Pharmaceutical Executive Global Digest 24 June 2011

2 News• India propose ban on physician gifts• J&J ordered to pay $327 million

4 ASIA UPDATEAre you ready for the new China?

12 PARTNERSHIPSWhy risk mitigation is key to alliance management.

13 COMPETITIONBrands + generics = ‘branerics’.

14 PHARMACOGENOMICSAre issues of race holding back progress?

15 APPOINTMENTSWho’s on the move?

18 EVENTSUpcoming pharma conferences from around the world.

24 June 2011

www.pharmexec.com

Pharm Exec’s Emerging Pharma Leaders 2011

Meet 2011’s Emerging Pharma Leaders — Can these 30 trendsetters build

competitive scale from scarcity? See page 7.

Global Digest

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News For more on these news stories and all the latest breaking

pharma news, look at our website www.pharmexec.com

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News

India Propose Ban on Physician Gifts

J&J Ordered to Pay $327 Million A South Carolina, USA, court has found that Ortho-McNeill-Janssen Pharmaceuticals, a

subsidiary of Johnson and Johnson (J&J), violated state consumer-protection laws by using

misleading marketing for its antipsychotic drug, Risperdal. Janssen Pharmaceuticals, the maker

of the drug, received a Warning Letter from FDA in April 2004 over misleading product claims

made in a “Dear Doctor” letter that the company sent to healthcare providers in November

2003. According to FDA, the Janssen promotional material minimized the risks of

hyperglycemia-related adverse events associated with Risperdal, and misleadingly

claimed that Risperdal was safer than other atypical antipsychotics.

The court ordered J&J to pay $327 million in fines. According to

Bloomberg report, Circuit Court Judge Roger Couch assessed a

$300 penalty per sample box of the drug that was distributed

and a $4000 penalty for the publication of the “Dear

Doctor” letter, for a total penalty of more than $327

million. A much larger penalty could have been

assessed if the fines had been levied on a per-

prescription basis.

J&J plans to appeal the ruling. According

to Bloomberg, the South Carolina case is

one of about 10 such suits brought by

states over misleading marketing of

Risperdal. J&J succeeded in getting the

charges dismissed in a similar suit in

Pennsylvania and won an appeal

after being fined in West Virginia,

after which the state dropped its

case.

Amy Ritter

India’s Department of Pharmaceuticals has released a 14-page “voluntary code” for

drug marketers, which includes a strict ban on gifts to prescribers, among other things.

The code, which is open for public comment until June 30th, states that “no gifts,

pecuniary advantages or benefits in kind may be supplied, offered or promised to

persons qualified to prescribe” a drug. Additionally, “gifts for the personal benefit of

healthcare professionals (such as tickets to entertainment events) also are not [to] be

offered or provided,” the code states.

Other proposed rules in the code limit drug sampling “to prescribed dosages

for three patients,” and sample packs “shall not be larger than the smallest pack

presented in the market.” Providing samples of “anti-depressant, hypnotic, sedative

or tranquillizer” drugs in any amount or packaging unit is disallowed, under the

proposed code.

The full document and code is available

here. The regulations are voluntary

for now, but “its implementation will

be reviewed after a period of six

months form the date of its

coming into force, and if it

is found that it has not been

implemented effectively…the

government would consider

making it a statutory code,” the

document says.

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http://www.bloomberg.com/news/2011-06-03/j-j-ordered-to-pay-327-million-on-deceptive-marketing-claims.html

News

LEADING CLINICAL RESEARCH ORGANISATION SEEKS

STRAIGHT TALKING LONG-TERM RELATIONSHIP

Pharma Leads in Corporate Sustainability, Says SurveyA survey on the real and perceived sustainability efforts of the top 100 companies

around the world reveals that the pharmaceutical/healthcare industry is leading the way

in corporate sustainability.

The study, Sustainability Leadership Report: Measuring Perception vs. Reality

by Brandlogic and CRD Analytics, surveys ten industry sectors: pharma, consumer

discretionary, consumer staples, energy, financials, industrials and transportation,

information technology, materials and mining, and telecommunications and Internet.

Data from participants was used to establish a sustainability IQ matrix which

grouped companies into one of four areas: laggards (low perception, low reality),

promoters (high perception, low reality), challengers (low perception, high reality),

and leaders (high perception, high reality). Abbott Laboratories, AstraZeneca, Bayer,

GlaxoSmithKline, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, all ranked in

the “leader” category. Roche fell into the “challenger” category; BASF, fell into the

“promoter” category; and no one from pharma ended up in the “laggard” field.

Interestingly, corporations such as Amazon and McDonald’s did.

http://blog.pharmtech.com/2011/06/08/pharma-leads-in-corporate-sustainability-says-survy/

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Appointments Events15 18AAAppppppppoooiiinnntttmmmeeennntttsss EEEvvveeennntttsss

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http://sustainabilityleadershipreport.com/

http://www.kendle.com/

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Are You Ready for the New China?

To date, the Chinese government has

sent mixed signals about the role of

novel, patented drugs in the new universal

healthcare system it aims to have in place by

mid-decade. Although there are programs

that actively support innovation, healthcare

authorities stress that high drug prices are

firmly in the cost-containment crosshairs,

and that even newer on-patent drugs may

be subject to mandatory price limits.

Thus, making a strong case for innovation

The days of making easy money in China off high-priced branded generics

are over. Jon Zifferblatt explains why every multinational in should be

examining ways to freshen and adapt their product offerings.

in drug policy should be a critical element

in any short-term strategy for foreign drug

investors in China. The issue is how to

create the traction that will convince the

government to recognize a new drug’s

value. Two possibilities that hold promise

are: 1) pharmacoeconomic strategies that

can demonstrate superior cost-effectiveness;

and 2) leveraging potential opportunities

in a parallel, for-profit private healthcare

system to support the basic public service.

Making the Case China’s health regulators have already

indicated that pharmacoeconomic

evaluations will impact decisions on market

access. Pharmacoeconomic strategies are

well known to foreign manufacturers

from their experience in other markets,

hence companies would do well to bolster

functional capabilities in this area as part of

their China operations.

In contrast to the pharmacoeconomics

tool, the likelihood of a private health

system continuing to serve the discretionary

upper-income market is less clear. Given the

potential importance of this setting, investors

must understand the current state of private

healthcare and monitor developments in this

area so that, at such time that a legitimate

and sizable private medical market emerges,

pharma is ready to greet it.

Is the Past a Prologue? Unfortunately, the record on support for

private healthcare is a checkered one.

As China began to loosen healthcare

restrictions at the beginning of the 2000s,

a decision was made to allow the sale of

selected hospitals to private investors. Over

the next few years, significant numbers

of mid-size/county hospitals and SOE

hospitals were sold off. But once they were

privatized they placed significant emphasis

on short-term profits, often at the expense

of service quality (and, in some cases,

medical ethics). Sales of medicines were a

key source of those profits and there was

a built-in incentive to overprescribe and

charge high premiums to patients.

Despite these handicaps, private

healthcare might still have succeeded if

private hospitals had been allowed access Allan

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to one key medical asset: talented doctors.

In China, physicians are licensed to practice

at a single facility. According to MOH

regulations, doctors choosing to practice at

private hospitals had to forfeit affiliation

with their government facility—thus

exiting the path for promotion through

physician ranks as well as ending the

process of academic advancement.

China’s first attempt at private healthcare,

then, can be seen as a complete failure—a

system comprised of poorly managed

facilities staffed by medical personnel

whom the vast majority of patients had no

interest in patronizing.

Getting It RightThe country’s healthcare reforms, now

entering a phase of national and regional

implementation, are fundamentally

changing the structure of medicine and its

delivery across many levels. Although the

original language of the healthcare reforms

does mention private healthcare (and

commercial insurance), it is only within the

past several months that regulators have

begun to more fully articulate their position

on private medical facilities. And there are

now strong signs that the government

is preparing for a relaunch of private

healthcare—and that this time, they intend

to get it right.

A major step forward for private

healthcare has been the recent release of

“Opinions on further lifting restrictions

to private hospitals,” co-authored by

the National Development and Reform

Commission (NDRC), Ministry of Health

(MOH), Ministry of Finance (MOF),

Ministry of Commerce (MOC), and

Ministry of Human Resources and Social

Security (MHRSS). This offers a number

of regulatory enticements to encourage

private investment in healthcare facilities—

including the opportunity to participate

in basic medical insurance reimbursement

systems and favorable tax policies.

Significantly, the opinion also paves the way

for 100 percent foreign-owned healthcare

facilities, although no timetable for this

process is given.

Allowing top-level physicians to retain

their positions and standing in government

hospitals while practising part time in

private settings is the key to the future

of private healthcare in China. Here, the

signs are also positive. Following its typical

modus operandi, the MOH has put in

place a number of pilot projects allowing

physicians to practice at multiple sites.

These programs have built momentum

over the past year and now include sites in

Hainan, Henan, Guangdong, Sichuan, and

Yunnan.

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Healthcare authorities are no doubt

hoping (even more fervently than before)

that an upper-tier private health system

will emerge to lure more affluent medical

consumers away from public institutions,

thus freeing more resources for patients

relying solely on basic government

insurance programs.

However, the devil is in the details. For

pharmaceutical manufacturers, key issues

will be the extent to which private facilities

will be allowed to fuel their profits from

pharmacy sales—the current situation in

public hospitals which the health reforms

mean to bring to an end—and whether

products sold in private hospital settings

will be subject to the same tightening price

controls as those in the public sector.

Coping StrategiesWhile a robust private health system in

China is by no means a foregone conclusion,

pharma companies should be considering

the strategies they will employ if China

moves in this direction, and also how

they could influence policy to increase the

likelihood that it will. Three key actions

come to mind:

1) Companies need not wait for the

creation of a private healthcare system to

build relationships with key physicians and

decision-makers.

2) Market access departments at HQ should

be closely monitoring China’s treatment of

domestic versus foreign innovative products.

3) Companies should be sending the

message to healthcare authorities that

offering a choice for premium/for-profit

services and medicines will create more

medical consumer satisfaction, promote

better health outcomes and ease the

burden on the expanded public system.

Ultimately, pharma must understand that

two prime forces guiding the Chinese

government in its actions are fear and pride.

Fear of widespread popular discontent

over cost and access to medical care has

driven the sweeping changes in healthcare

and pharma that are now under way, but

pride in the country’s emerging status on

the global stage means that China strongly

desires to be able to boast of having a

world-class medical and drug market.

If industry wishes to enjoy the fruits of

a continued presence in China and sell

premium, innovative products, overseas

drugmakers will need to respond to both.

Jon Zifferblatt is Pharm Exec’s Asia

correspondent.

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Pharm Exec’s Emerging Pharma Leaders 2011Can these 30 trendsetters build competitive scale from scarcity?

Pharm Exec’s 2011 roster of Emerging

Leader 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.

We’ve selected executives drawn from a

range of mission-critical functions, varied

geographies, and diverse gender and cultural

characteristics. The profiles highlight the

trends and values that will shape strategy in

biopharmaceuticals for the remainder of the

decade. We’ve distilled some of the more

interesting insights below.

The real meaning of “lean.” This year’s

leaders are aware it is not enough just to “do

more with less.” All agree that the change is

strategic, not temporary, and relates squarely

to the higher long-term risk profile of the

business.

Information is now borderless, posing a

significant challenge to stronger employee

engagement. Rapid improvements in IT

are forcing leaders to be more transparent,

but this requires a commitment to make

information verifiable to employees and team

members.

The key emotional chord in today’s pharma

workplace is to convey a sense of urgency.

Time and space for action are compressing

due to the impact of improvements in

technology, accessibility of information,

the globalization of competition, and a

changing demographic of the market base.

Complacency is a trait associated with older

forms of organization linked to a command-

and-control leadership style, when the

prudent response for anyone with leadership

aspirations was to defer and deliberate.

The talent pipeline is spouting in a different

direction. Under previous generations, drug

research and other good ideas germinated

in “mature” markets, preferably the home

office, with production and secondary

services devolved to low-income countries.

Looking forward, that pattern may well be

reversed.

The real driver of “human resources” is the

power of the personal connection. Many

of our 30 leaders urged that management

restore what is “human” about human

resources, through a renewed emphasis on

counseling and support for “soft” skills such

as leadership training, talent development,

and mentoring.

The best innovations are often a

consequence of a workplace failure. Making

mistakes is “part of the job,” and what counts

is a willingness to try something new.

One thing has not changed: There are few

future leaders who can’t cite passion as a

factor that got them to where they are today.

The lucrative pay in pharma is one thing,

but if you are not fired up by the potential

that working in this space has in improving

the state of health for millions of patients,

then perhaps a career in accounting is more

appropriate.

Click here for the 30 Emerging Leader profiles. X/G

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http://pharmexec.findpharma.com/pharmexec/Profiles/Emerging-Pharma-Leaders-2011/ArticleStandard/Article/detail/726109?contextCategoryId=49659


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DOUG DRYSDALE

CEO, Alvogen

Doug Drysdale knew from a young age

that he’d end up in pharma. “When

I first left high school I worked in a

hospital lab. Then I went to university,”

he says. “Coming out of there, it was

hard to see sometimes how you would

commercialize a life sciences degree and

how you could actually make a career

out of it—what’s interesting

academically is sometimes

difficult to turn into a career.

But the pharma industry

immediately struck me as

a way to do that.” Read

more…

KIMBERLY SABLICH

Vice President, Vaccines, Commercial

Strategy, GlaxoSmithKline

Kimberly Sablich, vice president

for vaccines commercial strategy at

GlaxoSmithKline, ascended quickly in

her pharma career, and she credits it to

growing up in a household with a single

working mother. “With my mother as a

role model, I never questioned

whether I was going to have a

career and I was always sure I

wanted to be in the business

world, like Mom,” says

Sablich. Read more…

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DENNY KRAICHELY

Associate Director, CMC

Team Leader, Portfolio

Management & Technical

Integration, Johnson &

Johnson

“What appeals to me most about the

pharmaceutical industry is our focus

on the development of new medicines

to improve patients’ lives,” says Denny

Kraichely, Johnson & Johnson’s associate

director and CMC team leader in

portfolio management and technical

integration. “It inspires me that I am a

part of a pharmaceutical industry with

so many examples of changing life-

threatening diseases to manageable

chronic conditions.” Read more…

HEATHER BRESCH

President, Mylan

Twenty years ago Heather Bresch accepted

a data entry position at Mylan, a small

generics and specialty pharmaceutical

producer headquartered in Canonsburg,

Pa. Today, she is president of the company.

As an advocate for access to affordable

healthcare and generics

utilization, Bresch admits that

her professional life has

influenced the causes that

she cares about. Read

more…

LEIGH-ANN DURANT

Associate General Counsel, Clinical

Trials and Medical Affairs, EMD Serono

Many of this year’s

Emerging Pharma

Leaders started out as

physicians, sales reps, or

pharmacists. Leigh-Ann

Durant took a different

path—she became

a lawyer. Durant debated

between medical school and law school

for a while, and law school won. After

becoming involved in international law

and relations during a year abroad in

Finland, and after clerking for the Chief

Justice of the Supreme Court of Rhode

Island, Durant says pharma crept into

her career. Read more…

d

CRAIG LIPSET

Head of Clinical Innovation, Pfizer

As head of clinical innovation

for Pfizer Worldwide Research &

Development, Craig Lipset runs a tight

ship. He works with senior scientists

to define the future for clinical

trials and ensure that the

company’s R&D initiatives

are connected and can

leverage one another.

Read more…

JENNIFER LEEDS

Executive Director, Head of

Antibacterial Discovery, Novartis

“I always really loved

biology. But what

probably got me

most interested in

microbiology was my

mom working in a

doctor’s office. I would

just come in and watch the urologists

do all this testing, looking at pathogens.

That was my first exposure to bacteria.

I just really enjoy it.” Half a lifetime

later, Jennifer Leeds, executive director

and head of antibacterial discovery,

has put that passion to great use over

eight-and-a-half years at Novartis. Read

more…

JANE BRANDMAN

International Marketing Leader,

Merck

Merck’s Jane Brandman was working

on the issue of managed markets and

reimbursement before it was industry’s

cause célèbre. Not so long ago,

reimbursement in oncology,

for example, wasn’t even an

issue—if it was approved,

it was reimbursed, says

Brandman. Read more…

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DAVID REDFERN

Chief Strategy Officer, GlaxoSmithKline

At 44, David Redfern is already

something of a pharma industry

veteran. With 17 years’ experience

behind him, he now leads

GlaxoSmithKline’s M&A and

corporate development activities,

has responsibility for its global

dermatology business,

and is chairman of ViiV

Healthcare—an HIV/AIDS

joint venture with Pfizer

that he was instrumental in

establishing. Read more…

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VATCHE BARTEKIAN

President and Founder, Vantage

BioTrials

For Vatche Bartekian, pharmaceutical

work is all in the family, and has been

for years. “I had many uncles, aunts, and

cousins who were doctors, pharmacists,

and pharma professionals,

including my own brothers,”

he says. “The pharmaceutical

and health industry has

always appealed to me.”

Read more…

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PHILIPPE SZAPARY

Senior Director, Immunology, Centocor

“I never thought I’d end

up in the pharmaceutical

industry,” says Philippe

Szapary. “Like many of

my peers in R&D, I was

in academic medicine.

I was on the faculty at

the University of Pennsylvania in internal

medicine. I was taking care of patients,

teaching medical students and residents,

and engaging in clinical research and

epidemiology.” Then, says Szapary,

“One thing led to another and I ended

up in R&D using many of the skills I had

developed in academia, now on a much

broader scale, and thus impacting a lot

more lives and people.” Read more…

ANDREAS JEKLE

Senior Research Scientist, NovaBay

Pharmaceuticals

After pursuing a post-doctorate

degree in San Francisco, USA,

Dr. Andreas Jekle found the

road challenging for a foreign-

born scientist trying to enter the

pharmaceutical world. Luckily, a

fellow German helped him land

his first job at Roche in 2003. Now,

as Senior Research Scientist at

NovaBay Pharmaceuticals, Jekle is

getting the chance to “combine drug

development work with my passion

for basic science.” Read more…

EVAN LIPPMAN

Executive Director, Crestor, AstraZeneca

For Evan Lippman,

previously the

commercial leader for

Nexium and now leader

of the Crestor brand

at AstraZeneca, the

shifting tides of pharma

don’t change the goals of his team.

“Leadership is about solving complex

problems and delivering on business

objectives,” he says. “I can’t think of

any other industry that enables you to

do that in a way that benefits people

like pharma does. I don’t know why you

wouldn’t want to be a part of that.”

Read more…

DAVID STERN

EVP, Endocrinology, EMD Serono

Being responsible for all commercial

operations in the US for EMD Serono’s

endocrinology therapeutic areas—HIV,

growth deficiency, and infertility—has

taught David Stern two things:

1) That failure is the first step

towards success; and 2) When

the success comes, it’s

truly worth the effort.

Read more…

NICOLE MOWAD-NASSAR

VP, Cardiorenal &

Metabolic Marketing,

Takeda Pharmaceuticals

As vice president of

cardiorenal and metabolic

marketing at Takeda Pharmaceuticals

North America, Nicole Mowad-Nassar

is responsible for the company’s key

brands—Actos, Uloric, and Edarbi—as well

as its diabetes pipeline and partnerships

with Orexigen and Affymax in the areas

of obesity and renal care, respectively.

“Diabetes, hypertension, and obesity are

conditions almost every person can relate

to in some way. Either they are a patient

themselves or have a loved one or friend

who is impacted,” says Mowad-Nassar,

who is attracted to her sector of work for

these reasons. Read more…

RALANA CLEMENS

Product Training Manager, Diabetes,

Boehringer Ingelheim

For Alana Clemens, diabetes is more

than just something she focuses on

from nine to five. As the woman who

trains the sales team that focuses

on Boehringer Ingelheim’s diabetes

initiatives, she admittedly

knows a great deal about

the disease. But she’s

also a patient. And an

advocate. Read more…

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BYRAN LITTON

Senior Director of Sales, Oncology

Business Unit, Eli Lilly

“Modern leadership is

about a couple of things:

It’s as simple as trust

and lending a vision to

people; to have that

singular vision that can

really give people the lens by which

they look at everything that comes

to them. To me that’s a calming force

that’s absolutely necessary.” In over 11

years, Byran Litton, senior director of

sales, oncology business unit at Eli Lilly,

has relied on diverse experiences to

shape his leadership style. Read more…

:

JOHN STUART

National Sales Director, Genentech

Heck no,” says John Stuart, when asked

if he always knew he would work in

healthcare or pharma. “I went to school

knowing I would be a salesperson,

but never really articulated in my own

mind what kind of sales I

wanted to be involved in.

In fact, when I interviewed

with Genentech, I had no

clue who they were at the

time.” Read more…

STEVE ERTEL

Senior Vice President,

Corporate Development,

Acceleron Pharmaceuticals

When Steve Ertel

graduated from Duke University

with a degree in biomedical engineering,

he was one of only a handful of

graduates in his major that decided to

forgo medical or graduate school. Instead,

he was ready to take his education and

training to market. The first job Ertel

landed was with a venture capital firm,

which represented a combination of

interests—finance and business, applied

to biology and medicine—and supplied

him with a firsthand look at how

investors fund biotech startups, and what

they look for. Read more…

ersit

AMAR SETHI

Vice President, Science

& Technology, Pacific

Biomarkers

An academic background

in clinical chemistry

combined with a solid understanding

of a key therapeutic segment—lipid

control medications—set the foundation

for Pacific Biomarkers vice president

for science and technology Dr. Amar

Sethi’s career as a pathfinder in drug

development. Read more…

ROB ETHERINGTON

Senior VP, Commercial,

Actelion Pharmaceuticals

Rob Etherington has

been with Actelion for

11 years, and has seen

the company grow from five employees

to more than 300 in the US alone, and

around 2,500 worldwide, in that time.

In the past decade, revenues at Actelion

have grown from zero to nearly $1

billion in annual sales. And Etherington

has been there through it all. Read

more…

MARK IWICKI

CEO, Sunovion Pharmaceuticals

In the short time that elapsed

from receiving Mark Iwicki’s

Emerging Pharma Leader

nomination to speaking

with the man himself,

he had been promoted

from COO of Sunovion

Pharmaceuticals (Marlborough, Mass.)

to the company’s CEO (effective late

June). The speed with which this career

hike took place is in keeping with Iwicki’s

progress at Sunovion (formerly Sepracor).

Joining the CNS and respiratory treatment

company as executive vice president

and chief commercial officer in 2007, he

quickly revamped its commercial model

and masterminded a move to single-

territory ownership. Read more…

d

LYNN SHATKUS

International Marketing Training

Director, Abbott Laboratories

Lynn Shatkus’s current role as

international marketing training

director at Abbott Laboratories seemed

predetermined. “I come from

a long line of training; my

parents were both teachers

... so I think it was sort of fate

that I’d end up working in a

training role.” Read more…

SOMA GUPTA

Senior Director & Commercial Team

Leader, Oncology, Pfizer

As senior director and team leader in

commercial development for Pfizer

Oncology, Soma Gupta handles

commercial oversight of Pfizer Oncology’s

newly emerging hematological

malignancy assets and its early

development portfolio. As a Pharm.D

by training, Gupta says she thrives on

the challenge of working in

specialty categories where

the unmet medical need is

exceptionally high and the

products delivered have

a meaningful impact.

Read more…












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CHARLOTTE CHUI

Head of Strategic

Planning, Business

Development and

Licensing, Greater China,

Novartis

“I was rather naïve and thought that

science could solve anything,” says

Charlotte Chui of her early years studying

the discipline (her undergraduate major

at Harvard was biochemical sciences).

“When I realized that wasn’t the case, I

took a bit of a detour.”

Fortunately for science—and pharma, in

particular—that detour (into the finance

industry) wasn’t permanent. Read more…

JESSICA MONROE

Director, State

Government Affairs

& Policy, Johnson &

Johnson

Jessica Monroe recalls

a former boss who would always ask,

“What is a leader?” He would then

answer that a leader says, “I have a

plan. Follow me.” Director of state

government affairs and policy for

Johnson & Johnson, Monroe tries to

integrate this approach into her own

goals and objectives as she works with

governments, operating companies, and

other healthcare and pharmaceutical

interests on a daily basis. Read more…

STEVEN BLUM

Director, Health

Economics, Forest

Laboratories

For Steven Blum, director

of health economics

for Forest Laboratories, being aware

of budget impacts is fundamental to

the job. “Our role is to help support

and communicate the product’s value

proposition,” he explains. Blum and

his team do this by keeping track of

data and performing various studies

throughout a product’s lifecycle,

including retrospective studies,

electronic medical records analyses,

surveys, and prospective studies looking

at data alongside clinical trials. Read

more…SALVADOR GRAUSSO

Executive Director, Global Pricing, Merck

If you work on a team with Sal Grausso,

you’ve probably heard the following

phrase: “Strategy without execution

is not strategic.” As executive director,

global pricing, at Merck, Grausso likes

to keep himself at “the tip of the spear”

with respect to market access

and reimbursement; the

difficult and politically

ticklish issue of drug

pricing requires not only

good ideas, but also

implementation.

Read more…

STUART SOWDER

Vice President, External Medical

Communications, Pfizer

With three advanced degrees under

his belt, Dr. Stuart Sowder, PharmD.,

JD, MBA, credits “mother necessity” as

a major role in his drive for obtaining

the tool set that he needed to succeed.

After spending eight years working in

healthcare (retail and hospital pharmacy)

and obtaining his law degree, Sowder,

who is vice president, external medical

communications at Pfizer,

decided that entering the

pharmaceutical industry

provided many exciting

options for a lifelong

career. Read more...

LARS MERK

Director, CNS Marketing,

Johnson & Johnson

According to Lars

Merk, director of

CNS marketing for

Johnson & Johnson, there are two

separate effects of the convergence of

digital technologies and healthcare.

The first is an explosion of newly

available interactions that leverage

digital technologies. The second is the

realization that healthcare delivery is

changing and technology is a catalyst

for greater efficiency. Read more…

CLICK HERE FORTHE FULL ARTICLE









http://pharmexec.findpharma.com/pharmexec/Profiles/Emerging-Pharma-Leaders-2011/ArticleStandard/Article/detail/726109?contextCategoryId=49659

High Risk to High Reward

Pharma and biotech companies have

joined together, in increasingly complex

ways, to fill pipelines, lower development

costs, and bring products to market. To

tackle these multifaceted alliances, it is

important to take the big-picture view of

alliance management — and then apply

common-sense tools to mitigate the risk

and maximize the value of these vital

strategic partnerships. Since Eli Lilly first

established an office dedicated to alliance

management in 1999, the alliance practice

has evolved from managing relationships

to minimizing risk.

So how do we deal with the risks we

encounter at the onset of a partnership,

during the execution phase, and in all

ongoing interactions thereafter? While

we can’t cover every available method, we

offer here several representative examples.

Contingency planning. In some cases of

contingency planning, business partners

don’t want to introduce any negativity.

In other situations, team members might

Managing alliances requires more than good people skills; it requires good risk mitigation too.

David Thompson and Stephen Twait of Eli Lilly report.

find scenario planning a distraction in an

action-oriented project and give it low-

priority status. Lilly’s alliance management

team is taking a more proactive approach.

Having discussed the possibilities, our

teams are more prepared to work together

and to make rational decisions quickly.

Teams are able to communicate relevant

information rapidly to all important

internal and external stakeholders.

Leadership turnover. We pay careful

attention to changes in staffing and then

take the time needed to bring new leaders

up to speed using the comprehensive

background materials we have created

over the course of the alliance. This process

enables us to affirm the business goals of

the partnership and avoid any barriers to

project progress.

Document everything. It is useful to create

appropriate records of alliance decisions

and the action items that result. These

records are available in case questions arise,

when new team members

need to be brought up to

speed or when we need

early notice of potential risk

factors.

Lessen human risk. Human

interactions always contain the potential

for tension and discord. We have developed

tools that help participants manage

their way through various situations

and opinions. We use a short video to

demonstrate how quickly situations can

deteriorate under certain circumstances,

and we use structured listening, in which

one person is chosen to speak for each team

in a particular discussion. This has the effect

of forcing each side to actively hear the

other’s opinion and respond to the content

of the message.

Minimizing risk = value. Over the last

decade, we have seen firsthand how a

redefinition of our group’s role — from

facilitating relationships to mitigating risk

— has made a positive impact in strategic

collaborations at all levels. Whether

the nature of the services we provide is

proactive or reactive, our methods aim to

reduce business risk, human risk, and legal

uncertainties.

About the AuthorsDavid Thompson is the Chief Alliance

Officer at Eli Lilly. Steven Twait is Director

of Alliances and M&A Integration at Eli

Lilly. He can be reached at [email protected].

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http://pharmexec.findpharma.com/pharmexec/Partnerships/High-Risks-to-High-Reward/ArticleStandard/Article/detail/719600

Competition 2.0: Brands vs. Generics

Numerous articles have welcomed the five-

year patent cliff for pharma companies,

during which 18 of the top 20 prescription

best sellers will face generic competition

in the leading developed markets. The

frequency and intensity of brand versus

generic competition has grown dramatically

and will surge globally as the industry

continues its transition into the competitive

stage of its lifecycle.

There are several reasons for increasing

brand versus generic competition:

• Generics companies have intensified their

patent challenges, entered markets earlier,

and targeted more off-patent blockbusters,

including biosimilars, as well as smaller

brands.

• They have taken advantage of more

supportive laws, regulations, and policies in

many markets.

• Innovator companies, with fewer new

products, are trying to extract maximum

sales from their existing brands by

continuing post-patent promotions.

• Innovator companies have focused on

Innovator and generics companies are colliding as they invade each other’s turf, writes Stan Bernard.

emerging markets, where brand versus

generic competition is more common.

• Increasing generic competition cuts across

most products, lifecycle stages, and markets.

• Innovator companies are realizing that

generic competition in emerging markets

can be even more formidable, often with

dozens of generic copies for a single brand.

It is important for innovator professionals

to understand the new dynamics of brand

versus generic competition and the potential

implications and actions for their companies.

Braneric CompetitionBrand and generics have come together

to form “Braneric Competition.” Three

competitive factors have catalyzed this

fusion:

Competitive Duration. The patent

demarcation line has blurred as innovator

and generics companies have entered earlier

and more aggressively into each other’s turf.

The combination of earlier generic entry and

longer brand promotion has expanded and

extended brand versus generic competition.

Corporate Convergence. Increasingly, many

large branded and generics companies

are marketing both generic and original,

branded products. Many other multinational

brand companies, including Abbott, Pfizer,

and GlaxoSmithKline have partnered with

or purchased multiple generics companies.

Commercial Hybridization. As a result of

corporate crossbreeding and intensifying

competition, branded and generics

companies have adopted many of each

other’s commercial approaches.

Winning Innovator ApproachesSuccessful innovator companies are

adopting several approaches to help

compete against generic competition:

Planning. Generics companies often initiate

competitive planning with targeting brands

eight to 10 years earlier, beginning in Phase

III or at the launch of an innovative product.

Innovator professionals need to focus on

extending the brand’s patent life, and create

more comprehensive, longer-term generic

competitive plans that extend a brand’s life.

Customization. Innovators need to

analyze and prioritize potential markets,

stakeholders, and competitors. Because

every product, market, and competitor set is

different, innovators should customize their

approach for each situation to determine

the appropriate timing, resources, and

commitment.

Preparation. Strategic planning can be

used during brand versus brand exercises

by adding a generics competitor; when

competing against a generic copy of a

rival brand; or when preparing to compete

against the generic version of the company’s

brand.

Training. Innovator companies need to

embed competitive mindsets, expertise, and

capabilities throughout their organizations.

Stan Bernard is President of Bernard

Associates.



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To Screen Or Not To Screen

In May, a collection of academics,

physicians, scientists, and activists were

convened by the Novartis Institutes

for Biomedical Research to discuss the

current state of global health equity,

or why certain populations continue to

suffer from illness and disease at a rate

disproportionate to other populations.

Many of the presentations focused on

socioeconomic disparities as a barrier to

access, but if government leaders with

both the inspiration and power to enact

change are few and far between, and

the prevailing ethos among the moneyed

classes is one of “personal responsibility”—

as opposed to civic duty—then what else

can be done?

Pharmacogenomic research and new drug

development, that’s what. But first, you’ll

need to be screened, to determine what

sort of human being you are, genetically

speaking. “How much ‘Asian’ do you have

in you?” asked Charmaine Royal, PhD,

Associate Research Professor at the Duke

Institute for Genome Sciences & Policy,

imitating the awkward conversation a

Ben Comer outlines how notions of race are unbalancing the progress of pharmacogenomics.

doctor might need to have with a patient,

after it was discovered that carbamazepine

can cause “serious and sometimes fatal

dermatologic reactions” in patients with

the HLA-B*1502 allele, which, it turns out,

is found “almost exclusively in patients

with ancestry across broad areas of Asia,”

according to FDA’s black box warning.

If a strong correlation can be shown

between the presence of a genetic marker

and drug toxicity, it follows that new

drugs targeting ethnic populations with

high incidences of a given disease can be

developed to focus on genetic markers and

drug efficacy, right? Not exactly.

... before personalized medicine can deliver on its many promises, researchers will need to toss out

racial designations...

“Population categories, including race

and ethnic group, are clearly inadequate

to describe fully the pattern and range

of variation among individuals,” wrote

Charles Rotimi, PhD, Director of the Center

for Research on Genomics and Global

Health, National Institutes of Health, and

Lynn Jorde, Professor and Chair of Human

Genetics at the University of Utah, in the

New England Journal of Medicine last

October. The major problem with race is

that it’s self-identified: “Genetic analyses

of individual ancestry show that some

self-identified African-Americans have

large proportions (more than 50 percent)

of European genetic ancestry, whereas

some self-identified European-Americans

have substantial recent African genetic

ancestry,” wrote Rotimi and Jorde. Go back

far enough, and we are all Africans.

But there are major barriers to genomic

screening, namely cost and selection. There

are also problems with sample diversity

and storage for research. Issues like these

won’t stop pharmaceutical companies from

conducting clinical trials based on racial

designations, like the one AstraZeneca

completed in mid-May, which studied the

efficacy of Symbicort, an asthma drug,

in 742 self-identified African-Americans.

Results from AZ’s 52-week study “are

consistent with safety and efficacy data

from the ... previous Symbicort studies

conducted among predominantly

Caucasian patients,” according to a release

on the study. Also, self-reported African-

American populations have shown a higher

prevalence of asthma, compared with

self-reported Caucasians. It’s unclear what

studies like these actually prove.

The science of pharmacogenomics is

progressing, and the cost of screening

and full genotype mapping will come

down, but before personalized medicine

can deliver on its many promises, drug

researchers will need to toss out racial

designations that reduce the likelihood of

diagnosis in other populations.

Ben Comer is Pharmaceutical Executive’s

Senior Editor.



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http://pharmexec.findpharma.com/pharmexec/Back+Page/To-Screen-or-Not-to-Screen/ArticleStandard/Article/detail/726086

On the moveCarla Schoonderbeek and her team have

been appointed as international law firm

Hogan Lovell’s new life sciences lawyers.

Ms Schoonderbeek’s team includes Bart

Jong, Hein van den Bos, Paul Loeb, Ruth

Franken and Frederique Reijntjes. Ms

Schoonderbeek’s experience covers all

areas of pharmaceutical, medical device

sector and biotechnology law.

Networks in Health,

launched by Doctors.

net.uk, has welcomed

Beverly Stainsby as

International Account

Director. Ms Stainsby’s

responsibilities will

include delivering

and managing international engagement

campaigns for the firm’s pharma clients.

Her previous role was Client Services

Director for IMS Health Europe, the Middle

East and Africa. Ms Stainsby’s global data

service providers experience amounts to 17

years and includes management positions

in Nielsen and Cegedim.

Medgenics (Virginia, USA) has appointed

Isaac Blech to its Board of Directors. Mr

Blech has invested more than $7 million

into Medgenics and was recently part

of the firm’s Strategic Advisory Board.

As a major shareholder and director

of Socialwise, Mr Blech is amongst the

most successful private financiers in the

biotech industry. Blech has founded

seven firms: Celgene Corporation, Genetic

Systems Corporation, Icos Corporation,

Nova Pharmaceuticals and PathoGenesis

Corporation.

Eli Lilly has announced the appointment

of Andrew Hotchkiss

as President for the

Australia, Canada

and Europe. His

most recent position

was Vice President

and International

Business Unit Leader

for Lilly Oncology. Mr Hotchkiss earned

a biochemistry degree from University

College, Cardiff, and has over 25 years of

managerial experience.

Jonathan B. Lloyd Jones has been

appointed as TetraLogic’s Chief Financial

Officer and Vice President of Corporate

Development. Mr Lloyd Jones has 25 years

of corporate development and finance

experience. His previous appointments

include Vice President of Finance at

TransMolecular and Senior Director of

Corporate Development at Genzyme. Mr

Jones earned an MBA from The Wharton

School of the University of Pennsylvania.

King’s College London

has announced that

it is set to launch

a Centre for Stem

Cells & Regenerative

Medicine to be led by

Professor Fiona Watt,

former President

of the International Society of Stem Cell

Research. The Centre, which will be based

at Guy’s Hospital, will bring together the

cutting-edge stem cell research currently

taking place across the College and its

partner NHS trusts, as part of King’s Health

Partners. Through the Centre, King’s aims

to drive collaboration between scientists

and clinicians to translate the potential of

stem cells into clinical reality for patients.

XCELERON (York, UK), a company involved

in accelerating drug development using

ultra-sensitive bioanalytical analyses, has

announced that Dr David Roblin has been

appointed to its Board of Directors in a

non-executive capacity. Dr Stuart Best has

also joined the company as Senior Director

Operations.

Appointments


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Events

PharmaBrand Summit 2011

Date: June 27–29, 2011

Location: Montreux, Switzerland

Engaging and networking are the

key points of this year’s PharmaBrand

Summit. The event offers the

chance for sponsors to present their

services and products to important

European decision makers from the

leading pharmaceutical, bio and

medical technology companies. The

hottest topics are discussed through

presentations, case studies and

discussion forums.

For more information visit

http://www.pharmabrandeurope.com/

Social Media in the Pharmaceutical

Industry

Date: July 6–7, 2011

Location: London, UK

Building on the success of SMi’s

inaugural Social Media in the

Pharmaceutical Industry conference, the

group announces their follow-up event,

which will be focused on keeping our

audience up-to-date with developments

in the ever-changing social media

sphere. The conference is the only event

to focus exclusively on how social media

can be used within the pharmaceutical

industry and healthcare to foster

patient-doctor interaction, knowledge

of new treatments and also a greater

understanding of various healthcare

issues.


www.smi-online.co.uk/events/overview.

asp?is=4&ref=3498

Pharmaceutical eMarketing

Congress

Date: September 13–14, 2011

Location: Lisbon, Portugal

The Pharma eMarketing Congress

reflects the dramatic marketing

changes in the pharma industry

that were prompted by technology

changes in the past decade. By

coming to Lisbon you will be able

to learn from the real pioneers of

the pharmaceutical eMarketing and

brainstorm the best practices in this

booming pharma sector.


www.flemingeurope.com/

pharmaceuticals-conferences/europe/

pharma-emarketing-congress-2011

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Events

Life Sciences Commercial IT Summit


Location: Philadelphia, PA, USA

This events offers insight into solutions

and hear industry specific case studies

on:

• Increasing Agility and Decreasing

Costs through Adoption of Cloud-Based

Platforms

• Developing Mobility Strategies and

Deploying Mobile Applications

• Customizing and Automating Global

CRM Systems

• Creating User-Friendly Collaboration

Systems.


http://www.cbinet.com/conference/

pc11087

Pharma/Bio Forum on Preclinical

Development


Location: Boston, MA, USA

This forum provides a unique platform

for industry professionals to manage

successful partnerships throughout the

preclinical R&D process.

Hear cutting edge case studies on:

• Common pitfalls and IND approvals

• Issue specific exposure at site of

efficacy to improve safety

• Regulatory and safety strategies for

novel constructs

• Best practices for managing global

CROs

• Preclinical considerations for orphan

drug development.


http://www.cbinet.com/conference/

pc11095

BioPharma Istanbul 2011


Location: Istanbul, Turkey

Istanbul 2011, organized by Pharmanet

Consultancy, is the largest international

partnering meeting conducted in

Turkey in the fields of Pharmaceuticals/

OTC/Biotech, to be held in Istanbul

during September 29–30, 2011. The

event will bring together investors and

business leaders from pharmaceutical,

biotech and OTC companies to discuss

and exchange opportunities for

investment, partnering, distribution,

R&D and manufacture.


www.biopharmaistanbul.com/

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Editorial Julian [email protected]

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European Sales ManagerJames Gray Tel. +44 1244 393 [email protected]

US Sales ManagersBill CampbellTel. +1 847 283 [email protected]

Justin Iacobucci Tel. +1 978 567 [email protected]

Sales Operations ManagerClaire [email protected]

Group Publisher Andy Davies [email protected]

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thTuesday, September 27 , 2011

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On September 27, 2011, the 5th annual Prix Galien USA 2011, the Nobel Prize of

drug research and development, will be presented. The award ceremony is a remarkable event,

attended by a stunning coterie of Nobel Laureates, top academics, and C-level and R&D executives from top companies. Our theme: better cross cultural contacts,

harmonized regulation, internal business process improvements, new information technologies,

and effective public-private partnerships can remove barriers to the commercialization

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our efforts will extend to all who see medical innovation not only as an industrial policy asset

but as a source of social progress – where private enterprise and public engagement combine

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Pharmaceutical Executive Global Digest 24 June 2011