RESHAPING THE INDUSTRY TO TAKE FLIGHT.images2.advanstar.com/PixelMags/pharma-executive/pdf/2015-07.pdfresearch, our clients see Covance, following our combination with LabCorp, as

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Covance Inc., headquartered in Princeton, NJ, is the drug development business of Laboratory

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and its subsidiaries around the world. © Copyright 2015. Covance Inc.

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JULY

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www.PharmExEc.com

From the EditorJULY 2015 Pharmaceutical executive

William loonEy

Editor-in-Chief

[email protected]

Follow Bill on Twitter:

@BillPharmExec

The Human Chain Pharm ExEc’s 2015 rostEr of EmErging LEadErs—our eighth to date—is not only a way

to recognize a few individuals who’ve made a difference in their organizations. It also serves as

a barometer to track larger changes in the workplace: how work is done; who does it; and for

what outcome or purpose. with the support of Pharm Exec’s Editorial advisory Board (EaB), we’ve

selected 17 executives drawn from a range of mission-critical functions, varied geographies,

and diverse race, gender, and cultural characteristics. Together, they symbolize the sweeping

changes our industry is undergoing, from an era where growth was the assumed baseline for all

management decisions to a future of iffy margins and bitterly contested market share.

This year’s group knows better than any-one that a frayed business model quickly concentrates the mind. So what are the trends and values that will determine

true leadership in big Pharma for the remainder of the decade? We’ve distilled fve of the more interesting insights, as follows:

ItÕs all about the team. Teams are refective of how work gets done in large organizations facing complex challenges that rarely can be addressed with a single set of capabilities. Team performance is critical to organization P&L because it is the team that creates the context and sets the baseline for decisions taken by senior management. The team is also the arena for indi-vidual career advancement. No one mentions it, but team meetings can also be a graveyard for reputation. In big Pharma bureaucracies, what was once the right way and the wrong way is now the way of the multiple choice. It’s easy to stray, so a deft hand in internal politics has become a necessary navigational skill.

LeadershipÑitÕs never about you. Leadership today is a collective exercise, amounting—almost—to an abnegation of the self. Our 17 EPLs are parsimonious in using that frst person pronoun. The emphasis is on other-directed qualities like empathy and listening. It should be no surprise when leaders discover what their team members actually feel about them. In con-trast to the command and control methods of a previous era, our 2015 leaders are more willing to let others carry the fag to ensure everyone is invested in a positive result. As one EPL notes, “if I can take credit for anything, it’s that I hired well.”

The key emotional chord in todayÕs pharma workplace is to convey a sense of urgency. The role of a leader must not be confused with hand-ing out trophies at the country club. A balance has to be struck. But that urgency has to be laced with a larger sense of purpose. Our EPLs call it “hard empathy”—being tough-minded on stan-dards but tender-hearted and hopeful in relation-ships. The essential mediating ingredient is deci-siveness. It’s still true that pharma leaders don’t

progress by going wobbly. “Analysis paralysis” remains a curse in any organization.

The best innovations are often a consequence of a workplace failure. A repeated theme in the interviews is that good organizations impose no sanctions on failure. Making mistakes is “part of the job,” and what counts is a willingness to turn a setback into a “best practice” that can be shared with others as a mid-course corrective. Management will need that approach to navigate through changes that are becoming harder to account for in advance.

Culture countsÑbut make it simple. Raptor’s rare disease CEO Julie Smith said it best in mak-ing reference to her ever-present canine compan-ion, Ninja: “Dogs are an important part of the culture here.”

Enough said. Finally, our annual Emerging Leader profle

is complemented by a separate feature this month—a Roundtable on the themes of talent and diversity in tomorrow’s biopharma work-force. Executives from two big Pharma compa-nies, a start-up biotech, a leading Pennsylvania-based hospital system, and an HR diversity specialist met at St. Joseph’s University Business School on April 10 to consider what’s needed to ensure our industry has the people to stay proftable in a fast-changing marketplace.

One interesting dynamic emerging from the discussion is the competition traditional pharma faces from an invigorated biotech sec-tor flush with the momentum of a hundred IPOs. Nimble biotech has the hands on business model—and the cash—to vie for big Pharma professionals disgruntled by a seemingly end-less cycle of restructuring and consolidation. A second point of consensus is that workforce diversity must be given higher priority inter-nally, as a business imperative instead of an HR objective. And what we mean by “diversity” must stretch beyond the obvious aspects of gen-der, race, and ethnicity to incorporate true diversity of thought—because, regardless of where it comes from, the single biggest premium for our industry is a good idea.

ES638061_PE0715_003.pgs 07.01.2015 19:32 ADV blackyellowmagentacyan

From the Editor4 WWW.PHARMEXEC.COM PHARMACEUTICAL EXECUTIVE JULY 2015

©2015 Advanstar Communications Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specif c clients is granted by Advanstar Communications Inc. for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your written request to Permission Dept. fax 440-756-5255 or email: [email protected].

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Murray L. Aitken Senior Vice President, Healthcare Insight,IMS Health

Stan Bernard President,Bernard Associates

Frederic Boucheseiche Chief Operating Off cer,Focus Reports Ltd.

Joanna Breitstein Director, Communications,Global TB Alliance

Drew Bustos Vice President, Global Communications, Cegedim Relationship Management

Don Creighton Senior Director, Market Access, PriceSpective, an ICON Company

Rob Dhoble CEO,Adherent Health

Bill Drummy CEO, Heartbeat Ideas

Les Funtleyder Portfolio Manager, Esquared Asset Management

John FureyGlobal Franchise Head Vaccines, Baxter Healthcare

Terry Hisey Vice Chairman, Nat’l Sector Leader, Life Sciences,Deloitte

Michele Holcomb Vice President, Corporate Strategy,Teva Pharmaceuticals

Bob Jansen Principal Partner, Zensights LLC

Kenneth Kaitin Director & Professor, Center for the Study of Drug Development,Tufts University

Clifford Kalb President,C. Kalb & Associates

Bernard Lachapelle President,JBL Associates

Rajesh Nair President, Indegene

Daniel Pascheles Vice President,Global Business Intelligence,Merck & Co.

Elys Roberts President,Ipsos Healthcare North America

Alexander Scott Vice President, Business Development,Eisai Corp. of North America

Sanjiv Sharma President, Inf exionPoint LLC

Michael Swanick Global Practice Leader Pharmaceuti-cals and Life Sciences, PwC

Mason Tenaglia Managing Director, The Amundsen Group, an IMS Company

Peter Tollman Senior Partner, Managing Director,Boston Consulting Group

Al Topin President,Topin Associates

Bill Trombetta Professor of Pharmaceutical Marketing,St. Joseph’s University Business School

Joseph Truitt Senior Vice President and Chief Commercial Off cer, Achillion Pharmaceuticals

David Verbraska Vice President, Worldwide Public Affairs and Policy, Pf zer

Albert I. Wertheimer Professor & Director,Pharmaceutical Health Services Research, Temple University

Ian Wilcox Vice President, Hay Group

Peter Young President,Young & Partners

Pharmaceutical Executive’s 2015 Editorial Advisory Board is a distinguished group of thought leaders with expertise in various

facets of pharmaceutical research, business, strategy, and marketing. EAB members suggest feature subjects relevant to the

industry, review article manuscripts, participate in and help sponsor events, and answer questions from staff as they arise.

UBM ADVANSTARJoe Loggia, Chief Executive Off cer; Tom Ehardt, Executive

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Systems; Julie Molleston, Executive Vice-President, Human

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Business Development; Tracy Harris, Sr Vice-President; Dave

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UBM PLCTim Cobbold, Chief Executive Off cer

Andrew Crow, Group Operations Director

Robert Gray, Chief Financial Off cer

Dame Helen Alexander, Chairman

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VOLUME 35, NUMBER 7

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Table of Contents Pharmaceutical executive JULY 2015

Pharmaceutical executive voLUme 35, nUmber 7 (Print ISSn 0279-6570, Digital ISSn: 2150-735X) is published monthly by Ubm Advanstar 131 W. First St., Duluth, mn 55802-2065. Subscription rates: $70 (1 year),

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neWS & AnALYSISWashington report

10 Too many breakthrough Therapies?Jill Wechsler, Washington correspondent

STrATeGY & TACTICSintellectual Property

44 Confronting the Post-Grant Patent ThreatBy Brian W. Nolan

InSIGhTSFrom the editor

3 The human ChainWilliam looney, editor-in-chief

country report: Peru

45 out of the ShadowsFocus reports, Sponsored Supplement

although questions around sustainability still cloud Peru’s transition to a

modern healthcare system, there is no doubt that the country’s

economic resurgence in recent years is having a positive impact on

Peru’s pharmaceutical infrastructure.

executive roundtable

building Tomorrow’s biopharma WorkforceWilliam looney, editor-in-chief

Pharm Exec recently convened a panel of industry team

leaders and hr specialists at St. Joseph’s University haub

School of Business to explore some useful best practices in

three key areas: talent recruitment and retention; skills

training; and workforce diversity.

36

2015 emerging Pharma LeadersThis year’s Pharm Exec list of 17 leaders is ripe with the

diversifed backgrounds and skills required to advance to

the “c-suite” in a new era of change for the biopharma

industry. we profle executives spanning a range of mission-

critical functions, including roles in vaccines and generics,

fnance and manufacturing, organizational design, patient

engagement, and digital technology.

16Getty Images/Qweek


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PHARMACEUTICAL EXECUTIVE JULY 2015this month on PharmExec.com

Data Point

Pharm Exec Connect Join The Conversation! @PharmExecutive http://linkd.in/PharmExecMag

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Coming soon toPharmExec.com

Drug Adherence UpdatePharm Exec takes its annual look at the latest trends in promoting adherence to drug therapy. Case examples highlight best practices and new technological applications.

Readers Weigh InThe ruling simply makes the necessary statement of “get on with it!” One way or another, access needed to be addressed, so we can get on with the work to deal with cost, quality, and value. And it’s interesting how private sector PBMs, and now doctors (ASCO, Sloan Kettering) are making just as much noise about cost as the feds.

Chris Bowe, 6/26/15 “‘Rx’ for the Latest SCOTUS Decision on Obamacare”

bit.ly/1BRcaBs

It seems that any attempts to disparage social media users from discussing these topics is not only an exercise in futility, but may encourage them to share potentially sensitive study information. It’s become impossible to stop. What if we encouraged patient engagement with investigators, and each other, but allowed researchers to moderate the content?

Steven Kyle, 6/24/15 “Can Facebook Hurt Your Clinical Trial?”

bit.ly/1Kpm3ZU

Think it’s time we get Yogi Berra to weigh in on Obamacare. Déjà vu all over again. All the Obamacare drama, political handwringing, and—in the end—states are unable to f ll the patient accessibility gaps, Medicaid budgets are soaring, and the consumers are paying more, for less.

Consultant guy, 6/4/15 “States Face Harsh Realities of Obamacare”

bit.ly/1RDGRvR

Poll data courtesy of online Pharm Exec readers between Oct. 8 and Nov. 8, 2014Top Stories Online

Taking Flight: 2015 Pharma 50June Issue onlineMichael Swanick, David Hole, and Ben Comerbit.ly/1KLLyDH

Bridging Industry’s Charisma ChasmJune Issue onlineDan Bobearbit.ly/1ESyyov

2015 Pipeline ReportNovember Issue onlineJosh Baxtbit.ly/1vam3jC

2015 Brand of YearMay issue onlineWilliam Looneybit.ly/1Rvtwrk

The Importance of the Emotional Sell Blog postPamela Walkerbit.ly/1JlEsH3

Most-read stories online:

May 25 to June 24, 2015

Slow or negative growth in developed economies58%

Slowdown in high-growth emerging markets42%

Q: Which of these

concerns you the

most with regard to your

f rm’s growth prospects?


H E L P I N G C L I E N T S

T O I M P R O V E L I V E S I S

W H AT W E D O .

S C I E N C E I S H O W

W E D O I T .

O P T I M I Z I N G Y O U R P O S T - M A R K E T I N G I N V E S T M E N T

At PRA, we understand what post-marketing research is – and just as importantly – what it is not. Our insight is what

sets us apart. The insight of our team of specialized, post-marketing experts that ensures the right design and

approach for your study. The insight to achieve operational efficiencies through our simple, flexible, and

customized approach. The insight to utilize our global teams to harness practical knowledge of local regulations, standards of care, and cultural customs. The insight to leverage industry-transforming, data-driven approaches and

predictive analytics to provide you with access to the best target site and patient populations. And lastly, the

wisdom to connect these varied insights to make a difference – for you, our clients, and for the patients who inspire

us to do what we do.

www.prahs .com/solutions/post-marketing-research


10

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Pharmaceutical executive JULY 2015Washington Report

JILL WECHSLER is

Pharmaceutical

executive’s

Washington

Correspondent. She

can be reached at

jwechsler

@advanstar.com

The FDA program to

expedite the develop-

ment and approval of

innovative drugs for

serious and life-threatening

conditions is a great success, but

determining whether an experi-

mental compound has real

transformative potential is

proving to be a challenge for

sponsors and for the agency.

Expert review teams in the Cen-

ter for Drug Evaluation and

Research (CDER) and the Cen-

ter for Biologics Evaluation and

Research (CBER) are meeting

deadlines and goals for assess-

ing breakthrough designation

requests and for expediting

reviews of these products, but

the process is resource intensive

and raises questions about how

FDA can keep up with the del-

uge in candidates.

When the breakthrough pro-

gram was established as part of

the FDA Safety and Innovation

Act of 2012, advocates envi-

sioned about 2-3 designations a

year. As of the end of May, the

agency had received 308

requests for breakthrough status

and had granted the designation

for 90. Nearly 15 important new

therapies have come to market

more quickly as a result, con-

tributing to the recent rise in

new drug approvals. FDA acting

commissioner Stephen Ostroff

pointed out at the annual meet-

ing of the Food & Drug Law

Institute (FDLI) in April that

two-thirds of the new drugs

approved last year took advan-

tage of at least one FDA expe-

dited review program.

The popularity of

the breakthrough

drug initiative is not

su rpr i s i ng , a s i t

o f f e r s ex t e n s i ve

ha nd-hold i ng by

FDA experts that can

cut years off develop-

ment, and the agency

is approving market

applications for cer-

ta in “home run”

treatments in less

than six months. This helps

patients gain faster access to

life-saving therapies and treat-

ments for serious conditions.

The breakthrough imprimatur,

moreover, is particularly impor-

tant to small f rms seeking to

attract attention in the invest-

ment community.

Sustainable program?The large number of break-

through requests and a denial

rate of more than 50%, however,

is prompting FDA and stake-

holders to weigh options for

refining and clarifying break-

through criteria to create a more

manageable program. The

agency is examining past desig-

nation decisions and why it

turned down certain requests to

see if the bar is too high or too

low and how to better educate

industry on which promising

experimental products really

qualify for breakthrough status.

FDA “can’t sustain a program

where everything is a break-

through,” commented John Jen-

kins, director of CDER’s Off ce

of New Drugs, at an April work-

shop on breakthrough therapy

designation criteria organized by

the Brookings Institution. Really

fast development should be pos-

sible for true breakthrough can-

didates that demonstrate large

treatment effects and can be easily

measurable in small populations.

But FDA has to devote extensive

resources to evaluating designa-

tion requests and to supporting

the development and accelerated

review of breakthrough candi-

dates. Kay Holcombe, senior vice

president of the Biotechnology

Industry Organization (BIO),

agreed that some products are

“more breakthrough than oth-

ers,” and that clearer def nition of

“substantial improvement” and

what is “transformative” would

be helpful.

CDER deputy director for

science operations Richard

Moscicki offered the possibility

Too Many Breakthroughs?FDA wants pharma to be more selective in seeking special status for promising therapies

Denials of breakthrough designation

are more linked to problems with the

design and analysis of clinical data,

as opposed to a failure to show

substantial improvement over

available treatment

Getty images: comstock


At Astellas, we believe we can make a real impact on the future.

That’s why we are fully committed to developing medicines that make a

difference where they’re needed most, in areas like oncology, urology,

infectious disease, cardiology and transplant.

Astellas congratulates Jim Robinson, president of Astellas Pharma US, Inc.,

on being recognized as an Emerging Pharma Leader by Pharmaceutical Executive. His commitment to high performance at Astellas is changing

tomorrow for patients.

Changing Tomorrow, Together

@AstellasUS www.astellas.us


12

www.PharmExEc.com

Pharmaceutical executive JULY 2015Washington Report

that FDA could either limit the

number of breakthrough candi-

dates, or strive to evaluate these

products more effciently. FDA

is working with stakeholders to

assess the reasons for designa-

tion denials and to encourage

companies to l imit break-

through requests to therapies

that offer truly substantial

improvements in patient care. In

addition, industry may provide

specifc funding to support the

unexpectedly large break-

through program, an issue that

is slated for discussion as part

of the next round of drug user

fee negotiations.

An internal FDA assessment

of breakthrough designation

requests and denials for 2012-

2014 indicates that large bio-

pharma companies are more suc-

cessful than small firms in

gaining designations; that most

submissions provide data from a

single Phase I or Phase II clinical

trial; and that submissions with

a prognostic biomarker do rela-

tively well. Randomized clinical

trials are not necessary to gain

breakthrough status, and trial

size depends on the specifc indi-

cation and nature of the product.

Denials of breakthrough designa-

tions are more closely linked to

problems with the design and

analysis of clinical data, as

opposed to a failure to show sub-

stantial improvement over avail-

able treatment.

Sponsors also withdraw about

15% of breakthrough designation

requests before they receive the

agency’s decision. This occurs for

a range of reasons, and further

analysis could help improve pro-

gram processes and reduce wasted

efforts on all sides.

Karin Van Baelen, head of

global regulatory affairs for Jans-

sen Pharmaceuticals, noted at the

Brookings workshop that her

company had a very positive

experience with the break-

through designation process, but

also received a denial on a project

that perhaps was “overly ambi-

tious” and based on a too-small

sample size. “The experience has

helped us better understand the

breakthrough criteria,” she com-

mented, and provided “very valu-

able feedback” on developing

that compound further. Compa-

nies should exercise some self

control, she added; submitting

everything for breakthrough sta-

tus wastes the frm’s resources as

well as FDA’s.

Meanwhile, programs to

accelerate approval of important

new drugs are expanding glob-

ally. Japan, for example, has

established the SAKIGAKE des-

ignation program for innovative

medicines and medical devices

that are developed frst in Japan

and offer “radical improvement”

over existing therapies to treat

critical diseases, explained Yoshi-

hiro Matsuda of Japan’s Pharma-

ceuticals and Medical Devices

Agency (PMDA), at a CMC

workshop in April sponsored by

the Drug Information Associa-

tion (DIA). Matsuda described a

greatly accelerated development

and approval process for such

therapies, combined with stron-

ger post-marketing oversight.

Ref in ing F DA’s break-

through program is challeng-

ing, as the agency fnds wide

variation in trial characteris-

tics, patient populations, and

available therapies for different

treatment areas. Thus, FDA

analysts can only approximate

a “substantial improvement

threshold,” but hope to better

identify patterns and character-

istics that will signal therapeu-

tic success.

Production problems stymie breakthroughsManufacturing issues and

inspection delays can block FDA

approval of a breakthrough therapy,

even in situations where the clinical

data is good, but the company

runs into problems with production

scale-up and site inspections.

Sponsors often have to generate

manufacturing data in roughly

half the time, which requires

new approaches to product and

process development to ensure a

reliable supply of a quality product

at launch, noted Brian Kelley,

vice president for bioprocess

development at Genentech, at

the DIA CMC workshop. The

breakthrough designation “does

not mean that sponsors can do

less,” he said; they just “need to

start sooner.” This may involve

front-loading of critical product and

process characterization activities,

and reaching agreement with FDA

on which actions for optimizing

process and methods can wait until

after launch.

John Groskoph, senior director

at Pfzer, observed that most

breakthrough market applications

are being fled after Phase II

studies, about two years ahead of

a traditional new drug application

(NDA). This presents “signifcant

challenges” to the development

team, and may be further

complicated if the frm seeks to

fle simultaneous applications

in Europe, Japan, and emerging

markets, as well as in the U.S. At the

Brookings meeting, Kay Holcombe

of BIO urged close examination of

ways to prevent approval delays

due to diffculties in producing a

drug according to specifcations.

“If this is a hurdle at the end,” she

said, “we need to deal with it more

effectively.”

ES636633_PE0715_012.pgs 06.30.2015 02:44 ADV blackyellowmagenta

Questions: Contact Sara Barschdorf at [email protected]

US: 1 866 267 4479 EU: +44 203 564 4649

Web: www.quintiles.com Email: [email protected]

Register

now

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Patient

adherence

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Event OverviewIn a healthcare economy that is under pressure to provide

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commitment to supporting health systems through effective

adherence support programs. This Quintiles sponsored

webcast will cover key topics including what it takes to

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Hans Holger Bleß

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Editor

Pharmaceutical Executive

Register for free at

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Securing the pharma environment Assess the threats, disrupt your

adversaries, extend your capabilities

It is the question every pharmaceutical IT executive should be asking: Can you face your Board of Directors, senior managers, employees, suppliers, and customers and assure them your organization is secure from potentially catastrophic cyber threats?

The honest answer—given the hard realities now confronting virtually every organization—is, at best, uncertain. Today’s threats are more sophisticated. Breaches are more frequent. And the cost in time, dollars, and brand value are more punishing.

Cyber security specialists now acknowledge that organizations can no longer hope to build impenetrable ƬUHZDOOV�DURXQG�WKHLU�HQWHUSULVH��

Security must instead focus on identifying threats, disrupting adversaries, and extending security measures across the organization.

Let’s examine precisely what this means for the pharmaceutical sector.

A growing threatExperts now estimate the annual cost of cybercrime and espionage at $100 billion for the U.S. economy and almost $300 billion worldwide. A joint Ponemon and HP study showed that the average cost to resolve a single attack was more than $1 million, and in many cases far more.

In the last two years alone, we have witnessed successful and damaging cyber-attacks against leading retail FKDLQV��EDQNV�DQG�ƬQDQFLDO�LQVWLWXWLRQV��

entertainment giants, non-profit organizations and governmental agencies—even the White House. Hospital networks, insurance firms, and other healthcare organizations KDYH�VXƫHUHG�KLJK�SURƬOH�EUHDFKHV��

In fact, healthcare organizations

account for 43% of major data

breaches reported in 2013. Since

federal reporting requirements

were instituted for organizations

handling protected health data, the

U.S. Department of Health and Human

Services has tracked more than 1,100

separate breaches where the data

of more than 120 million people was

compromised.In those and other

attacks, hackers gained access to YDVW�WURYHV�RI�LQIRUPDWLRQ�DƫHFWLQJ�

thousands of organizations and tens of millions of consumers worldwide. Lost or compromised data includes proprietary company IP, sensitive internal communications, consumer names, home addresses and telephone numbers, credit account information, PIN codes, social security numbers, and even patient ages, illnesses, and test results.

7KH�ULVN�WR�SDWLHQW�LGHQWLƬDEOH�KHDOWK�

records is substantial: A patient health record is worth an estimated $500 on the black market, compared to just $25 for a credit card number. The total enterprise cost of compromised SDWLHQW�GDWDtLQFOXGLQJ�QRWLƬFDWLRQV��

credit monitoring, legal fees, and brand damage—is almost incalculable.

Here are perhaps the most sobering statistics of all: The majority of breaches occur at the application layer, and it now takes an average of 243 days for an organization to discover a breach. That means many organizations—including SKDUPDFHXWLFDO�ƬUPVtDUH�DOUHDG\�breached. They just don’t know it yet.


Unique concernsThe very nature of modern pharma

creates its own vulnerabilities.

In today’s increasingly collaborative

PDUNHWSODFH��SKDUPDFHXWLFDO�ƬUPV�

must work and share data with a

growing range of stakeholders. Those

can include numerous business units

and R&D, universities and external

collaboration partners, vendors and

other supply chain partners, as well

as physicians, clinicians, and CROs.

Given the proliferation of these

collaborative relationships and the

growth of M&A in pharma, companies

must increasingly manage more

numerous and complex system

identities. They must provide

convenient-but-secure, tiered access

to crucial files, systems, and

intellectual property. Most must

handle fast-changing roles, which

often creates risky “inherited rights”

across the enterprise.

While collaboration certainly drives

RSSRUWXQLW\��LW�DOVR�SRVHV�VLJQLƬFDQW�

security challenges to pharma

organizations of all sizes. C-suite leaders

must also be concerned about the loss

of IP through counterfeiting, espionage,

and other methods. Cyber criminals

now work to compromise R&D pipelines,

material sourcing, pricing, and other

strategic information. For life sciences

ƬUPV�SXUVXLQJ�JURZWK�WKURXJK�PHUJHUV�

and acquisition, there is a very real risk

of absorbing malware and other threats

during IT integrations.

As pharmaceutical organizations

leverage the power of cloud, mobility,

high-performance computing, and

other new-style technologies, they

must address new and more complex

security challenges.

These unique characteristics, and

the high value of the data involved,

may attract more sophisticated and

determined attackers. Bad actors often

initially target lower-level, lower-value

systems, and then work to gain a toe-

hold with administrative rights, and

later attack IP or consumer records.

Smaller and less sophisticated supply

chain vendors may be particularly

vulnerable to cyber-attacks.

,Q�D�UHFHQW�KLJK�SURƬOH�DWWDFN��D�VSHDUSKLVKLQJ�HƫRUW�IRUZDUGHG�DQ�email containing a link to a site where malware was downloaded, thus exploiting a known vulnerability in the healthcare organization. In another breach, hackers outside the United States are suspected of compromising the personal data of millions of hospital patients.

How to respond?In today’s increasingly collaborative

pharmaceutical marketplace, identity

control must be a primary objective of

any workable security program. Most

large or growing companies employ

federated ID management with tiered,

QHHGV�EDVHG�DFFHVV�DQG�KLJKO\�HƫLFLHQW�

provisioning and de-provisioning

of identities.

They must know the source of an ID,

how it was created and provisioned, and

must be able to control and monitor

appropriate levels of access. A true

enterprise-class security approach will

provide secure, collaborative access

tuned to the needs of R&D and external

partnerships as well as to sales,

manufacturing, and other internal

stakeholders.

A good security model should also

address the requirements of Big Data

and front-end analytics, cloud, mobility,

and other still-emerging technologies.

To provide greater security in the

pharmaceutical environment, HP

recommends a three-fold posture.

Disrupt your adversaries. A broad

new spectrum of security solutions are

now available to help pharmaceutical

ƬUPV�LGHQWLI\�DQG�GLVUXSW�EDG�DFWRUV��

strengthen security performance, and

protect sensitive data from internal

DQG�H[WHUQDO�WKUHDWV��6SHFLƬF�WRROV�

include real-time techniques such as

self-healing, which uses expert, crowd-

sourced intelligence.

Address the threats. Life sciences

organizations can leverage expertise

and specialization to better understand,

manage, and reduce cyber risks.

6SHFLƬF�VWHSV�FDQ�LQFOXGH�LQLWLDO�VHFXULW\�

assessments, identifying security

threats, formulating security strategies,

legal and regulatory compliance,

and creating a more holistic security

environment.

Extend your capabilities. More and

more organizations, in pharmaceuticals

and elsewhere, now use managed

security services to get out in front

of enterprise security threats. A

managed environment can address

security roadmaps and monitoring,

infrastructure management, incident

response planning and rehearsals,

and threat intelligence.

Given this complex threat environment,

forward-looking pharmaceutical

executives are now working with

proven enterprise security partners.

Ideally, a strong security partner will

RƫHU�FRPSUHKHQVLYH�FDSDELOLWLHVt

including consultative assessment and

optimization services, security design

DQG�LQWHJUDWLRQ��VSHFLƬF�WRROV�DQG�

technologies, and the option to deliver

remote monitoring and management for

a secure pharmaceutical environment.

'HSHQGLQJ�RQ�WKH�RUJDQL]DWLRQoV�VSHFLƬF�

risk environment, a robust security

program may incorporate penetration

testing, social engineering to adjust

behaviors and processes, more detailed

system and network analysis, and

ongoing security management.

Those are the realities of today’s threat

environment. When we are home and

away from work, most people check

to ensure their doors and windows are

locked each night. In light of recent

KLJK�SURƬOH�EUHDFKHV��FRQVXPHUV��

investors, and other stakeholders are

asking tough questions about how

organizations are protecting their data.

As a pharma IT executive, it’s your job

to have the answers.

© Copyright 2015 Hewlett-Packard Development Company, L.P.

For more information, go to

hp.com/enterprise/healthcare

ES635204_PE0715_015_FP.pgs 06.27.2015 00:03 ADV blackmagentacyan

16

www.PharmExEc.com

Pharmaceutical executive JULY 2015Emerging Pharma Leaders 2015

Getty Images/Qweeky

RAHUL ARAS, CEO, Juventas Therapeutics

ARIS BARAS, Executive Director and

Co-Head, Regeneron Genetics Center

JAY BARBER, Associate Vice President,

Global Inf uenza Franchise & Product

Strategy, Sanof Pasteur

JULIAN BERTSCHINGER, Co-Founder and

CEO, Covagen

DAN DIETRICH, Vice President,

Global Operation Services, Novartis

Pharmaceuticals Corporation

ARJUN HANDA, Vice Chairman and

Managing Director, Claris Lifesciences

STACI L. JULIE, Senior Vice President and

Chief IP Counsel, Teva Pharmaceuticals

MATTHEW LANG, Associate General

Counsel of Litigation & Investigations, Gilead

Sciences

JACOPO LEONARDI, North America Region

Head, Hemophilia and Blood Disorders,

Baxter International

KEN MILLER, Worldwide President, BD

Diabetes Care

GABY MISHEV, Associate Director of

Marketing, Genentech

LIVIU NICULESCU, Vice President, Global

and US Medical Affairs, Takeda Oncology

JAMES ROBINSON, President, Astellas

Pharma US

SANDRA SANCHEZ Y OLDENHAGE,

Deputy CEO, Probiomed Mexico

JULIE SMITH, CEO, Raptor Pharmaceuticals

MENASSIE TADDESE, Vice President,

Finance, Global Innovative Pharmaceuticals,

North America, Pf zer Inc.

TIMOTHY WHITE, Senior Director and Head

of Global Customer Interaction, Lundbeck

2015 EmergingPharma Leaders

And the Leaders Are ... (in alphabetical order)

Meet Pharm Exec’s 2015 roster

of 17 Emerging Pharma

Leaders. Selected independently by

our editorial staff with support from

members of our Editorial advisory

Board, this year’s group adds to

a list of more than 200 alumni

dating back to June 2008. we called

that f rst cohort of leaders “the

change generation” and frankly the

description remains apt today—

change is still the constant because

there is no single commercial model

that offers a suref re guarantee of

success. what is different is a greater

diversity in leader backgrounds and

the skills required to advance to the

“c-suite.” we are seeing more bench

strength in vaccines and generics,

once adjacent businesses that are

now key sources of product and

process innovation; a transformation

of f nance and manufacturing roles,

from a technical function to a

strategic priority; new competencies

in organization design that help

f eld forces get even closer to the

customer; the ref guring of medical

affairs as liaison to a more informed

patient community; and the advent

of a new generation of in-house

technologists, imported from outside

the industry, with the capabilities to

deliver customized digital messaging

in multiple channels, on many fronts.

— William Looney, Editor-in-Chief


17

www.PharmExEc.com

JULY 2015 Pharmaceutical executive Emerging Pharma Leaders 2015

The 48 Hour Turnaroundrahul aras, ceO, Juventas therapeutics

“Running a start-up, there are

moments that test your convic-

tion, that have you questioning the basis

of your technology, the data you’ve gath-

ered to date, and your overall vision.

Larger companies might have the ability

to ride these moments out, but young

companies don’t have that liberty.”

Rahul Aras, CEO of Juventas Thera-

peutics, recalls a period following the

company’s f rst fundraise while in the

midst of a key large animal study for lead

product, JVS-100, a gene therapy devel-

oped to activate the body’s repair path-

ways, now in Phase II trials for patients

with advanced ischemic heart failure and

late-stage peripheral artery disease.

Juventas was in between its Series A

fundraise and a board meeting when it

saw preliminary results from a large

animal study that were “discouraging”

relative to benef ts seen in earlier rodent

studies. “When data comes in that are

not consistent with the primary objec-

tive, a start-up has the choice to either

fold or respond.”

Aras and his Cleveland-based team

had a tough conversation: “Do we

believe in the biology, the science that

is the foundation of the experimental

treatment, and in the data produced to

date? If so, then this new data is trying

to tell us something.”

Despite having just 48 hours to solve

the problem, the team didn’t panic, but

intensely scrutinized the results. The group

was able to f nd a signal that frames the

basic concept at the heart of the treatment’s

mechanism of action, that in patients/ani-

mals with greater tissue damage, they saw

a stronger, more demonstrable response to

the treatment. An effect that has been rep-

licated in recent human clinical trials eval-

uating JVS-100 in patients with advanced

chronic heart failure.

The team responded in remarkable

time with an action plan for a mid-study

course correction and was able to meet

its timeline for a successful investiga-

tional new drug application. Moments

like this can def ne a company, although

in reality, there are dozens of compa-

rable moments, the CEO notes.

Aras credits the team he constructed

for its ability to maintain focus and

make calm decisions when challenges

present themselves. If he takes credit for

anything, it’s that he’s hired well. “I

look at myself as a team builder.”

“Hiring is a key focus,” he noted.

“Setting goals and making sure we meet

them is essential for any management

role, and we’ve hit all our milestones in

budget.” But Aras pins the success

Juventas has experienced to date on hav-

ing recruited top tier talent and main-

taining an open culture where employees

have the opportunity to succeed.

Juventas takes fun seriously, Aras

adds. Anyone in the drug development

industry will agree this is not an easy job,

so levity can be a vital instrument. There

are a lot of factors out of your control.

In this industry, everyone comes to work

with a purpose, adds the CEO. “We take

our commitment to developing therapies

seriously but want to enjoy the journey.”

As the company has grown, Aras has

seen his role expand from basically being

a project manager in the early days, to the

quintessential CEO managing multiple

functions. Every day is different as Aras

spends copious time traveling from Cleve-

land to the coasts, constantly communicat-

ing Juventas’ story, executing on business

development and managing clinical prog-

ress. “It’s clearly a cliché, but we’re always

raising funds”—$45 million to date with

VC backing as well as support from

Takeda Ventures and the Cleveland Clinic.

Juventas’s technology is born of

Cleveland Clinic science, where Aras

worked in the innovation off ce as the

Director of Life Science Commercializa-

tion spearheading the biotech portfolio

and seeking partnerships. Prior to his

time at the Cleveland Clinic, Aras fol-

lowed his PhD in biomedical research at

New York University with a stint at Cold

Springs Harbor’s Off ce of Technology

Transfer. Becoming a CEO of a biotech

company was def nitely not according to

plan, but it can be tricky to plot a career

at the mesh of science and business.

“I moved to Cleveland for two years,

10 years ago,” Aras jokes. “It’s a nice

place to build a company and an attrac-

tive place for a lot of talented, entrepre-

neurial minds. It’s amazing how many

people have roots in Ohio,” he notes.

Juventas has done well recruiting people

who have worked at more traditional life

science hubs and may have seen this as an

opportunity to get back closer to home.

“Looking forward, Juventas will con-

tinue to operate lean and with a focus on

its later stage trials,” Aras says. The com-

pany, he conveys, is founded on being dis-

ciplined, diligent, and cash conservative.

“We’ve been able to stay focused

while adapting to shifting environments

for eight years,” Aras says. The com-

pany was founded during the market

crash; the Dow was down 700 points

the day Juventas closed its Series A.

“Now, we can benef t from the current

enthusiasm around biotechnology and

gene therapy to assist fundraising, but

we’re not changing course or jumping

on any fads or bandwagons.”

— Casey McDonald


18

WWW.PHARMEXEC.COM

PHARMACEUTICAL EXECUTIVE JULY 2015Emerging Pharma Leaders 2015

As an undergrad at Duke, Aris Baras

had the proclivity to reach high. In

a leadership course, his class was tasked

to connect with pioneers in their f elds of

study. Possessing MD/MBA intentions,

and a Greek-American background,

Baras made a hopeful but improbable

plea to connect with industry titan Roy

Vagelos, chairman of the board at Regen-

eron and retired chairman of the board

and CEO of Merck & Co.

“I f gured, why not try to reach out to

him.” Baras found contact information for

an administrator of a board that Vagelos

was on and sent a request. Shockingly to

Baras at the time, Vagelos responded in

less than 24 hours. He soon learned that

“Vagelos’ commitment to education and

mentoring is unparalleled.” Stemming

from the initial contact, Baras got to know

Vagelos, speaking and meeting several

times a year. His input and guidance con-

tinue to be invaluable, he adds.

Clearly, Vagelos saw something in

Baras, which is evident in his willing-

ness to give up his time. And to further

his support of the young MD/MBA, f ve

or six years ago, Vagelos offered another

priceless networking opportunity when

he facilitated a connection with biotech

colossus, Regeneron’s chief scientif c

off cer (CSO) George Yancopoulos.

Baras began working with the CSO

and Regeneron team members taking on

projects while still in academia. “Yanco-

poulos’ ability to drive innovation,

develop new technologies, and deliver

major breakthroughs over and over again

are legendary.” If you’re counting, that’s

a pair of awfully stellar mentors to have

in one’s corner before leaving school.

While completing his training, Baras

contributed substantial time to Liquidia

Technologies, a company engineering pre-

cision particle-based vaccines and thera-

peutics, as well as doing some consulting

for Regeneron’s translational medicine

and technology development activities.

Baras has now been at Regeneron for

f ve years, and is the executive director

and co-head of the Regeneron Genetics

Center (RGC), which he co-founded.

Building from the ground up and now

as co-head along with Dr. Alan Shuldiner,

Baras oversees the 50-employee RGC that

cuts across all of Regeneron’s drug discov-

ery processes by applying large-scale

human genetics to drug discovery. It has

three goals in mind. First, the RGC aims

to assist target discovery through novel

gene discoveries and genetics validation

for new and existing drug targets. Second,

the program aims to inform the develop-

ment of product candidates in Regeneron’s

pipeline by identifying potential indica-

tions, supported through human genetics,

for these development programs. And

third, the RGC enables pharmacogenetics

analyses to tease out potential populations

with better responses to therapies.

Baras directs collaborations with

numerous external organizations, and

most notably with the Geisinger Health

System, in an effort to build one of the

world’s largest comprehensive genotype-

phenotype resources combining genomic

and de-identif ed clinical data.

The RGC has sequenced over 50,000

participants in its f rst six months—and

is shooting for a f ve-year goal of 250,000

individuals. The RGC’s capacity could go

even higher as Regeneron continues to

scale its program. There may also be stra-

tegic opportunities to participate in the

President’s Precision Medicine Initiative;

Yancopoulos was invited to the White

House for Obama’s announcement and

has participated in planning workshops

for this initiative.

Aside from the Greek connection

with his mentors, Baras is amazed by

the work culture at Regeneron and con-

siders it to be the “sweet spot” where

substantial resources are available for

R&D and technology development.

Teams can move quickly on exciting sci-

ence and innovation without being held

up by bureaucracy. “It’s a perfect blend

of freedom to commit to innovation

and to have the resources to pursue

important scientif c questions.”

Baras places an emphasis on building

teams and is committed, “to f nding tal-

ented and motivated people who f t into

the culture, share an unwavering pas-

sion for science, and are driven to make

a difference for patients.” Regeneron

affords its research teams “a pretty f at

structure,” as Baras points out, “it’s

important to be inclusive giving every-

one a voice and the opportunity to make

meaningful contributions.”

Additionally, Baras contends that

process is critical to success and empha-

sizes the importance of teamwork in

delivering results and making an impact.

Regeneron is working across many dif-

ferent f elds, therapeutic candidates, and

technology development opportunities.

“There needs to be real discipline in tak-

ing on a project and delivering results.

Regeneron has an excellent culture and

proven track record of internal collabo-

ration that has delivered major break-

throughs and technological advances

time and time again.

“We like to dream big, get things

done, and have a lot of fun. We con-

stantly strive to inspire our teams and

to be poised to take on the next big chal-

lenge without being afraid of failing.”

— Casey McDonald

Third Gen Greek Aris Baras, Executive Director and Co-Head, Regeneron Genetics Center


19

www.PharmExEc.com


Jay Barber’s nearly 20-year tenure at

Sanof Pasteur has seen him earn his

chops in pretty much every one of the

company’s sales and marketing depart-

ments. He got started “on the ground

f oor in telesales,” then moved up to

become a sales training manager. He

also spent time in customer service,

eventually leading the department as

the company aligned its customer ser-

vice with its commercial strategy.

Embarking on an MBA, he found he

particularly enjoyed the marketing

courses, so he then decided to take a

step down for a role as a product man-

ager in marketing. Before long he was

back at a senior level, becoming senior

marketing director for the company’s

US pediatric vaccines.

Barber’s relentless quest for new

skills and experiences saw him leave

Sanof Pasteur at this point (14 years

in) to try his hand as a strategic leader

at an advertising agency. But after 18

months of this, he realized he “wasn’t

meant to be on the advertising side of

the business.” Returning to Sanof Pas-

teur, he picked up where he left off and

his ascent continued apace.

Viewing his role as a mobilizer of

immunization through marketing,

Barber’s portfolio spans pediatric vac-

cines for polio, pertussis, Hib (Hae-

mophilus inf uenza type b), adolescent/

adult pertussis boosters and Sanofi

Pasteur’s entire f u franchise. His cam-

paigns have used personal stories, fam-

ily testimonials, non-prof t collabora-

t ions , and socia l responsibi l it y

initiatives to reach healthcare provid-

ers and the general public. Most

recently, as commercial lead for the

launch of Fluzone High-Dose, a vac-

cine specifically designed for the

elderly, he developed a creative cam-

paign that broke through a commod-

itized inf uenza vaccine market and

exemplif ed his deeply held belief that

protecting people from vaccine pre-

ventable diseases is both a business

imperative and a moral commitment.

The Fluzone High-Dose vaccine US

marketing approach not only helped

Sanof Pasteur’s global f u franchise

reach €1 billion sales in 2014, it also

resonated with Barber personally. “My

parents are of the age to qualify for this

vaccine now; I’m really proud to know

they’ve got a better chance of not get-

ting the f u because of something I was

directly involved with.” Within three

years of leading the launch of Fluzone

High-Dose vaccine, Barber had

increased sales of the vaccine option

by 160%.

Barber is happiest doing what he

does now on a daily basis, that is, strat-

egizing: “thinking about where we

need to be and what we need to invest

in to be successful.” The key challenges

of the last five or six years in this

regard, he says, have been those

brought about by health economics.

“From the moment you’re working

with R&D in the clinical development

of a product, you’re no longer thinking

of designing a clinical trial just on

medical outcomes; you’re thinking

about how the trial may generate the

data for a strong pharmacoeconomic

story that demonstrates a health eco-

nomic benef t to policymakers, payers,

or practitioners,” he explains.

But rather than throw obstacles in

the way of the drive to prevent or cure

illnesses, health economics has made

strategizing “more fun”, says Barber.

“And if you’re talking about what’s

right for public health, it’s pretty easy

to prove the value of vaccines, because

by immunizing you reduce hospitaliza-

tion and you reduce complications of

other diseases. In fact, what I’m seeing

is that the focus on health economics

is strengthening the argument for the

value of what we do.”

Last June, Barber made his first

foray outside the US to lead the global

f u franchise, and his goals now are

f xed around “strengthening my skills

globally and leveraging the marketing

learnings from the US globally.”

He admits “for me, the unknown is

vast, going from a very US-centric

point of view to absorbing a new way

of working.”

But Barber’s Sanofi Pasteur col-

leagues are conf dent that his new role

will provide a greater platform for his

talents, and an ideal opportunity for

extending his vision to new markets.

And his wealth of experience stateside

can only be a boon to any future direc-

tion he takes.

“I can look back and say that I’ve

diversif ed my experience enough to

allow me to think more broadly than

if I’d stayed deep in one track,” he says.

“I’ve learned skills from every one of

my roles that I still use today.”

— Julian Upton

Triumph Through DiversityJay Barber, associate vice President,

Global inf uenza Franchise & Product Strategy, Sanof Pasteur


20

www.PharmExEc.com


L ike many of the most gifted entre-

preneurial scientists populating the

biotechnology space, Julian Bertsch-

inger’s story is almost antithetical to the

incrementally advancing career narra-

tives that def ne the conventional big

Pharma leader.

In 2007, at age 30, he went from his

post-doctoral program at the Institute

of Pharmaceutical Sciences ETH Zürich

to founding and leading biotech start-up

Covagen, along with his colleague, Dra-

gan Grabulovski. The Zurich-based

company was established to develop the

technology platform invented by Gra-

bulovski, FynomAb, which fuses bind-

ing proteins derived from the human

Fyn SH3 domain to antibodies to create

therapeutics for the treatment of inf am-

matory diseases and cancer.

With seed money from Novartis’s

Venture Fund, Covagen grew from a

one-employee concern (Bertschinger

steered the ship alone for six months

while Grabulovski completed his PhD

thesis) to a 30-man outf t, raised more

than $60 million in venture capital, and

entered a strategic collaboration with

Mitsubishi Tanabe Pharma Corp. in

2012, eventually catching the attention

of Janssen aff liate Cilag, who acquired

the company last August. Now 38,

Bertschinger sees the Janssen purchase

as his “new beginning.”

Jumping in solo at the entrepreneur-

ial deep end back in 2007, of course,

had its challenges, and from day one

Bertschinger had to tackle that steep

learning curve that can propel scientists

from bench to boardroom. Initially,

Covagen had no laboratory; when he

located one, Bertschinger had to clean

it himself before he could start work.

He also set up and administered the

company website. More urgently, he had

to develop business skills to communi-

cate credibly with investors. In this

regard he welcomed support from Anja

Koenig of the Novartis Venture Fund,

who was “crucial for my personal devel-

opment,” he says. “I was a hardcore sci-

entist, extremely focused on data and

facts. Anja helped me to relate on a busi-

ness level; she had insights into all the

different VC funds available and the

political situations behind them.” It was

an education very different from what

he’d been used to. “I gradually got more

and more exposure to the outside

world,” he says, “all the while learning

the different aspects of drug develop-

ment in a hands-on role.”

Managing employees was also some-

thing Bertschinger had to learn effec-

tively from scratch. But starting from

the position of sole employee, it’s a skill

he has been able to ref ne gradually,

building his team from the ground up.

“When the time came, I had to pitch to

investors, I had to hire people, I started

to become a real manager,” he says.

Since then, he has striven to maintain a

“biotech culture,” where employees feel

they can make decisions independently

with “no committees and few processes

behind the decision making.” People in

the company “feel a very strong owner-

ship of their projects, so we have a high

level of commitment,” he adds. It’s an

intimate, supportive culture; one Jans-

sen colleague praises Bertschinger’s

“daily engagement with the Covagen

team over coffee and lunch.”

Bertschinger sees no reason why the

merger with Janssen will diminish the

Covagen culture. Of course, he’s

encountered processes that make things

move a little more slowly, but integra-

tion with a bigger organization “gives

us access to resources in terms of exper-

tise and money that we could only

dream of,” he says. And he is positive

about how big Pharma in general has

become more open to external innova-

tion, embracing novel platforms at an

early stage. In just the last few years he

has seen monoclonal antibody technol-

ogy become a commodity in the indus-

try. “Companies are now ready to run

experiments like they do with Cova-

gen,” he says.

Now focused on establishing Cova-

gen as a “highly productive R&D unit

within Janssen that is compliant with

the wider organization,” Bertschinger

wants to see “how a big company func-

tions and how you have to work in such

an environment to be successful. ”Hav-

ing advanced from complete business

novice to leader of a high-value biotech

in a few short years, one has faith in his

ability to repeat this achievement within

big pharma. He has proved he has the

staying power to see an idea through to

fruition, to battle through rough terrain

until it becomes smoother riding. One

of his favorite pastimes outside work is

playing the violin. He took it up at age

seven and, more than 30 years later, still

rehearses every week with a university

alumni orchestra. Clearly, when he

commits to something, Bertschinger

really commits to it.

— Julian Upton

From Soloist to Conductor Julian Bertschinger, co-Founder and ceO, covagen


21

WWW.PHARMEXEC.COM

JULY 2015 PHARMACEUTICAL EXECUTIVE Emerging Pharma Leaders 2015

Amechanical engineer by trade, Dan

Dietrich has approached each new

role in his 20-plus-year journey leading

teams and programs in manufacturing,

quality, project management, supply chain,

and operations through the lens of what he

calls the “Four Pillars.” Three of those pil-

lars are solid and straightforward in their

own rights: The position has to have a

global impact; it must include a lead team

that can work with and support Dietrich;

and the role needs to be in an area new to

him, so he can expand his learning.

It is the fourth pillar in Dietrich’s crite-

ria checklist, however, that may be the

most def ning in his career—where the

now-VP of Novartis’s global operation ser-

vices f rst started as a forensic engineer,

performing car accident reconstruction.

“Whatever I take on, it has to be bro-

ken,” says Dietrich, who, while earning a

BS in Mechanical Engineering at the Uni-

versity of Colorado, served in the US Air

Force from 1988-1994, working as an F-16

aircraft maintenance specialist. “I love to

build teams up. I love to optimize or blow

up the processes. Walking in when it’s just

chaos—people are miserable and structure

isn’t clear—to walking away and having

people excited about what they’re doing

and owning what they do, that’s where I

have the most fun.”

Rooted as an engineer, Dietrich, 44, has

consistently followed the job philosophy of

once a process is in control and operating

at steady state, teams are mature and self-

directed, it’s time to move on to a new role

and challenge. He proudly dubs himself “a

process and operations guy,” skills he notes

that are highly transferable. Dietrich is

quick to point out that he’s never been a

subject matter expert in his various leader-

ship roles and doesn’t intend to be, instead

relying on surrounding himself with such

experts. For the results-driven Dietrich, his

reputation and value has been built on cre-

ating new growth opportunities through

the art of process redesign and organiza-

tional restructuring.

Dietrich’s resume is rife with such

examples, including when he took over as

global head of operations and strategy for

Novartis’s drug supply group in Basel,

Switzerland, in 2009. At the time, the team,

Dietrich says, had gone through a series of

managers, was losing several subject matter

experts, and was overall dissatisf ed as a

group. According to Dietrich, he

approached this role the same way as the

others, working with the operations team

on either a turnaround strategy or a plan-

ning activity. He leaned on

his experience to date in

quality management mod-

els (he achieved a Six

Sigma Black Belt in 2007),

as well as his skills in

empowering teams and

installing a global cross-

functional matrix leader-

ship structure. Within six

months, the external drug

supply group increased

productivity by 20% and

team members reported via surveys of

being much more satisf ed, according to

Dietrich. “Processes were globalized and

def ned for them,” he says. “Expectations

were crystal clear for them, and now they

owned the deliverables.”

Another example occurred during Diet-

rich’s initial foray into the healthcare sector

after transitioning from the automotive

industry (he was launch program manger

for Johnson Controls Inc. from 1997-2000,

where he led teams in the US and Japan

around the annual Toyota vehicle launch

updates as part of Toyota’s joint venture

with GM). In 2000, Dietrich joined

LifeSpring Nutrition, a nutraceutical

startup in Northern California focused

largely on the aging population. He was

originally hired into a sales and marketing

role, but after LifeSpring lost its funding

following 9/11, Dietrich was thrust into an

operations role as general manager and

would eventually be named CEO of the

company. Charged with helping boost

LifeSpring’s prof ts, he restructured opera-

tions and reduced operating cost by over

50%. It was here where Dietrich honed his

skills in people optimization and started to

merge his mindset around the two elements

of empowering people and pursing opera-

tional excellence.

“That was one of the best jobs I ever

had, just because I learned so much so

quickly,” says Dietrich, who before joining

LifeSpring was considering pursuing an

MBA. “One of my very close friends at the

time shared with me her experience around

getting an MBA and what that’s done for

her and her career. She was working at

[LifeSpring] and she said,

‘You know, Dan, either

you can go to school and

learn about it, or you can

come work at this com-

pany with me and learn it

and live it.’”

In 2003, Dietrich sold

LifeSpring, and in parallel

was pursued by Chiron

Corporation due to his

experience with Toyota.

He was hired to lead the

biotech’s end-to-end process optimization

initiative. Dietrich’s team freed up more

than $30 million in inventory for Chiron’s

key Betaseron brand, and reduced manu-

facturing and distribution cycle times by

50%. Novartis acquired Chiron in 2006

and offered Dietrich the position of global

head of the drugmaker’s PharmOps Oper-

ational Excellent program, based in Basel.

Including his time heading up Novartis’s

third-party clinical drug supply operations,

Dietrich spent f ve years in Switzerland,

often traveling between 10 manufacturing

sites in China, Japan, Egypt, and Europe.

In 2011, he returned stateside, where he

joined clinical operations, based at Novar-

tis’s US headquarters in New Jersey. After

increased responsibilities, Dietrich was pro-

moted to his current role, managing a cen-

tralized group that delivers services to the

global and local clinical study teams for

Taming the Chaos Dan Dietrich, VP, Global Operation

Services, Novartis

See Dietrich, page 35


22

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F or Arjun Handa, leadership is a

family trait. His father, Sushil,

founded injectables firm Claris 15

years ago; before that he had a track

record of business

v e n t u r e s i n t h e

Indian healthcare

sector. In the 1980s

he s e t up C ore

Healthcare and in the

1990s he was instru-

mental in bringing

Quintiles to India.

Handa wasted no

time in meeting his

family’s entrepre-

neurial expectations.

O n g r a d u a t i n g

A h m e d a b a d ’ s

Gujarat University

with a degree in Accounting in 1999,

he set up an IT f rm that was quickly

successful; he continued to run it when

he moved to Boston to complete his

MBA at Northeastern University.

When he returned to India in 2004, his

father suggested the firm should

become the IT arm of Claris and the

two companies merged.

On joining Claris proper, Handa

spent time in product development,

“learning what was driving the com-

pany’s growth,” before rising to a lead-

ership position in manufacturing,

where he spent four years. Head of

operations from January 2006, he

became chief operating off ceer in Jan-

uary 2008; in September 2008, at age

28, he was made CEO.

In the meantime, the Carlyle Group

paid $20 million for a 14% stake in

Claris. The investment helped to fuel a

major global expansion; by 2009, the

company had a presence in 76 coun-

tries and had achieved a compound

annual growth rate of 40% over f ve

years. Amid this activity, Handa was

offered his role as CEO. Wary of his

lack of experience in f nance, sales and

HR, he chose to spend a year “famil-

iarizing myself with those three func-

tions” while easing

into the position. The

carefu l t ransit ion

underlined his dili-

gence and pragma-

tism; when it was

time to fully lead the

company, he knew it

inside out.

From his earliest

days in the Claris

labs , Handa sug-

gested taking the

company’s biggest

product, a generic

version of propofol,

into the US. His father was apprehen-

sive, anticipating too many challenges

as the product was patented there. “But

I told myself, one day I’m going to do

this,” says Handa. True to his word,

last year Claris f led the product in the

US and settled the patent litigation

around it; Handa hopes to receive

approval soon.

He has also proved his mettle in

more trying circumstances. In 2010,

the company was the subject of an

FDA import alert, after reports of con-

tamination.

“We had to work towards a resur-

rection,” says Handa. “We had to

change our architecture of quality, our

quality systems, our culture.” In 2012,

the company had a successful FDA

audit and was allowed back into the

US, where its products now number 36

(and counting). Handa regards “that

whole turnaround as a great personal

achievement.”

While the growth of the Indian

pharma market has been huge over the

last 15 years, Claris’s injectables busi-

ness remains mostly export oriented;

this sector is still evolving at home.

Claris’s injectable products are “more

cutting edge; they achieve better rec-

ognition and sales in countries with

more developed markets,” says Handa.

(The company’s infusions business was

transferred in 2013 to a joint venture

with Japan’s Otsuka and remains

focused on the Indian market and oth-

ers “where infusion is a high-volume/

low-value commodity”). Handa is

keen, however, to commend the

changes India has experienced.

“There’s more potential to do busi-

ness here now. There are more hospi-

tals, more manufacturing facilities,” he

says. “And there’s a lot more talent.

Company founders and their key people

used to have to resolve learning curves

as they went along. Now, there are sea-

soned professionals who can join a

company and be instantly instrumental

in leading it. The nurturing of talent

has turned erstwhile middle managers

into good senior professionals.”

As for his own career development,

Handa credits his father as his “true

mentor.” But he follows his own path.

“I am not as motivated by scale as I am

by niche,” he says. As an entrepreneur,

he is concerned with identifying gaps

in the market. “My father’s generation

has given India the basic infrastruc-

ture. What is needed now is what is

missing. Our business model has to be

a balance of off-patent and improved

products.”

With plans to roll out 48 new prod-

ucts over the next three years and solid-

ify the company’s position in regulated

markets such as the US, Handa is well

on the way to securing his goal for

Claris—for it to be “one of the most

admired companies in the injectables

segment.” He has also been rewarded,

many times over, by that “time, energy,

and focus” his father devoted to mak-

ing sure his son would carry the skills

and expertise to be the right leader for

the company’s future.

— Julian Upton

The Son Also RisesArjun Handa, Vice Chairman and Managing Director, Claris Lifesciences


23

www.PharmExEc.com


Staci L. Julie might research patent laws

in Estonia or investigate potential

assets in South Korea as she leads her team

through the complex, ever-changing ter-

ritory of intellectual property rights laws

and regulations. To stay current with Teva

Pharmaceuticals’ expansive portfolio of

generics and brands, leadership encour-

ages a culture that pushes employees to

stretch, Julie said. This kind of environ-

ment suits her just f ne. Julie has built a

career reaching into unfamiliar areas to

master new skills and subjects.

Early on, Julie’s father encouraged her

to study chemistry for her undergraduate

degree, given her aptitude for math and

science in high school. After college, she

again sought the advice of her father, a

lawyer. He suggested a career in patent

law, which at the time had very few female

attorneys. “You have to be open to trying

things that stretch yourself,” Julie said. She

enrolled in Georgetown University Law

Center, and, in 2000, Fish & Neave, now

known as the Ropes & Gray intellectual

property group, hired her directly out of

law school. The Wilmington, Delaware,

native hesitated at the thought of a life in

New York City. She asked her then-f ancé,

Richard, a native New Yorker, to promise

they would leave if she ever grew tired of

it. As an associate, Julie began work on

her f rst litigation case, which ended up

lasting four years. Her client was Teva.

One day, Julie’s contact at Teva called her

up and asked if she ever thought about

coming in-house. After four years in the

big city, Julie looked longingly at the sub-

urbs again.

In March 2004, she signed on as asso-

ciate director of legal affairs of Teva USA.

Her career then rocketed upwards through

eight positions within legal affairs and IP

divisions. In March 2015, she became

Teva’s senior vice president and chief IP

counsel. In this global role, Julie leads a

team that deals with all patents, trade-

marks and copyrights related to branded

and generic products. She also provides

f nal guidance on the evaluation of poten-

tial assets and any other opportunities

related to IP strategy. “The energy is invig-

orating. Even when you think you might

have a slow day, you always f nd you have

something new to do.”

As Teva expands into other countries,

the IP team

must navigate

new patent

and regula-

tory regimes

to find the

best ways to

get products

to market.

The U.S. reg-

ulatory sys-

tem is directly

linked to the

patent, which creates a clear mechanism

within product development, Julie

explained. “Some of the territories we are

moving into are not linked systems, which

creates uncertainty.” But uncertainties can

translate to opportunities.

Julie likes pushing the boundaries of

tradition within pharmaceutical IP. She

regularly studies IP functions and proce-

dures in other industries, like technology,

“to see what’s different from how pharma

has always operated.” Her hard work paid

off earlier this year when she led the team

that defended a case before the U.S.

Supreme Court – and won. In Teva Phar-

maceuticals USA, Inc. v. Sandoz, Inc., the

Supreme Court ruled in a 7-2 opinion that

the U.S. Court of Appeals for the Federal

Circuit must be more deferential in review-

ing the decisions of trial judges who over-

see patent infringement litigation. The

Federal Circuit had earlier nullif ed Teva’s

patent for its multiple-sclerosis drug

Copaxone. As a result, the Supreme Court

sent the case back to the federal circuit for

further proceedings. “The case involved a

legal issue specif c to all patents,” Julie

said. “And it’s still not over, but it will be

changing patent law as a whole.”

The Supreme Court case can be

chalked up as a win, but success necessi-

tates a willingness to accept failure, she

said. “How you deal with failure, how

quickly you learn from it, adapt to it, and

move on from it is crucial,” she said.

Julie encourages her team to admit to

and address failures. “If employees are

worried about failing, and they don’t raise

their hand when something bad happens,

then that’s a problem,” she said. An

equally critical aspect to leadership is to

celebrate individual successes because

employees want to be recognized, both

one-on-one, and in front of their peers.

She described her approach to leadership:

be an active listener and be aware of how

you are perceived by your team. “I haven’t

been shy to ask people what I can do to

improve,” she said.

Besides better communicating, compa-

nies should also be grappling with the best

way to grow well in an increasingly global

and connected world, Julie said. For her

team, which spans 11 countries, Julie

looks for commonalities to leverage Teva’s

scale, but also nurtures local business and

marketplace knowledge. “A local under-

standing of patent laws creates value for

those jurisdictions, and I don’t want to lose

that in the name of globalization.”

Another approach to managing industry

complexity is to build a community of

experts within each department. “We

have to f gure out what skill sets we need

to bring in so we have enough different

perspectives to pursue a creative path,”

Julie said.

Despite keeping a busy schedule, Julie

is quick to point out that she herself plays

different roles outside of work as a T-ball

coach and fantasy football fanatic. She

is mother of twin six-year-old daughters,

rabid Philadelphia Eagle fans, just like

her. Her husband, Richard, gave up his

law career to stay home and raise the

girls. “That is a huge factor of my suc-

cess,” Julie said.

— Kathleen Raven

Stretching to Success Staci l. Julie, Senior vice President

and chief iP counsel,

teva Pharmaceuticals


24

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“He traded on respect—whether

addressing the opposing council

or a court security off cer, he held every-

one in equal esteem,” reminisced Matt

Lang. Not all lawyers can point to a men-

tor who demonstrated extreme kindness

and respect inside and outside the court-

room. But as a young attorney, Lang

learned a valuable lesson under the guid-

ance of Edward A. McDonald of Dechert

LLP in New York. Lang, who leads a team

of 22 lawyers and staff within Gilead Sci-

ence’s litigation and investigations divi-

sion, focuses on building strong relation-

ships not only with colleagues, but also

his adversaries. This approach may be

counterintuitive to litigators, accustomed

to playing the role of antagonist, but in

the end leads to the best results, Lang said.

In his short career, Lang has proved

to be a quick study of getting good results.

Born in Toronto, Lang pursued a Bach-

elor of Arts in classical history at Queen’s

University in Kingston, Canada, where

he won several awards for his studies.

After graduation, he enrolled in the Uni-

versity of Pennsylvania Law School—fol-

lowing his father’s advice to take advan-

tage of opportunities outside his comfort

zone. Lang met his wife, Leah, in law

school and together they pursued their

law careers in New York. At Dechert,

Lang noticed that he gravitated towards

litigation and securities cases for pharma

clients. “With pharma being such a regu-

lated industry, I think lawyers are at the

forefront of a lot of issues companies deal

with on a day-to-day basis,” he said.

When he and his wife decided to

move to the West Coast to be closer to

family, Lang began looking at job post-

ings with Gilead. He found an opening

in litigation and investigation in Gile-

ad’s corporate headquarters in Foster

City, Calif. At the time, in 2009, it was

the only position of its kind. “I thought

the position had a tremendous potential

for growth,” he said.

Now, as associate general counsel,

Lang guides his colleagues through myr-

iad responsibilities. His team handles

non-intellectual property litigation and

disputes, including securities, product

liability, commercial litigation, and inter-

nal investigations such as government

inquiries. Lang and his group oversee the

collection of documents for litigation,

called e-discovery, as well as privacy and

information management and records

outside of litigation. “At any given time,

the group might be working on strategy,

witness interviews, or internal employee

training,” he said. “I like to roll up my

sleeves and get into the details.”

So do other senior leaders at Gilead,

which is all part of the company’s cul-

ture of leading by example, Lang said.

The company’s market cap hovers

around $175 billion, even with only

around 7,500 employees, which means

every position has to have a big impact.

“It’s crucial that we preserve our cul-

ture,” which operates within a f at orga-

nizational structure and places a pre-

mium on integrity and accountability,

he said. Much of Gilead’s explosion in

growth can be attributed to the leader-

ship’s focus on decision-making rooted

in data and science. When the company

agreed to pay $11 billion for Pharmasset

in 2011, industry critics reacted harshly

and swiftly. “They said we overpaid,

that the compound wasn’t fully tested,

and that it was too much money to gam-

ble,” Lang said. On top of that, no one

believed Gilead could get the product to

market fast enough to make the invest-

ment worthwhile. But Gilead leadership

had already analyzed the science behind

PSI-7977, as the experimental drug was

called then. Gilead marketed sofosbuvir

as Sovaldi in December 2013 and the

hepatitis C drug has since become a

textbook case of a drug that has the

potential to cure a disease.

Lang expects the fast-paced growth

to continue at Gilead, and with it,

increased complexity for staying current

on laws that affect pharma companies.

Each year has been completely unlike the

previous during his tenure that trends or

future directions are difficult to pin

down. It will be important to gain exper-

tise in new subjects. Areas of interest for

Lang’s team are product liability, securi-

ties litigation, employment legal risks,

and developments with the False Claims

Act, also known as the “Lincoln Law,”

which targets people and companies who

defraud governmental programs.

With employees in more than 30

countries and his own growing team,

Lang has given newcomers a lot of

advice in his six years with Gilead. He

encourages recently arrived team mem-

bers to be patient and immerse them-

selves in the company’s values, and get

to know the operations and culture well

before attempting to drive major

changes. New employees who might

come in with a lot of experience typi-

cally want to recreate what worked well

elsewhere. “But they might try too

quickly to make a change, without being

cognizant of the culture in which they

are operating in,” Lang said.

— Kathleen Raven

First in a New Functionmatthew lang, associate General counsel of litigation & investigations,

Gilead Sciences


25

www.PharmExEc.com


For Jacopo Leonardi, life is a privi-

lege, a deep well of opportunity

that must be replenished every day.

The son of a schoolteacher and a busi-

nessman, that life left few marks until,

at age 17, an auto accident injured his

neck and nearly killed him. Exposure

to illness and infrmity—the night side

of life—left a permanent imprint on his

young character. “It was a close call

that forced me to realize how just ‘dial-

ing it in’ every day was not a produc-

tive way forward,” Leonardi says.

“Instead, I resolved to model my

behavior on two traits of character:

hope, expressed through a positive,

optimistic attitude; and purpose, which

is seeking real meaning from your own

life and in relations with others. It’s the

truth I learned from my parents during

that long recuperation: to shape your

own destiny, you must be fully present

for the journey.”

Early relationships proved instrumen-

tal in directing Leonardi to a career in

healthcare. “I was inspired by my father’s

positive energy and inspiration, which he

shared with everyone. That led me to the

helping professions, like healthcare. I also

had an intense curiosity to understand

issues on a deeper level, which drew me to

research.” As an undergraduate at Rut-

gers, Leonardi was a Henry Rutgers Hon-

ors Scholar and later almost opted for an

academic track in neuropsychology before

changing his mind to enroll in the MBA

program at Duke University. “I did it

because I like to build things from scratch,”

noting with a laugh, “I thought even then

the US health system could use an overhaul

and I was the right person to do it.”

But it was Jac’s girlfriend, now his wife

Leslie, who connected him to pharma, as

a sales representative for Eli Lilly & Co.

“I was lucky because at the time Lilly was

launching a lot of new products, which

eventually led me to assignments in early

stage product planning and commercial-

ization. These roles gave me the ideal com-

posite view, consisting of expertise in the

science as well as mission-critical down-

stream stakeholder relationships.

In 2009, Leonardi found his real tie

that binds—to the patient. “I accepted a

position in Baxter’s Biotherapeutics Fran-

chise, where we focused on a patient-cen-

tric business model designed to speed

patient awareness and diagnosis for sev-

eral rare diseases; on average, it was taking

patients over a decade to get a proper diag-

nosis for these conditions.”

His views were put to the test in 2012,

when he took on a turnaround assign-

ment to inspire and grow the US hemo-

philia business, which was affected by

conficted leadership and low morale. To

remedy both defcits, Leonardi and his

teammates created a bold vision of “striv-

ing for a life without bleeds, one person

at a time.” “There is much unmet medical

need in inherited bleeding conditions like

hemophilia,” Leonardi says. “We know

that when these people aren’t bleeding,

they’re living.”

This vision, which has now evolved

into a true calling, acts as a spark that

inspires the Baxter team and its commu-

nities to prevent bleeding. “We’ve helped

over 900 patients move to a prophylaxis

regimen aimed at preventing bleeds,

translating to over 15,000 bleeding epi-

sodes prevented.”

Earlier this year, Leonardi got the nod

to lead the entire North America Hematol-

ogy business, a $1.6 billion franchise of

six brands, extending geographically from

the US to include Canada, Puerto Rico,

and the Caribbean. The business will be

a centerpiece of the new company, Bax-

alta, the spin-off of Baxter’s BioScience

division. Describing his new role, Leon-

ardi says he sees himself as a patient advo-

cate, delivering results that matter to

patients. His current focus, in addition to

exceeding operating plan commitments,

is building on his success in re-energizing

employee engagement in the US with

another corporate culture initiative high-

lighting the new company’s emphasis on

purposeful, patient-centered innovation,

encapsulated in the message: “The Prom-

ise of the Baxalta spark.”

Leonardi is explicit about the capabili-

ties required to lead Baxalta and other

healthcare companies of the future. “The

single most important thing you can do as

a leader is to create, develop, and engage

top-performing teams,” he says. “And to

inspire those teams with a vision flled with

hope, clarity and purpose. Serve them by

helping to create a meaningful, winnable

game and clearing the path to success.”

Leonardi notes that lessons in leader-

ship come from all angles. In addition to

Baxalta CEO Ludwig Hantson and

hematology division president Brian

Goff, he derives his greatest inspiration

from his North America team and espe-

cially Shannon Resetich, leader of the US

hematology business. “We are in the

incredible position we are today because

of her and the others on this, the best

team in healthcare.”

Another leadership characteristic is self

awareness and life balance. “I keep myself

grounded by deliberately keeping up with

best friends I have known since I was 13,”

Leonardi says. “Leading with the heart

is a trait that is still in infancy in this indus-

try because, frankly, it is undervalued and

hard to teach. But if you look at where the

world is going, companies without a cul-

ture of ethics and purpose will stumble.”

— William Looney

Leading with the PatientJacopo leonardi, North america region head,

hemophilia and Blood Disorders, Baxter international


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Before Ken Miller had f nished his

degree in Business Administra-

tion at the State University of New

York at Albany, he was courted by

three organizations—Eli Lilly & Co.,

Rhône-Poulenc Rorer, and MetLife.

On graduation, he decided he liked

the sound of the healthcare com-

pany best, as it was “focused on

doing good for the communities it

served.” So he began carrying the

bag as a sales rep for Rhône-Poulenc

in Westchester County, NY.

Miller moved quickly up the sales

and sales management ladder;in 1998,

he decided to take up a marketing

opportunity at Pharmacia Corpora-

tion, where he would become director

of marketing. Five years later, Miller

moved to Basel, Switzerland, to take

on the same role for Roche, before

going onto Novo Nordisk to lead the

organization’s business development

and new product commercialization

division.

He joined BD (Becton, Dickinson

and Company) in 2011, and the last

four years have seen him traverse the

organization’s infusion, drug delivery,

and medical solutions businesses,

before being appointed worldwide pres-

ident of BD Diabetes Care in January.

Returning to BD’s diabetes business

(where he also previously served as

worldwide vice president) is particu-

larly gratifying for Miller, as it’s here

that he says he sees most clearly how

patients benef t from the organization’s

products. In an industry that isn’t

averse to platitudes about caring and

altruism, Miller’s commitment to help-

ing others is sincere and heartfelt.

He speaks proudly about a letter

he received recently from a 7-year-old

boy, Brady, who was struggling to

manage his diabetes because of a fear

of injections.

“Brady saw our new 6mm syringe

and after that overcame his fear and

started taking his insulin injections.

He sent us the most beautiful picture

that he’d drawn: on one side is a mon-

ster, representing the big syringe, and

Brady is there, crying; on the other

side, he’s smiling, holding our small

syringe. It touches my heart to know

that what we do has such an impact on

patients’ lives.”

For this reason, Miller always

encourages his teams “to keep the

patient at the center of their decision-

making.” He praises BD’s Leadership

Standard in helping to create a “more

inclusive and impactful workforce.”

The Leadership Standard, intro-

duced in 2013, is focused on accelerat-

ing the development of key talent at

multiple levels, via courses at BD Uni-

versity, for example, or through its

Leadership Accelerator programs.

“Our progress is closely tied to our

leaders; they are driving our transfor-

mation to a more global, innovative,

and customer-centric organization,”

Miller says.

With his appointment to a global

leadership role, Miller’s own career

development is continuing apace. “It

has been a great learning experience,”

he says. But his time in Switzerland

also helped to attune him to the cul-

tural differences of patients around the

world and how products should be tai-

lored accordingly, whether that is

“simply from a pricing perspective,

making products far more affordable

in countries such as China, Turkey, or

Brazil, or about introducing products

that are more technically complex to

markets that have the infrastructure

to embrace them.”

He hasn’t thought too hard about

where he’ll be in f ve years’ time—

after all, he’s only been in his new role

for a matter of months—but he says:

“If I can look forward, I’d just like to

be in a position where I can continue

to have an impact on people and on

communities.”

If you hadn’t noticed already, “com-

munity” is a key word for Miller. It

drives his activities outside work just

much as it does in the office. “My

friends and my church community are

paramount to me,” he says.

Miller has partnered with his

church on programs to address home-

lessness and tackle literacy in African-

American and minority groups. Added

to that, he’s a member of the board of

the directors of the Northern NJ–

Rockland County Chapter of the Juve-

nile Diabetes Research Foundation

(JDRF), the largest charitable sup-

porter of type 1 diabetes research

(T1D). Its mission is not to rest “until

T1D is fully conquered.”

“What I’ve learned to appreciate is

that you can be tough on standards

and have a high commitment to excel-

lence and delivering exceptional

results,” Miller says. “But at the same

time you can still be tender-hearted

with people.”

— Julian Upton

Community ChampionKen Miller, Worldwide President, BD Diabetes Care


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W hen asked to describe the accom-

plishment she is most proud of in

her relatively short career, Gaby Mishev

replies: “The f rst time somebody on my

team got the promotion he had been work-

ing towards was a particularly proud

moment for me.”

An associate director in marketing at

Genentech, Mishev grew up in New York

City with a brother and parents both of

whom are lawyers. She attended Brearley,

an all-girls private school on Manhattan’s

Upper East Side, where she showed herself

to be a smart, self-disciplined, and strongly

intentional student.

Today, at 37, she comes across as self-

lessly reserved with a strong desire to help

others and a tendency to def ect attention

from herself and onto those she works

with. She is also the possessor of enviable

equipoise. “I learned it from my parents.

They’re the calmest lawyers in New York,”

jokes Mishev.

As a teenager, however, the last thing

on her mind was a future career at a bio-

tech company, or anywhere else for that

matter. “I didn’t even know about the

industry then,” she says.

She did, however, know two things

about herself that would point her in the

ultimate direction. She loved solving puz-

zles, the hard kind. And she loved science,

the applied kind that uses science to help

people. Intuitively, Mishev followed the

advice a friend would give her many years

later: “Let your skills be your life direc-

tives,” he told her. “Instead of chasing

titles, positions, or big salaries, follow what

you love doing and what you do well.”

First stop, Harvard, where Mishev

received a BA in computational neurosci-

ence. Next, across the pond, to Oxford

University for further study and an MSc

in neuroscience and then back to Cam-

bridge for an MBA at the Massachusetts

Institute of Technology’s prestigious Sloan

School of Management.

And it was there, at business school,

that her goal came into full focus. After

attending several healthcare courses, the

related bits and pieces scattered through-

out her life like snippets of

f lm on the cutting room

f oor began to coalesce—

books read, conversations,

papers written, people

met, courses taken, puz-

zles solved.

Mishev believes in hap-

penstance. “So much, I

think, is about listening

and talking to people,

hearing about their experi-

ences and thinking, ‘Oh, that sounds really

interesting.’ I realized that the pharmaceu-

tical industry was where I could pursue all

those other things I loved, as well as being

in a place that’s at the forefront of science

and at a point in the healthcare system

where science really becomes helpful to

people.”

In 2006, Mishev started her industry

career at Roche in New Jersey as an ana-

lyst, and quickly moved up to senior ana-

lyst assigned to launching a brand. “I was

involved in forecast and market research,

which I love,” says Mishev. “It’s a wonder-

ful place I think to start in the commercial

organization because it gets you out talk-

ing to so many of the different functions.”

The next chapter of her life was the

result of a different kind of happenstance.

In 2009, the year of big Pharma’s big merg-

ers, Roche acquired full ownership of

Genentech for $46.8 billion. And with

that, Mishev accepted a new position with

Roche’s new subsidiary, packed her bags

and along with her favorite pair of jeans

set off for California to begin work at

Genentech.

“I don’t even remember when I last

wore anything but jeans,” says Mishev,

giving us a glimpse inside Genentech’s cul-

ture, which the company itself def nes as

“intensely casual.” Genentech, founded in

1976, was already a legendary biotech as

makers of bio-blockbusters Rituxan, Avas-

tin, and Herceptin. Today, it employs

nearly 12,900 people and last year accrued

$16.3 billion in revenue. “Employees work

hard, but they also know how to enjoy

themselves,” according to the company.

Mishev, who lives with her husband

and two children in San

Francisco, concurs. Genen-

tech promotes a work-life

balance that allows her to be

home for dinner and go

camping on the weekends.

In her current position,

Mishev is responsible for

Actemra, the f rst interleu-

kin-6 (IL-6) receptor-inhib-

iting monoclonal antibody

approved to treat rheuma-

toid arthritis. The company launched

Actemra in 2010 into what has become an

increasingly crowded disease space cur-

rently populated with 11 other approved

therapies, each having their value for

patients.

“Actemra is also indicated for pediatric

juvenile idiopathic arthritis and systemic

juvenile idiopathic arthritis,” says Mishev,

who has the lead strategy role for the brand

as well as sitting on its global marketing

team as a voting member.

“We all have a different thing that

brings us to work every day,” reflects

Mishev. “One of the things that I really

enjoy about this type of work is solving

problems. It gives me a sense of accom-

plishment.”

Mishev manages a small brand team,

which, she says, requires listening, adapt-

ing to change, and providing what the cus-

tomer needs. “Genentech takes the extra

step to consider what the patient really

needs,” she says. “At Genentech, when you

onboard to a brand, the very f rst thing

that’s addressed is the patient’s experience

with that disease state, and the patient’s

experience taking the medicine, which is

invaluable for remembering what it is that

you came to work to do that day.”

— Marylyn Donahue

The Puzzle MasterGaby Mishev, Associate Director of Marketing, Genentech


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As a physician treating patients in

Romania, Liviu Niculescu often

thought of the big picture issues with con-

voluted healthcare systems. During one

stint on a urological surgery team,

Niculescu remembers thinking to himself,

how do we know what’s really best for a

patient? Would avoiding an invasive pro-

cedure ultimately be more benef cial? And

of course, who’s paying?

These questions led the now vice pres-

ident of global and US medical affairs for

Takeda Oncology (formerly Millennium

Pharmaceuticals) to travel to Boston for

an additional degree in public health at

Harvard. Niculescu considers the move to

be one of many risky strides he’s taken in

his career, and his willingness to tread into

unfamiliar waters, a key attitude he tries

to impart on his mentees.

Niculescu has transitioned numerous

times from his clinical career to outcomes

research and to medical affairs. He stepped

into a director position with a foot in Latin

America-based clinical trials, followed by

a US position and, subsequently, a global

role. His willingness to bounce from post

to post has been equaled by his aptitude

to toggle between therapeutic areas spend-

ing his earlier years in pain and inf amma-

tion and making the move to oncology in

2008.

It’s been an indirect but purposeful

career path, far from anything that was

planned or preordained, he laughs. Each

leap could be characterized by serendipity

and curiosity. One’s ability to learn rapidly

and function in a new environment is key.

“I’ve found at each step that the ability to

learn quickly is more important than hav-

ing the specif c necessary knowledge com-

ing into a role.

“I try to remember this as a leader for

my team as we prepare for the f rst global

launch of an oral therapeutic to treat mul-

tiple myeloma,” adding that he often, quite

strongly, encourages his team members to

consider taking bold steps of their own

into roles for which they may not consider

themselves ready. “Don’t underestimate

the role that luck plays in our careers. If

an opportunity with more exposure comes

your way, even if it doesn’t seem to be the

right time, jump on it! It’s hard to control

when and how opportunities come, but

you can control your training and skills,”

he explains.

“During several transitions in my

career, I had mentors or colleagues that

really believed in me—sometimes more

than I believed in myself.” Former boss,

Simon Lowry, who’s now at Novartis, saw

Niculescu through several stages at Pf zer.

And Gail Cawkwell, now with Purdue

Pharma, was vital, “a tremendous inspira-

tion showing me what it means to be med-

ical director: how to put patients f rst, the

signif cant impact this has on business, the

value of long-term thinking, and f nally,

how to bring this mindset to day-to-day

business activities,” says Niculescu.

It’s been vital to maintain relationships

with mentors along the way, he says. While

at Harvard, Niculescu was heavily inf u-

enced by Peter Neumann, now director of

the Center for the Evaluation of Value and

Risk in Health at Tufts Medical Center.

The two have maintained a collaborative

relationship since. Mentors have become

colleagues who inform Niculescu’s every-

day work and also impact his current role

as mentor and team leader.

“As a leader, my role is to build mem-

bership within teams and to def ne clear

objectives,” Niculescu notes. “I spend a lot

of time f nding people and seeing how they

work together. It’s vitally important to

build leadership within each team. I spend

lots of time getting feedback on myself and

the team. There’s a strong effort to listen

more than talk.”

For example, Niculescu explains, “I

know that if the team is having lunch, and

they eat faster than me, I was talking more

and listening less.”

Before the move to Takeda Oncology,

eight years at Pf zer gave Niculescu the

chance to learn the global business of

healthcare and pharma, bringing him

exposure to the realities of the industry in

different countries and regions. Takeda

Oncology has been building a global

entity, so the experience in different envi-

ronments at Pf zer prepared Niculescu to

work with people in all different cultures.

Healthcare around the world is becom-

ing increasingly complex—the pace of

change is accelerating. And with medical

advances, expectations for pharma’s

potential around the world are increasing.

“The aspirations are sky high, but we

can’t shy away from questions, even if

we’re establishing a high bar,” Niculescu

says. “Can we cure cancer? And if we can,

how can we provide access to these treat-

ments?” Niculescu believes that profes-

sionals in medical affairs will be key for

developing these treatments, largely

through collaborations with other compa-

nies as well as academic researchers,

groups that have innovative thinking in

their blood. “I think, as an industry, we’ll

be up to the task”

— Casey McDonald

The Frontier Function liviu Niculescu, vice President of Global and uS medical affairs, takeda Oncology


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For Jim Robinson, the past is an ever-

present reminder of how important

earned reputation is to the business of phar-

maceuticals. As president of Astellas

Pharma US, Robinson, a youthful 45, rep-

resents a global Japanese-based company

with two centuries of uninterrupted history

behind it. “There is a deep well of integrity

and trust that comes with success in serving

multiple generations of patients. The Astel-

las culture is founded on a commitment

each of us makes to maintain that trust,

with patients, every single day.”

Honoring this cultural heritage is a par-

ticular challenge for Robinson. Not only is

the US the second largest market for Astel-

las after Japan, with more than $2.95 bil-

lion in sales last year, it presents manage-

ment with a disruptive dynamic marked by

transformations in the customer and payer

base. “The bar has been set higher for the

industry in meeting the expectations of key

stakeholders. Health reform is forcing insti-

tutional changes in the way care is f nanced

and delivered; payers are demanding more

evidence to differentiate medicines on the

basis of real-world value and impact on

overall health outcomes; and regulators

want better assurances of safety and eff -

cacy, which places more pressure on inno-

vative companies like Astellas to develop

the data that satisf es this standard, pre- and

post-marketing. All of this is coming

together simultaneously, presenting both

challenges and opportunities for Astellas.”

Robinson’s background makes him

well-suited to the task of adapting US phar-

ma’s traditional, physician-focused business

model to today’s competitive realities. As

the middle of f ve children in an Irish immi-

grant family from Skokie, Illinois, Robin-

son grew up knowing that competition was

a given—and that opportunity had to be

grasped quickly. It was his family’s next

door neighbor, a sales rep for Syntex, who

f rst sparked his interest in the pharmaceu-

ticals trade. “I had some interesting conver-

sations with him about patients and the

physicians who cared for them. The strong

human element in this business appealed to

me, so when I f nished college at DePaul

University and the wife of our rugby coach

told me of a position as junior sales rep for

Schering-Plough, I dropped plans for law

school and took the job.”

Robinson spent the next 13 years at

Schering-Plough, a pioneer in introducing

novel marketing and sales tools like DTC,

whose innovations spawned a new genera-

tion of topflight marketers—many of

whom, like Robinson, now hold key posts

elsewhere in the industry. “Right after I

started, in 1992, I found myself involved in

the launch of Claritin, which proved to be

an iconic, unprecedented success. The job

allowed me to build a strong

selling proposition for Clari-

tin based on the rigorous sci-

ence and clinical value

behind the product. Overall,

I liked pharmaceutical sales,

as it provided the opportu-

nity to form close relation-

ships with physicians, and to

see my territory grow based

on my own individual

effort.”

Today, those days are largely over. Rob-

inson is working with a map that is far more

abstract. “Individual contacts with clini-

cians are now only part of the equation.

Decisions on prescribing are made by com-

mittees through formularies that can reduce

clinical discretion, focusing not on the indi-

vidual but the entire population being

treated. Unfortunately, the human element

in the work of detailing a medicine has

diminished.”

Robinson was recruited by Astellas in

2005 in a new post, vice president for health

systems, which was charged with making

sense of the shifting alignments in health-

care and to help the Japanese company nav-

igate the changes. Robinson coined a new

mantra for the commercial teams, which

he calls “the customer touch.” “It was

founded on the simple premise that if you

ask customers what they want, they will tell

you. I insisted that everyone who worked

with me had to start each day with a com-

mitment to learn something new from a

customer. As a manager, it was the only sure

f re way I could ensure our business plans

would never stray from the fundamentals.”

A new look was also needed to help coor-

dinate the logistical challenges posed by

Astellas’s expanding pipeline, which has

spawned the launch of seven new prod-

ucts—including Astellas’ f rst entries in the

hotly contested cancer space—since Rob-

inson joined the company.

In 2011, Robinson was chosen to lead

Astellas’ entire sales and marketing organi-

zation, where he introduced a top-to-bot-

tom restructuring plan to accommodate

those larger trends in the business environ-

ment, from consolidation in the private

payer, provider and insur-

ance segments, to phase-in

of new healthcare delivery

mechanisms under the

Affordable Care Act (ACA).

Examples include account-

able care organizations

(ACOs), where drugs must

compete with other products

and services for a share of a

f nite pool of funding. “We

decided to direct our com-

mercial efforts in a more integrated struc-

ture, the Strategic Account Business Unit

(SABU). Each SABU is empowered to iden-

tify and understand what the customer is

really focused on, translate this knowledge

into a seamless cross-functional strategy,

and f nally to determine the right mix of

resources Astellas needs to develop and

implement what the customer wants and,

ultimately, benef t patients.”

In his current post as president, Robin-

son continues to be involved in business

model innovation. He relates that the SABU

structure has been pilot-tested in f ve differ-

ent US markets, with the direct involvement

of key customers. “This has led to some

signif cant f ne tuning, particularly because

of the sheer diversity of demographics and

The Customer

Touch James Robinson, President,

Astellas Pharma US

See Robinson, page 35


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Sandra Sanchez is a pioneering female

innovator in a country where healthcare

is mostly the provenance of men—and old

habits. More than any man, the youthful

Sanchez is rec-

ognized in her

native Mexico

as the face of the

country’s f edg-

ling biotech

industry. Not

only did she

oversee launch

of Amgen’s bio-

tech business in Mexico, taking it from

start-up to national sales leader in complex

biologic drugs, Sanchez is now plotting the

transformation of Probiomed, an estab-

lished local producer of APIs, into a global

export powerhouse focused on next-gener-

ation biosimilar drugs.

Her success is more than personal. San-

chez sees Probiomed as the vanguard of a

new life sciences growth model centered on

the unmet health needs of emerging coun-

try markets, one built on low-cost, high-

quality “frugal” innovation. “Probiomed

is unique in Mexico for our strategy that

begins with knowledge of the gene, devel-

oping cell lines, and progressing to an end-

product based on the underlying biology

of a specif c condition,” says Sanchez. “In

Mexico we can do that eff ciently because

we are vertically integrated, and for less

than what it would cost in the US or

Europe, thus making life-saving medicines

available to vulnerable populations.”

She takes special pride in serving as a

Board member for the global NGO, Save

the Children. “When your business has an

impact on patient lives, especially children,

you move the needle on many fronts.

Healthy behaviors must start at the begin-

ning of life if we are to tackle the many

diseases that continue to kill millions

worldwide but are entirely preventable.

Obesity here in Mexico is a good example.

We have the highest rate for children of any

country.”

Sanchez believes that, in pharmaceuti-

cals, doing well f nancially confers a respon-

sibility to do good for people. While she

never planned her entry into the pharma-

ceuticals business, the connection to health-

care came naturally. “My father was a well-

known psychiatrist here in Mexico.

Through him, I was able to see the world of

pharmaceuticals not as a trivial pursuit but

one with a positive impact on people’s lives.

At university, I developed a strong interest

in business as a way to get things done. That

drew me toward a career where I could mix

the practical aspects of commerce with the

larger societal welfare context you get from

work that raises the standard of health.”

After a brief initial stint as an assistant

brand manager in Mexico, Sanchez moved

to positions of increasing responsibility at

Pf zer, Merck & Co., G.D. Searle, Pharma-

cia, and Amgen. Deliberately, Sanchez

opted for assignments that exposed her to

all aspects of the biopharma business, from

strategic planning to operations. A good

part of her career has also been spent in the

US, where she is a dual national due to hav-

ing an American mother, a native—and

very assertive—New Yorker.

Sanchez attributes three personal char-

acteristics to the inf uence of her mother:

a tendency to speak directly, without arti-

f ce; a disdain for gender stereotypes; and

a high energy quotient. “She was different

in possessing a singular sense of self and

the conf dence to set her own terms in life

rather than be def ned by the circumstances

she was given. Historically, these are not

characteristics you generally find in a

Latina,” Sanchez conf ded. “I learned the

hard way that the culture in Mexican busi-

ness discourages straight talk, particularly

from women. Recognizing those nuances

in conversations and opting to empathize

rather than confront helped me reverse

some early career setbacks, when I was run-

ning blind as to the impact I had on the

sensitivities of others on my teams. At the

same time, I inherited my mother’s love for

exercise that years later still give me the

physical and mental stamina to match the

output of any male colleague.”

Sanchez cites Amgen as the point where

her years of experience and high-octane

personality all came together to remarkable

effect. In addition to getting the governance

right—prior to registering as a local busi-

ness, Amgen was virtually unknown in

Mexico—Sanchez had to overcome numer-

ous obstacles, including an essential

requirement for commercial manufactur-

ing that could only be resolved with

changes in the law, which Amgen suc-

ceeded in doing despite being a newcomer

to Mexico’s patronage-laden politics. More

important, Sanchez quickly obtained a

local license to operate that normally took

foreign multinationals years to achieve,

securing national formulary status for 85%

of Amgen’s product portfolio. Sanchez also

takes pride in Amgen’s recognition, just

two years after opening for business, as one

of the best places to work in Mexico.

The winning streak has continued at

Probiomed, where Sanchez is committed

to securing three goals: (1) improving cor-

porate governance, above and beyond the

standard required for a family-owned busi-

ness; (2) globalizing company operations

to leverage opportunities beyond the Mex-

ican market; and (3) seeding organic

growth through new products and devel-

opment of biosimilar drugs. “Probiomed’s

business model is consistent with a key pub-

lic health objective for all countries, rich or

poor—to f nd savings from the substitution

of off-patent innovator biotech products

for safe, high quality, low-cost biosimilars.

These savings can then be applied to invest-

ment in the next generation of innovative

biologic therapies,” Sanchez says.

After slightly more than a year as Dep-

uty CEO, Sanchez tells Pharm Exec that

Probiomed is exporting products, manu-

factured in four state-of-the-art facilities in

Mexico, to 14 countries on four continents.

Local employment has risen to more than

Biotech Builder Sandra Sanchez y Oldenhage, Deputy CEO, Probiomed Mexico

See Sanchez, page 35


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W hat’s the formula for building a

West Coast biotech? Changing

out break room bowls of candy for

fruits and nuts and promoting employee

f tness seem like no brainers. A distance

runner, CrossFit enthusiast CEO might

may be a bit of a cliché. Her ever-orbit-

ing Miniature Pinscher, Ninja, for the

Northern California dog-friendly off ce

should round out the image.

“The dogs are an important part of the

culture here,” explains Julie Smith, recently

appointed CEO of Raptor Pharmaceuti-

cals. “Everybody has to be ready to deal

with the fun and chaos (and mishaps) they

bring. It’s a wonderful way to bring down

stress in an off ce with people not having

to worry about rushing home to take out

their pets.”

Smith, an East Coast native who is now

“happily and hopefully, permanently relo-

cated to the West Coast,” is building more

than a culture. She’s conf dent that Raptor

Pharmaceuticals is f t to become a rare dis-

ease leader.

“We have every opportunity for growth

in the rare disease space,” she says, “We

are very conf dent that we’re going to be a

story of which people will want to hear

more.” Becoming a leading rare disease

company is at the heart of Raptor’s mis-

sion, and with the alignment of patient cen-

tricity and scientif c integrity, Smith hopes

to steer the f rm to the front.

Smith sees her role as chief growth off -

cer of the public biotech, which has one

commercial product and several Phase II

trials underway in new indications.

The launch of Procysbi (cysteamine

bitartrate) delayed-release capsules in an

orphan indication has been a successful one

so far, she says. The drug gained FDA

approval in April 2013, followed by Euro-

pean approval in September.

Commercializing a rare disease product

in the US and Europe entails growing a

complex business. It has meant recasting

the company with a high performance,

more seasoned team, which has been an

exciting experience, Smith notes.

“I’ve based most of my career moves on

assessments about people. I believe in the

caliber of the Raptor team, the integrity,

and the science. I’ve come to learn that life

is too short to work with anyone that’s not

like that.”

Smith joined Raptor as executive vice

president of strategy and chief operational

off cer in September 2012 and took the

helm as CEO in January of this year.

The appointment followed an extensive

rare disease upbringing. Smith cut her teeth

at Bristol-Myers Squibb, then in 2000, she

took a position as the second business per-

son hired at Novazyme, a start-up eyeing

Pompe disease. Genzyme acquired the

company, and Smith had the opportunity

to see its product all the way to the market,

a fulf lling experience, she notes.

Smith stayed on at Genzyme and was

employed as VP, globalmarketing at Gen-

zyme for almost five years until 2006.

While at Genzyme, Smith gained exposure

to the business on the truly global scale, the

complexities of distributing and commer-

cializing products to 88 countries.

After Genzyme, Smith spent two years

at Jazz Pharmaceuticals and then four at

Enobia Pharma, a company targeting

hypophosphatasia, the ultra-rare disease of

bone mineralization. Smith served as chief

commercial off cer of Enobia, which was

considering going public but was pre-

empted from doing so by a substantial bid

from Alexion. Alexion has the Enobia

product, Asfotase Alfa, in front of regula-

tors now, Smith noted proudly. FDA

granted priority review for the treatment

in March.

In her career, Smith has observed indus-

try changes that she is bringing to her

efforts at Raptor. “Where we used to see

huge sales forces, and all the benef ts and

challenges that come along with them,

we’re now seeing a much more targeted,

more scientif c, and more sophisticated

exchange of information,” she says. “It’s

no longer a volumes game.”

For a company like Raptor in the rare

disease space, but across the industry as

well, the level of science is higher, so the

commercial efforts must follow. “Even if it

were permissible, simply buying a doctor

lunch just wouldn’t be enough—you need

a brilliant f eld force that can master the

science and educate effectively on the

approved label,” Smith says.

Rare disease treatments, with their sub-

stantial price tags, clearly have been at the

forefront of the value proposition conversa-

tion for some time now. Smith sees the mis-

sion at Raptor as providing value on a dif-

ferentiated basis.

With the team for growth in place, Rap-

tor may look to grow opportunistically via

business development. “We are somewhat

agnostic to specif c areas of growth, but

confident in our ability to add value,”

Smith says. “We’re not going after the sex-

iest newest highest risk areas like gene ther-

apy. We know how to develop therapies,

get them to patients, and commercialize for

rare disease patient populations. So we can

continue to grow with core capabilities in

rare diseases.”

— Casey McDonald

Chief Growth Off cer Julie Smith, ceO, raptor Pharmaceuticals


32

WWW.PHARMEXEC.COM


For Menassie Taddese, soccer proved the

pivot point for an essential life lesson.

Arriving in the US in 1982 as an 11-year-

old immigrant from Ethiopia, Taddese had

one skill that he could use to make friends:

an aff nity for what he and other foreigners

called football, the sporting world’s sim-

plest game. “I established my American

identity in an Alexandria, VA, youth soccer

league, where a strange sounding name of

double consonants proved less important

than me helping the team move ball to goal.

But suddenly our coach

died, and l had to confront

a break in the connections

that had given me such con-

fidence in a new country.

With no replacement in

sight, I went to my father

and told him, as a 13-year-

old, that I intended to take

on the grunt work of coach-

ing if he would serve as the

necessary adult, presiding

over our Sunday games and

signing the paper work

required to legitimize the fun we kids were

having in beating all those uptown rivals.”

His father agreed—reluctantly—and

the ruse worked. “I became the team’s chief

motivator and disciplinarian. I took on the

risk of making decisions for the group. I

mustered the courage to force teammates

two or three years older than me to do laps

because they jeopardized our wins by fail-

ing to listen. And I came to trust my

instincts, a trait I still summon every day

at Pf zer to counter the tendency of bright

people to over-think a necessary decision—

that ‘paralysis by analysis’ mindset.”

When asked why he took on this assign-

ment, Taddese alludes to something fun-

damental about the nature of leadership.

“I did it because of the personal fulf llment

I got from loving the game and my team-

mates. I learned who I was. At 13, I became

self-aware. Some people never experience

that in a lifetime.”

Another youthful driver was the exam-

ple of his parents, who, despite having no

formal education beyond high school,

pushed Menassie and his siblings to become

the f rst in their extended family to obtain

advanced degrees. “I was always good at

numbers and I inherited from my parents

an analytical nature, so that led me to con-

centrate in economics and accounting as an

undergraduate at Virginia Tech, which I

then followed up with an

MBA from Penn State.”

His f rst inclination was

to pursue a career in the

technology sector, a path

that appeared set after a job

offer from a tech giant. But

a friend’s recommendation

quickly brought a second

opportunity, from Pfizer,

which prompted Taddese to

compare the two compa-

nies’ business models. “I

knew a lot about tech while

knowing next to nothing about health and

science. I realized quickly that Pf zer faced

a far more complex business challenge

based on the reality that there are so many

intermediaries between the patient and the

company making the medicine. As an ana-

lytical person, I liked that, with so many

interested stakeholders, you have to connect

the dots and think things through—in

healthcare, it’s harder to manage for a

100% outcome.”

In his ensuing 18 years with Pf zer, Tad-

dese has had ample opportunity to test that

premise, with diverse assignments covering

most line and corporate functions at HQ

and internationally. After a series of rota-

tional assignments in corporate, his f rst

major postings were in Treasury followed

by a role in South Africa as f nance director

(CFO) and then country manager. In 2011,

he became vice president for f nance in the

US primary care division, Pf zer’s largest

single business segment, where he super-

vised the f nancials side of a $13 billion

annual revenue stream. Currently, his

expertise is leveraged to promote eff ciencies

in high-growth opportunities for innovative

patented products.

Taddese views himself as a facilitator,

working to speed decisions and direct

resources to achieve the best outcomes for

the business. “The analytical piece is my

foundation,” he says. “Many times, I am

the one person in a room of specialists with

the capacity to drill down and ‘pressure test’

different ideas. I ask the pertinent ques-

tions—what, why, where, how, and when—

so that all perspectives are aired and con-

sidered. Then I help the team progress to a

decision and make certain we have the

resources necessary to execute.”

“Ability to take a macro view is critical,”

Taddese says. In that sense, his work exem-

plif es the industry trend toward a transfor-

mation of the CFO role, from in-house

numbers cruncher to integrator and strate-

gist for the entire business. One corrective

that Taddese applies in evaluating his own

leadership at Pf zer is being able to innovate

at a pace that exceeds the rest of the market.

“The future of our GIP portfolio depends

on this. It’s about removing obstacles that

slow decisions unnecessarily. For example,

in an organization as large as Pf zer, scien-

tif c validation of assumptions has to be

coupled with good instincts and an appro-

priate tolerance for risk.”

Looking forward, Taddese is frank

about the hurdles facing the industry from

a demographic transition in the patient base

combined with the growing market power

of payers. “Before 2050, communities of

color will be the majority of the US popula-

tion,” he says. “Given the long lead times

in drug development, this means the indus-

try needs to promote more diversity in clin-

ical trial populations while investing heav-

ily in evidence-based tools that demonstrate

how our products improve health out-

comes. There are many opportunities for

companies who get this right.”

Lessons from a Sporting LifeMenassie Taddese, Vice President, Finance, Global Innovative

Pharmaceuticals, North America, Pf zer Inc.

See Taddese, page 35


33

WWW.PHARMEXEC.COM


Not often will you f nd someone who

has worked as a tour manager for

a record label or a third-party Apple

vendor on this list. But Timothy White,

senior director and head of global cus-

tomer interaction management at Lun-

dbeck, has done just that. Growing up

in Pennsylvania, White was surrounded

by the pharmaceutical industry, but

before he took his f rst position in the

industry at Merck & Co., he was heav-

ily invested in PM Records.

This correlated to his Bachelor of

Arts from Lehigh University, majoring

in History and minoring in Music Busi-

ness Administration. This path seemed

unlikely for someone working in the

pharma industry, but after taking an

entry level web-development position at

Merck, this would soon change. White

noted that his mentors and the leader-

ship he worked under would go on to

mold his role as a leader later in his pro-

fessional career. At Merck, his manager

taught him a lot of the business basics,

but more importantly how to effectively

manage a creative team and not micro-

manage, a quality that suits him in his

position at Lundbeck. Soon after his

time as the head of eMedia at Merck,

White moved on to Novartis in Spain,

furthering his exposure to the pharma

industry. As head of eMarketing, White

developed the strategy for all digital and

multichannel marketing efforts, drove

innovation in new channels, and did it

with a team of seven employees.

“Working under my mentor at

Novartis was where I really learned how

to inspire a wider organization around

transformation, something I use almost

every day,” White says. After multiple

successful years within Novartis, with

responsibilities growing to support

greater Europe, White was recruited

into his current position at Lundbeck.

Lundbeck is a mult inat ional

research-based pharma company that is

focused on improving the lives of indi-

viduals living with brain diseases. Cur-

rently, the company is undergoing a

strategic transformation from having a

limited product portfolio with a strong

focus on the European market, to hav-

ing a more broad CNS portfolio with a

true global footprint. To help achieve

this, White’s role is tasked with trans-

forming Lundbeck’s overall customer

experience to meet its diverse stakehold-

ers’ needs through multiple channels of

communication.

“We want to maintain a center of

excellence that supported all of the var-

ious ways in which we communicate

with our various stakeholders,” White

says. “What we communicate is cer-

tainly the most important thing, but

with the growth of digital and social

media, and our customers changing

preferences to obtaining information,

‘how’ we communicate is becoming cru-

cial as well.”

White and his team have developed

and managed Lundbeck’s corporate

social media strategy, created and exe-

cuted integrated digital strategies for all

brands, changed the approach to how

Lundbeck interacts with various cus-

tomers through key scientif c and pro-

motional events, and implemented a

new holistic approach to customer rela-

tionship management (CRM) and mul-

tichannel communication.

The key to his success is a diverse

team and a willingness to empower his

staff of 12 professionals from a mix of

countries. White explained how build-

ing a diverse team ended up paying div-

idends by providing critical thinking

required to address alignment issues

and sensitive discussions around tech-

nology. White also put a few younger

people in key slots and empowered them

to act on behalf of the group, just like

his mentors put faith in him early on in

his career.

When asked what drives the com-

munication changes in the pharma

industry, White calmly responds: “The

consumer world has driven a big change

in pharma, particularly how we interact

with our customers.” White noted cer-

tain issues he feels are impacting the

industry and Lundbeck. One is the dis-

ruptive impact of new technology,

which is affecting all industries at the

moment; it has the potential to disrupt

the life sciences signif cantly more than

the others.

Overall, White’s message is a com-

pelling one and his role is signif cant for

our youngest EPL, at an early stage of

his career. These are the type of people

that will champion change within the

pharma industry and continue to rise

through the ranks. White is especially

focused on doing the right thing; he did

not interview to be PR-friendly, but to

really shed some light on how younger

people need to be heading into this

industry if they really want to direct the

change they want to see within the

industry.

— Miraj Barodia

Hip to the Customer Experience Timothy White, Senior Director & Head of Global Customer Interaction Management, Lundbeck


Congratulations, Dr. Liviu Niculescu, on your recognition as a Pharmaceutical Executive

Emerging Biopharm Leader!

We would like to congratulate Liviu Niculescu on his recognition as one of Pharmaceutical Executive’s “2015 Emerging Biopharm

Leaders.” Liviu is a well-respected and dynamic leader whose charismatic personality and innate and thoughtful patient-centric

approach position him as a vanguard of our Global Medical Affairs team and within our company. With astute professionalism,

he acts with intention, as a leader, a mentor, and a colleague, personifying the very core of Takeda’s values: integrity, fairness,

honesty and perseverance. Liviu is an integral part of achieving our aspiration and of the success of Takeda Oncology.

At Takeda Oncology, a singular focus drives our aspirations to discover, develop and deliver breakthrough oncology therapies.

%\�FRQFHQWUDWLQJ�WKH�SRZHU�RI�OHDGLQJ�VFLHQWLƂF�PLQGV�DQG�WKH�YDVW�UHVRXUFHV�RI�D�JOREDO�SKDUPDFHXWLFDO�FRPSDQ\��ZH�DUH�

ƂQGLQJ�LQQRYDWLYH�ZD\V�WR�LPSURYH�WKH�WUHDWPHQW�RI�FDQFHU��

We’ve built a portfolio of paradigm-changing therapies and a leading oncology pipeline. Though we’ve made great strides in our

ƂJKW�DJDLQVW�FDQFHU��ZH�DUH�GHWHUPLQHG�WR�GR�PRUH�t�WR�ZRUN�KDUGHU�DQG�WR�UHDFK�KLJKHU��:H�FRQWLQXH�WR�VHHN�RXU�DVSLUDWLRQV�

with the same passion, agility and entrepreneurial spirit that has sustained our patient-centric culture and has made us the

leaders in oncology that we are today.

We know that our mission is not a quick or simple one, but we are up for the task: we aspire to cure cancer.

©2015 Millennium Pharmaceuticals, Inc. All rights reserved.

Visit us online at takedaoncology.com


35

www.PharmExEc.com


Novartis within the general medicines area.

His organization provides support to the

teams responsible for executing clinical tri-

als, from startup to database lock, from

executing the protocol to identifying which

sites to use, to ensuring sites understand

the protocol and attract the right patients.

Dietrich oversees seven teams encom-

passing 130 employees in the US, Switzer-

land, and India. The teams provide services

in central analytics; vendor management;

IT systems; quality control for data tools

such as the trial master fle (TMF) and the

clinical trial management system (CTMS);

study budget management; and clin-ops

process improvement. The creator and sys-

tem owner of TAPAS (Trend and Pattern

Alert System), Novartis’s home-grown clin-

ical data mining system, is part of Dietrich’s

leadership team. The tool, he says, has

transformed how the company conducts

its risk-based and adaptive monitoring by

providing algorithm and threshold-based

scores of key risk factors for all current

Novartis trials. The operationalization of

this tool and process globally is one of Diet-

rich’s greatest professional successes.

“That’s a big feld I’ve seen within just

the last couple years of how can we man-

age big data, whether it’s coming externally

or from our own internal systems,” says

Dietrich. “How can we translate all that

great data into knowledge to help us predict

risk and take action and mitigate early?”

— Michael Christel

1,300 people. In terms of operational excel-

lence, Probiomed facilities are today rated

the highest in value added per unit of pro-

duction among all manufacturing sectors

in Mexico.

What has Sanchez learned about the art

of leadership? She cites four hard-earned

lessons. First is a clear vision, communi-

cated and shared consistently. “Your role

as leader is to articulate the agenda—to set

aspirations, develop the strategy but NOT

to seek to execute against plan yourself.

Help your team fgure that out; make it

clear you are there to add value.” Second,

leadership is always about people. “It’s

never about you—what matters is how well

you as leader connects with the team. Del-

egate tasks, but don’t delegate relationships.

And give power away—yes, hold the fag

but let others on the team move it forward.”

Sanchez also believes in what she refers

to as “hard empathy: Be tough-minded on

standards of performance, without being

blind to the impact you have on others.”

Third, a leader must hold values that are

authentic, because these values underpin

everything a manager does. The fourth les-

son is about perspective. “I treat ‘work-life

balance’ as an active verb, one that will

change many times over the course of a

career.”

The next step for Sanchez is making Pro-

biomed a global player in biotech. This

means approaching business as a commu-

nity-building effort. “We have to do a better

job at the politics of working with all stake-

holders to secure that ‘win-win’ outcome.”

— William Looney

Continuous market churn also requires

a new set of qualifying criteria for the next

generation of pharma leaders. Taddese cites

three character traits as key.

The frst is courage and tenacity. “Lead-

ers will have to make tough decisions that

divest the status quo. There will be frequent

setbacks; the capacity to persevere and to

learn from mistakes will be a distinguishing,

stand-out factor in superior management.”

Taddese, himself, had to cope with a profes-

sional low point during his time as South

Africa country manager. “I aimed high and

made decisions I thought were appropriate

for the local market, but weren’t fully aligned

with regional or global interests.” The lesson

Taddese draws from the experience is to

move on and communicate the positive—

one where a setback can become a reverse

“best practice,” preventing the same out-

come from being repeated elsewhere.

The second character trait is cultivating

a strong network of support. “Allies are not

won by accumulating business cards but by

advocating on behalf of others.”

The third trait is cultivating the art of

listening. “The higher up the ladder you go,

the more important it is to hear more—and

to speak less. And leveraging social media

as a business tool puts a premium on inter-

pretation. That is hard to do if you aren’t

an active listener.”

What’s next for Taddese? The job

description is secondary; what’s essential is

cultivating that fertile mix of people and

personalities that helped spur his childhood

success on the soccer feld.

— William Looney

customer preferences that exist in a country

as big as the US. But the critical metric

around the SABU has not changed: to refo-

cus our marketing and sales skills to address

the evolving needs of customers and to cus-

tomize each relationship in a way that keeps

us fexible and nimble.”

Looking at the larger concept of active

leadership, Robinson says the key task of a

big Pharma leader today is to “unstick” sta-

tus quo thinking and move the organization

toward a culture that can adapt to change.

“Being a change agent requires frst remov-

ing internal barriers among functions so

that colleagues who do want to do things

differently are allowed to collaborate,”

Robinson says.

A practical expression of this is the

Guiding Coalitions program Robinson

introduced that brings employees with like-

minded interests together from different

parts of the company to solve an organiza-

tional problem or contribute to a social

cause. Three projects have been launched

to date, including one that encourages Cross

Therapeutic Area meetings to exchange

ideas on improving services by the company

to local communities.

Looking forward, Robinson contends

that future leaders will share one character-

istic: relevance. That is achieved, he says,

by staying one step ahead of market trends.

“Sifting out signals from the noise, main-

taining a high level of understanding of the

business you are in—this will not change,

but become even more important as com-

petition emerges from different quarters.”

— William Looney

Dietrich, from page 21

Taddese, from page 32Sanchez, from page 30Robinson, from page 29


36

www.PharmExEc.com

Pharmaceutical executive JULY 2015Executive Roundtable

Getty Images/

In a knowledge industry like biopharma, people are the intangible asset that marks the difference between a status quo or standout performance. Pharm exec recently convened a panel of industry team leaders and HR specialists at St. Joseph’s University Haub School of Business to parse out some useful best practices in three key areas: talent recruitment and retention; skills training; and workforce diversity

LOONEY: The pharmaceutical

industry is a knowledge industry.

Knowledge is a function of

human capital—the cumulative

measure of native intelligence,

learned skills, environmental

awareness, and pooled effort that

lead to improvements in the

human condition. It follows that

attracting a deep, diverse pool of

in-house talent should stand as a

top strategic goal for today’s bio-

pharmaceutical enterprise—but

is it? What is the current “state of

the art” in promoting a produc-

tive, engaged and high-quality

pharma workforce? Are we there

yet, or is this just an aspiration?

LiONEL PhiLLiPs, iNsidE EdGE

CONsuLTiNG: Recruiting, moti-

vating, and retaining a strong

management team is the most crit-

ical function of a leader today. It

should be the f rst thing in mind

when a leader sets objectives for

the business. In pharma, the best

way to build that momentum is by

keeping your eye on the patient

perspective. Conveying the mes-

sage that we exist to make patients

well is a powerful “force multi-

plier,” one that transcends our

own individual agendas. It brings

focus and acts as a moral compass

to drive results.

When hiring people, I pay less

attention to the standard resume

background than I do to intangi-

bles like attitude and perspective.

I’ve offered jobs to people with no

direct exposure to biopharmaceu-

Building Tomorrow’s Biopharma Workforce

FAST FOCUS

» Emphasizing to teams that they exist to make patients well brings focus and establishes a positive connection to the ultimate goal of any business: delivering value to customers.

» Encouraging diversity of thought is just as important as the traditional markers of diversity based on demographic indicators.

» The quality of the relationship between a high-value employee and his/her manager is the most reliable indicator of workplace satisfaction and talent reten-tion—so managers need to double down on the per-formance metric of serving as an effective team leader.

Photo: Jon Dart, St. Joseph’s University


37

www.PharmExEc.com

JULY 2015 Pharmaceutical executive Executive Roundtable

ticals. I know people with impres-

sive credentials in corporate

f nance who were able to transi-

tion to community-based service

organizations dedicated to making

people healthier. The lesson I bring

is that, in this industry, the surest

guide to making the right hire is

whether a candidate really cares

about patients. The patient is fun-

damental to understanding how

our medicines are developed, mar-

keted and used in the real world

clinical setting. Being patient-cen-

tric also avoids the tendency of big

organizations to turn inward, to

be bureaucratic and inflexible.

These are not the characteristics

of an innovative pharmaceutical

company capable of attracting the

next generation of talent.

LOONEY: Companies talk about

connecting to patients, but is

aff nity to the patient really con-

sidered in the recruitment and

talent development practices of

today’s pharma HR function?

PhiLLiPs: It is acknowledged as

a factor. But it needs to be better

prioritized. When discussing

stakeholders, the fallback position

of the “C-suite” is to cite the inter-

ests of the shareholder as para-

mount. I’d phrase it differently:

when patients come f rst, prof ts

tend to follow, which means the

shareholder wins, too. There is

also a strategic shift in customer

attitudes favoring drug marketing

that is less abstract and more

hands on. The primacy of social

media today puts a premium on

authenticity and transparency,

which requires a pharmaceutical

company to build on the human

connections available through the

patient population. This can also

serve as a formidable recruiting

tool. Millennials are not only

active users of social media, they

are now the largest US population

cohort, surpassing the boomer

generation. Surveys show that mil-

lennials rate reputation and social

responsibility very highly among

attributes of a potential employer.

A strong patient focus can be very

useful in attracting the best among

the next generation of industry

leaders.

LOONEY: Embracing the patient

has to be framed in the larger con-

text of embracing diversity. I

don’t def ne this purely in ethnic,

racial, or gender terms but also

in recognizing that drug compa-

nies now must present themselves

as an integral part of healthcare.

I’d like to ask Kay Brady how the

hospital sector is approaching its

own distinctive relationship with

the patient.

kaY BRadY, LaNCasTER GEN-

ERaL hEaLTh: Our mission is to

serve an extensive network of

patients in Lancaster and the sur-

rounding communities of central

Pennsylvania. This community is

highly diverse in almost every

measure. From an organizational

standpoint, we took a f rst step

seven years ago in hiring a vice

president for diversity programs.

Our first initiative was an in-

house training program to foster

cultural competencies among the

work force. Our initial review was

that while this training increased

awareness, we still needed to

understand more about the drivers

that would lead to more inclusive

behaviors. So we refocused on

understanding how a broader per-

spective of inclusion could take us

beyond the traditional def nitions

of diversity.

We conducted an employee

inclusion survey that revealed a

surprising conclusion about our

priorities. Instead of what we

thought would be a preoccupation

with the demographics around

age, gender, race, etc., the survey

identif ed the biggest problem as

a disconnect between what a col-

league felt he or she was contribut-

ing and its impact on the larger

group. In particular, ideas and

proposals perceived to be innova-

tive or different did not always

gain traction. Yes, our challenge

turned out to be a lack of diversity

of thought.

Bridging this gap has subse-

quently become a key element of

Lancaster’s HR strategy. We

developed HR training to help

colleagues understand how per-

sonal styles at work differ and to

navigate effectively in a world

where change is a constant. More

important, we added annual met-

rics around retention and talent

development as well as including

adaptability and emotional intel-

ligence in the talent review pro-

cess. I see these learned behavior

changes as critical because hospi-

tals traditionally operate on the

basis of vertical structures that

can reinforce “command and con-

trol” management. There is also

an ingrained analytical mindset

in the healthcare business. Being

able to look beyond that and

Roundtable Participantskay Brady, Vice-President,

Human Resources, Lancaster General Health

sheila mathias, Senior Director,

Regulatory Affairs, Braeburn Pharmaceuticals

Robert Oliver, President and Chief Operating Off cer,

Otsuka America Pharmaceuticals

Lionel Phillips, President,

Inside Edge Consulting Group

Lori Thorell, Vice-President,

Strategic Development, Worldwide Clinical Trials

Winselow Tucker, Vice-President,

Global Disease Area Lead, Novartis Oncology

William Looney, Editor-in-Chief,

Pharmaceutical executive


38

www.PharmExEc.com


incorporate more subjective,

qualitative thinking—founded on

self-awareness, listening skills,

and the willingness to acknowl-

edge different perspectives in

group settings—leads, in our

view, to better decisions.

LOONEY: It seems this approach

fts well with the patient interest

as the determinant of organiza-

tion strategy.

BRadY: Our target is indeed

the patient. In contrast to my pre-

vious roles in the pharmaceutical

industry, where the patient has no

direct presence on site, at Lan-

caster Hospital I have eight foors

flled with patients right above my

office. We have adjusted our

recruitment process to identify

specific patient-centric traits in

potential employees, like empathy

and compassion. In fact, all inter-

viewers have a list of patient-cen-

tered competencies that we devel-

oped to help everyone across the

organization identify the right

person and convince them to join

us. And it’s not pure altruism at

work here: reimbursement under

federal programs like Medicare

now depends on our patient satis-

faction scores.

LOONEY: How important are for-

mal recognition and award pro-

grams in recruiting and retaining

talent?

LORi ThORELL, WORLdWidE

CLiNiCaL TRiaLs: It depends.

These can either be wildly success-

ful or a total rout, depending on

how well such events are executed.

Often, peer-to-peer recognition is

more meaningful than a hand

down from executives in the

C-suite. In addition, workers are

skeptical of award programs that

try to include everyone. The rec-

ognition has to be perceived by the

group as carrying value.

Tomorrow’s skills set

LOONEY: Before we can recognize

talent, we must determine what

the industry needs in terms of

professional skills and capabili-

ties. Have these changed in the

last few years? What is the ideal

profle that you look for in flling

the talent pool, particularly as the

more experienced baby boomers

begin retiring?

BOB OLivER, OTsuka PhaR-

maCEuTiCaLs: The industry has

undergone a sea change in the last

decade. Employment has con-

tracted due to the patent cliff,

health reform has transformed

the customer base and raised the

leverage of payers, and, in a

related trend, volume sales are

tilting away from high-reward

innovation—85% of all medi-

cines prescribed here in the US are

now generic. Most important,

there is no obvious, universal

solution to this disruption in the

biopharma business model. This

is why Otsuka’s talent planning is

now focused on fnding people

who can manage through ambi-

guity—that is today’s required

skill. Past performance does not

predict future success.

shEiLa maThias, BRaEBuRN

PhaRmaCEuTiCaLs: My back-

ground is regulatory. I have

worked in large pharmaceutical

organizations, but my current

frm is small—I am one of only 13

employees. What stands out for

me is the capacity to be fexible—

to adapt to circumstances in this

era of so many disruptive innova-

tions in healthcare. In my former

roles, I was more of a regulatory

strategist, focused on the clinical

side. At present, my role requires

exposure to nearly everything,

from labeling, to contract manu-

facturing, to market intelli-

gence—the entire gamut of regu-

latory operations. The conclusion

I draw from my varied experience

is that, regardless of size, bio-

pharma companies overall are on

a downsizing trend. They want

people who can shift bandwidth

and work with others just to get

the work done.

LOONEY: Are the big pharma

players really capable of shifting

cultures to create a more versatile

work force?

maThias: It is certainly harder.

When I interviewed at Braeburn,

the message was “we are recruit-

ing you for regulatory, but you

will not be defned by regulatory.”

This means they are looking for a

skill set that involves a willingness

to take prudent risks, to step out-

side the boundaries of a formal job

description. I also think this fex-

ibility is appealing to people from

larger companies affected by the

competitive restructuring and job

losses. This is expanding the

career possibilities for those will-

ing to handle the uncertainties in

building a start-up company.

BRadY: Lancaster Hospital

has a different work force demo-

graphic than big pharma. Some

70% of our 7,000 employees are

non-exempt, where wages tend to

be lower. Nevertheless, even here

the skills requirements are signif-

cant, especially as we implement

the employee health record (EHR).

Education and training in the use

of this technology has been under-

way for the last four years. At the

start, we were forced to invest

heavily in recruiting a strong IT

staff, along with the incentives

required to retain them. Today, we

are at the point where all our

employees are comfortable with

EHR. We have identifed leader-

ship skills for our in-house clini-

cians as another priority. The phy-

sician spends his days in a world

framed by short, 15-minute inter-



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Breaking through the complexity: improving oncology

treatment and

access in the UK

Event OverviewIn the UK, like on a global level, personalized oncology

healthcare approaches have seen a dramatic increase. This

would suggest a positive development for patients in the

UK, but it also entails some potential huge difficulties for the

NHS. Data suggests that half of biopharma are integrating

personalized medicine into their product development to help

with product differentiation and therefore market access.

Local commissioning groups in the UK have to manage the

budget impact of oncology products, with the advances

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• Uncover best practice approaches to improving

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on making oncology innovation feasible while

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Who should attend

Decision makers in Market Access, Regulatory

Affairs, Real-World / Late Phase research, HEOR,

patient-centric / patient engagement programs, payer

/ provider relations, Brand managers, Marketing

Managers/Directors, Pricing & Reimbursement, Medial

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Assessment, Pharmacovigilance


40www.PharmExEc.com


actions where an assessment is fol-

lowed by a diagnosis, after which

he or she moves on to the next

patient. Business and management

acumen is not taught in medical

schools, which is one reason we

are partnering with St. Joseph’s

Haub Business School on a cus-

tomized MBA curriculum for our

clinicians.

LOONEY: So the skills curve is def-

initely increasing? Can you

describe your metrics of success?

BRadY: Yes. We get 17,000

applications for around 1,500

positions per year. Our basic tool

is a “hire to fit” sysrem that

matches candidates with a set of

essential competencies for each

position. It’s basically a profile

founded on the historical charac-

teristics of people who were suc-

cessful in that position. Twenty

percent of this evaluation covers

emotional intelligence markers like

empathy, compassion, and patient

focus. It demonstrates how serious

we are in creating a mission around

the patient. In addition, 40% of

our openings are flled internally.

To build the ranks, we launched a

high-potentials evaluation track to

groom clinicians for management

and administrative leadership posi-

tions. We can take a nurse and

offer him the opportunity for a slot

in finance, after which he can

move on to IT. The result is an

employee more valuable to us than

limiting him to a nursing role.

In regard to metrics, we initi-

ated a program in August 2014 to

track our hiring decisions to the

90-day and one-year staff turn-

over rate. That’s our basic ROI—

making the right hiring choices

preserves our talent pool and

keeps personnel costs down.

ThORELL: The cost of recruit-

ing a new staff member and then

training the person in functional

skills and adapting to the culture

can only be amortized over time—

a staffer who leaves in six months

or a year is actually a net fnancial

loss to the organization.

LOONEY: Biopharmaceuticals has

traditionally been seen as an

“insider” business. Is the pre-

ferred capability set shifting

toward the external—is familiar-

ity with adjacent sectors like con-

sumer retail now seen as an asset

among potential industry hires?

PhiLLiPs: The imperative today

is to differentiate your products by

offering superior value. You have

to stand out and that in turn

requires the capacity to move

away from old ways of thinking.

Recruiting talent from different

backgrounds adds an element of

internal tension that can result in

a better decision.

ThORELL: Given my back-

ground in clinical research oper-

ations, I have always looked at

pharmaceuticals as a service

industry. When we hire people,

we take technical competence as

a given, or a set of skills that can

be taught or transferred. The real

stand out, intangible factor is cul-

tural ft. Will the candidate aptly

refect the values the company is

seeking to project? Someone

from a different sector back-

ground may actually present

those values better than a veteran

who has been doing the same

thing in pharma for years. I was

at a large CRO for 17 years, but

just recently decided to make a

change, moving to a company

one-tenth its size: my new

employer, Worldwide Clinical

Trials, has 1,400 employees,

while my former employer had

more than 14,000. I ended up

here because I would have more

autonomy and influence in a

highly specialized, fexible orga-

nization. I now tout these values

as my own in representing my

new company with clients.

LOONEY: Other than cultural ft,

what are the critical skills that

you see emerging in clinical trial

operations? I understand there is

a growing need to tease out

underlying trends that may not

always be apparent with a cur-

sory reading of trial data. So how

do you recruit for curiosity?

ThORELL: As the volume and com-

plexity of data expands, require-

ments for positions in clinical trial

research are changing at warp

speed. Disruptive trends like the

adoption of the electronic medical

record as well as the breakdown

of the traditional patient/physician

relationship in favor of informal

health providers like Walgreens or

CVS mean that the model for clin-

ical trial research must change,

too. Technology and big data are

going to raise the ante on human

interpretive skills—the capacity to

make sense of vast, disaggregated

fows of information—and curios-

ity is a flag for that. We need

workers who are fexible to change

along with the opportunities that

technology presents to us. Hence,

when we recruit we look for evi-

dence of thinking that comes “out

of the box.”

Buy in from the top? LOONEY: We’ve identified why

and how pharma must update its

criteria for recruiting and retain-

ing management talent. The key

question is whether this aware-

ness is actually changing the

mindset in the leadership C-suite.

Do they get it or is there a prob-

lem in executing around the poles

of awareness, diversity, and

inclusion?

PhiLLiPs: The CEOs I speak

with through the Get Together


41

www.PharmExEc.com


Group are acutely aware of talent

recruitment issues and the impor-

tance of building a more diverse

and fexible workforce. If there is

a problem, it lies with translating

this support into something

doable on the ground.

BRadY: If this is part of a

CEO’s own agenda, and the

resources are adequate, then the

organization will likely move for-

ward. The big danger is having

good ideas get lost in translation.

There is not always the discipline

to have deeper conversations

around capabilities. You require

this to build a true leadership pro-

gram that focuses on institutional-

izing these capabilities throughout

the organization.

All the talk about fnding and

keeping talent is occurring at a

time when the basic license to

operate for a healthcare supplier

like Lancaster General is under-

going a major transformation.

We face what banking and phar-

maceuticals faced 10 years ago.

The number of healthcare deliv-

ery networks in place fve years

from now will be fewer than

what we have today. Scale is

going to change everything. We

need different capabilities. Our

CEO recognizes that. While

practicing physicians will con-

tinue to dominate our talent base,

the way we train and motivate

them is changing.

Talent networking

LOONEY: What do we mean by

talent retention? Is this a dynamic

process, where we expect that the

supply of talent will ebb and fow

depending on circumstances?

BRadY: Talent retention is not

a mandate to keep everyone. Our

discussion so far indicates a con-

sensus that organizations beneft

where there is a periodic restock-

ing of human capital. There is

healthy turnover and not so

healthy turnover. Like everything

else, strategies around keeping

good people are changing. The

common practice for years was to

identify and differentiate the best

talent and give them exposure to

a variety of challenges, after

which most will opt to stay with

the company. Today, numerous

studies favor a different approach,

based on the premise that the rela-

tionship between a high value

employee and his manager is a

more reliable indicator of whether

someone will stick around or not.

If you don’t get along with your

manager, you aren’t going to stay

with us. Hence, our efforts have

switched to helping to drive that

critical reporting relationship in a

mutually positive direction. We

are training our managers today

in the virtues of being a strong

team leader. It’s about how to

lead, not how to manage. There is

a subtle but important difference.

ThORELL: We need to be cau-

tious about the label “high poten-

tial.” Just because someone is per-

forming at a superior level in their

current position does not guaran-

tee he or she will excel in the next

position. You can be a very pro-

ductive salesperson but overcom-

pensate in managing others who

may not be as good at the art of

selling as you were.

LOONEY: Work in biopharma

today is organized around

teams—the era of the individual

“star” is over. How does HR pro-

mote team-based behaviors?

BRadY: The frst thing we do is

make a conscious effort to help

staff our teams with the best and

most appropriate people. I am reg-

ularly approached by cross-func-

tional team leaders for access to

our talent management system to

match assignments with compe-

tencies. Our list of high potentials

is also made available. The second

item is using MBA programs like

our relationship with St. Joseph’s

to train our people in “soft” man-

agement capabilities like infuenc-

ing, coaching, negotiation work-

shops, and war games. HR also

runs an open enrollment aspiring

leadership program to help col-

leagues determine whether that

track might be for them.

TuCkER: One little noticed

aspect of team effort is the modest

degree of control a leader or a

group has in executing around the

project. Collaboration can lead to

inertia if the responsible contrib-

uting functions and capabilities

are not clearly defned. A matrix

structure overcomes that by chan-

neling resources across the full

organization. You encounter less

uncertainty about what is required

to get the job done, so I think the

matrix is an important element in

empowering a team.

Culture counts

LOONEY: Is there a predominant

culture theme in the biopharma

industry today? Can this culture

be summarized in a single tag

line—participatory, inclusive,

innovative, risk-averse, bureau-

cratic or global?

PhiLLiPs: Culture in the

pharma industry is most often

associated with bureaucracy. It was

always built on the idea that the

industry is unique: there is a right

way to do things in biopharma,

and a wrong way. That’s what the

culture teaches us. The biotechnol-

ogy sector is different, and is prob-

ably doing the best at building a

culture that is not bureaucratic,

since these companies are smaller

and need to stay nimble. They

carry more risk while competing

against the resources of the inte-

grated big pharma giants.


42www.PharmExEc.com


TuCkER: Culture is important

because it provides a rationale for

differentiating the firm in a

crowded marketplace. It’s a

shorthand way of defning how

the company operates in a global

context—and what the values are

that get people of different gender

or race or nationality into the

workplace every day. Let’s not

forget that a strong internal cul-

ture can be a signifcant recruit-

ing tool. The best job candidates

are going to evaluate the com-

pany culture in terms of whether

it is a good fit for them. They

want a culture that will allow

them not to survive, but to thrive.

Talent ROI LOONEY: I’d like to ask Kay Brady

what happens when she presents

her talent development and lead-

ership programs to the C suite for

op plan/budget approvals? Must

you document a specifc ROI?

BRadY: I get the occasional push

back on ROI, but our CEO is the

champion of Lancaster General’s

talent and leadership initiatives. He

has a clear understanding of the

power of our people as a driver of

fnancial and shareholder perfor-

mance. As individual success stories

have proliferated, and as our suc-

cession planning reaches down

through three layers of talent, buy-

in from the top has only increased.

LOONEY: In a broader sense, how

have talent programs adapted to

a shrinking work force in bio-

pharmaceuticals? More than

200,000 high paying jobs in the

US industry have disappeared

since the great recession of 2008-

2009. Have talent programs come

to be perceived as a frill?

BRadY: Several things have

happened. First, the purpose of

any talent retention or develop-

ment program can no longer be

vertical—to push people up the

ladder. Frankly, there are no lon-

ger enough slots to reward talent

with promotions. The focus must

be instead on encouraging people

to consider horizontal moves that

expand their skill set and offer

opportunities to work with col-

leagues from different back-

grounds. The second change is

that no one assumes that high

potentials will stay with us for a

lifetime. We aren’t going to keep

people forever—that’s a given in

today’s shifting workforce.

Finally, work/life balance is

becoming the dominant factor in

keeping employees productive

and happy. Our data shows that

when work and life is not in bal-

ance, people start looking for

options elsewhere.

TuCkER: The shift is really

around defining success as a

goal. Career advancement is no

longer a linear process. Success

cannot be measured through the

title or job description of your

next position. It is all about

incorporating different experi-

ences, moving into new geogra-

phies and finding new skills.

Those skills may—or may not—

lead to a more senior position.

Instead, it’s about the journey.

Both the employer and the

employee must be transparent

about that and to manage expec-

tations. People have to be

encouraged to see that a role as

“executor” is just as vital and

important to the company’s

future as that of the strategist.

Diversity—making it meaningful LOONEY: What about programs

to promote greater diversity in

employment? Is diversity valued

more in large biopharma compa-

nies than in smaller frms?

TuCkER: I have witnessed

firsthand many initiatives to

promote workplace diversity.

We tend to address the issue in

the same way as other strategic

challenges: we identify what

needs to be done, create a plan

and convene a team to execute

around a specifc target. Experi-

ence suggests that is not a sus-

tainable approach. There is too

much attention to achieving a

number. The real driver of

change is how well we relate

diversity programs to the bot-

tom line. Making that connec-

tion between diversity and com-

m e r c i a l r e s u l t s — w i t h

data-based metrics to confrm

it—is the only way to change

behavior. I also believe that

diversity initiatives must be

integrated within a larger pro-

gram geared to building and

retaining talent. Diversity is not

a side bar activity.

Photo: Jon Dart, St. Joseph’s university


43

www.PharmExEc.com


WiLLiam LOONEY

is Pharm exec’s

Editor-in-Chief. He

can be reached at

wlooney@

advanstar.com.

Success factors

LOONEY: Are there any fnal mes-

sages that bear exploring? What

would you say to your CEO on

gaps or issues that require his or

her direct attention and support?

BRadY: There is a tendency in

HR to set multiple goals—trying

to do too much. HR has to be clear

and focused on what it intends to

achieve through the planning

cycle. For Lancaster General, that

is identifying and building the

capabilities of our workforce in a

manner that advances our overall

business strategy. How does what

we do ft with the organization’s

strategy? Be clear and don’t be

hesitant to say “no” when an idea

just doesn’t ft.

TuCkER: That clarity also has

to be ingrained within the per-

formance evaluation process.

PhiLLiPs: Teams will con-

tinue to be central to how the

big biopharma companies make

decisions and execute around

them. Teams are living organ-

isms. One way to perform better

is to make every member of a

team feel that he or she is out-

standing—part of a high-per-

forming group. In addition,

teams need an internal sponsor

or champion, one who can help

run interference when the group

encounters various types of

bureaucratic delays.

maThias: A clear purpose

and specifc deliverables is still

the overriding determinant of a

successful team. But a sponsor is

still important, particularly if

that person has the clout to

ensure the team will not get lost

in the organization chart. It is

especially needed when the team

is seeking to do something that

is innovative or disruptive.

TuCkER: The message that

resonates the most to me is

moving from diversity as an

organization objective to diver-

sity as a business imperative.

Hiring and retaining a work

force around the commitment

to diversity as an end result is

not just an exercise to move up

the rankings in competition

with other company HR depart-

ments. We must show that those

companies who are most diverse

are also companies with a supe-

rior ROI, expressed through

business results that outpace the

competition.

OLivER: There is no shortage

of talent in the biopharma feld.

What will determine commer-

cial success is how well a com-

pany develops that talent. You

have to invest in your people,

not only with the financial

resources and incentives they

need to thrive but in fostering a

cultural attitude around contin-

uous learning. Keeping people

on the cutting edge, exposing

them to new ideas and “stretch”

goals, with an appropriate toler-

ance for failure, is more impor-

tant than in-house skills train-

ing. This latter is the traditional

way, but in a business world that

no longer has any clear bound-

aries between the right and

wrong path, you have to give

allowance to learn in uncom-

mon ways. That can include tap-

ping into best practices in other,

adjacent industries beyond

pharmaceuticals.

G2G: detailing diversityDiversity in the biopharma

workplace is an objective that

cannot be achieved in isolation—

networks need to be established,

not only across functions and

geographies but among companies,

too. Filling that requirement is the

mandate of the Get Together

Group (G2G), a biopharma-based

coalition of more than 150 working

professionals committed to helping

minorities and women maximize

their career potential through

advocacy, training, and raising

awareness. Founded in 2005, and

based in the Philadelphia area, G2G

operates on the basis of a simple

message of personal responsibility

and self-empowerment: “own your

development.”

Lionel Phillips, President of

Inside Edge Consulting, who also

currently serves on the Board

of G2G, emphasizes that the

issues his group addresses are

universal. “Employment in the

biopharmaceutical sector is no

longer a lifetime guarantee, so

everyone in the industry today has

an interest in standing out, to excel.

Our main role is to sponsor meetings

and encounters that allow people

to learn directly from each other.

We have senior executives sharing

that ‘what I wish I had known when

I started’ perspective with the next

generation of potential leaders. It’s a

great format for a two way exchange

on what is useful in keeping pace

with disruptive change—and

profting from it,” Phillips told Pharm

exec. G2G has many top sponsors,

including Pfzer, Bristol-Myers Squibb,

and from the academic side, St.

Joseph’s University Haub School of

Business as well as other institutions

of higher education.

On Saturday, Oct. 3, G2G will

hold a full-day diversity leadership

conference in New Brunswick,

NJ, on the topic “Recognizing

and Developing Your Leadership

Potential.” Top executives from the

pharmaceutical industry will host

the meeting, including a leadership

roundtable and a networking

reception. Plenaries and two

workshops will highlight the future

skills needed to manage changes

in healthcare. For additional

information and registration details,

go to www.gettogethergroup.org.

—William looney


44

www.PharmExEc.com

Pharmaceutical executive JULY 2015Intellectual Property

BrIan W. nolan

is a partner at Mayer

Brown. He can be

reached at bnolan@

mayerbrown.com

Recent activities by invest-

ment frms, in particular

those of Kyle Bass, have

biopharmaceutical com-

panies crying foul and seeking

relief from Congress. The actions

generating angst among industry

insiders are investment frms fling

inter partes review (IPR) petitions

seeking to invalidate drug patents.

For a life sciences company that

falls within an investment frm’s

crosshairs, an IPR has the potential

to wipe out a patent critical to a

drug franchise’s revenue stream.

The America Invents Act (AIA)

of 2011 created new post-grant

review proceedings that allow a

petitioner to ask the United States

Patent & Trademark Office

(USPTO) to reconsider whether it

should have issued a patent. An

IPR allows a petitioner to submit a

petition along with evidence from

experts to explain why earlier

printed publications or patents dis-

close the invention or show that the

claims encompass an obvious

change. The rules governing IPR

proceedings make it an attractive

way to challenge patents. First, any

entity can fle an IPR petition—the

patent owner need not have threat-

ened the fler with infringement.

Second, the USPTO will defne the

claims using a standard that will

likely result in a broader construc-

tion than if a district court heard a

challenge. Finally, the USPTO only

requires a challenger to show by a

preponderance of the evidence

(“more likely than not”) that the

prior art discloses the invention.

This standard is lower than the dis-

trict court standard, which requires

clear and convincing evidence of

invalidity. These rules have moti-

vated many entities to challenge

patents using an IPR.

Under these rules, petitioners

have had success in having the

USPTO cancel at least some claims

in over 75% of the proceedings

that reach fnal decision. Although

the majority of IPR filings deal

with patents in the high-tech indus-

try, several biopharma patents

have confronted IPR petitions.

Generic drug companies seeking to

market copycat products have sub-

mitted many of these petitions. But

investment firms’ uses of IPR

against biopharma patents have

garnered the largest reaction.

The straw that broke the camel’s back?The Coalition for Affordable

Drugs and Hayman Capital Man-

agement, entities related to Kyle

Bass, have fled several of these IPR

proceedings. Kyle Bass asserts that

he fled these challenges to prevent

drug companies from extending

patent protection and associated

higher prices for products based

upon questionable patents. But

altruism may not be the sole reason

for Bass’s flings. It is thought that

the Bass entities have taken short

positions in companies that rely

upon the challenged patents to pro-

tect drug franchises. This invest-

ment strategy may pay dividends if

the challenged patent protects a

drug franchise that generates a

majority of the revenue stream for

a biopharma company. In fact, the

frst such flings by the Bass entities

may have succeeded under this sce-

nario. In February, the Bass entities

fled challenges against two patents

owned by Acorda Therapeutics

covering its Amprya franchise. The

first filing caused about a 10%

drop in stock price, while the sec-

ond caused about a 5% drop.

The Bass entities have not lim-

ited their petitions to Acorda.

They subsequently fled petitions

against patents covering Shire’s

Lialda and Gattex, Jazz Pharma-

ceuticals’ Xyrem, Pharmacyclics’

Imbruvica, Biogen Idec’s Tec-

fdera, Celgene’s Revlimid, Poma-

lyst, and Thalomid, and Horizon

Pharma’s Vimovo. Investors’ reac-

tions to these flings appear mixed.

Some of the challenged compa-

nies’ stocks rose while others fell

around the time of the flings. For

those that closed lower, the drops

were not as pronounced and long-

lasting as those experienced by

Acorda. Thus, those holding short

positions in the challenged com-

panies may have found it diffcult

to proft from the IPR flings.

Biopharma Goes to WashingtonThe filings by investment firms

have caused many in the bio-

pharma industry to seek the assis-

tance of Congress to address what

they perceive as a misuse of the

post-grant proceedings created by

the AIA. Recent testimony by

Hans Sauer of the Biotechnology

Industry Organization (BIO) evi-

dences this view. In March, Sauer

testifed before the Senate Judiciary

Committee about what he

described as “misuse of the patent

system” to support “investment

schemes” by a “hedge fund.”

According to Sauer, biotech com-

Confronting the Post-Grant ThreatChallenges from investment frms to biopharma patents spur the industry to action to protect its drug franchises

Continued on Page 50


SpECIAL SpoNSoREd SECTIoN

Photo Credits: Cameron RochettepHARMABoARdRooM.CoM I JULY 2015 S2

This sponsored supplement was produced by Focus Reports.

Project Director: Cameron Rochette

Project Coordinator: Gabriela Córdova, Alina Cotfasa

Project Publisher: Mariuca Georgescu

To read exclusive interviews,

visit www.pharmaboardroom.com

Since 1995, Peru’s pharma market has grown

f vefold, and today is worth USD 2 billion. During

this period, Peru’s economy has emerged from the

shadows: with an average annual growth rate of f ve

percent during the period, even managing eight percent

during the global f nancial crisis. But how exactly

did the country come to perform so well, especially

considering the economic volatility experienced by

many of its neighbors over the same period? And what

does this mean for the pharma industry?

OUT OF THE SHADOWS

PERU


HEALTHCARE & LIFE SCIENCES REVIEW PERU SpECIAL SpoNSoREd SECTIoN

S3 JULY 2015 I pHARMABoARdRooM.CoM

Aldo Deflippi, executive director of

AmCham Peru, says that since the 1990s

the country has enjoyed a relatively steady

government administration, which has

contributed to not only strong economic

growth but also a much larger middle-

class population. “The stability of Peru’s

fscal accounts, currency and laws for

the last 25 years has created growth,

reduced poverty, increased exports and has

developed the country,” he notes. “These

characteristics are distinctively different

compared to previous decades in Peru that had high infation

and fscal defcit.”

Furthermore, the establishment of over thirty bilateral

investment treaties with nations across the globe has led Peru

to a signifcantly more competitive position worldwide for

investment; between 2002 and 2012, foreign direct investment

(FDI) increased from USD 3 million to USD 12 million.

“The openness of Peru to trade has encouraged the country

to concentrate on those products that are best produced here

and to import products of low cost and high quality,” remarks

Deflippi.

Unmasking the Umbra

Many multinational companies with a long-standing presence

in Peru used to have factories in the country; since the 1990s

all of these companies have closed their facilities as part of a

consolidation process to other larger countries in the region like

Mexico, Brazil or Colombia. Nevertheless, the fvefold growth

of Peru’s market between 1995 and 2010 to a market today

worth USD 2 billion represents a sizeable opportunity for phar-

maceutical companies with a South American presence.

Under the umbrella of a new slogan

“Science: Applied to Life”, 3M is under-

going a major revamping in marketing

policy to change the way the organiza-

tion is perceived worldwide. “Health-

care currently represents 18 percent of

our business, but we need to grow 20

to 25 percent year-on-year, because of

stagnant growth situations in the min-

ing and oil & gas businesses today,”

comments Darío Lareu, general man-

ager of 3M Peru, Ecuador, Bolivia and

Paraguay. “This year, healthcare will

present the biggest opportunity.”

“Within healthcare, we have a mar-

ket access strategy,” explains Christo-

pher Wackett, business unit manager of

3M Peru’s hospital division. “We want

to not only partner with the government

as a service or product provider, but in

many other ways as well. For example,

within our Infection Prevention Divi-

sion (IPD), we have a sterilization business. We are looking to

partner with IPD to centralize all the sterilization needs of the

Ministry of Health, and this is gaining signifcant traction.

That will be an interesting opportunity for us, since 3M has

the gold standard product worldwide for sterilization, which

is a much more cost-effective technology than some other op-

tions in the market today.

“We plan to duplicate the size of the company within fve

years by giving huge importance to the hospital business,” notes

Alejandra Muñoz, healthcare director Andean Region at 3M.

“In order to expand our business we need to widen the cover-

age of our footprint by focusing on the developing regional areas

and not just Lima. We should also change the way we see our-

selves; for example, from being mere strategic partners of hospi-

tals, we should become their suppliers as well,” she concludes.

“By the same token; we should create awareness of the real costs

for treating a patient and developing fresh and current ideas on

health economics, which as a country Peru still needs to learn.”

Applying Science to Health

Darío Lareu, general manager of 3M Peru

Alejandra Muñoz, healthcare director Andean Region, 3M

Aldo Defilippi, executive director, AmCham Peru


SpECIAL SpoNSoREd SECTIoN HEALTHCARE & LIFE SCIENCES REVIEW PERU

pHARMABoARdRooM.CoM I JULY 2015 S4

This growth took a slight nosedive in

2014, when the market experienced a

cleansing of sorts. “Wholesalers and phar-

macy chains found themselves with high

inventories, and they needed to fnd some

logistical effciency in their own distribu-

tion systems,” notes Guillermo Browne,

director general of MSD Peru, which had

to make adjustments as did most research-

based companies in the country. “In 2014

the market decreased around two percent

in volume and six percent in its value in

US dollars. In that kind of environment

I had to make some immediate struc-

tural changes. Last year was ultimately

successful but more because of institu-

tional sales rather than retail.”

“Historically, pharmaceutical com-

panies used to aggressively push mer-

chandising through every channel pos-

sible,” says Boehringer Ingelheim Peru’s

managing director Javier Castro. “Big

chains started to reduce inventories,

resulting in a signifcant decrease in many

companies’ retail sales last year. The country’s commercial dy-

namics have strengthened sales channels to be more effcient,

especially in managing inventory approaches.”

a Free For all

Peru’s constitution does not permit price

control, essentially creating a free market

scenario that poses problems for major

international pharmaceutical companies

that generally offer higher-priced prod-

ucts. “Research-based companies do not

sell to the government on public bids,”

says Augusto Rey de la Cuba, executive

director of Asociación Nacional de Lab-

oratorios Farmacéuticos de Perú (ALA-

FARPE), the association for research-based

pharmaceutical companies operating in the country. “They

only do direct sales because of the price. ALAFARPE’s mem-

ber companies simply cannot compete with local prices or the

prices of Chinese or Indian companies present in Peru. There

is a system in Peru for corporate bids in which the Ministry of

Health, EsSalud, and the national army buy medicines together

annually in an attempt to improve prices.”

Zero Toleranceto Bloodstream Infections

Guillermo Browne,

director general,

MSD Peru

Augusto Rey de la

Cuba, executive

director, ALAFARPE

Javier Castro,

managing director,

Boehringer

Ingelheim Peru


HEALTHCARE & LIFE SCIENCES REVIEW PERU SpECIAL SpoNSoREd SECTIoN

S5 JULY 2015 I pHARMABoARdRooM.CoM

“Free pricing is not the perfect solution in

an unstructured market, and people do not

know what the real price is versus what they

should pay,” adds José Antonio González,

general manager of Roemmers Peru. “I too

would like to have nice prices and a big mar-

ket, but I have a small market.”

Furthermore, many pharmaceuti-

cal companies face complex challenges

when it comes to Peru’s regulatory system.

Until 2009 for example, the legal time

for approving new drugs, including

biologics, was seven days; in 2015 approv-

als can take up to three years. For years,

the system was largely unregulated, but

serious efforts to alleviate this regulatory

conundrum in recent years have been met

with varying degrees of success.

regUlatory revolUtion

“The implementation of Law 29459

(also known as the Law of Pharmaceu-

tical Products, Medical Devices and

Sanitary Products)

in 2009 focused on

transforming an

unregulated mar-

ket into a more se-

cure, quality-based

healthcare model,”

notes Cesar Amaro,

director general of

Dirección General

de Medicamentos,

Insumos y Drogas (DIGEMID), Peru’s

regulatory agency. “This new law focuses

on the regulation of biotechnological and

biosimilar products which represent an

important area for development. This law

also pays attention to the interchange-

ability between brand generics and patent

protected drugs.” As such, the idea was for

this Law to set new standards on approvals

as well as ensuring better quality, effcacy

and safety of health-related products. This

has been particularly important in recent

years as the government has been looking

to purchase biosimilars, which many in

both the private and public sectors will cut

expenditure costs signifcantly.

“Patients look for affordable medicine,

and so does the government,” says

Akhilesh Vijay, general manager of Accord

Healthcare Peru. “But this will not add

long-term value to patient treatment. When

biosimilars are newly registered, we need to

produce safety and

effcacy studies. As

a responsible generic

player Accord carries

all the requisite

studies. The current

scenario demands

DIGEMID to reach

a consensus on fast

tracking registration

of biosimilars on the

availability of such

studies. Bioequivalence studies are not

a requirement in Peru at the moment but

they should be, and Accord can provide

these as well.”

“Our strategy is to establish more

therapeutic segments and grow with

our biosimilar portfolio in this market,”

Vijay mentions. “Biosimilars represent a

signifcant Business in Peruvian institutions.

Only certain companies with sophisticated

technology can offer biosimilars. Adoption

of stricter norms by DIGEMID including

GMP inspections will slowly wash off

inferior products from the market, and

pave way for high end generic products.

Competition will boil down to few players,

and thereby only affordable and quality

products will be made available to the

patient community.”

Can PerU “innovate”?

Oscar Seclen, commercial manager of

Janssen Peru and president of ALAFARPE,

also points out that the development of

new molecules in the country is becoming

more commonplace among pharmaceuti-

cal companies, although there is still much

work to be done. “New laws are instigat-

ing clinical research in our country,” he re-

marks. “Starting from the public domain,

there is a lot of recognition for innovation;

Colaboración.

Eso eslo que nosotrosllamamos unainnovaciónmedica.

En Janssen, buscamos respuestas a algunas de

ůĂƐ�ƉƌĞŐƵŶƚĂƐ�ŵĄƐ�ĚŝİĐŝůĞƐ�ĞŶ�Ğů�ĐĂŵƉŽ�ĚĞ�ůĂ�ŵĞĚŝĐŝŶĂ�

Creemos que no hay nada más poderoso que la colaboración.

No debería haber barreras en la búsqueda de

tratamientos inovadores.

La colaboración va más allá de los nuevos tratamientos.

Desde la detección temprana hasta el acceso y distribución

de los medicamentos, buscamos socios que quieran las

mismas cosas que nosotros: mejores resultados para

nuestros pacientes.

Nuestra misión nos impulsa. Nuestros pacientes nos inspiran.

Colaboramos con el mundo por la salud de todos.

Akhilesh Vijay,

general manager,

Accord Healthcare

Cesar Amaro,

director general,

DIGEMID


HEALTHCARE & LIFE SCIENCES REVIEW PERUSpECIAL SpoNSoREd SECTIoN

pHARMABoARdRooM.CoM I JULY 2015 S6

still, the investment levels are low if we

compare them to countries abroad. This

is where a huge opportunity appears just

before our eyes and the private sector be-

comes necessary. As a guild, ALAFARPE

acts as a catalyst for the private sector to

reach its full capacity by providing recog-

nition for what we consider outstanding

research and innovation. The authorities

have a very important role in all of this;

they are the ones that need to set the right

conditions and stage if we truly want to be-

come an innovating country.”

The Building Blocks of

healThcare

Peru’s healthcare system was largely under-

developed for many years; but the coun-

try’s newfound fortune of recent years has

allowed for a signifcant overhaul and re-

form of the system.

However, the road to a com-

prehensive and universal system

is rocky. Peruvian Congressman

Gustavo Rondón, secretary for the Com-

mittee on Health and Population, notes

that the budget for

healthcare in Peru

is one of the lowest

in Latin America.

“As such, we must

prioritize investment

in this area effcient-

ly. Peru often gets

ahead of itself with

technological devel-

opments or innova-

tion, while we still

need to implement

the basics. We become idealists; we want

the latest technology, but in reality that

will only reach a few people. We should be

more practical than theoretical by putting

norms into practice and allocating more

personnel and equipment.”

One of the key goals of Peru’s Ministry

of Health is to now provide universal health

coverage for all Peruvians by 2021. Between

2011 and today, the number of affliates as-

sociated with Seguro Integral de Salud (SIS),

the public health insurance agency run by

the Ministry of Health that provides access

to basic health services to unemployed Pe-

ruvians and those unable to pay for social

security or private insurance, has increased

from 12 million to 15 million, nearly half

of Peru’s entire population, in part due to

increased funding for the agency. With 25

percent of the population without any ac-

cess to social protection today, there is still a

great deal of work to be done to ensure that

universal coverage is reached.

Leading the charge in this endeavor is

Pedro Grillo, chief of SIS. He has an im-

mense weight on his

shoulders to not only

ensure universal cov-

erage but to guaran-

tee that the system is

sustainable to main-

tain this coverage by

improving the infra-

structure, services

and security of Peru’s

public health institu-

tions. “To introduce the process of universal

insurance reform in Peru, we must revise our

beneft plans to suit the needs of our poli-

cyholders,” Grillo stresses. “We have intro-

duced a performance-based model exchange

with other public institutions such as public

hospitals and regional health facilities. We

also exchange services with EsSalud (Peru’s

social security) and we purchase services to

private providers of health services, in order

to grow our supply base for our members.”

Moreover, the Ministry of Health an-

nounced a USD 3.5 billion investment in

infrastructure projects in November 2014,

aimed at revamping old hospitals with

crumbling infrastructure and building up to

50 new hospitals within fve years. This in-

vestment has received mix opinions among

various stakeholders, but certainly provides

good opportunities for the private sector.

“We are now starting to see brand

new public health centers pop up across

the country, in

places like Piura,

Chiclayo, Tumbes,

Cuzco, Arequipa or

Tacna,” states Caro-

lina López-Torres,

general manager

of Hospira Peru.

“Consequently, I

think we can com-

pete with other

Latin American

countries’ hospitals. This is great news for

us and for industry; now is the moment

to invest and support the sector. Contracts

with foreign companies with more expe-

rience can be very benefcial. In my posi-

tion, it is critical to be the frst to get our

type of products to these hospitals.”

ouT of The shadows

While Peru’s future still remains unclear

as the mist that shrouds its majestic Ma-

chu Picchu in mystery, it cannot be denied

that the country’s economic improvement

in recent years is having a positive impact

on healthcare infrastructure throughout.

Time will tell if Peru has what it takes to

ensure a sustainable transition to a modern

healthcare system.

Carolina López-Torres, general manager, Hospira Peru

Gustavo Rondón, secretary for the Committee on Health and Population, Congress of Peru

Pedro Grillo Rojas, chief, SIS

Esperanza: Hope for CancerThe Instituto Nacional de Enfermedades Neoplásicas

(INEN) is Peru’s oldest institution dedicated to cancer control

and prevention, with a history that stretches back to 1939. “Our

institution is the national gold standard for prevention and

oncology healthcare practices,” comments Tatiana Vidaurre,

chief of the organization. “INEN can be matched with the best

oncological institutions worldwide.”

INEN is tasked with operating Plan Esperanza, the national

program for providing cancer services to all of Peru’s popula-

tion. “Plan Esperanza has made an unprecedented change in

access to comprehensive oncology healthcare on time, opening full coverage for the

protection of cancer patients, which is free for the poorest population,” says Vidaurre.

Tatiana Vidaurre, chief, INEN


50

www.PharmExEc.com

Pharmaceutical executive JULY 2015Intellectual Property

panies are particularly vulnerable

to these schemes because they

“tend to be small, derive most of

their revenues from one or two

products on the market, and have

a handful of very valuable patents

protecting those products.”

Congress has taken heed of the

industry’s complaint by proposing

legislation that may address the

concerns. The Protecting Ameri-

can Talent and Entrepreneurship

Act (PATENT Act) started as a bill

in the Senate to address concerns

about “non-practicing entities”

seeking to enforce their patents in

federal district courts. The House

of Representatives is considering

the Innovation Act, which also

seeks to raise the bar on “non-prac-

ticing entity” patent suits.

Recognizing that the PATENT

Act appears to have suffcient sup-

port to pass Congress, members of

the biopharma community have

thrown their support behind it, but

have highlighted the need to add

provisions that level the playing

field in post-grant proceedings.

The industry has proposed revi-

sions that seek to make it more dif-

fcult for a challenger to institute

an IPR and ultimately prevail in

showing a patent claim invalid.

Examples of the proposed

changes advocated by those in the

industry can be gleaned from recent

testimony provided to the U.S. Sen-

ate Committee on the Judiciary.

Henry Hadad of Bristol-Myers

Squibb succinctly put forth several

proposals that minimize some of

the risks that post-grant proceed-

ings present to biopharma patents.

These proposals include affording

patent owners more opportunities

to submit evidence, aligning the

claim construction used by the

USPTO with that applied by district

courts, and applying a clear and

convincing evidence standard to

prove invalidity.

The Senate has responded to

the pleas of the industry by amend-

ing the PATENT Act to include

some of the provisions suggested.

Although not in the current ver-

sion, there has been some discus-

sion about modifying the PATENT

Act to prevent the use of post-grant

proceedings against patents

involved in challenges under the

Hatch-Waxman Act or Biologics

Price Competition and Innovation

Act. But the House version of pat-

ent reform has not adopted any

changes to post-grant proceedings

other than to craft rules that will

prevent investment frms from ini-

tiating a challenge.

Industry ImpactThe use of IPR proceedings by

investment frms has highlighted

the threat that current post-grant

proceedings present to biopharma

companies. This threat fows from

petitioners’ successes at invalidat-

ing claims through IPR proceed-

ings as compared to the expected

success in a district court chal-

lenge. The amendments to the

PATENT Act proposed by many

in the industry should more closely

align the success rates seen in IPR

proceedings with those in district

courts, while still maintaining the

low cost and quick resolution of

patent disputes sought when Con-

gress created post-grant review

proceedings. Although the Senate

has accepted many of the indus-

try’s proposals, the House has not.

Hence, the industry will need to

lobby members of the House. Fur-

ther, the industry should continue

to lobby members of Congress to

seek a prohibition against using

post-grant proceedings in generic

and biosimilar challenges. This

would insulate a drug franchise

revenue stream from challenges in

a petitioner-friendly forum.

Until the drug industry con-

vinces Congress to modify the

post-grant proceeding rules, it is

vital for those in the industry to

factor post-grant challenges into

their business planning. These

proceedings provide a competitor

a lower hurdle to offering a com-

peting product. Further, the com-

petitor can bring a challenge at

any time, increasing the need for

a patent owner to conduct due dil-

igence earlier in a product life cycle

to ensure strong patent protection.

When acquiring drug products, a

company will need to consider

whether a post-grant challenge

has the potential to devalue the

acquisition. Finally, a drugmaker

will have to modify its thinking as

to what patents may be vulnerable

to a challenge. With the introduc-

tion of IPR proceedings, a bio-

pharma patent owner can no lon-

ger simply ask if there is another

company out there that wants to

sell a competing drug. In consider-

ing that a larger cast of characters

exists that may challenge a patent,

a patent owner will have to con-

duct due diligence on additional

patents or accept the possibility it

may be drawn into a patent battle

it never saw coming.

Until the drug industry convinces Congress to

modify post-grant proceeding rules, it is vital for

companies to factor post-grant challenges into

their business planning

Continued from Page 44



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Event OverviewBiopharma companies today want to take advantage of

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