulatory appraisal that takes into account trends and utilizes
methods of speeding up approval; fully formulated marketing thinking that incorporates bold
differentiation, global branding, lifecycle management schedule, and perhaps even launch
partnerships.

Most important to remember for pre-launch planning is the secret weapon savvy marketers rely on.
Sophisticated analytics can help companies answer key questions throughout each stage of pre-
launch planning, ensuring the best strategies and most informed tactics.

Analytics can help from beginning to end of the planning process and even provide a foundation for
management throughout a product’s life.

What the future holds for Pharma companies is uncertain. However, company leaders ready to
proactively plan for success, to continue to innovate, and to rely on the significant power of
marketing to boost product launches, sales and profits, will help Pharma survive and thrive.

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