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Leaders Emerging Pharma Health System Changes M&A Due Diligence European Innovation

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VOLUME 34, NUMBER 8 Emerging Pharma Leaders

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From the Editor 3 leader speak

Pharm ExEc’s 2014 rostEr oF EmErging lEadErs—our eighth, comprising an honor class of nearly 200 recipients to date—is more than just a way to recognize young executives who’ve made a difference in their organizations. Each list also serves as a window on work in an industry that, perhaps more than any other, relies on human capital as the coinage of success. Because our nominees are selected on the basis of a track record in directing teams, we can identify current trend lines around leadership behaviors: in a distracted world, fxing clear goals, with messages that motivate; keeping people on point and accountable for results; taking on reasonable risks while accommodating failure; and avoiding those process regimens that plague large institutions through a commitment to William looney diversity—in culture, ideas, and talent. Editor-in-Chief [email protected] he following is a capsule summary of in- There will be no profts from tomorrow’s individ- Follow Bill on Twitter: T sights about our changing industry gleaned ually targeted biologics if process technologies fail from the 15 emerging leader profles com- to keep pace with the complexities of reproducing @BillPharmExec piled by the Pharm Exec editorial staff: them in a scalable, cost-effcient manner, for safe new competitors in the pharma space. This use by patients worldwide. year’s list features two young CEOs from Russia numbers don’t tell the full story. While and Portugal whose companies are venturing big data has been touted as the solution to the beyond their protected domestic base to test industry’s evidentiary challenges, there is a grow- big-time opportunities in the US, Europe, and ing awareness that numbers alone do not create Japan. Antonio Portela, CEO of Portugal’s Bial, the interpretive knowledge required to guide capped years of effort in securing an FDA market- decisions. A prized asset for managers these days ing license in November 2013 for the epileptic is the ability to draw insights, establish context, drug Aptiom—the frst new medicine developed and simplify the complex, which means that data in Portugal for sale in the US. R-Pharm CEO is best applied as a tool toward that larger end, Aleksey Repik is transforming Russia’s second- where the necessary judgments must be made by largest domestic drug company into a global people relying on learned experience and—yes — player linked to a network of partnerships with intuition. It follows that none of our leaders wish the cream of big Pharma, all while making his to be known as “quants,” but emphasize those company top of the league within Russia as the softer people skills that allow managers to adapt sole local producer able to meet global standards and stay ahead of the curve imposed by today’s for GMP. Both companies are family owned, a unruly markets. As one leader says, “always start familiar model for successful businesses in the with the end in mind.” And data can only take emerging market countries, and one that insulates you part of the way. them from the short-term investor pressures as- science is shaping career choices. As the sociated with being publicly held. Interestingly, recording of the human genome allows more many of today’s big Pharma players started out precise targeting of drugs to address specifc the same way—give or take a century. conditions, all diseases are becoming rare diseases, globalization of the talent pipeline. Job assign- with dozens of specialty biologics to treat them ments and career growth are tracking to a much now emerging from industry labs. For our leaders more global trajectory, with many of our leaders in commercial development, the best therapeutic remarking how they have benefted from postings opportunities are now found in this space. This outside their cultural comfort zones. Europeans is despite the fact they all cut their management are obtaining high-profle assignments managing teeth on traditional small-molecule products for US businesses, while one of our American lead- chronic, big population conditions applied in pri- ers became a change agent in transforming his mary care settings with a high level of generic pen- company’s approach to market analytics in Japan. etration. The transition to specialty drugs imposes Overall, the immigrant experience continues to a signifcant learning curve on all marketers, and enrich the managerial talent pool in the US. Leg- this generation of leaders is frst to experience it. islators in Washington, take note. silo thinking—the albatross that still wanders. supply chain manufacturing—from pumpkin to Organizational structure, offce politics, culture the gilded coach. As three of our leaders can at- barriers, and the inbreeding created by functional- test, operations management is no longer a techni- ized expertise remains the key obstacle to turning cal backwater but a front line strategic capability strategy into results. The will to change has to be that has the undivided attention of the “c-suite.” matched with real incentives, says our group.

magentablackcyanyellow ES472822_PE0814_003.pgs 07.26.2014 04:05 ADV PHARMACEUTICAL EXECUTIVE AUGUST 2014 www.PharmExec.com

4 Pharmaceutical Executive’s 2014 Editorial Advisory Board is a distinguished group of thought leaders with expertise in various facets of pharmaceutical research, business, and marketing. EAB members suggest feature subjects relevant to the VOLUME 34, NUMBER 8 industry, review article manuscripts, participate in and help VP OF SALES & GROUP PUBLISHER TEL [732] 346.3018 Russ Pratt [email protected] sponsor events, and answer questions from staff as they arise. EDITOR-IN-CHIEF TEL [212] 951.6735 William Looney [email protected] Murray L. Aitken Clifford Kalb MANAGING EDITOR TEL [732] 346.3022 Senior Vice President, President, Michael Christel [email protected] Healthcare Insight, C. Kalb & Associates IMS Health SENIOR EDITOR TEL [212] 951.6738 Bernard Lachappelle Benjamin Comer [email protected] Stan Bernard President, EUROPEAN & ONLINE EDITOR TEL 011 44 [208] 956.2660 President, JBL Associates Julian Upton [email protected] Bernard Associates SPECIAL PROJECTS EDITOR TEL [212] 951.6742 Rajesh Nair Marylyn Donahue [email protected] Frederic Boucheseiche President, COMMUNITY MANAGER TEL [732] 346.3009 Chief Operating Off cer, Indegene Hannah Becker [email protected] Focus Reports Ltd. Daniel Pascheles ART DIRECTOR TEL [218] 740.6411 Joanna Breitstein Vice President, Steph Johnson-Bentz [email protected] Director, Communications, Global Business Intelligence, WASHINGTON CORRESPONDENT TEL [301] 656.4634 Global TB Alliance Merck & Co. Jill Wechsler [email protected] EDITORIAL OFFICES TEL [212] 951.6600 Drew Bustos Elys Roberts Vice President, Global Communications, President, 641 Lexington Avenue, 8th f oor FAX [212] 951.6604 Cegedim Relationship Management Ipsos Healthcare North America New York, NY 10022 www.pharmexec.com SALES MANAGER-EAST COAST TEL [732] 346.3054 Don Creighton Barbara Ryan Mike Moore [email protected] Managing Director, FTI Consulting Senior Director, Market Access, SALES MANAGER–MIDWEST, SOUTHWEST, WEST COAST TEL [847] 283.0129 PriceSpective, an ICON Company Alexander Scott Bill Campbell [email protected] SENIOR PRODUCTION MANAGER TEL [218] 740.6371 Rich Daly Vice President, Business Development, Karen Lenzen [email protected] President, Eisai Corp. of North America AstraZeneca Diabetes AUDIENCE DEVELOPMENT MANAGER TEL [218] 740.7285 Michael Swanick Kelly Kemper [email protected] Global Practice Leader Pharmaceuticals Rob Dhoble REPRINTS 877-652-5295 EXT. 121 and Life Sciences, PwC CEO, [email protected] Adherent Health Mason Tenaglia Outside US, UK, direct dial: 281-419-5725. Ext. 121 Managing Director, CLASSIFIED SALES & RECRUITMENT TEL [440] 891.2793 Bill Drummy The Amundsen Group, an IMS Company Tod McCloskey [email protected] CEO, DIRECT MAIL LISTS TEL [440] 891.2773 Heartbeat Ideas Peter Tollman Tamara Phillips [email protected] Senior Partner, Managing Director, James Forte Boston Consulting Group Vice President, Marketing, JOE LOGGIA, Chief Executive Off cer; TOM FLORIO, Chief Executive Campbell Alliance Al Topin Off cer Fashion Group, Executive Vice-President; TOM EHARDT, President, Executive Vice-President, Chief Administrative Off cer & Chief Les Funtleyder Topin Associates Financial Off cer; GEORGIANN DECENZO, Executive Vice-President; President, CHRIS DEMOULIN, Executive Vice-President; REBECCA EVANGELOU, Poliwogg Investment Advisors Bill Trombetta Executive Vice-President, Business Systems; JULIE MOLLESTON, Professor of Executive Vice-President, Human Resources; TRACY HARRIS, Sr Vice- John Furey Pharmaceutical Marketing, President; DAVE ESOLA, Vice-President, General Manager Pharm/ Global Franchise Head Vaccines, St. Joseph’s University Business School Science Group; MICHAEL BERNSTEIN, Vice-President, Legal; FRANCIS Baxter Healthcare HEID, Vice-President, Media Operations; ADELE HARTWICK, Vice- Joseph Truitt President, Treasurer & Controller Matt Gross Senior Vice President and Director, Health and Life Sciences Chief Commercial Off cer, Global Practice, SAS Achillion Pharmaceuticals Terry Hisey David Verbraska Vice Chairman, Vice President, Regulatory Policy, ©2014 Advanstar Communications Inc. All rights reserved. No part of this publication Nat’l Sector Leader, Life Sciences, Pf zer may be reproduced or transmitted in any form or by any means, electronic or mechani- Deloitte cal including by photocopy, recording, or information storage and retrieval without Albert I. Wertheimer permission in writing from the publisher. Authorization to photocopy items for internal/ Michele Holcomb Professor & Director, educational or personal use, or the internal/educational or personal use of specif c Vice President Corporate Strategy, Pharmaceutical Health Services Research, clients is granted by Advanstar Communications Inc. for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, Teva Pharmaceuticals Temple University 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 Bob Jansen Ian Wilcox 440-756-5255 or email: [email protected]. Principal Partner, Vice President, Advanstar Communications Inc. provides certain customer contact data (such as Zensights LLC Hay Group customers’ names, addresses, phone numbers, and e-mail addresses) to third parties who wish to promote relevant products, services, and other opportunities that may Kenneth Kaitin Peter Young be of interest to you. If you do not want Advanstar Communications Inc. to make your President, contact information available to third parties for marketing purposes, simply call toll- Director & Professor, free 866-529-2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer Center for the Study of Drug Development, Young & Partners service representative will assist you in removing your name from Advanstar’s lists. Tufts University Outside the U.S., please phone 218-740-6477. PHARMACEUTICAL EXECUTIVE does not verify any claims or other information appear- ing in any of the advertisements contained in the publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. PHARMACEUTICAL EXECUTIVE welcomes unsolicited articles, manuscripts, photo- 2011 Neal Award Winner for graphs, illustrations, and other materials, but cannot be held responsible for their “Best Commentary” safekeeping or return. To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477.

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6 Contents

Healthcare Reform A Mission to Transform William Looney, Editor-in-Chief

Mid-career students at Brown University’s new Executive Masters in Healthcare Leadership program are challenging the status quo with workplace projects focused on one thing: removing the organizational silos that slow innovations in the delivery and f nancing of heathcare. 40

2014 Emerging Pharma Leaders This year’s class of 15 leaders is engaged in work that is very much of the moment, with capabilities that range from deep therapeutic know-how to management and operational excellence—all bound by an underlying commitment to the patient perspective that brought them to this industry in the f rst place. Our choices are a ref ection of a simple truth: pharma remains at heart a people business. 16 NEWS & ANALYSIS STRATEGY & TACTICS INSIGHTS Washington Report Compliance From the Editor 10 Struggle Over Social 44 Only Fools Rush 3 Leader Speak Media Continues In: The Importance William Looney, Editor-in-Chief Jill Wechsler, Washington of Pre-Acquisition Correspondent Due Diligence Back Page By Severin Wirz Global Report 54 Google Glass—A User’s 12 EFPIA’s ‘Integrated Guide in Healthcare By Sean Turbeville, David A. Wells, Strategy’ for Europe: and Charles Wolfus Out of the Frying Pan, Into the Fire? Ref ector

Country Report: Chile 45 Pharma’s Changing Landscape Focus Reports, Sponsored Supplement 2014 kicks off a def ning period for healthcare in Chile as a new national drug law is implemented, with the hopes of creating a system that makes access to medicines easier and more transparent for patients.

PHARMACEUTICAL EXECUTIVE VOLUME 34, NUMBER 8 (Print ISSN 0279-6570, Digital ISSN: 2150-735X) is published monthly by Advanstar Communications Inc., 131 W. First St., Duluth, MN 55802- 2065. Subscription rates: $70 (1 year), $125 (2 years) in the United States and Possessions; $90 (1 year), $145 (2 years) in Canada and Mexico; $135 (1 year), $249 (2 years) in all other countries. Price includes air-expedited service. Single copies (prepaid only): $7 in the United States, $9 in all other countries. Back issues, if available, are $20 for the United States and Possessions, $25 for all other countries. Include $6.50 per order plus $2 per additional copy for US postage and handling. If shipping outside the United States, include an additional $10 per order plus $3 per additional copy. Periodicals postage paid at Duluth, MN 55806 and additional mailing off ces. POSTMASTER: Please send address changes to PHARMACEUTICAL EXECUTIVE, PO Box 6180, Duluth, MN 55806-6180. Canadian G.S.T. Number: r-12421 3133rt001, Publications mail agreements NO. 40612608. Return Undeliverable Canadian Addresses to: IMEX Global Solutions, P. O. Box 25542, London, ON N6C 6B2, Canada. Printed in the USA.

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: Is the pharma The supply chain is less secure Qsupply chain more 8% secure than f ve years ago?

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2014 Pharm Exec 50 June issue online No change in Waseem Noor, Michael security levels Kleinrock 66% bit.ly/1qkZbyr

Vaccines: Fire in the Cold Chain July issue online Kevin Fitzpatrick, Nitin Readers Weigh In Keep in Touch! Mohan Amazing that GSK is so motivated to treat an Scan here with your bit.ly/1tBJXWE smartphone to sign up for entirely preventable disease. If they were really weekly newsletters about health instead of prof ts, their sales force would be out selling smoking cessation products and advocating for clean air legislation. Oh well, I guess if getting an extra 5% improvement on your FEV1 (statistically signif cant, clinically not-so-much) is worth breaking the healthcare bank account, then party on GSK reps, party on! TMACK, 7/8/14 “Deep Breadth: GSK Doubles Down on COPD and Asthma” Coming soon to bit.ly/1chKB4V PharmExec.com Abrams Talks When you say “monitor,” you mean monitor what Social Media at DIA they themselves, and those acting on their behalf, Blog post are posting, right? If you mean monitoring for Ben Comer bit.ly/1rC6YuE independent user-generated content (to correct misinformation, maybe?), I can’t f nd reference to that. Laurie Meehan, 7/10/14 Social Media “Making the Most of Social Media (Within FDA’s New Guidelines)” bit.ly/1jbDO2H Questions Pharma I see a history-making alliance in the works. The Should Be Asking pharma industry should partner with women’s health Annual Industry Audit Blog post Pharm Exec ranks the top 25 bit.ly/1icXNh3 advocates to form the “Freedom to Fornicate pharma companies based on Foundation.” more than a dozen metrics, and Skip Mendler, 7/3/14 IDs industry’s top performer in “Will the Supreme Court Spur OTC Contraceptive Development?” Most-read stories online: delivering shareholder value. Photos: Thinkstock June 25 to Julu 24, 2014 bit.ly/Uj2x9F

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10 Washington Report

Marketers don’t have to in- Struggle Over Social form FDA of every corrective posting, but should keep a record of such communications. Media Continues That advice builds on another Tweeting limited, corrections okay, says FDA, as industry, FDA guidance published in regulators wrestle with the digital world. January 2014 that aimed to simplify how marketers should he Internet and interactive risky, as proposed by industry; inform OPDP of Internet post- T social media provide an without equal presentation of ings. FDA acknowledges that effcient, low-cost way to risks and benefts in a charac- presubmission is not practi- send messages fast to millions of ter-limited message, OPDP ad- cal for continued participation people—and to targeted patient vises marketers to “reconsider in social networks and online populations. But pharma com- using that platform,” especially forums; after initially submit- panies have been slow to take for products with complex indi- ting information on a website, advantage of these methods, cations or serious risks. OPDP permits companies to largely because of FDA rules that A second draft guidance send in a monthly list of its control what manufacturers can gives marketers some leeway to postings, while keeping records state about their products. FDA correct misinformation on drugs of postings on fle. has been rolling out new guidelines for using interactive media in recent months. The new guid- The irony of the social media ances clarify some murky areas, marketing debate is that patients but may not make online communications any easier. increasingly turn to the Internet to FDA’s Offce of Prescrip- search for health information, tion Drug Promotion (OPDP) provides some useful advice in identify possible treatments, and its new advisories, which were confrm diagnoses. FDA, itself, is a discussed further in an OPDP webinar July 10 (slides avail- heavy user of social media. able at www.fda.gov). Overall, the agency sticks to its rules and medical devices posted on But in trying to defne which requiring ads and promotional the Internet by independent communications are a marketer’s messages to be accurate, not third-parties. Corrections of responsibility and thus should be misleading, balanced, and lim- “user-generated content” (UGC) submitted, this earlier guidance ited to approved uses. Because have to be truthful and not mis- raised a lot of objections from it’s very hard to get full risk in- leading, apply only to messages industry. Marketers complained formation into a 140-character outside company control, and that the guidance makes them tweet or search engine listing, should not be used as “a spring- responsible for too broad a range such communiqués may not ft board to engage in promotional of Internet postings and question FDA’s regulatory scheme for messaging,” explained attorney whether tweets and “likes” con- drugs and medical products, Jeffrey Wasserstein on the FDA stitute advertising or labeling— according to a draft guidance Law Blog (www.fdalawblog. or really fall under “free speech” on using the Internet and social net, June 17, 2014). Marketers that lies outside FDA rules. media platforms with charac- should address only the spe- A fnal guidance is slated to ter space limitations (published cifc misinformation cited, but address FDA’s concerns about June 16, 2014 at www.fda.gov). are not expected to continually using links to other Internet sites There’s no leeway to use icons monitor the site and track fur- that discuss drug risks and bene- to indicate that all drugs are ther comments. fts. FDA has warned against connecting to off-label information, Jill Wechsler is Pharm Exec’s Washington correspondent. She can be reached at and that a “one-click” process [email protected].

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Washington Report 11

for linking to full risk and beneft information does not satisfy its Sunshine gets murkier requirements for fair balance and Pharma marketers received an unpleasant surprise from the Obama full disclosure. administration just as everyone was leaving Washington for the July FDA also includes on its list of 4th holiday. As part of an extensive update to rules governing Medi- social media guidances a docu- care payments to physicians for 2015 is a proposal to kill an impor- ment published in December tant provision in the Open Payments program that exempts reporting 2011 on how industry can re- for payments to providers of certifed continuing medical education spond to “unsolicited requests” (CME) programs. That policy recognized that marketers don’t know for off-label information—both which physicians attend a CME session or what the program costs online and in public meetings. per attendee. OPDP advised marketers to The Centers for Medicare and Medicaid Services (CMS) justifed provide answers to such ques- the change as creating a “more consistent reporting requirement,” tions privately and off-line, an without explaining how marketers should calculate the value of edu- approach that remains in effect cational programs for physicians and teaching hospitals. The about- despite loud objections that it’s face evidently refects pressure from patient advocates who consider impractical and confusing. industry-supported CME a backdoor way to infuence prescribing and feared the reporting exemption would encourage more pharma fund- Nothing new ing of such programs. The change “will be a blow to doctor education These social media guidances re- and good patient care,” says John Kamp of the Coalition for Health- care Communication. It also dims prospects for marketers to gain fect FDA’s continuing struggle to any leeway from CMS on reporting the value of textbooks and journal reconcile drug advertising regula- reprints provided physicians. tion with changing information technology. The agency held a hearing on FDA & the Internet age. The agency’s response was keting to support new product back in October 1996 to explore to propose new research on how launches and to reach targeted appropriate pharma use of web- consumers respond to risk in- patient populations. sites and chat rooms. The dis- formation presented on various The irony of the social media cussion addressed strategies for websites. So Congress added a marketing debate is that patients correcting erroneous product in- provision to the FDA Safety & increasingly turn to the Internet formation posted on the Internet, Innovation Act of 2012 (FDA- to search for health information, manufacturer use of links to other SIA) requiring the agency to ad- identify possible treatments, and websites, and impact of rules set dress social media communica- confrm diagnoses. FDA, itself, by the Federal Trade Commission tions by July 2014. is a heavy user of social media to and international agencies—all Even with the new advisories, announce new approvals, broad- issues that were not resolved and pharma companies may continue cast safety warnings, and raise remain controversial today. to lag far behind other industries policy issues. Meanwhile, FDA ramped up in utilizing the Internet to com- FDA’s insistence that market- citations for noncompliant Inter- municate important information ers convey only truthful and bal- net messages, culminating in 14 to the public. Drugmakers have anced information on products violation notices in 2009 to com- been using social media primar- also ignores developments that panies sponsoring search engine ily for corporate operations— permit outside parties on all sides ads that lacked full risk informa- announcing fnancial reports, to weigh in on company claims tion. Other letters held companies hiring employees, recruiting and present alternative positions. accountable for statements from clinical trial investigators and Increased transparency in re- third-party websites and blogs. participants, and disease aware- search results and treatment rec- Marketer objections prompted ness. There is disagreement over ommendations, readily available another FDA public hearing in how effective the Internet is for through Internet websites and November 2009, where dozens detecting adverse drug events. social media, speaks to the need of industry representatives and And it’s not clear how pharma for new regulatory approaches by IT vendors demanded changes in can utilize opportunities to im- FDA and much greater enforce- FDA rules to better ft the digital plement “multi-channel” mar- ment “discretion.”

magentablackcyanyellow ES472813_PE0814_011.pgs 07.26.2014 04:04 ADV PHARMACEUTICAL EXECUTIVE AUGUST 2014 www.PharmExec.com

12 Global Report

collaborative solutions to ad- EFPIA’s ‘Integrated dress the EU’s growing health and competitiveness challenges.” It urges changes in percep- Strategy’: Out of the tion, more “thinking outside the box,” better understanding Frying Pan, Into the Fire? of future demands and of the Industry’s grand vision for reshaping the life sciences in Europe value of investment, and the “need to address the system may ultimately prove to be a lost cause. as a whole” in order to create sustainable systems. Of course t’s diffcult to open an email trum begin work to improve the central refrain of the vision Ior an envelope in Brussels Europe’s future, EFPIA calls is “ensuring that the pharma- these days without yet an- for greater political collabora- ceutical and life sciences in- other agenda falling out of it, tion,” the industry association dustries—jewels in Europe’s carrying the promise of a new specifes. economy—continue to thrive.” start. With a new European Consequently, much of the Parliament installed, a new Eu- Into the fre content is devoted to the need ropean Commission president It is reasonable to expect that for the industry to be “highly appointed and a new Commis- new European leaders and poli- competitive” and for “innova- sion on the way, and guarded cymakers will begin work to tion-led growth.” The merits optimism that the worst of the improve Europe’s future. But of the industry—in terms of recession is over, this outpour- given the notorious absence of those familiar claims relating ing of recommendations and political collaboration in Eu- to products, jobs, exports, or recipes is hardly surprising. ropean health affairs, it is im- research commitment—occupy Hope springs eternal in the hu- prudent to assume that all that much of this manifesto. man breast. The trend is refected in the medicines sector, with a Given the fundamental nature of plethora of manifestos and the challenges that Europe is facing, strategy proposals from industry, regulators, and cam- what emerges may actually be paigning organizations. One of worse than the current imperfect the most grandiose is the self- styled “groundbreaking vision context for medicines. towards a life sciences strategy for Europe,” launched in high work will improve the situation So, too, does the catalogue summer by the European Fed- for the drug industry. Given the of the economic problems the eration of Pharmaceutical In- fundamental nature of the chal- industry faces. EFPIA warns dustries and Associations. lenges that Europe is facing, against “making it diffcult to This “landmark paper” what emerges may actually be obtain innovative medicines, claims to provide steps to- worse than the current imper- increasing user charges, or del- wards “an integrated strategy” fect context for medicines. EF- isting services from the benefts for the sector in Europe. “With PIA and other industry advo- catalogue.” It complains about Europe now emerging from the cates of radical change run the the distortion that internation- crisis, there is an opportunity risk of jumping out of the fry- al reference pricing creates in to improve health prospects ing pan only to fnd themselves the European market for medi- of citizens, while promoting in the fre. cines—going so far as to call economic growth. As new Eu- The essence of the EFPIA for an urgent review of “the ropean leaders and policymak- call to arms is a plea for “a new practical operation of the free ers across the political spec- generation of partnerships and movement of goods principle in medicines.” It blames “the Refector is Pharmaceutical Executive’s correspondent in Brussels.

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14 Global Report

current patchwork of valuation for health, was unambiguous in penditure under control and im- and assessment criteria across urging greater emphasis on pre- prove health outcomes without Europe” for being “arbitrary vention rather than treatment: the contribution from increased and politicized,” and “leading “Only a tiny fraction is spent innovation that Viehbacher and to wasteful and costly duplica- on prevention,” he said, asking EFPIA appear to be counting on. tion of effort.” And it cautions “Does this proportion make EFPIA quotes European Com- that “arbitrary fnancial poli- sense, when many of the most mission estimates that, without cies” are inhibiting investment prevalent chronic diseases are new approaches, average health- in research. largely preventable?” And the care spending could rise from EU health council in June cham- 7% to 9% of GDP by 2060, Other voices clamoring pioned health promotion and placing a strain on national f- All this is fair enough. It is the role disease prevention as “key fac- nances. The conclusion EFPIA of a powerful sector association tors for better health,” and rec- draws, that “halting and revers- to extol the merits of the sector ognized “the importance of in- ing the progression of chronic it represents, and argue the case vesting in health promotion and diseases is the best investment for it to receive favorable treat- disease prevention in improving that health systems can make,” ment. But there are other voices the health of the population.” may be correct—but it may also clamoring to be heard, and other be true that the objective might tendencies shaking the ground. Selective myopia be achieved by prevention rather The presumption that in all the There is a form of selective than by treatment. prospective changes, “medicines myopia in the vision of the Against this background, have a key role to play,” is one EFPIA strategy. Its president, EFPIA may not win the back- that the industry will naturally Christopher Viehbacher, who ing it expects for its priorities make. It is not, however, univer- is also CEO of Sanof, said as of “removal of inequalities to sally shared—and some of the he outlined the strategy: “Only better patient benefts,” support alternative thinking comes from a signifcant improvement in for “systems to speed access to sources which are also powerful. health outcomes, supported by medicines,” or “the building of Not least among those voices increased innovation, can keep a thriving innovative life sci- is the European Union itself. Its healthcare expenditure under ences sector.” If the outcome of years of ruminations about how control.” This is not strictly all this radical re-thinking and to make health systems sustain- speaking true. It presupposes new partnerships is that much able have still to lead to defnite that the long-hallowed ap- greater priority is given to pre- conclusions, but the trend is evi- proach to healthcare expen- vention, EFPIA’s ambitions for dent in the interim decisions it is diture remains intact: that is, a “new European life sciences now reaching. In early July, the seeking better and better medi- strategy that will beneft pa- EU Council gave legal force to a cines to treat more and more tients and society as a whole” long series of recommendations illnesses. may prove to be of no beneft that include telling Austria “to That presumption is at the whatever to the drug industry. reinforce preventive healthcare, very least questionable, and at On the contrary, budgets for which public spending is be- worst, may be rendered invalid for treatment might be sub- low EU average,” Croatia that by a seismic shift in European ject to cuts much sharper than control over public expenditure health strategy that could pro- those that industry currently on healthcare “is not achieved,” foundly modify the resource- complains of, and the trends in and France that pharmaceuti- allocation between treatment spending might move resources cal spending is one area where and prevention. If the allocation irreversibly from treatment to “effciency could be further im- of resources was inverted (it is prevention. Industry optimists proved.” By contrast, Finland’s customarily estimated that less would do well to remember the “stronger focus on prevention” than 5% of current healthcare somber conclusion of that fa- is “credible and relevant.” spending is devoted to preven- mous couplet about hope spring- At a summit in April to dis- tion, with the rest devoted to ing eternal in the human breast. cuss chronic disease, Tonio treatment), it might also be It concludes tartly: “Man never Borg, European commissioner possible to keep healthcare ex- is, but always to be, blest.”

magentablackcyanyellow ES472805_PE0814_014.pgs 07.26.2014 04:04 ADV Seeing the Whole Picture Harnessing the Power of Data to Drive Smarter Marketing Decisions ON-DEMAND WEBCAST

EVENT OVERVIEW: Webcast participants The rapid growth of digital channels has made the marketing activities of will learn: life science companies more complex than ever before. A lack of uniform n How to create a standardized measurement standards, siloed reporting and incompatible data across governance around key both agencies and brands have created an environment where many digital marketing sources

organizations are unable to determine which channels are driving real n How to overcome barriers impact and where change is needed. to establishing a single reporting system capturing In this webinar, leading experts in digital marketing and analytics will share all digital marketing data. insights and best practices for capturing and integrating disparate sources n How to ensure successful of marketing data into a system that can give organizations the ability adoption of digital to see how each channel and channel spend is truly afecting marketing measurement systems by all performance. agencies and vendors

Who Should Attend:

n Marketing professionals within life sciences and health care companies

Presenters

Sponsored by Gary Angel Iya Khalil, PhD Principal, Executive Advisory Services Vice President EY and co-founder, GNS Healthcare

Moderator Peter Buscemi Founder, Sara Barschdorf Presented by Four Quadrant, LLC Webcast Manager, Pharmaceutical Executive

For questions, contact Sara Barschdorf at [email protected]

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16 Emerging Pharma Leaders

2014 Emerging Pharma Leaders This year’s class of 15 young executives is deeply of the moment, with assignments that include advancing therapies against hepatitis C, building new cell-based platforms in regenerative medicine, creating new businesses beyond a protected home base, restructuring the supply chain to accommodate a new generation of complex biologics, and transforming raw data into “news I can use” analytics. The emotional viscera that binds all is a commitment to the patient. Despite those legions of lawyers, accountants, bankers, and regulators—none of whom made the list this year—pharma remains at heart a people business.

And the Leaders Are… Sachin Jain, Chief Medical Information and Innovation Offcer, Merck & Co. (In alphabetical order) Arnaud Lesegretain, Vice President, Global Brand Development , Eli Lilly & Co. Joerg Ahlgrimm, VP of Operations, Baxter BioScience Tom McDonnell, Vice President, Product Strategy Lead—Neuroscience, Shire Pharmaceuticals Jenise Doutsas, Global Strategic Lead, Fertility, Ferring Pharmaceuticals Jamey Millar, VP Oncology Business Unit Head, GlaxoSmithKline Brian Goff, Global Franchise Head, Hemophilia, Baxter Healthcare António Portela, CEO, Bial Ian Harris, Senior Director and Platform Leader, Cell Therapy, Janssen Research & Development Alexsey Repik, Founder and Chairman of the Board, R-Pharm Susanne Heinzinger, Executive Director of Product Strategy and Alliance Monica Tellado, VP, US commercial operations. Gilead Sciences Management, Achillion Pharmaceuticals Hayden Thomas, VP, formulation development, Vertex Pharmaceuticals Michael Injaychock, Director, Marketing Innovation, Research and Jocelyn Trokenheim, Head of Global Business Development Offce and Commercial Analytics, Eli Lilly & Co. Strategy, Takeda Pharmaceuticals

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18 Emerging Pharma Leaders

Man on the Mark Joerg Ahlgrimm, VP of Operations, Baxter BioScience

y the middle of 2015, global Liquid advice healthcare giant Baxter Interna- “Don’t preach water and drink wine,” B tional Inc. is expected to offcially says Ahlgrimm, whose operations arm split off its BioScience business, establish- encompasses more than 10,000 employ- ing the unit as an independent, innova- ees across facilities in the US, Europe, and tion-focused biotechnology company. The in Singapore. “You have to demonstrate new organization, which will maintain its the expectations you have from the orga- industry-leading role in developing and nization through your own behaviors.” manufacturing plasma-based proteins to For Ahlgrimm, that philosophy ad- treat hemophilia and other rare bleeding heres to the mantra: “never become com- disorders, plans to support as many as 20 placent. Something can always be made product launches in the next few years. better.” He is quick to acknowledge that Helming the operational component of he had to learn that mindset himself early these pursuits will be Joerg Ahlgrimm, the in his career. Ahlgrimm’s frst experi- commodate new products and growing division’s current vice president of opera- ence in the pharmaceutical industry was global demand, while allowing enough tions and global supply chain. Ahlgrimm through an internship while enrolled at fexibility to be a leader in local mar- was appointed to the post in late 2013, Ernst-Abbe-Fachhochschule Jena, an kets. In today’s cost-constrained market, when the BioScience unit combined its applied sciences university in Jena, Ger- Ahlgrimm has been integral in fnding global operations structure and network many. He eventually joined Baxter in ways to gain consistency and effciency under one leader. As the defning stage in 2001 as supervisor of packaging schedul- across Baxter’s manufacturing facilities. the division’s evolution nears, Ahlgrimm ing in Vienna, Austria. Three years later, In 2012, his team successfully negoti- is developing an aggressive strategy to Ahlgrimm was promoted to director of ated and implemented a manufacturing ensure that operations and supply chain supply chain for Baxter BioScience before services partnership with Sanquin Blood management is optimized to support Bio- being named vice president of global sup- Supply Foundation, which provides Bax- Science’s future growth. ply chain in 2008. ter up to 1.6 million liters of incremental Amid Baxter’s business transformation “At the beginning of my career, I was plasma fractionation capacity annually and the completion of fnal steps in sepa- convinced that to play to my strengths to support global growth of plasma-de- rating its BioScience and Medical Products was much more important than to con- rived treatments. The agreement not only businesses, one could certainly assume sider my weaknesses,” says Ahlgrimm, helped meet a supply need for Baxter in a Ahlgrimm’s focus is on the big picture 41. “I received good constructive feed- relatively short timeframe, but it also pre- these days. After all, as head of operations, back in some of our talent review pro- vented the need to build another facility his organization supports more than $5.5 cesses around my personal behaviors. in the short-term. billion in sales and more than $2 billion in This taught me to be much more open to Ahlgrimm’s hope is that such efforts value of production. Ahlgrimm’s belief is feedback.” will help raise the bar in developing effec- that operations, which he calls the “back- Ahlgrimm credits those experiences tive therapies for some of the most com- bone” of a premiere biotech company, for adjusting his leadership style for the plex conditions in the world. Along with will be an important enabler for the new better. Ahlgrimm became a better listener targeting hemophilia and other chronic BioScience company in the years ahead. It and instead of focusing more on all the bleeding disorders, Baxter produces plas- seems clear that Ahlgrimm—who has held things he already did well, he took a hard ma-based therapies to treat immune de- a number of leadership positions at Bax- look at opportunities for improvement. fciencies, alpha 1-antitrypsin defciency, ter since 2001—is intent on viewing the “One big learning over time was this and burns and shock. The company is looming spinoff and all the accompanying whole notion of building networks, estab- also developing programs in new prior- expectations as his opportunity to apply lishing mentoring relationships, gaining ity focus areas, including niche areas of the day-to-day management skills that feedback, and continuously working on oncology and biosimilars. have gotten him this far—on the precipice becoming a better you,” says Ahlgrimm. “The products we produce support of leading the operations of a new global Following that process has translated patients who rely on them every day to biopharmaceutical company. Ahlgrimm’s to tangible success for Ahlgrimm. Dur- manage very challenging, chronic, and forward-minded and collaborative leader- ing his career at Baxter, he has helped often rare conditions,” says Ahlgrimm. ship style has served as a driving force of identify ways in which the company can “For every patient who needs them today, change at Baxter, his colleagues contend. expand its global supply chain to ac- we have an obligation to make sure they

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Emerging Pharma Leaders 19

have uninterrupted access to our quality projects,” says Ahlgrimm. “The commer- drugmakers being very much internally products. My day-to-day job is also one cial success of these launches, especially focused to now tapping more heavily of my biggest challenges—just making in a biopharmaceutical company, is very into external networks to support the sure that our patient community gets a much dependent on how strong opera- many diverse aspects of their business. reliable supply. And in the long term, tions is able to keep up with demand, set This has resulted in increased activ- we are challenged to fnd ways for more up the large-scale manufacturing process ity around industry consolidation, as- people to get these valuable treatments. to execute those launches from a day-to- set transfers, and spinoffs, Ahlgrimm There are so many people in the world day management point of view, and then acknowledges. He points to the im- with rare diseases who don’t receive any successfully deliver these new treatments portance of companies “sharpening treatment, or who are not even diag- to patients.” their profle” by removing silos in sup- nosed, even though a treatment or help Though certainly ambitious, Baxter ply chain manufacturing, purchasing, for their condition is available. Our goal feels the 20-product goal is an achiev- R&D, and other specialty areas—and is to make sure that those people are be- able plan, Ahlgrimm says. He believes, integrating them into a more end-to- ing helped, too.” from an operations standpoint, that the end-focused organization. Ahlgrimm believes the limited treat- recent restructuring of the BioScience “When you look at the microeconom- ment reach for patients with rare disor- business has helped establish the or- ic environment, the ability of an organi- ders is a combination of lack of aware- ganizational foundation to enable suc- zation to change faster than the market ness and funding or health economic cessful product launches over the next conditions and the competition will de- issues in certain regions. Baxter’s goal few years. In fostering internal align- termine success going forward,” says Ahl- of 20 product launches in the next few ment around these efforts, Ahlgrimm grimm. “Demonstrating change, being a years, the company hopes, will make is inspiring BioScience colleagues about change agent yourself, and then helping a difference for patients around the the importance of the operations strat- your organization to go through change world—provided respective clinical trial egy through global internal town hall and accept change as a normal part of programs are successful. meetings, recorded video messages, and how you run your business is, in my eyes, “From the operations point of view, presentations. He notes that industry critical for our future success.” we’re getting involved very early in these trends continue to refect a shift from — Michael Christel

Thriving Through Change Chicago, managing the fertility business for 12 states “at a much bigger scale, ge- Jenise Doutsas, Global Strategic Lead, Fertility, Ferring Pharmaceuticals ography, and dollar volume.” But as she n the late 1990s, Jenise Doutsas, a took on this role, Organon announced I psychology major with a master’s they were going public; “literally two degree in occupational therapy, was days later,” says Doutsas, “they were ac- working at a hospital in Detroit when quired by Schering-Plough.” she found she was about to be laid off, a But her rise continued apace; at result of institutional changes at the hos- Schering she became an executive dis- pital stemming from the Clinton Admin- trict sales manager for the company’s istration’s tranche of healthcare reforms. fertility products. Two years later, an- So she set about thinking about what she other merger meant another paymaster, else could do that was “both healthcare- Merck & Co., where she moved up to related and fulflling.” At the hospital she associate director of global marketing, would see pharmaceutical reps coming working with the Januvia team. and going and thought, “I could do that.” Doutsas is proud of how she not only She applied to Organon Pharmaceu- survived but thrived during those major ticals for a sales job. Organon noted her From there her upward trajectory has company upheavals. “I think what they lack of a traditional sales background been steady and swift. Organon promot- taught me is that there really isn’t any- but Doutsas convinced them she had ed her to district manager and she moved thing constant,” she says. “You wonder been “selling” every day: selling to pa- from Detroit to Virginia, where, aligned if you’re going to like working for a new tients the importance of doing their ex- by territory rather than therapeutic area, organization, but you have to be ag- ercises, selling to physicians the need for she was given responsibility for manag- ile. If you believe in yourself and what an occupational therapy consult before a ing the reps for women’s health, pain, you’re working toward, you can make it patient was discharged. She got the job. and anesthesiology. She then headed for through the transitions.”

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20 Emerging Pharma Leaders

It helped, she says, that she had stuck where you don’t want to be,” Fertility is a therapeutic area she outstanding colleagues. “Organon she explains. But perhaps her biggest already knows well, of course, but, had a family feel and at Merck I strength has been her fexibility, her as she explains, “with a big move like was surrounded by really talented willingness to face up to hard choic- this you have to do something you can people, such as Arpa Garay (execu- es and those major upheavals. “I’ve leverage, something you can contrib- tive director and US market leader, taken risks and made big moves,” says ute straight away.” For Doutsas, the diabetes, at Merck), who is by far Doutsas. “To do that demonstrates key draw is the opportunity to experi- the best leader I’ve worked with. commitment and the ability to adapt ence a global marketing position out- She taught me that strategy is really to new environments.” side the US. about picking one or two things you She is currently demonstrating that Heading abroad is a natural step want to do and doing them big. She ability again. As Pharm Exec went to for someone so well versed in relo- challenged me to think differently press, Doutsas was in the midst of em- cating from state to state. And this and push myself into areas where I barking on the biggest change of her is just the start of a new phase in her might initially be uncomfortable.” life and career so far, leaving Merck nomadic career. After Europe, she Doutsas also had very clear ideas —and the United States—to move to says, “there’s China, Brazil, all those about her goals and aspirations and Europe to become global strategic amazing places. I see myself being en- has not been afraid to communicate lead for fertility at Ferring Pharma- gaged with the emerging markets at them—“If you’re not your own big- ceuticals, a Swiss-based, mid-size bio- some point.” gest advocate, you might fnd yourself pharmaceutical company. — Julian Upton

of Novartis US Primary Care Business The Healing Mission Unit, where Goff led work on new pa- Brian Goff, Global Franchise Head, Hemophilia, Baxter Healthcare tient care models to drive the company’s therapies for hypertension, Alzheimer’s or Brian Goff, a successful career disease, and osteoporosis. F can be measured by a single met- In 2012, Goff was approached by ric—the steady, uninterrupted Baxter’s BioScience division for a new cycle of progress in human health. With opportunity as head of the global he- more than 20 years in the industry under mophilia franchise, a big selling, high- his belt, Goff can cite numerous examples profle segment where the company had of how new medicines have transformed a strong market advantage due to its adversity into advantage, reducing the breakthrough work on the biology of burden of disease for patients. The blood disease. “The position attracted 45-year-old therapeutic franchise leader me because it covered an area I was less at Baxter likes to show audiences a video familiar with—diffcult, hard to treat, short of two boys at play and then ask and often rare diseases with a high level if they recognize one of them has hemo- of unmet medical need. Another thing philia. “My point is you cannot tell the I liked was Baxter’s connection to pa- difference. In a stunning reversal from degree from Skidmore College, Goff was tients.” As a pioneer with 60 years of the disability and premature death that recruited by J&J, where he was offered innovations in this area, Baxter had ex- plagued victims in previous generations, an internal audit position. “I wanted a tensive patient knowledge to draw on as that young boy with hemophilia can now more outward facing role that exposed it advanced the state of care for hemo- be treated with medicines that allow him me to the broader business, which led me philia, from the early blood transfusions the right to a normal life.” to sales and marketing.” Goff spent 14 to the safer and more patient-friendly Goff was exposed to the industry years at J&J in a series of brand build- clotting protections provided through early on, through a family neighbor who ing assignments, then in 2005 joined recombinant therapy. happened to be a sales rep. “Typically, he Novartis at its Basel HQ as a global mar- Looking back, Goff tells Pharm Exec talked a lot about his work in educating keting director. After his frst year he that culture counts. Each of the three physicians and from that I learned about moved to the cardiovascular franchise pharma majors he has worked for pro- the direct relationship between medi- to lead global marketing in the anti- vided valuable insights that broadened his cines and controlling disease.” Imme- hypertensive space. Success here led to career horizon. “At J&J, I was tutored in diately after earning an undergraduate his appointment in 2010 as VP in charge the credo that ethical behavior toward the

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Emerging Pharma Leaders 21

patient is central to being a leader. Novar- Live, not scripted “The vision declares that Baxter intends to tis was strong on operational discipline, in- Every key function in the company was be active in the rare disease space, custom- cluding the expectation that performance enlisted to help draft the vision, the cen- izing treatments and services at the level of could be measured. Here at Baxter, I see a terpiece of which is a commitment by personalized medicine.” hybrid of these two, with a more entrepre- Baxter to raise the standard of care for The vision is a living document, in- neurial focus as well as the desire to align all patients with a blood disorder. “By tegrated with the group’s annual operat- to the patient through targeted, personal- standard of care, we mean enhancing all ing plan and used as a key performance ized medicine. So I am glad my career has aspects of patient care—with a particular benchmarking tool. “It’s a calling, not unfolded the way it has.” focus on effcacy —to help every patient a statement. It aligns with all the deci- Goff decided the frst thing he needed strive to be bleed free. To the patient, every sion points taken around the business,” was a vision statement to help drive and single bleed matters, so it must matter to Goff says. In fact, the vision contributed execute the group’s strategy. A key sup- us as well.” Goff also wanted to make this to success with the project that Goff is port for this work was Dr. Bruce Ewen- pledge work globally, from two dimen- particularly proud of: a partnership Bax- stein, a Harvard Medical School hema- sions: geographically, making no distinc- ter negotiated with Hemobras, a Brazil- tologist and also Baxter’s VP for clinical tion between Baxter’s commitments to ian parastatal enterprise supervised strategy on hemophilia. Ewenstein had patients in emerging and developing coun- by the Ministry of Health, to provide long advocated a research agenda he tries as well as the mature markets; and by Baxter’s advanced recombinant protein chose to summarize in the succinct de- disease area, including not just hemophilia blood clotting therapy for the more than clarative “bleed free, one patient at a but a host of much rarer human blood 10,000 hemophilia A patients in Brazil time.” Goff decided to make this concept disorders like Von Willebrand’s disease, who lack it. The pact, signed in Novem- the core of the vision, but to render it in all marked by the absence of essential pro- ber 2012, grants Baxter exclusive rights a bit larger type: as “a bleed free world.” tein factors that promote normal clotting. to supply the drug to Hemobras for use

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22 Emerging Pharma Leaders

by Brazilian patients over a 10-year pe- took to provide treatment cover for this Mentor award. “The industry is chang- riod, after which Baxter will transfer the high-cost, high maintenance population ing so fast. What keeps me up at night production technology required to man- in the US. “Our key learning from this is worrying that our talent bench might ufacture this complex biologic to Hemo- project is how diffcult it can be to get all be lagging or too thin—I actually believe bras, in return for royalty payments that three main parts—infrastructure, edu- that, from a long-term investment point will continue for another decade. cation, and access—to ft together, in a of view, the people pipeline outweighs “The arrangement is a win for every- way that conforms to local practice pat- the product pipeline.” For the next gen- one involved. It amounts to a new busi- terns that can be very different than we eration of managers, Goff offers a single ness model, in which Brazil eventually have here.” insight, drawn from experience: take bets becomes self-suffcient in an essential On a more basic level, Goff believes on yourself; expose your inventory of medicine; Baxter benefts from a stable the most important aspect of being a lead- skills and assets to risk; and don’t let the market, with a guaranteed revenue er is developing new talent. That requires, learning curve go fat. “If there is an as- stream; and patients get assured access to today, a strong commitment to diversity, signment that scares you more than oth- the product.” According to Hemobras, evidenced by Goff’s work to advance ers, take that one. And if you are a people 30% of eligible patients have been con- women at Baxter and his recognition by manager, give the best of your people new verted to Baxter therapy in the frst year the Healthcare Businesswomen’s Asso- assignments before they are ready.” alone, a stark contrast to the decades it ciation as recipient of its 2014 Honorable —William Looney

Road to Ex-cell-ence Ian Harris, Senior Director and Platform Leader, Cell Therapy, Janssen Research & Development

hen he left school, Ian Harris the potential to be the frst marketed al- W wanted a career in brewing. logeneic product to improve vision loss in He enrolled on a biochemistry individuals with dry age-related macular degree with the intention of going on to degeneration (AMD) with geographic study a master’s in brewing at Heriot- atrophy, a condition for which there is Watt University in Edinburgh, UK. But currently no treatment. As one of the after spending, as part of his frst degree, key inventors of the platform used for a year in the pharmacutical industry de- the development of the therapy, Harris veloping in vitro disease models for der- was responsible for the preclinical phar- matology and oncology at the old Glaxo- macology, mechanism of action studies, SmithKline site in Greenford, brewing cell manufacturing process development, fell off his agenda. Harris now wanted a and product characterization. career translating science into therapies. Such work, of course, can’t be done Following a PhD in Biochemistry and alone. “You can achieve more through Molecular Biology at the University of colleagues than you can on your own,” Leeds, UK, and a postdoctoral fellow- says Harris. He’s striven to create mean- ship at the University of California, Har- ingful ways to engage his team in the embrace change and be open to inventive ris became a group leader at Beiersdorf work surrounding CNTO 2476, drawn technologies and platforms. Skin Research Center in Hamburg, Ger- from Janssen’s “start-up culture driven Bringing a novel therapeutic platform many. He joined Johnson & Johnson in to create value according to milestones.” into a mature company like J&J, which 2000, becoming principal research sci- He entrusts ownership of projects to can be predisposed to standardized pro- entist for its subsidiary, Janssen, in 2005. each of his team members, mentoring tocol and resources, can have its chal- Today, as senior director and platform them on the tools needed to meet their lenges. But Harris’s command of open, Leader for Janssen Cell Therapy, Harris goals. He has passed on the advice he has effective communication helped him se- leads a group responsible for manufac- taken to heart during his career: “Start cure the necessary investment and sup- turing clinical supplies of cell products with the end in mind. Be effcient. Ques- port from leadership. He helped to devise and determining mechanism of action. tion everything. Do what you believe in. and execute a two-day summit for 130 Harris’s work at Janssen on the cell- And if things are not working, it is up J&J attendees, including the company’s based therapy CNTO 2476 has gained to you to fx it.” The result has been to chief biotechnology offcer, chief medi- international renown. CNTO 2476 has unite his group with a shared vision: to cal offcer, and worldwide chairman of

magentablackcyanyellow ES474449_PE0814_022.pgs 07.29.2014 21:54 ADV 2014 Fall Meetings Drive Your Career to the Next Level with DIA’s Meetings.

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Emerging Pharma Leaders 23

pharmaceuticals, to foster team build- participating in conversations with glob- is, translating innovative science into ing while informing on all aspects of the al health authorities about how products meaningful therapies for patients— product development, supply chain and like CNTO 2476 can be evaluated and Harris is now aiming to broaden his marketing of CNTO 2476. The feed- brought to market. His recent confer- skills and experiences “to enable a back from the event was overwhelmingly ence and meeting presentations have general manager role.” His Janssen positive. His infuence on the J&J manu- looked at approaches to the regulation colleague, Rob Willenbucher, has no facturing supply chain saw him win the of the importation of tissues and cells; doubt that Harris will gain further Worldwide Supply Chain Collaboration as keynote speaker at the International strength and recognition as a leader Excellence Award in 2008. Alliance for Biologics Standardization and pioneer in regenerative medicine. Harris’s reach extends far beyond joint workshop he discussed viewpoints “Over the next decade I expect his J&J. As an active member of the Alli- from the US industry regarding frst-in- efforts to lead to the further develop- ance for Regenerative Medicine (ARM) human and marketing authorization. In ment, approval, and success of treat- Technology Committee and the Com- essence, says a colleague, “he’s assisting ments like CNTO 2476,” he says. “He mercialization Committee of the Inter- in the identifcation and establishment of will truly have a hand in shaping the national Society for Cellular Therapy a whole new class of therapies.” future of this industry.” (ISCT), Harris has an infuence on the Having proved himself capable of Brewing’s loss, it seems, has very regulatory environment for cell-based the career goal he set when he caught much been cell therapy’s gain. therapeutics and regenerative medicine, the pharma bug at university—that — Julian Upton

A ‘Rare’ Find Susanne Heinzinger, Executive Director of Product Strategy and Alliance Management, Achillion Pharmaceuticals

o say that Susanne Heinzinger’s marketing strategies at a big pharma T career trajectory has taken her subsidiary and, more recently, with two from one spectrum of the health- specialty biotech companies, includ- care arena to another may be an un- ing directing the successful marketing derstatement. Before entering the phar- launch of the C1 esterase inhibitor, Cin- maceutical industry as a sales person, ryze, approved in 2008 for hereditary Heinzinger, who earned a Bachelor of angioedema (HAE), a rare blood disor- Business Administration degree in ac- der. Today, Heinzinger is executive di- counting, worked as an auditor; she rector of product strategy and alliance picked the job of auditing hospitals and management at Achillion Pharmaceu- home healthcare companies, mainly be- ticals, where she leads the company’s cause she had always had an interest in global product positioning and launch the healthcare industry. efforts for its hepatitis C virus pipeline “But after I was exposed to the sales built around developing commercial- representatives coming in and seeing ly competitive regimens that address made, getting into the pharmaceutical how they interacted with the provid- many patient types while offering high industry.” ers and the value that they provided the cure rates and favorable safety profles. A choice, according to Heinzinger, doctors and how the doctors really lis- A career focus on rare disease and new that has deliberately attracted her to tened to what they had to say, I thought ways to fght infections with still-sig- smaller, startup companies in the life maybe I should have a career change,” nifcant unmet medical need is indeed sciences space. Such motivation, she says Heinzinger. a long way from the days of audit trails says, stemmed from a desire to view A reference from a friend in the in- and fnancial cross-checks. and contribute from the inside to dustry helped Heinzinger land a job “It’s funny, because a lot of people many different facets of the biophar- as a pharma sales rep, and the career thought I was crazy at the time,” says maceutical business. And that versa- transition was underway; and not just Heinzinger. “People that I knew in ac- tility, combined with the perspective any transition, but a launching point counting kind of questioned, ‘What of working at R&D companies, where to the infuential and all-encompassing are you doing? Are you sure you’re risk and failure are natural occurrenc- roles that she now seemed destined for. making the right move?’ I have to say es, has proven invaluable in not just Through the years, Heinzinger has led it’s one of the best career choices I’ve helping Heinzinger cement a diverse

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industry background, but preparing been integral to Cinryze and the cur- terferon, the traditional standard of her for the changing healthcare envi- rent HCV portfolio at Achillion. For care known for its severe side effects. ronment. From 2002 to 2005, Heinz- example, when other drug developers Achillion is currently developing mul- inger was a senior regional manager targeting HAE were pursuing acute tiple direct-acting antiviral agents for at OraPharma Inc., a former subsid- indications, Heinzinger, through her HCV, with the hopes of a once-daily iary of Johnson & Johnson, which close interaction with the patient ad- oral regimen with shorter treatment was acquired by Valeant Pharmaceu- vocacy community, uncovered that durations. ticals International in 2012. While patients were really interested in a “Going from a small, rare disease at OraPharma, Heinzinger was pro- prophylaxis indication. This enabled to a large disease state, it was def- moted to a newly created position of the focus of the commercial plan to be nitely different; but there’s still a lot of director, reimbursement. There, she directed towards this specifc patient similarities in the two markets,” says helped spearhead a new approach to need. Cinryze currently owns more Heinzinger. reimbursement and directed its im- than an 80% share of the HAE-treat- Working for a company involved in plementation by the sales team. The ment market. the suddenly burgeoning HCV treat- effort was a key driver of product “I interacted with the patient ad- ment space has given Heinzinger a growth at OraPharma, an oral care vocacy groups before the drug was unique perspective on the changing company, and its eventual acquisition. available and I really understood the healthcare delivery landscape. She Heinzinger joined Lev Pharmaceuti- burden of hereditary angioedema on recalls how when she started in the cals, the developer of Cinryze, in 2006 the patient and on many of the family industry, it was healthcare providers as director of marketing (Lev was ac- members and friends,” says Heinzing- and physicians that wielded the big- quired by ViroPharma in 2008). She er. “I also interacted with them after gest infuence in therapeutic prescrib- led the marketing efforts around Cin- Cinryze was launched.” ing decisions. That has shifted to the ryze from Phase II through year-one payer community today, she says, not- launch. Today, Cinryze is the only Patient portfolio ing, as evidence, the extensive market FDA-approved C1 esterase inhibitor Heinzinger notes that with HAE, a ge- research her team conducts on what for routine prevention of HAE. HAE, netic disorder that only affects about drives prescribing behavior. which is triggered by defciencies in 1 in 10,000 to 1 in 50,000 people Heinzinger believes that the shift- C1 inhibitor proteins, is character- worldwide, it was easier to get to ing infuence of stakeholders in the ized by unpredictable and recurrent know those afficted more intimately healthcare process, combined with attacks of infammation affecting the through advocacy groups and setting advancing R&D paradigms in a num- hands, feet, face, abdomen, urogenital up advisory boards. “I remember talk- ber of disease settings, reinforces the tract, and larynx. With the tendency ing to a mother who said, ‘My son has importance of leadership groups in of throat attacks, suffocation result- HAE and I know exactly how long it pharma that foster adaptability. Par- ing from HAE is a real concern. takes me to get from my house to the ticularly in the world of startups and In early 2010, Heinzinger was school to pick him up and take him to specialty biotechs, nimble workfow hired at Achillion, where she directs the hospital if he has an attack,” says and quick thinking is a strategic im- efforts around commercial strategy Heinzinger. “That was the unpredict- perative for R&D and brand teams and planning, market assessments, able nature of it. There were patients alike; they could be focused on one reimbursement, patient access, valua- that said they were afraid to fy on strategy one day and a very different tions and forecasting, and pricing and airplanes because what if they had an one the next. business development support. Her attack on an airplane? Once Cinryze “Things change very quickly at alliance management role involves was available, patients would tell me our company, especially in hepatitis overseeing drug licenses Achillion has that they can live a more normal life.” C,” says Heinzinger. “The develop- with companies in China and else- Though the market for HCV is ment landscape is moving at such a where. It is in the areas of patient ac- considerably larger (the virus infects fast pace. Almost every time we go cess and engagement, however, where 170 million to 200 million people to a medical conference, there’s new Heinzinger has distinguished herself globally), Heinzinger was drawn to data that comes out and we adjust from other young executives in the Achillion with a similar motivation: our strategy accordingly. Tracking the industry. Her extensive relationships to work in a disease area with sig- competitive landscape and adapting with patient advocacy groups—mak- nifcant unmet need. While newer and your commercial focus to adjust for ing sure the patient perspective is more responsive treatments for HCV the changing environment is essential represented in product development have emerged in recent years, many to launch and commercial planning.” and commercialization plans—has are still used in combination with in- — Michael Christel

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The Culture Connection platforms make a difference as the local customer base evolved? A stronger hand Michael Injaychock, Director, Marketing Innovation, Research and Commercial on the market research function would Analytics, Eli Lilly & Co. go far in helping affliate management ichael Injaychock owes his answer these basic questions. unusual surname to the butch- M ered efforts of a US immigra- Venturing east tion offcial to interpret the handwritten Injaychock thought for a while before scrip on the landing card of his great taking the job, largely because he had no grandfather from Poland. It’s a small but experience working outside HQ and he ironic footnote to the blazing path the and his wife had a six-month old child 36-year-old marketing executive at Lilly at home. He acted because of the op- has made in delivering purposeful multi- portunity it provided to mobilize an en- channel market experiences, removing tire function across all the disease areas much of the mystery from market re- Lilly serves and test new ideas in a local search through high-tech data analyt- business that was ripe for change. “The ics that accurately defne and decode best work in market research involves successful customer engagements. Even thinking ahead, not just reinforcing de- more intriguing: the focus for his efforts cisions of the brand teams. We wanted is in Japan, a country whose approach to to unlock the complementary power of business has always been more relation- qualitative and quantitative customer in- ship-driven than analytical. sights. By understanding customer moti- Injaychock joined Eli Lilly in 2007 vations and unlocking the vast amounts after fve years in a Washington-based focused on personal and professional of data that was being released through fnancial services consulting role and a growth, not just the job.” He quickly advances in IT, we could tap into a truly subsequent MBA from the University of advanced to a brand leader role in the innovative approach to marketing—one North Carolina. Course work there as diabetes franchise at HQ in Indianapo- that informs our messaging and service well as a stiff self-evaluation of his for- lis, where he helped rejuvenate the aging packages to help differentiate against the mer job led Injaychock to conclude his genetically engineered insulin product, competition and ensure our medicines future lay in a post that carried a larger Humulin. While few saw opportunities reach the right patient every time they purpose. “I captured my ideal position in the business, he set out to re-launch are needed.” in three words: marketing that mat- the franchise, using a tailored pric- After arriving in Japan, Injaychock ters.” ing strategy and reserving his limited quickly realized his mandate necessitat- That desire was reinforced by an ear- marketing investments around targeted a transformation of market research ly personal experience in the power of ed niche segments to improve share of from a support function to a strategic modern medicine. “Just after I fnished voice in areas where the product still driver of change. To do that, he set a my undergraduate course at the College made a difference for endocrinologists goal to make market research the “go-to of William and Mary, my grandfather and patients. source” for innovation within the orga- suffered a severe stroke. The right drug His work caught the eye of Lilly’s nization. “I felt that a mission focused administered at the right time saved chief marketing offcer, who was look- on fnding innovative ways to track and his life. My grandfather lived another ing for a candidate to more deeply un- shape the customer experience, with ten quality years, long enough for me derstand relationships with customers metrics that allow the commercial orga- to name my daughter after my grand- in Japan, the company’s second largest nization to benchmark progress against mother. That real-life testimonial about market outside the US, through mod- sales targets, would make market re- the value of medicines is better than ern, insights-based market research. search a full partner to the brand teams. any marketing message, which is what Among other things, Lilly had an active I wanted my group to be recognized as attracted me to a career in pharmaceu- portfolio of relatively new products in an amazing service leader, starting from ticals.” Japan but little was known about how the premise if you can measure it, you Injaychock interviewed with a the changing role of the traditionally can improve the experience of the cus- number of drugmakers but chose Lilly all-important physician was affecting tomer: to plan, do, check and act.” due to the company’s emphasis on the the product life cycle—were Lilly’s mes- Concepts like leading and partner- long-term opportunities for leadership. sages about its medicines actually get- ing demanded a sea change in attitudes “I liked that my discussions with Lilly ting through? Could new technology within the Japanese organization to-

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26 Emerging Pharma Leaders

ward market research. To address that, the network’s local digital technol- do a self-check and consider I might be Injaychock introduced a new vision ogy expertise to test different ways wrong—and actually there might be a concept, the Shield of Market Research, to reach out to various segments good reason for being wrong. In other which repositioned the function as in- of the healthcare community. This words, success in Japan meant I had to house champion of the customer, rely- proved a benefit to both companies. work harder and to be more selective in ing on hard data analytics to inform Also, under Injaychock’s lead, Lilly bringing people along with me, making product teams when they are not deliv- has championed expanded group de- sure my infuence could be felt when it ering what the customer needs —and to tailing programming that keep Lilly really mattered. It’s a trait I learned demand a corrective change in course, in front of the medical profession as here that I expect that will carry residu- when required. “It fostered a cultural the door closes on traditional means al benefts further along in my career.” change in how we worked, from in- of engagement through the deploy- trospection around decisions already ment of legions of individual sales Three points to ponder made, to outward, forward-looking en- staff. Such initiatives enable Lilly Injaychock anticipates returning to gagement.” Japan to make more highly differen- Indianapolis later this year in a senior tiated channel investments through marketing role, perhaps with the as- Changing minds through innovation the insights derived from advanced signment to build a better customer After witnessing the successful transfor- customer analytics. These have led experience around Lilly products. Pro- mation of the Market Research function, to a significant improvement in con- jecting his own experience to others, Injaychock was offered an extension on sistency and satisfaction indicators what skills or talents does Injaychock his assignment along with expanded based on the metrics of customer think are important for future success responsibilities, with a new mission to feedback and market performance. in the biopharmaceutical space? He leverage his 20 member-team to deliver Injaychock’s efforts earned him the points to three. First is what Injay- innovative experiences across key cus- Lilly Marketer of the Year award at the chock describes as “learning agility,” tomer touch points, including the Web end of his frst year at the affliate HQ which involves discerning what is key and “peer to peer” detailing. He also in Kobe. The award highlighted his skill and strategic about any situation de- got the nod to create a new Commercial in “turning the complex into simple, spite having limited information. Be- Analytics team. In the Web space, by understandable solutions.” ing able to “see around the corners” of combining consistently market research “I regard my three years in Japan those information gaps is critical. Sec- evaluations and analytics, his team was as my biggest accomplishment because ond is fexibility in decision-making, able to quantify that interactive product it made me appreciate diversity and because today there are few hard and content was more productive: physicians the importance of a connected, global fast rules that will guide a particular needed to view this content at times mindset,” Injaychock told Pharm Exec. course of action. Third is a determi- most convenient to their own schedules, “I also gained an appreciation for diver- nation to execute—getting it done. and that these online engagements actu- sity in both opinion and background. I “This is an industry riddled with dis- ally enhanced, rather than limited, the arrived in Kobe as a minority, an expe- ruptions, from new technologies to effectiveness of later live contacts with rience I did not have back home. I am a the endless restructurings among the Lilly sales representatives. contrarian by nature, which can some- stakeholders that drive our business. In addition, Injaychock negotiated times make people uncomfortable. But So there are always going to be barri- to extend and enhance an e-channel being in Japan, where I had such little ers to realizing your plan; don’t turn alliance with a local network pro- cultural understanding, it made me this reality into an excuse to not get ducer, M3 Global, which gives Lilly aware that when I am the only one in the to the goal.” Japan the opportunity to leverage room with a different opinion, I need to — William Looney

Information Innovator With dual degrees from the Harvard Medical and Business schools, Jain, at Sachin Jain, Chief Medical Information and Innovation Offcer, Merck & Co. age 33, has chosen his own distinctive ca- or Sachin H. Jain, health is a fam- years specialized in pain management at reer path by focusing on that larger policy ily vocation, with roots that extend New York’s Memorial Sloan-Kettering world beyond the clinic, where advanced F back to his grandfather’s philan- Cancer Center and who has devoted data analytics and systems management thropic work to provide basic medical much of his time raising awareness of this can be leveraged to improve the quality services to India’s rural poor. Jain’s father critical patient care issue among health of the patient experience in confronting is an academic physician who for many practitioners in India and other countries. disease. “Healing is an art, but today the

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real creativity lies in the hard evidence be- model shaped by hard evidence around hind it,” Jain says. outcomes. “What he did was offer me the Jain’s commitment to digital innova- opportunity to create new strategies with- tion as a driver of health improvement in Merck, putting in practice the ideas that dates back to an undergraduate class at came out of my government service and Harvard taught by quality expert Don patient care training and experience,” Jain Berwick. “I joined the class by accident,” told Pharm Exec. relates Jain, “but I quickly realized data- Soon after, Jain accepted the new po- driven quality measurement was becom- sition as Chief Medical Information and ing a driver in healthcare operations Innovation Offcer, responsible for lead- as well as the centerpiece of efforts to ing and executing on new strategies to reform the US system. That’s precisely leverage digital information to draw new where I wanted to be.” Jain developed insights about human health, and apply a close relationship with Berwick, who them to future innovations. Sachin began he considers a mentor along with Com- by recruiting additional talent from di- monwealth Fund President David Blu- and bundled payments; these also gave verse areas like health information tech- menthal, who served as the Obama Jain exposure to the politics and policy nology, logistics, clinical medicine, health Administration’s frst National Health around healthcare at the state level, services research, market access, and in- Information Technology Coordinator since many of the proposals came from vestment banking. His strategy has been (NHITC), and Harvard Business School there. Jain tells Pharm Exec that helping two-pronged: building information-based Professor Michael Porter. to build this critically important unit collaborations with leading global payers, Half-way through Jain’s medical from scratch stands as one of his most provider organizations, and delivery sys- residency at Boston’s Brigham and important career accomplishments, tems to derive relevant insights into human Women’s Hospital, Blumenthal offered noting that the CMMI is responsible for health; and working with health informa- him a position as his Special Assistant stretching the boundaries of the ACA tion technology organizations to co-devel- to help support the phase-in of the beyond what was feasible politically. “I op innovative solutions that will improve $19 billion Electronic Health Record am most proud of the talented team we patient outcomes. Specifc areas of focus (EHR) meaningful use incentive pro- hired because these people are the best include appropriate use of medicines, im- gram covering physician practices and guarantor that the reform law will be proving adherence rates, promoting health hospitals. After a stint with Blumen- applied in ways that make a difference literacy, avoiding medical errors, and ad- thal, Jain was approached by Berwick, in patients’ lives.” vancing clinical decision supports to pro- who by then had been appointed by duce better health outcomes. Obama as Administrator of the Center Move across healthcare for Medicare and Medicaid Services Jain left Washington to fnish his medical Bridging the digital divide (CMS) at the Department of Health of residency at the Brigham and Women’s The team has launched more than a doz- Human Services. “Berwick was aware Hospital and to co-found the Elsevier en innovative projects involving collabo- of my interest in new payment models journal, Health Care: The Journal of De- rations with outside companies whose for health, so he offered me the chance livery Science and Innovation, of which he strengths and data resources comple- to help launch the new CMS Center is co-editor-in-chief. Jain’s work in government Merck’s own. Highlights include for Medicare and Medicaid Innova- ment required extensive outreach to stake- projects to empower patients to achieve tion (CMMI), established through the holders in the private sector, including, better outcomes from their medical care Affordable Care Act (ACT) to initiate most importantly, the patient. Jain still and their adherence to their medicines. pilot projects testing alternatives to sees patients regularly at the VA hospital One is with Walgreens and researchers traditional fee for service.“ in Boston and is a member of the teaching at Northwestern University and the Alli- Jain spent a year with Berwick, serv- faculty at Harvard Medical School. These ance of Chicago to develop and digitize a ing as a Senior Advisor and, briefy, as exposures led to conversations on digital patient-friendly and accessible standard CMMI’s Acting Deputy Director for health with Merck’s Chief Medical Off- for the writing of prescriptions that con- Policy and Programs, where he helped cer, Michael Rosenblatt, M.D. Rosenblatt forms to drug label requirements. Anoth- to draft the unit’s strategic plan and re- believed that mastery of the digital infor- er is a frst-of-its-kind collaboration with cruited staff for hands-on operational mation space is an essential part of doing a major ACO, Heritage Provider Net- roles in approving and executing new business for any pharmaceutical company work, to support high-tech solutions to value-based payment models, including seeking to broaden its offerings beyond the engage patients and improve their adher- accountable care organizations (ACOs) pill to a more integrated, service-oriented ence to care plans for chronic diseases.

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Other projects leverage well-estab- desire to demonstrate how digital in- in many quarters is lacking at present.” lished real-world databases to better formation can be applied productively Looking ahead, Jain is optimistic understand diseases, patient percep- to solve practical challenges facing the that the promise of a digitized health tions and behaviors, use of medicines, health system. Says Jain, “It’s an op- world will be realized. “I see a real and medical outcomes. These include portunity to work this theme across all convergence of thinking in healthcare. collaborations with the Regenstrief In- the silo platforms in health. In doing Everyone is now talking the same lan- stitute, a major health information ex- so, we are making the larger point that guage, about the importance of deci- change with 13 million unique patient effciency in healthcare depends on a sions that improve outcomes; the issue histories, as well as Maccabi Healthcare stronger societal commitment to the in- is how best to get to that destination Services, a major health system in Israel. teroperability of standards on electronic together.” What binds these initiatives is the health information, a commitment that — William Looney

Launch Leader dianapolis, then three years in Germany leading a diabetes team of 280. That led Arnaud Lesegretain, VP and Global Brand Development Leader, Lilly to his current U.S.-based global assign- rnaud Lesegretain is a chart- ment in the highly competitive oncology A busting marketer who works on segment, where Lilly researchers are seek- the cutting edge of some very ing to break new ground in the complex novel science. As a VP for global product science of monoclonal antibodies and an- brand development at Eli Lilly and Co., giogenesis inhibitors, among others. Lesegretain is pioneering the transition Lesegretain notes how each assign- to a new generation of innovative can- ment bolstered his functional skills. cer therapies. In little more than a year, “France was ‘marketing 101’ for me, the 44-year-old brand leader and his learning how all key functions inter- 30-member cross-functional commer- played at an affliate level. In my global cial launch team worked with numerous payer role, I really built more in-depth un- medical, regulatory, and manufacturing derstanding of the payer needs in major colleagues to overcome hurdles to se- markets. In Germany, I tested my general cure the recent approval and launch of management skills by leading a large or- one of Lilly’s most promising new bio- ganization in a key strategic market for logic drugs—Cyramza (ramucirumab). Lilly and role modeling putting the cus- In April, Cyramza was approved by the Lesegretain says this is what led him to tomer and patient at the center of every- FDA for use in certain patients with ad- Lilly, whose recruiters emphasized long- thing we do. In my current role, in oncol- vanced recurrent stomach cancer. term career development rather than fll- ogy, I oversee key brand activities for the The fast timing required real fo- ing the day’s job titles. “Lilly was looking Cyramza program, including brand strat- cus, an attribute Lesegretain retains for people interested in spending the time egy, market research, launch preparation, from his introduction to the industry necessary to grow in a job and eventually market access, lifecycle management, and in 1994, when, after a brief six months serve as a leader. It was a mission that public relations. The big challenge in on- as a consultant for Arthur Andersen, he matched my motto, so I accepted a posi- cology is keeping pace with the science, joined the diagnostics frm bioMerieux, tion in the French affliate and started as which is very complex and fast moving. serving six years in a variety of fnance a sales representative. That was 12 years Cancer is not one disease but rather more roles in his native France as well as in ago; I’ve taken on more responsibility than 200 diseases, all of which have dif- the US and the UK. “After spending over time in different roles and increased ferent causes and treatments. Even within some time in fnance, I wanted to try my scope from local to global.” one tumor type, such as lung cancer, there something more customer-facing, so I True to Lilly’s word, Lesegretain’s are subtypes of cancer being identifed left bioMerieux to obtain an MBA at work has exposed him to major brand and further understood.” Harvard. There, I decided I wanted to areas of opportunity, leading teams span- Lesegretain’s most signifcant win to be a leader in global pharmaceuticals ning three key therapeutic areas. The frst date is his global brand stewardship of and set my sights on joining a leading was in neuroscience, where he accelerated Cyramza. Getting it through registration company that was dedicated to not only sales in France for Zyprexa and prepped and launch depended on executing from discovering life-changing medicines but for the Cymbalta launch, followed by a a unique and challenging road map. also developing its people.” stint in a global payer role based in In- “This innovative molecule is being in-

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30 Emerging Pharma Leaders

vestigated in a variety of cancers. In only tion: where can this new product make gram for Cyramza spans many potential 24 months, my team had to prepare for a difference to patients?” indications and geographic regions, it has data readouts from six Phase-III trials, Second, the team made sure its ac- been critical that we continuously update spanning fve tumor types. Our timeline tivities were aligned to the markets. each other and fne tune our overall plans was compressed. Yet, in each of the fve “Our remit was global but what we did across the board—clinical development, cases we were required to develop cross- not do is wait until we were fnished to submissions and approvals—to ensure functional launch plans across multiple ‘hand off’ launch strategy to the U.S. our success and continued progress.” countries.” With launch of Cyramza for The U.S. team worked with us from Lesegretain expects to keep applying stomach cancer in the US well underway, the start, which saved considerable these learnings as Lilly seeks registra- the global team is prepping for potential time once it was decided that Cyramza tion for a second indication on Cyramza. approvals in multiple European markets would debut here.” Globally, stom- “Despite its importance, people tend to and Japan. ach cancer is the third-leading cause take group collaboration for granted. Lesegretain cites three lessons from of cancer death worldwide. Through In fact, its merits are elusive in large or- his Cyramza journey thus far. The frst market research, we discovered that is ganizations because you cannot expect is pursuing your target with clarity and not just more prevalent but also treated people from different functions spread in confdence. “When you face this kind of very differently in Asia than in Western various places of the world to see every- complexity, with so many moving parts, countries. It is actually a rare disease in thing the same way. Leaders have to keep you have to strive for simplicity and fex- the US but common in Asia, with Japan emphasizing the value of each skill set in ibility. Boil it down to the essence and having the largest incidence. Therefore, the group activity and how it contributes challenge your group to stay focused on the Japan team was also integrated in to the larger objective.” the big picture. Lilly was on uncharted the virtual launch team that shaped the Above all, it’s essential to assemble turf when it came to gastric cancer; global strategy for the molecule. the right team. Attracting and developing it was not an indication where we had Lastly, constant dialogue between talent must always be a priority. “Great much experience. So we worked closely the global launch team and medical and teams make great things happen, and with the professional community, listen- regulatory submission teams is crucial. your role as a leader is to enable that.” ing for insights around a central ques- “Particularly as the development pro- — William Looney

Pushing Boundaries Tom McDonnell, Vice President, Product Strategy Lead—Neuroscience, Shire Pharmaceuticals

or Tom McDonnell, the accom- Switzerland, where, as senior director F plishments were fowing in fast and GM, he helmed the global brand and furious. Still in his 30s, the responsibilities for Equasym XL, then-Shire Pharmaceuticals product Shire’s frst introduction of an ADHD and marketing director had already treatment outside North America. led the successful launches of the com- “It’s always a tough decision when you pany’s key ADHD drugs, Vyvanse and move your family to another country. Intuniv, in the late 2000’s; Vyvanse, But it really broadened my perspective today, is the eighth-most prescribed of the world. It enhanced my creativ- therapy in the US. But it was actually a ity, my problem solving—even down few years later, when acting on the ad- to becoming a better listener because vice and encouragement of a mentor at of the language differences. Coming Shire, that McDonnell took on perhaps back then to the U.S., those skills have psychiatry brand team, orchestrating his most fulflling challenge, accepting really enhanced my ability to lead.” the commercial and clinical develop- a position with the drugmaker in Swit- McDonnell and family spent 18 ment project teams for the potential zerland, and uprooting his life across months in Switzerland, returning to use of Vyvanse in binge eating disorder the Atlantic. the states, close to Shire’s Wayne, Pa., (BED); and currently serves as VP and “It was the greatest personal and headquarters, in 2012. Since then, Mc- product strategy lead for Shire’s U.S. professional experience of my life,” Donnell, known for his energetic and neuroscience business unit, where he says McDonnell, who relocated his enthusiastic leadership style, has di- oversees a group of 35 people support- wife and three young children to Nyon, rected the global effort for Shire’s adult ing Vyvanse and Intuniv for the treat-

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ment of ADHD and the development in specialty markets such as ADHD Knoll Pharmaceuticals in 1997 and program for Vyvanse in BED. and BED. To that end, he is directing then worked his way up at Abbott McDonnell, 42, originally helped the pursuit of innovative physician Laboratories, which acquired Knoll in shepherd Vyvanse onto the market education channels, patient education 2000—believes organizational align- scene in 2008. Vyvanse, the frst long- methods, and targeted partnerships ment and commitment is the most acting prodrug indicated for the treat- with the major players in the health- critical factor for success. That may ment of ADHD, is approved for treat- care ecosystem to achieve consistent seem obvious, but McDonnell points ing the disorder in patients six and branding and increase clinical develop- to struggles the industry still has at above and for maintenance of ADHD ment interest for hopeful new indica- times in clearly articulating a product’s in patients six and above. The drug, tions. benefts to the consumer. Remember- upon its original launch, achieved “As your marketplace changes, if ing that the fundamentals in areas such greater than 10% market share in 18 you don’t change, you won’t be in that as people management and sales and months, a result that proved to be a marketplace for very long,” says Mc- marketing have not changed—despite testimony of sorts to McDonnell and Donnell. “You need to take a much added industry complexities in recent his team’s passion for helping patients more holistic approach now than in the years—will be key to steering product in with ADHD. past, and understand the role that each strategies and positioning in the fu- “For me, it was when I was a prod- of the individual stakeholders play and ture, he says. uct manager and sitting in market be able to address their needs in order “We still need to have the right tar- research behind the glass watching to have better patient outcomes.” get market, we still need to have cor- mothers of children with ADHD talk McDonnell believes the role of the rect and compelling messages, and we about their struggles and how it af- patient or caregiver in this scenario still need to track our success and how fected their children and their family,” is much more powerful than it has those messages and information are says McDonnell. “To be able to be a ever been, citing a “tenfold” increase being received,” says McDonnell. small part helping that patient and that from a decade ago in consumer access In delivering on these core beliefs family is what gets me up in the morn- to health information and education at Shire while also adapting to change, ing.” amid the explosion of digital media. McDonnell says the most critical skill The US cost burden attributed to Mindful of this evolution, McDon- he draws upon as a leader is his ability ADHD, according to the most recent nell’s approach is to inspire colleagues to listen— specifcally around defn- estimates, is between $36 billion and at Shire to share a collective vision—by ing a simple and strategic framework $52 billion. McDonnell, as commercial understanding what motivates each of for the brand: “Where we play, how and product strategy lead, was also in- his team members and framing their we’re going to win, what capabili- strumental in the 2009 US launch of goals in the context of the patient. To ties we need, and how do we measure Intuniv, which represented a new class help that cause, McDonnell brings cus- success.” McDonnell also stresses the of ADHD drugs. Intuniv is approved tomers into Shire on a regular basis importance of a leader in the product as an adjunctive therapy for children and also fosters close collaborations strategy space who can build a collab- and adolescents with ADHD who between vendors and product teams to orative culture throughout the organi- are having a suboptimal response to better enhance brand engagement with zation and be a bold decision-maker. It their current stimulant therapy. The the consumers and professional audi- is these people, McDonnell says, that drug, which is not a controlled sub- ences. are the ones usually able to take a long stance, is a once-daily treatment that, “When you keep the patient in the view of what the future market for a as a nonscheduled medicine, provides center of everything that you do, it brand and its life cycle looks like or fexibility in managing the symptoms makes it easy to understand and ad- should look like before others catch of ADHD. McDonnell’s team helped dress what the needs are in the mar- on. The true test for success, however, Intuniv achieve $200 million in gross ketplace,” says McDonnell. “Your may come down to simply the ability to sales in the drug’s frst full year. approach to the different stakehold- keep things simple. In a forward-driven business, how- ers may be different. It may be new, “We work in a very complex indus- ever, McDonnell does not rest on the it may not feel as comfortable, but it’s try with lots of regulations and lots laurels of past success. Responding important to challenge yourselves and of data and information,” says Mc- to what he believes is a changing and challenge your team to see the larger Donnell. “It’s very important that we much more global biopharmaceutical picture.” simplify for people our programs and marketplace, McDonnell continues to When it comes to launching prod- our tactics in order to cut through the explore new ways to promote medi- ucts, McDonnell—who began in the clutter.” cines in the neurosciences, particularly industry as a sales representative for — Michael Christel

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by the outcome they provide to patients. Corporate Raconteur For that to happen, a sophisticated, real- Jamey Millar, VP Oncology Business Unit Head, GlaxoSmithKline time patient assessment is needed, which torytelling, since time immemo- requires “a move from siloed fragmenta- Srial, has served an important role tion in delivery of care to truly more in- in conveying information, expecta- tegrated care that is connected to infor- tions, and obligations. Stories can func- mation systems,” says Millar. “EMRs tion as orientation guides, uniting readers and other health information technol- or listeners around a common set of as- ogy must converge so that people can see sumptions. The best stories also contain the whole as opposed to the component an element of surprise, a reminder of the parts. All stakeholders need to be looking unexpected possibilities, and chance oc- at the same holistic picture, as opposed to currences that bind our lives together. the skewed version seen from their paro- After completing a liberal arts under- chial points of view.” graduate degree in English Literature at On the subject of failure as a prereq- Hamilton College, in upstate New York, uisite for success, Millar says he worked Jamey Millar, GSK’s vice president, on- in a global product strategy role at cology business unit head, took the logi- P&G, working closely with a cardiovas- cal next step: he got a job with Procter & cular research and development team. Gamble Pharmaceuticals. “I spent four years on medicines that, in “I don’t think that’s necessarily the the end, never made it out of late stage direct path into the pharmaceutical behind decisions, set direction, and to development,” says Millar. “But those business, but as it turned out, Hamilton motivate and inspire—all of this is so four years taught me more about drug College had a career channel pipeline to important,” says Millar. “I think we’re development as a process, the nature of Procter & Gamble,” says Millar, who often overwhelmed by businesspeak that interactions with regulators, the chal- has worked in the pharmaceutical in- has gotten increasingly harder to relate lenges with clinical trial design, recruit- dustry for 24 years. “I interviewed with to in a meaningful way. To personalize ment, and completion, functions critical P&G and evaluated options between it and tell a story can be effective, but it to our industry.” consumer packaged goods and pharma- has to relate to the message that’s being Millar lives in Chapel Hill, NC, ceuticals, and chose healthcare without communicated. It can’t be storytelling where his wife, Anna, is a senior asso- hesitation and haven’t looked back.” for storytelling’s sake.” ciate at the University of North Caro- At the end of his 11-year tenure at Millar says he worked on the com- lina’s Kenan-Flagler business school. P&G, Millar served as a country man- pany’s diversity and inclusion initiative, Millar boastfully says that his wife ager in the UK, Netherlands, and Ire- for example. “There are two approaches: graduated in the top 10% of her class land. Working for an American company you can share the background statistics, at Harvard Business School, which in England, he decided to join a British the demographics and make the business is “why I bring a lot of work home.” company and work in America. Thirteen case for diversity and inclusion, which is Millar has four children, including years later, Millar has held a variety of irrefutable. Or, you can tell a story about 14-year-old twins. Outside of the of- leadership posts at GSK in general phar- how diversity and inclusion have im- fce he stays busy with travel ice hock- maceuticals, pricing, contracting, and pacted your view of things. That’s what ey, travel soccer, chorus, musicals and payer marketing, and the health system/ I chose to do, and I think that resonates a nine-year-old son who plays three hospital businesses. In addition to head- with people because it’s more personal different sports. Millar himself plays ing up the company’s oncology unit, Mil- and memorable than quoting the ratio- in a 40+ fast pitch baseball league, and lar also sits on GSK’s commercial lead- nal side of a particular subject.” coaches his son’s baseball team, too. ership team, which reports up to North One story pharma likes to tell is about On the question of younger genera- American president Deirdre Connelly. the shift from cost to value, from quantity tions entering the workforce, and what Colleagues at GSK say Millar is a to quality. GSK was the frst company to if any challenges they present to leader- good listener, but also a good storytell- de-couple sales rep compensation from ship, Millar says the difference today is er. Does the ability to spin a tight yarn the amount of product sold. But despite that the older generation looked for a come in handy in the corporate setting? signifcant strides being made on the pay- company that could offer a long-term “I think, increasingly, storytelling in the er and provider side, instigated in large career, while the newer generation, fresh workplace is a way to frame and contex- part by the Affordable Care Act, prescrip- out of school, is “looking basically for tualize strategic intent, explain rationale tion drugs are still paid for by the pill, not work that subsidizes what they want to

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do in terms of their lifestyle and work- hold the narrative he’s used since the to continue to look for opportunities life balance…two very different things.” beginning of his career, “which is not to lead teams that make a difference Asked to tell a story about the next to seek specifc roles but to continue to for patients.” phase of his career, Millar says he’ll be stretched, to continue to learn, and — Ben Comer

given the baton at the climactic last Taking the Plunge lap of Aptiom’s race to market and António Portela, CEO, Bial trusted to fnish the job. November ortugal’s Bial is a mid-sized, 2013 saw FDA approval of the drug, P family-owned company that has making it the frst Portuguese drug to just celebrated its 90th birthday. be approved in the US. Under a license Its pre-history goes back to 1908, when agreement with Sunovion Pharmaceu- the resourceful 14-year-old Álvaro Por- ticals, it hit US pharmacy shelves in tela began working at the Padrão Phar- April this year. macy in Porto. By 1924, the pharmacy Maintaining family control of the had grown into a laboratory, thanks company in an era of rampant consoli- considerably to the efforts of a young dation is also no small achievement. Alvaro, who was now in charge, at age “Bial’s R&D investments—more than 30. EUR40 million annually—are huge for Álvaro inaugurated a new company, youth. But blood is thicker than wa- a company of its size,” he says. “It’s not Bial, and began marketing the hugely ter. Still, he decided to “test” himself common for a company based in a Lat- successful Benzo-Diacol in Portugal frst, away from Bial, going to the UK in country to have a clear, long-term from 1929. He ran Bial for nearly 40 to work as a medical rep for Roche, strategy. But our long-term view of years, his son António Emílio taking carrying the bag for a year and a half where the company needs to be is only over in 1962. When António Emilio before moving to business analysis and possible through a family-controlled died suddenly in 1979, his 21-year-old later marketing. business model.” son Luís was readied for the role, be- After four years at Roche, Portela Portela’s commitment to the Bial coming president of the company at 27. was convinced this was the right indus- “family” is as sentimental as it is stra- Luís was initially reluctant to enter try for him. Being a medical rep, par- tegic. “My father ran Bial for over 30 the business—he wanted to pursue a ticularly, gave him a vital perspective, years and he probably knew everyone career as a medical doctor—but came seeing how the drugs impacted peo- in the company by name,” he says. on board out of respect for his father ple’s lives. He came back to Portugal “Today, with employees spread all and grandfather’s work. He proved in 2004 and joined Bial. Working his over the world, that’s not really pos- to be as adept a businessman as Ál- way up over seven years from deputy sible, but I can say that I know most varo had been. During Luís’s tenure, marketing director to heading the com- people by name. I have a lot of respect Bial began its own R&D activities (in pany’s international operations, he be- for the work that the previous genera- 1993), expanded internationally (frst came CEO in January 2011 at the age tions have done.” to Spain, South America, and Africa), of 36. But he is also well aware that se- and in 2009 received EMA approval Again, like his father, Portela is curing Bial’s long-term focus is as im- for its epilepsy drug Aptiom (known proving to be more than up to the job. portant as maintaining its traditions. as Zebinix in Europe), which became While he champions Luís’s 1993 deci- Portela is looking out to the open wa- the frst 100% Portuguese drug to be sion to embark on an innovation strat- ter. “We want to make sure the R&D distributed to the world market. egy as the source of Bial’s major ex- wheel is properly oiled,” he says. “It When Luís handed control to his pansion, António has been at the helm was diffcult to go through the innova- son António, Bial entered the fourth as the company started chalking up tion process the frst time, so it’s key Portela era. But like Luís, António had successes at a dizzying rate. He took that we stabilize our R&D efforts as not been immediately sure he’d wanted the reins of a frm that had not only we close this frst cycle of innovation a career in the family frm. He stud- weathered the fnancial crisis that had and move on to new countries.” ied economics, not science, graduat- hit Portugal harder than most, but In 2012 Bial’s revenue exceeded ing from the University of Porto with was thriving where other indigenous “the 200-million-euro barrier” for the an economics degree. He’d been Por- companies were going to the wall. If frst time; its products are now avail- tuguese swimming champion in his this was a swimming relay, he was able in 53 countries. With another

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promising Bial-developed drug (Opi- for commercialization in Japan by Ono in Bilbao, Spain, the 90-year-old com- capone, for Parkinson’s disease) now Pharmaceutical) and the establishment pany’s future looks pretty solid. in Phase III trials (and recently licensed of a new, EUR12 million research unit — Julian Upton

The Sole Proprietor Alexsey Repik, Founder and Chairman of the Board, R-Pharm

lexsey Repik is a practicing con- only four employees; three years of hard trarian, whose credo for success work delivered a worthwhile award, A rests on renunciation of the stereo- when the company emerged as one of types associated with the typical emerging the top specialty drug distributors in the market business: hierarchical, risk-averse, Russian Federation. Unfortunately, this and inward-looking, with little interest resulted in my second career setback in opportunities beyond what public pa- when the owners rescinded a promise to tronage offers in the form of predictable give me a minority share of the company. returns and protection against foreign More than anything, that led to a real- competition. With an initial investment ization I could trade on the knowledge of only $40,000, Repik followed his own and contacts I had amassed and start my singular instincts in building what is today own company—as an entrepreneur in Russia’s second-largest domestically-based the new Russia.” pharmaceutical company, with $2 bil- Repik founded R-Pharm in 2001, lion in sales last year. Those instincts rely serving the same specialty and hos- also see my youth as a positive because I on commitments often rejected by others pital segment he had mastered in his am willing to wait 30 years to see all this in his position, such as refusing to defne previous positions, while also regis- develop, hopefully in a way that sparks the progress as meeting only what is standard tering as the company’s sole owner—a interest of my fve-year-old daughter.” for Russia. Repik believes the benchmark status he retains to this day. Repik is Second, R-Pharm is singularly focused for future growth is competing at the level unabashed about calling himself an on pharmaceuticals. “Sector diversifca- of the global market, and R-Pharm is de- entrepreneur rather than an executive, tion is the traditional fallback among suc- termined to get there frst. repeatedly emphasizing how his com- cessful Russian businesses, but we have Repik’s current high profle is rooted pany’s progress has depended on fus- zero interest in taking that course because in some early career disappointments. ing his “street smarts” and openness you end up ceding your core competitive “I was an inquisitive young man with a to new ideas with the operational and advantage to others.” strong interest in the arts, especially his- execution excellence of the R-Pharm A third, and related, objective is look- tory, where under the Soviet system I management team, led by CEO Vas- ing beyond Russia toward international was able to secure scholarships as well as ily Ignatiev, an industry veteran with markets. “Pharmaceutical sales in Rus- status as head of a student society dedi- stints at BMS and AstraZeneca. “I’d sia today amount to less than 2% of the cated to learnings of the medieval period. characterize my role today as unlock- global market. To expand and stay prof- But it all fell apart when, despite these ing the potential of our 2,800 employ- itable, domestic companies must look credentials, I failed to win acceptance to ees.” outward.” Repik notes a tendency of Moscow University. That disappointment businesses in emerging country markets pushed me to abandon academic cre- Four ways forward to strive for designation as a “national dentials for something more technical.” From the start, Repik has held fast to four champion”—and stop there. “It’s a pro- Repik instead trained as an economist, basic principles in running the business. foundly short-sighted view, which fails to where in 1995 he was introduced to the The frst is autonomy, a position guar- recognize that big Pharma competitors healthcare feld, helping hospitals in the anteed by his position as R-Pharm’s sole are already active on our own home turf. Moscow region manage their costs. shareholder. “With no outside owners, we At some point we need to come forward The assignment was short-lived, can make our own investment decisions with high-quality offerings, alone or in however, as the upheavals of the Yeltsin and take necessary risks to grow the busi- partnership, to compete for share on their era led Repik to join a small, family- ness long-term.” Repik employs a rule of home bases as well.” owned specialty pharmaceutical compa- thumb requiring three quarters of annual The fourth principle is keeping pace ny. “When I started in 1997 I was one of profts to be reinvested in the company. “I with customer needs, largely through

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an unrelenting commitment to qual- Yes to Yaroslavl helped drive new co-production and ity. In fact, Repik tells Pharm Exec that Preparation for this expansive step was promotion deals with companies rang- customer centricity is pushing R-Pharm carefully plotted though a constant ing from India’s Dr. Reddy and Japan’s toward the innovative side of the mar- upgrading of R-Pharm capabilities in Meijii Sankyo Kowa (frst ever for a Rus- ket. “The traditional business model for producing a growing variety of medi- sian company) to most of the Western pharmaceuticals is like a tree, growing cines—including biologics—all to the majors, including MSD, Roche, AbbVie, from the root, which is originator drug highest Western standards. Says Repik, BMS, Boehringer-Ingelheim, Novartis, innovation, to the branches and leaves, “we are the frst Russian company to and Pfzer. Many of these deals give R- which represent processing or assembly design production to meet all global Pharm exclusive rights to marketing new functions like distribution and market- GMP requirements, which is unprec- technologies in Russia, as the local part- ing.” R-Pharm is pursuing that model in edented here.” In 2008, when Rus- ner of choice. Repik notes that another reverse. “In Russia and throughout the sia’s state fnances were in crisis and vocal industry actor—the Russian gov- former Soviet Union, we are the leading hospitals—a major source of R-Pharm ernment—likes it too. distributor and manufacturer of a wide revenues—were not paying their bills, Looking forward, Repik will fo- range of generic and branded drugs, Repik decided to invest $130 million cus his efforts on the international both for our own account and as a ser- in new state-of-the-art manufacturing side of the business, particularly in vice contractor for others. But the next, facilities in Yaroslavl, giving R-Pharm forging ties with local pharmaceuti- and most exciting, phase of our growth expertise to produce advanced APIs cal companies in other BRIC mar- is to plant new roots as a developer of and biologics like monoclonal anti- kets, Turkey. and especially with medicines, organically from our own fa- bodies that previously were not avail- Asia, where he is a strong supporter cilities in Russia as well as in partnership able in Russia. of President Vladimir Putin’s effort with other innovative frms worldwide.” “Some observers called it a fantasy to diversify Russia’s trade ties into To push that along, in 2011 R-Pharm project located in the middle of nowhere, the region. A recent example of that established a dedicated Overseas Unit and it certainly tested our risk limits, commitment is the $5 million grant with offces in San Diego and Boston but today these facilities are central to R-Pharm awarded in April to Japan’s to explore in-licensing and development our value proposition with an increas- Nagoya University for pharmacologi- options with the US scientifc, academic ing number of international industry cal research in oncology. and venture capital communities. clients.” In fact, the investments have — William Looney

Sharpening the Learning Curve Monica Tellado, VP, US commercial operations, Gilead Sciences ith a background that in- tiated a treasury excellence program, W cludes one of the largest au- and “it seemed like a good opportu- tomotive makers in the coun- nity to see different parts of treasury try and one of the largest tech frms, for a big company,” says Tellado. Monica Tellado, vice president of US “But I didn’t stay very long.” commercial operations for Gilead, Expectations and reality were mis- brings a needed sense of urgency to aligned at Ford, says Tellado, who pharma’s planning cycle. next joined Intel, at a time when the Born in the US, Tellado left for company was growing quickly and Spain as a toddler and didn’t move entering new markets. Six years and back to the States until she enrolled in several fnance department roles lat- an MBA program at Carnegie Mellon er, Intel had “shifted from support- University’s Tepper School of Busi- ing new initiatives and new areas of ness. She split her undergraduate de- growth and opportunity to really fo- gree between Universidad Pontifcia cusing on cost-cutting,” says Tellado. won out for a few reasons: it was very Comillas, in Madrid, and Middlesex “So I decided to leave.” small at the time, but growing, and University, in London. At Carnegie Finance is a transferable skill, so Tel- the company was looking for someone Mellon, Tellado focused on fnance, lado looked out across many industries to build better processes, systems, and and the Ford Motor Company was a as she decided what to do next. She in- analytics, and to make fnance “a true heavy campus recruiter. Ford had ini- terviewed a lot, but ultimately Gilead business partner versus just a function

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that reports out the numbers,” says Tel- Tellado says she could deal with lon- lado emphasizes. “It’s important that ev- lado. It was also an opportunity to learn ger cycle times because Gilead, despite ery single person we bring on to the team a new and unique business sector. Tel- its dramatic growth in recent years, re- is really strong, both from a skill set per- lado joined Gilead just in time for a se- mains a lean and nimble organization. spective but also from the perspective of ries of product launches beginning with “We don’t have the challenge of having Gilead, and whether or not someone will Emtriva during her frst year with the to go to this committee or that commit- ft into the culture and environment.” company (2003), Truvada in her second tee,” she says. “We can bring a product Tellado can manage from 5,000 feet year (2004), and Atripla in 2006. in-house and get it ready to launch in or fve inches, depending on the indi- After working in the fnance depart- less than two years.” Indeed, Gilead an- vidual. “I think my natural style is more ment for the frst few years, an oppor- nounced that it would acquire Pharmas- hands off though…it’s high level – I’ll get tunity to transition over to the com- set—and what would become Sovaldi— involved in questions of what do we need mercial side presented itself. Tellado in late November, 2011. Sovaldi, which to accomplish and what are the business says she was promoted to manage the needs no introduction, was approved on problems we’re trying to solve—but I forecasting function, incentive com- Dec. 6, 2013, and made over $2.2 billion give the team the fexibility to get there,” pensation plan, and the rest of the sales during the frst quarter of 2014. says Tellado. “Strong players need room tools and data assessment supporting Tellado declined to speak on the re- and bandwidth and responsibility to the sales force. “I was still using my an- cord about the pricing and commercial- make sure they’re motivated and feel alytical skill set, but also getting much ization of Sovaldi for this profle, but that they’re contributing and making a deeper into the business side of things,” noted that in general, there’s an increas- difference.” Tellado also underscores the says Tellado. ing focus on healthcare management importance of “very high levels” of ac- In fnance, numbers are numbers and cost—“and there should be,” says countability as a crucial component of but “one of my frst impressions [upon Tellado. As a result, it becomes “even successful management. joining Gilead] was that the lead times more important to be able to clearly Married with three young daugh- are very different, in terms of how identify and clearly represent the value ters, Tellado says most of her outside you plan out to support a product in of new products and how they address interests have consolidated into sim- the pharmaceutical space versus the an unmet need, and how they help pa- ply spending time with her kids; her high-tech space, in terms of time-to- tients.” That means anticipating, early in family likes to travel and play sports. market,” says Tellado. “The planning product development, what health eco- Asked whether she would encourage cycle is a little slower in the phar- nomics and outcomes research will be her daughters to pursue careers in maceutical world versus the speed at needed to support a launch, and how to the pharmaceutical industry, Tellado which things change in the high-tech message not just product attributes but doesn’t hesitate: “I defnitely would. world, where you’re adding new fea- also a comprehensive value proposition. I’m very happy that I moved from the tures and you’re bring out your next Perhaps even more so for a smaller high-tech world to the pharma world… product and wheels are turning very, company, making the right hires, the and I’ve been here for a while now.” very quickly.” frst time, is a critical skill, one that Tel- — Ben Comer

Eye for Detail Hayden Thomas, VP, formulation development, Vertex Pharmaceuticals

hen George H. Bush sent troops thought he’d go to medical school. But W to Kuwait in August of 1990, a conversation with a department chair Hayden Thomas, PhD, current- of medicinal chemistry at the Univer- ly vice president of formulation devel- sity of Mississippi —Dr. W. Franklin opment at Vertex Pharmaceuticals, was Gilmore—changed Thomas’s trajectory. aiming high as an undergrad Air Force “[Gilmore] was talking about all the ROTC cadet. great things in medicinal and pharma- But the military got downsized short- ceutical chemistry, painting this vivid de- ly thereafter. All the new recruits got scription of pharmaceuticals…instead of cut, and Thomas, an Arkansan, “found helping one patient at a time as a medical myself, in my junior year, looking for doctor, you can help out thousands or something to do.” Having also focused even hundreds of thousands,” Thomas on science as an undergraduate, Thomas recalls.

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After graduate school beginning at and one thing a process chemist must real-time feedback, connectivity among Ohio State and completed at the Univer- have is very strong observational skills. employees and open communication sity of Michigan in Ann Arbor, Thomas These skills can be applied in the lab, lines, says Thomas. “Feedback should starting working “about a mile down the but they’re also important for watching always be received as a gift. The way I road” at a Parke-Davis’s research facil- people, in meetings and team settings,” try to give and get feedback is, feedback ity, a subunit of Warner-Lambert. He says Thomas. “You look for people that is given, you listen intently, you don’t ask landed at Pfzer through that company’s are highly effective at what they do, and questions about it—you receive it. You $90 billion acquisition of Warner-Lam- try to fgure out why they are effective. say thank you very much, and then you bert in 2000. Pfzer closed Thomas’s old If you can break it apart and take away take it away and try to analyze it from Ann Arbor stomping grounds in 2007. those learnings and apply them to your multiple angles. What was this individu- Vertex was a breath of fresh air, own approach, that’s a huge skill.” al really trying to tell me? And then you “unlike any other company in the The core objective of Thomas’s team try to apply it in the best way possible.” pharma industry,” says Thomas. With at Vertex is to take an active pharmaceu- Asked about the role of failure in roughly 40 direct reports in his current tical ingredient and put it into a dosage pharma leadership, Thomas says fail- role, Thomas underscores the impor- form that meets a patient’s needs. “It ure is simply part of the business. In a tance of being an effective member of doesn’t matter if you have the greatest way, “there’s no such thing as failure… a team. Coming from a graduate pro- medicine on earth for the worst disease, just because an experiment doesn’t turn gram centered squarely on himself, if it’s not in a form that’s acceptable”— out the way that you anticipated or were Thomas found the transition to team- according to performance metrics—“for expecting doesn’t mean that you didn’t work challenging at the beginning of patients, then you really haven’t deliv- get useful data, or that you didn’t learn. his career. “In grad school it’s all about ered anything.” What matters is how you respond to you. You have a tough project in front Thomas calls Vertex a leader in qual- failure,” says Thomas. of you, and four or fve years to solve ity by design and continuous manufac- Even though he never entered the it. You have all the expertise, all the turing processes. By using “real-time Air Force, Thomas did get his pilot’s knowledge, it’s you, you, you, and release testing,” and linking unit opera- license. His family and two children then you defend your work in a thesis tions together, Vertex is able to fnish take up most of his spare time. Thom- committee,” says Thomas. “That’s all products, on a continuous basis, that are as doesn’t own a plane, but likes to go good, but then as soon as you step into ready to use by patients as soon as they boating in the summers, and snow ski- the industry, it’s all about team.” leave the line,” says Thomas. “You’re ing in the winters. Successful teams are built on “trust taking a manufacturing process that’s In five years Thomas says he and rapport with the folks in your highly intensive from a labor and time hopes to be solving difficult prob- group…you need to build that personal and materials standpoint, and you’re lems. He says leaders should strive relationship,” says Thomas. That means streamlining it down to where you do a to eliminate their own positions by understanding “how each [team mem- manufacturing run in a day, maybe two constantly becoming more efficient. ber] thinks, what drives them, where at the most, and it’s released and ready to Being perceptive and constantly their passion lies, what their strengths go.” Hayden was instrumental in estab- looking for a better way to do things are, and where they are going.” lishing Vertex’s frst high-tech continu- is what keeps an organization “com- Observational skills are critical, says ous manufacturing facility in Boston. petitive and innovative, and moves Thomas. “I did a short stint in process On the manufacturing foor and off, the industry forward.” chemistry back at my former company, Vertex leadership puts a premium on — Ben Comer

heim to the power of data analytics More than a Number and the key role it plays in pharmaceu- Jocelyn Trokenheim, Head of Global Business Development Offce and tical sales and marketing. Strategy,Takeda Pharmaceuticals But a larger revelation was at hand ike many data analysts, Jocelyn fresh out of high school and speaking in that frst industry assignment. “En- L Tsai Trokenheim was schooled not a single word of English. After ob- lightenment struck when I began to to believe in the pure logic of taining her second Master’s degree in realize that numbers only tell half the numbers. Her early history as a “quant Management Science at Queen’s Uni- story. It’s actually people who truly jock” clearly helped the 42-year-old versity in Canada, she landed her frst defne a business and determine its immigrant from Taiwan adjust to life job at the pharma consulting frm ZS success. So I decided to get to know in the US, where she arrived in 1991, Associates, which introduced Troken- the human capital behind the num-

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bers—employees, physicians, and industry 12 years ago is the need to patients—as the best way to expand collaborate. Dealmaking and business my skills and make an impact where it development continues to drive our in- matters most. This is what led me to dustry as never before, with a focus not seek that larger world beyond consult- just on late-stage compounds that are ing and to join Takeda.” “battle tested” but on earlier stage deals After spending 10 years rising and new forms of pre-competitive ex- through the ranks in Takeda USA’s changes that may offer companies more commercial analytics group, Troken- opportunity for growth, while sharing heim chose a new path into the par- the risk.” ent company’s global Business Devel- With that in mind, Trokenheim urg- opment function. It turned out to be es younger industry colleagues to gain an ideal opportunity to hone those experience in working cross function- combined quantitative and qualitative ally and with people who can provide assets that account for much of the a different perspective. “The ability to progress she has made in her career. manage geographically dispersed, vir- As the company worked to digest two ment, who Jocelyn met in 2011 when tual teams and to understand different major acquisitions, she was given what she was part of a small team working strands of opinion from all over the proved to be a pivotal assignment: to on a US acquisition transaction. world is a must. To get others to ‘jump create an integrated global business On a practical level, Trokenheim on the bus,’ you need trust and that process and system operations plat- cites her biggest accomplishment to trust has to be earned through persua- form in global Business Development, date as the creation of a strong in- sion and example.” consolidating activities and processes house commercial analytics capabil- She also has some pithy advice formerly distributed across three con- ity during her days as head of Busi- around the popular concept of men- tinents. “People skills really counted ness Insights and Strategy at Takeda torship. “We need to be clearer about here, as my job involved working not USA— one that has been recognized what mentoring means and how it just within global Business Develop- as a “best practice” in the industry actually develops in the work place. ment but almost all functions across by TGaS, the group that benchmarks Based on my experience, on both Takeda. company performance in the market sides of the fence, mentorship devel- After only nine months, Troken- research field. “I was able to recruit ops when the mentor self-identifes heim was given the additional task and lead a team of 28 talented pro- the talent and acts to help the talent of driving the overall strategic direc- fessionals spanning mission-critical grow. Any pre-identifed or forced tion for Business Development world- functions—forecasting, market arrangement between mentor and wide, including creating the business analytics, commercial assessment, mentee typically ends up not working development group’s strategy as well decision science, market research, well. So I say the aim must frst be to as managing corporate-level strategic commercial reporting, and data gov- do your best, because once you excel, transactions. “Handling both opera- ernance—all in support of Takeda’s it will be the mentor who comes to tions and strategy seemed initially like in-market products, pipeline com- you, not the other way around.” an oxymoron, but as I rolled up my pounds, and business development What’s next? Trokenheim is open sleeves I began to see it as a position and partnering efforts. We estab- about career possibilities, emphasiz- combining the best of two worlds—the lished close cross-functional ties ing that what she likes about Takeda ability to contemplate the biggest, most throughout US Operations and were is the exposure to a broad range of promising ideas of the future while en- recognized for providing insights to projects. Whatever it is, Trokenheim suring our day-to-day performance help patients and move the business always returns to the Asian theme of milestones are met through deliberate, forward.” life in balance—“even though I enjoy hands-on execution.” my work, I don’t think my profes- That swift rise was nurtured by Timing and the right place sional life defnes who I am.” Spend- some valuable contacts she has made Although personal characteristics are ing time with her husband and their at different stages of her career. One a big part of her success, Trokenheim 9-year-old son, along with another prominent mentor is Anna Protopapas, has been fortunate in that her work enduring companion—her love of President of Millennium Takeda On- complements broader environmental music and family jam sessions on the cology Company and Executive Vice trends affecting the industry. “What ukulele—is truly the tie that binds. President of Global Business Develop- has really accelerated since I joined the — William Looney

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Photo: Thinkstock

now know it. The centerpiece of the A Mission to Transform curriculum is a requirement that each student initiate a “Critical Challenge Project” within their sphere of exper- Mid-career students at Brown University’s new Executive tise to address this aim, probing the Masters in Healthcare Leadership program are challenging way healthcare services are currently the status quo with workplace projects designed to do one organized, delivered, or fnanced. thing: remove the organizational silos that slow innovations in the delivery and fnancing of health services. Strafng those silos: The Critical Challenge project By William Looney An underlying goal of the Critical Challenge Project is to attack the bu- s the US healthcare system stum- lectual heft for integrative, outcomes- reaucratic or process silos that prevent bles toward a new consensus oriented programs that stress patient different parts of the system from co- A built around the “triple aim” of wellness and require medicines to do operating to advance a more holistic increased access, improved quality, and more than just treat disease. population health agenda. The empha- lower cost, the push is on for new ideas One institution, Brown University, sis is as much on doing something dif- that can test the boundaries of cur- has gone a step further than many of ferently as doing something important, rent practice. The Affordable Care Act its counterparts, with a new 16-month engaging stakeholders across the sys- (ACA) creates a range of incentives to Executive Master of Healthcare Lead- tem to achieve a measurable result that promote this goal, which has added to ership (EMHL) program dedicated to will allow the student to assess—quan- the momentum around novel reform empowering mid-career health profes- titatively or qualitatively—the effects approaches. Business management sionals with the diverse interests, skill,s of its implementation. schools have jumped with gusto into and capabilities to challenge that status The Critical Challenge Project is the fray, providing much of the intel- quo and “transform” healthcare as we a key criteria for admission; it also

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serves as the basis for much of the revolves around Bloodbuy, a small optimal price point.” It also works EMHL’s formal coursework, the stu- start-up enterprise he founded to cre- for the blood centers, which face a dent’s f nal grade, and subsequent ate a more transparent and structur- strategic dilemma as reform slows priorities upon his or her return to ally cohesive process for the exchange acute care utilization, which leads the workplace. Students give regular of price information and supply of to less demand for their commodity. progress reports on their project in a blood products between distributors “Bloodbuy’s technology enables them peer group exchange format, allow- and hospitals. to address this slowdown by helping ing diverse points of view to be incor- “If you want to improve the mar- them penetrate new geographies and porated in plans and objectives going ket,” Godfrey says, “the best place acquire new customers.” It’s a preci- forward. “This is not a static exer- to start is with the core commodity sion response to a gap unmasked by cise,” says EMHL Program Execu- of healthcare, which is blood. Es- the drive toward system reform, help- tive Director Judith Bentkover. “We sential services literally cannot be ing customers out of their silo to con- see it as a way to test theory against provided without it, so I see it as a nect to a relevant area of unmet need, practice, with transformative system critical pathway into the health sys- with greater eff ciency at each end of change as the ultimate objective.” tem—and, unfortunately, the logis- the market as the intended result. As a complement to this month’s cover feature on 15 Emerging Phar- ma Leaders for 2014, Pharm Exec “If you want to improve the market, the best made a recent visit to Brown’s f rst EMHL class of 28 mid-career pro- place to start is with the core commodity of fessionals, most under age 40, and healthcare, which is blood.” representing a wide range of sectors and occupations in the healthcare f eld, from traditional big Pharma tics of pricing and supply devised by Star power: Enlisting to health community activists. The blood center distributors are often the sales force purpose? To highlight a few of the non-transparent and lack much ac- Debbie McKee, general manager for more ground-breaking Critical Chal- countability to the hospitals that de- upstate New lenge projects being pursued by this pend on predictability in the supply York and Con- highly motivated class of young en- chain. Godfrey notes that the FDA necticut at Unit- trepreneurs—and thus to open a win- mandates uniform standardization in ed Healthcare’s dow on the future of healthcare. A the composition of blood products, Medicare and talk with f ve students indicates a which means there should be little Retirement unit, diversity of approaches, but all share differentiation in pricing—the prod- works on the the EMHL program objective of ex- uct itself is the same. Yet a strong front line of the posing the silo thinking that blocks spot market exists in many parts of insurance indus- progress toward changes that every- the country for blood products, with try’s efforts to adapt to new mandates one says they want, but are hard to the result that hospitals face wide under the ACA on cost-eff ciencies in achieve in practice. gaps in what they have to pay for the delivery of health services to se- blood, making it harder to accurately niors. Her Critical Challenge project Bridging the information gap account for their needs. is based on United Healthcare’s com- For Chris Godfrey, senior vice presi- To remedy this, Bloodbuy has de- mitment to accelerate the number of dent at Dallas-based venture capi- veloped data technology to help hos- star ratings it receives for quality of tal f rm HealthCap Partners, market pitals overcome the fragmented sup- services provided to enrollees in the signals are often ply chain and lack of transparency in company’s Medicare Advantage ben- missing in health- pricing by broadcasting their blood ef ciary plans. This is important f nan- care, resulting in needs to a broader audience, avoid- cially to all insurers because the ACA more uncertainty ing the traditional dependence on a now conditions reimbursement and and less eff ciency few local outlets. “It’s essentially bonus payments through Medicare in the deploy- about diversifying risk, so that as a on the quality star rating achieved by ment of human hospital I am going to have a better each plan, with CMS evaluating plan and capital as- chance of getting the blood prod- performance across 53 specif c qual- sets. His project ucts I need, when I need them, at the ity measures. “My project confronts

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an important silo that can impede our Pharma copes with trends like glo- tion like J&J we have to try this out progress against this goal, which is balization and high-cost drug devel- to see how it f ies. Where I am going the failure to mobilize United Health- opment, where the common thread with this is to get our top executives care sales agents to help win those is seeding “the will to cooperate” as to understand that change in this in- higher ratings. We have hundreds of a cultural imperative. Says Suther- dustry is permanent—organizational colleagues engaged in selling a plan land, “the way we educate our own learning ultimately can’t be applied and helping to service the contract workforces is very siloed. Technical piecemeal. And we have to be in it for with the member, yet having no input training always tends to relate to the long haul.” around the execution of the compa- specif c job roles and leadership de- ny’s star rating strategy.“ velopment is driven largely by inter- Measuring value that matters With management support, McK- nal issues rather than relating to the Deborah Pfeif e is CEO of Gould & ee and her team have initiated a pilot wider world of healthcare, especially Lamb, the leading program covering eight markets in that ‘trifecta’ of patient/customer ex- provider of Medi- United Healthcare’s Northeast ser- pectations around cost, quality, and care program vice area. It gives sales agents assign- access.” compliance ser- ments to ensure that members in their To address this challenge, Suther- vices for the glob- territories are on target in imple- land has secured financial and lead- al insurance and menting preventive care programs, ership support for a pilot project in self-insured mar- especially the wellness checks that his Infection Prevention Practice, to kets. Her Critical patients often fail to utilize. “So far, launch in the first quarter of 2015. Challenge is to I have been surprised by the number The centerpiece is a core healthcare create a metric that will allow insur- of people in sales who see this as evi- learning curriculum for new employ- ance underwriters to accurately value dence they are part of the wider so- ees and managers in three depart- an individual life care plan for solution to the cost of healthcare. Her ments of the Practice: sales, market- called “dual eligible” patients who are training at EMHL is helping McKee ing, and clinical/provider education. enrolled in Medicare but receive their take the pilot to the next step, which Six to eight course modules are be- care through the Medicaid program is aligning individual pay and bonus- ing planned, including an introduc- for the indigent. These are high-cost es around this broadened service ori- tion to the ACA and J&J’s corporate patients, usually with multiple chron- entation. “We have to provide a f rm response to its key provisions; how ic ailments, who also have very low response to the root question of eco- the innovation process works inter- incomes. nomic incentive: what’s in it for me?” nally, outlining the distinction be- The Medicaid program has for tween invention and innovation; and some time been contracting with pri- The learning organization: what each function can do to engage vate insurers to cover this group and Testing old boundaries more productively with the external to f nd ways to deliver care more ef- Jun Sutherland, worldwide director, stakeholder environment. f ciently—thus creating the rationale education and learning for J&J’s In- J&J, as a highly decentralized or- for Pfeif e’s project. “It is a priority fection Preven- ganization with some 250 separate for the insurance industry and actual- tion Practice, has operating units, might seem averse to ly for government and society as well, built his career any overarching approach to educat- to be able to anticipate what dollar helping life sci- ing employees. But Sutherland was amounts will be needed to keep this ence organiza- able to address this by securing ap- population well and out of hospital,” tions keep pace proval from the company’s Global Pfeif e told Pharm Exec. “A life care with the heady Management Board, and the Board plan is designed to estimate what the pace of scientif c member representing the Infection cost will be in services and supplies to discovery and the Prevention Practice authorized the help a patient with a chronic disease obligations it places on key functions budget to fund the pilot. The Board or condition maximize the ability to ranging from regulatory compliance will decide later next year whether to function for the rest of his/her life. to ethics and reputation manage- make the pilot permanent and to roll This is hard to do for those who are ment. His Critical Challenge project the concept out to other parts of the ill, but it is particularly challenging is arguably the most ambitious in the company. Says Sutherland, “this is a for dual eligible patients due to the group, given its scope: bridging what change management initiative, so it’s constraints imposed by the harshness he calls the “learning gap” as big not unusual that in a large organiza- of their underlying economic and so-

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cial circumstances.” Indeed, evidence communities I support by economic Silo-busting precedents: shows that failure to anticipate these troubles as well as cultural, linguis- Four lessons non-medical needs in a life care plan tic, and even geographic barriers,” All of the Critical Challenge projects ends up driving healthcare costs even says Sandoval. “Many of the people undertaken by this f rst, 28-member higher. “We must work to incorporate our clinics serve are unregistered 2015 class of the Brown EMHL pro- that fact into our metric.” immigrants with no f xed address, gram are intended to grow beyond Pfeif e told Pharm Exec she is transient seasonal workers who fol- the shelf life of academia; the students working with a private non-prof t, low the harvest and speak no Eng- expect these will shape their future as- the Foundation for Life Care Plan- lish. Getting these diabetic patients signments in the workplace as well. ning Research, to establish a research to proactively self-manage their con- Executing a project designed to es- analytics standard that allow under- dition is almost impossible: how do tablish something tangible around an writers to build cost estimates for this we do it? This was the essential ques- academic program raises an inevitable dual eligible population, which num- tion deserving an answer. My project question: are there lessons from the bers more than 10 million people. seeks to provide it.” experience that can be applied to cre- Says Pfeif e, “this is something that has never been done before—there is no prior research and we have ex- Executing a project designed to establish tremely limited precedents to go on. We are building this metric from the something tangible around an academic ground up.” program raises an inevitable question: are Curative power of community there lessons from the experience that can Nicolas Sandoval works for the pa- be applied to create a generic lesson plan tient at the most for business success? basic level, helping communities of economically What Sandoval is introducing, with ate a generic lesson plan for business marginalized the help of colleagues from Salud, is success? workers to navi- a structured program of group visits The consensus appears to be yes, gate the public for diabetes patient treated in network with Pharm Exec’s discussions with health bureau- clinics. It involves bringing 10-15 pa- the class yielding four strategic prin- cracy to obtain tients together for encounters with ciples: (1) understanding the goals of essential primary care services—ser- not only the physician, but a nurse, the organization f rst, to f nd ways vices that can make the difference pharmacist, medical assistant, dieti- to get others to align with your own between wellness and disability. A cian, and health educator. “It creates goals; (2) avoiding the visionary prison bilingual health educator for Salud a setting where basic messages about of “thinking small,” by going beyond Para La Gente, a network of federally health maintenance are reinforced internal politics to identify outside designated community health clinics through a structured group exchange stakeholders who will be affected, for in rural California, Sandoval has a built around four behavioral pillars: better or worse, by what you intend to strong interest in the “whole person” physical activity, nutrition, medica- do, and planning in advance to address approach of population health, es- tion adherence, and stress manage- each; (3) consider the underlying social pecially in identifying the most cost- ment.” Sandoval says the training he and cultural aspects of health care, in effective way to treat poor patients is receiving through the EMHL pro- addition to its more prominent scien- with chronic illnesses. His Challenge gram will move the project to the next tif c and clinical dimensions—that elu- project centers on the treatment of step, which is developing a list of in- sive 360 degree picture; and (4) always type 2 diabetes, a condition affect- dicators to demonstrate the program’s be transparent, which in the competi- ing as many as 60% of farm workers effectiveness in improving outcomes tive precincts of healthcare is not an in- in the areas of the state covered by for covered populations. “Under the stinctive act, but learned behavior. Salud’s network. ACA, as a federally qualif ed health “Control of diabetes requires a clinic, this metric is going to be neces- William Looney is Pharm Exec’s Editor-in-Chief. He can be reached at [email protected]. huge commitment to patient edu- sary to scale up and obtain an ongoing Disclosure: he is a member of Brown’s EMHL cation, a need accentuated in the source of funding.” Advisory Committee.

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es prior to the announcement Only Fools Rush In of a takeover bid. Once it is The Importance of pre-acquisition due diligence. determined that the company is serious about acquiring a ith the warm days of transfer a whole host of liabili- target company, the frst step W summer upon us, news ties from the target company should be to assess the target’s of yet one more take- to the purchaser in an acqui- initial risk profle. over bid might seem like déjà sition, including criminal and Asking certain key ques- vu. In late May, US medical- civil liability stemming from tions at the outset will help device group Stryker confrmed past wrongdoing. determine the target’s risk lev- that it was evaluating a bid for For example, a full decade el and the scope of any future UK-based Smith & Nephew. after buying orthopedic device due diligence. For example: Before that, GlaxoSmithKline maker DePuy Inc. in 1998, » What, if any, compliance announced a major three-part Johnson & Johnson ended up program already exists at deal to acquire Novartis’ vac- paying $77 million in fnes and the company? Having zero cines business. In June, Min- penalties to the Department of pre-existing compliance is neapolis-based medical device Justice and Securities & Ex- certainly not fatal to the deal, maker Medtronic announced change Commission due to the but is a good thing for the ac- a $43 billion bid to acquire subsidiary’s widespread brib- quiring company to know in Dublin-based rival Covidien. ery activity in Greece at the assessing risk. The reality starting to set in is that 2014 stands to be a record year for mergers and acquisi- Long before a deal is signed in ink, tions with a blistering $3.51 a company’s compliance and legal trillion in deals estimated to be set by year’s end. team should be involved in the What to make, then, of vetting process. this frenzy of M&A activity, especially with so much of it happening in the life sciences time of the acquisition. Expect » Does the acquisition con- and medical device industries? the latest round of mergers to template a full share pur- Mergers not only help boost similarly arouse scrutiny from chase or just an asset a company’s book value but U.S. government regulators, purchase of the target com- are also highly attractive to and those companies that have pany? The latter will carry many US companies in search ignored compliance issues in less successor liability for of lower corporate tax rates their pre-acquisition due dili- past wrongdoing. abroad. Experts have re- gence to suffer buyer’s remorse » What laws is the target com- marked that with many com- later on. pany currently subject to? panies facing expiring patents The acquisition of a company and decreased revenues, the Think compliance early on does not create jurisdiction growing M&A trend in the Long before a deal is signed in where none existed before. pharmaceutical industry is un- ink, a company’s compliance » What is the ultimate appeal likely to abate anytime soon. and legal team should be in- of the target company? Ac- volved in the vetting process. quiring an expanded market It pays to be cautious One reason why compliance share carries different risk But companies in search of an should have a seat at the M&A from solely purchasing new “easy buck” through an acqui- table early on is so that they technologies or patents. sition may end up getting more stay informed of upcoming than they bargained for. That’s deals in the pipeline in order to Asses the risks because successor liability laws marshal the necessary resourc- After this preliminary stage, the buyer should develop a better Severin Wirz is Manager of Advisory Services at TRACE International. He can be reached at [email protected]. Continued on Page 53

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Cover Art by Ignacio Gana. CHILE:CHILE: [email protected] Pharma’s Changing Landscape

represents an exciting time for healthcare “2014 in Chile with the implementation of a new national drug law; ensuring the creation of a system that makes access to medications easier and more transpar- This sponsored supplement was produced by Focus Reports. ent for patients and, moreover, assures a suffcient supply Publisher: Ines Nandin all over Chile,” explains Helia Molina, a doctor specializing Project Director: Martijn Jimmink in pediatrics and nephrology and Chile’s Minister of Health Project Coordinator: Gabriela Cordova since March 2014. The ‘Ley de Farmacos,’ or Drugs Law, For exclusive interviews

was passed by Chile’s former government in January 2014; www.pharmaboardroom.com or write to [email protected] its implementation now rests with the new administration.

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“The new government of Chile has The Chamber of the Pharmaceutical made a commitment to improving the Industry in Chile (CIF), which repre- health of the population,” Molina ex- sents the international innovators, will plains, “and the Ministry of Health will carefully monitor the implementation of expand the list of chronic diseases in- the new healthcare law, which requires cluded in the Regime of Explicit Health prescriptions to mention the name of the Guarantees (AUGE) plan, which en- chemical compound. While this is seen sures government-funded coverage for as positive for the customer, who will patients regardless of age, class, and From left: Helia Molina, Minister of Health; now have access to cheaper alternative ability to pay.” Ricardo Fabrega, director of the Public products and also their personal brand Health Institute This should contribute to boost a preference, for, innovators there is still market that is already expected to grow a major concern about bioequivalence. 8.2 percent between 2012 and 2017 according IMS Health. In Chile, as in other Latin American countries, simil- In 2012, the Chilean pharmaceutical market was worth a ares have high market penetration: generic drugs that do total of USD 2 billion, according to the latest available data not have proven bioequivalence. “If the law would allow from IMS. physicians to prescribe any generic drug including non- The new government plans to introduce further legisla- bioequivalents, all efforts made by previous governments tion to improve healthcare in Chile. In her paper entitled would be for nothing,” says Jean Jacques Duhart, execu- ‘50 Commitments for the First 100 Days of Government,’ tive vice president of CIF. “A large portion of products on President-elect Michelle Bachelet builds the basis of her the Chilean market cannot demonstrate quality, safety and plan for better health services for the nation, committing effcacy through bioequivalence studies. Similares are nei- to invest signifcantly in the construction of new hospitals, ther generics nor originals and have not demonstrated their increase the number of specialists to combat long waiting quality, effcacy and safety as recommended by the World lists in the public sector and provide patients with better Trade Organization.” access to free drugs. He also warns: “This is not merely a concern in terms As it currently stands, Chile’s universal healthcare plan of health and risk for patients but it also introduces an im- covers 80 percent of the population. The remaining 20 per- portant market distortion—different actors are competing cent are entitled to pick their coverage from a number of with different standards.” private insurance companies known as ISAPRES. 80 percent of people in Chile should have access to free drugs un- LeveL pLaying fieLd der FONASA, the public health insurance system; however, the reality is that there are often shortages at hospitals, and Chile is aiming to achieve complete bioequivalence of ge- as a result people turn to private pharmacies to fll their nerics by the end of 2014. Chile’s Public Health Institute prescriptions out-of-pocket. As a result, despite FONASA, is leading the bioequivalence testing, aimed at regulating out-of-pocket expenditures in Chile are some of the high- differences between generic and bioequivalent drugs. The est in the OECD: A total 4.6 percent of the average Chil- recently appointed director of the Public Health Institute, ean family’s budget is spent on healthcare, compared to the Ricardo Fabrega, echoes the need for drastic change and OECD average of 2.86 percent. stresses that: “laboratories that produce generics will have There is positive news on some fronts however: after to understand that they must comply with bioequivalence years of infamously tense relations between MNCs and studies; otherwise we will take them out of the market.” the government, both parties finally seem to have found The request for bioequivalence could be a game changer. a platform for dialogue. “As an industry, we have an ac- Companies producing similares could be forced out of the tive dialogue with the ministry regarding the expansion market, or to drastically change their practices. Accord- of access to innovative medicines, but the discussion is ing to Carlos Cicogna, managing director of MSD Chile, still young and we still have a lot to do,” explains Erich it could also drive investments from MNCs in the country: Viertel, country manager at Janssen Chile. “Finding the currently, MNCs are responsible for more than half of the best path to lead Chile toward economic development has bioequivalent generics on the market. “The environment is been an ongoing task of Chilean governments and lead- getting more attractive for innovators such as MSD: with ers over the last century. And if the country is able to the new regulations we will see an equal playing feld; fair sustain its current momentum, at the end of this decade conditions are being implemented. And as a result there is it will probably become the first fully developed country an increasing interest from the industry to increase invest- in Latin America.” ment in the country.”

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Cicogna, who has been in Chile since 2009, has already witnessed dras- The R&d incenTive tic change in the market: “There have been two major developments in the With the goal of making Chile a hub past fve years: the implementation of for innovation, the Chilean Ministry the new drug law and the shift in land- of Economy and CORFO, the Chil- scape: the top players on the Chilean ean Economic Development Agency, pharmaceutical market used to be local announced last year that four multi- players, but today the key players are From left: Jean Jacques Duhart, executive national companies would invest in multinationals.” vice president, CIF; Erich Viertel, country new research and development centers. manager, Janssen Another proposal currently being From the pharmaceutical sector, Pfzer discussed in parliament is the complete will invest in a precision medical cen- overhaul of ANAMED, the national regulatory agency for ter studying new genome-based diagnostic technologies for medicines in order to bring it in line with other regula- cancer. The aim is to enhance Pfzer’s precision medicine tory bodies around the world. Elmer Torres Cortes, general approach to help understand the underlying biology of dis- manager of ASILFA (the association representing generics ease and identify patients likely to beneft from new drugs. companies in Chile) explains, ANAMED is currently part For the project, Pfzer partnered with the government to of Chile’s Public Health Institute, but should be separated develop technology and research: CORFO has contributed in order for it to stand as an independent regulator of medi- USD 7 million out of a total investment of USD 21 million. cines. The current plan being discussed for ANAMED is “Our expectation is that with the initial support of the gov- for it to reach level four of the Pan American Health Orga- ernment, this will be the frst of a series of programs that nization (PAHO) assessment table, at which point it can be Pfzer will develop in Chile,” explains CORFO’s executive designated a reference authority for medicines. “ANAMED vice president Eduardo Bitran. “With this subsidy, which should be autonomous, independent and capable of moni- we consider seed money, we expect Pfzer to change its view toring the local and international industry. We believe this of the country and continue to develop applied research in is fundamental for the pharmaceutical industry in Chile,” Chile. As a country we are sending a signal with the aim Cortes adds. that other pharmaceutical companies will follow suit.”

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This strategy seems to be paying off: Chile lead the per capita rate of clini- “The feedback from the industry has cal trials in Latin America (0.34 per 10 been extremely positive and as a result 000 inhabitants, threefold of that of we have received many inquiries about Brazil or Mexico). the center,” says Ricardo Avila, medi- Roche has a long history of conduct- cal director at Pfzer Chile. “It seems ing Clinical trials in Chile. Currently that there is an increasing interest to the company has 19 on-going trials in increase investment in the country.” 10 different disease stages and is eager Pfzer’s country manager in Chile, Car- From left: Carlos Cicogna, managing to conduct more in the future. Accord- los Murillo, feels responsibility to turn director, MSD; Elmer Torres Cortes, ing to Ciro Caravaggio, general man- this project into a success in the coming general manager, ASILFA ager of Roche conducting clinical trials years and believes that Pfzer has paved in Chile can be expensive, the process the way for Chile to position itself as a biotech hub for can be slow, and requires signifcant approval hurdles. Latin America. “I expect the ecosystem to start fourish- “Furthermore, many don’t see the value the trials can bring ing soon,” he asserts. “This country is for our company to a hospital or a patient. For a major oncology hospital, an example of how we can work in partnership with the government.” Over the past decade, as clinical research activities have Tecnofarma: an outstanding example been growing steadily within Latin America, Chile has worked hard to become a regional leader for conducting With the introduction of the mea- clinical trials. Due to its qualifed human capital base and sures to enforce bioequivalence, favourable government environment, the country has com- companies must adapt quickly if they want to continue to compete petitive advantages for developing such a cluster. Currently, in the market. Tecnofarma, a Uru- guayan company that has been in the Chilean market since 1983, is moving rapidly on this front, and is bullish about its future prospects in the country, having Antonio Avila, general manager, recently secured new Santiago Tecnofarma offce space as part of the company’s continued growth plans. Antonio Avila, general manager of the company, arrived in 2011, after working experience in Venezuela and Dominican Republic, with a fresh outlook on the business. Avila adapted the business model to the current needs of the market. The company increased its business units and launched new products to the market while focusing on its core products. With a broad product portfolio, Avila is currently focusing on products for oncological and non-oncological therapies. “Tecnofarma launches about 4-5 products per year,” Avila says. “This is challenging for a pharmaceutical company and only succeeds with a well- planned business model.” The company has a positive attitude towards bioequivalence and Avila is confdent that the company will meet the deadlines for bioequivalence standards for its products in Chile: “The government created three product lists detailing the dates by which the products should have proven bioequivalence and therapeutic effcacy. We are already advancing on www.tecnofarma.cl each list and I am positive we will reach the objectives,” Avila explains.

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clinical research is an integral part Chile from a manager’s perspective of care and not an afterthought; it is critical! So many patients are Ciro Caravaggio took the helm of the Chilean operations of at the end of their treatment and Roche a little less than three years ago after an experience want new hope.” in Roche’s headquarters in Basel, and a career with the same Historically the clinical trial company in his home country, Canada. Caravaggio describes environment has been seen as a how different Chile and the Chilean environment were from matter for international compa- what he expected. nies but the CIF is working hard First and foremost I found healthcare was more politicized and Ciro Caravaggio, to turn around this situation. “We in the media than I was used to. general manager, are working on involving more lo- In particular as I arrived we were in the midst of launching Roche cal partners in clinical trials and Herceptin, a revolutionary product for the treatment of breast research and development. It is cancer. Herceptin was not reimbursed in the public setting at the time and several actors where pushing to get the drug approved. Immediately it became clear to our ambition to establish Chile me that there was no formal evaluation process in place. Naturally each country is as a leader for clinical trials and different in terms of market access and its reimbursement system but what was research in medicines”, CIF ex- different in Chile is that the industry is not offcially part of the reimbursement or ecutive vice president, Jean Jaques access process. Duhart said.

Cécile Bassereau, managing director B. Braun Chile, took changing Landscapes over the reins of the Chilean operation in 2012. She describes the challenges and achievements she faced as the head of Pharma M&As are back with a local operations. vengeance. Latin America, which I took the helm of a German company, in Chile while being is predicted to grow two to three French. In such a multicultural environment I am trying to trans- times faster than developing mar- mit that we have to be fexible and tolerant without prejudice. kets in the years to come, has Chile has been developing extremely fast, with a fve per- been a prime target. Chile has not cent GDP growth rate in the past decade. Nevertheless public been spared in this recent activity, Cécile Bassereau, hospitals in Chile do not have access to some state-of-the-art managing director, with several acquisitions in recent B. Braun technology and sometimes the cost of a medical device looks like a barrier. But it is important to look at long-term benefts. months. That being said, it is a challenge and our responsibility to infuence decision makers The dealmaking in Chile to make them adopt a long-term cost beneft approach to treatments with the help started in December 2013 when of state of the art technology. Grünenthal Group, an international research-based pharma- João Simões has been with Grünenthal since 2004. Prior to ceutical company headquartered his appointment as head of integration at Grünenthal Chile, in Aachen, Germany, completed he served as CFO for Latin America and country manager, in the acquisition of Andrómaco his home country, Portugal. Simões elaborates on the funda- Laboratories for an undisclosed mental differences between a country like Chile and Southern sum. Andrómaco is a leading European markets. Chilean pharmaceutical company I see similar trends in terms of healthcare. In Southern Euro- with over 70 years in the market pean markets, healthcare is substantially funded by the gov- that specializes in prescription ernment. In Chile we see a similar trend as the newly elected drugs, but also has a wide range government is moving forward with the improvement of the João Simões, head of integration, of high technology products, ge- country’s healthcare system; increasing coverage for Chileans. Grünenthal Chile nerics and OTC. Grünenthal ac- Public healthcare in Chile is improving its quality, but the coverage on medicines is still below the expectation of its cepted the public tender offer people. Chileans want access to medicines for which they do not have enough with respect to the acquisition of resources. Universal healthcare is a global trend, which we also see in Chile. all issued and outstanding shares Although I see both worlds coming closer the Portuguese and Chilean market dy- of Andrómaco. namics are still quite different today. Healthcare in Portugal is mostly funded by the João Simões, head of integra- government, while Chile still has a high patient out-of-pocket expenditure on health. tion at Grünenthal Chile, explains that the acquisition has been a

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major step in the company’s growth Prescription Drug Sales in Units strategy and has almost doubled its rev- Top 5 Ranking 2011 enues up to USD 450 million in Latin (Mkt Share) America. In the words of Grünenthal 1 Laboratorio Chile 6.2% Group’s CEO, Eric-Paul Pâques: “With 2 Laboratorio Saval 5.2% Empresas Andrómaco, we acquire the 3 Andromaco 4.7% best regional company to complement 4 Recalcine 4.3% our own business and our therapeutic 5 Laboratorio Bago 3.8% areas in the Andean countries and Cen- From left: Carlos Murillo, country manager, Top 5 Ranking 2014 tral America.” In Chile, it propelled Pfzer; Eduardo Bitran, executive vice president, CORFO (Mkt Share) Grünenthal into the market’s top four 1 Laboratorio Chile 5.8% companies. 2 Grunenthal Group 4.9% In May 2014, Alliance Boots, a British pharmacy-led The latest move 3 Saval Corp 3.8% health and beauty group, signed an agreement to acquire in a series of multi- 4 Abbott Corp* 3.8% Farmacias Ahumada (FASA) Group. FASA is a publically- billion dollar deals 5 Bayer 2.7% listed pharmaceutical specialist in Latin America compris- came in May with *Recalcine and Abbott consolidated ing of two retailers: Farmacias Benavides, based in Mexico year, with the ac- IMS Data April 2014 and Farmacias Ahumada, based in Chile. Together the re- quisition of CFR Pharmaceuticals by Abbott Laboratories. tailers operate over 1,400 stores, with combined revenues The largest maker of heart stents and adult nutritional bever- of around USD 1.4 billion: the third largest retail phar- ages joined the wave of mergers and acquisitions with a USD macy chain in Mexico with around 1,000 stores, and one 2.9 billion agreement to acquire Chile’s biggest drugmaker. of the three largest retail pharmacy chains in Chile with Santiago-based CFR sells a range of products for women’s around 400 stores. health, heart and respiratory diseases in 15 markets across

Deutsche Pharma: partner of choice Deutsche Pharma stands out as one of the more interesting cases of a local success story. The company was established in 1992 and expanded internationally to Ecuador in 1995. Two years later, when the Chilean branch got acquired by Sanof, Luis Agu- ilera, Deutsche Pharma’s general manager, continued leading the Luis Aguilera, general manager, company in Ecuador. In 2008 Ro- Deutsche Pharma emmers acquired the Ecuadorian based company and Aguilera decided to re-establish Deutsche Pharma in Chile. Today the company commercializes its own brands and acts as distributor, supplying the local market with a variety of products for paediatrics and dermatology. Focusing on high value products, Aguilera has found partnering to be an indispensible part of the company’s strategy. “There are segments of the market that have unmet needs and that is why we are constantly looking for partnerships that will add value to our portfolio,” he said. The company recently partnered with a New Zea- land based company for the distribution of the very frst bioequivalent isotretinoin, a medication primarily used to treat cystic acne.

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Multi Latina Biosano, a 100 percent Chilean phar- Reginato, Commercial Director at Bio- national standards, our current aim is maceutical manufacturer that special- sano. Biosano’s strategy is therefore to build a regional network with which izes in injectables, is a good example to expand its services portfolio and we can expand our activities into the of the many corporations that start in to increase its export markets. The fast growing Latin American market,” one Latin American country and spread company currently exports to 13 Latin explains Reginato. In order to expand throughout the region. “A company ac- American countries and Biosano is al- its product portfolio the company is tive in the Chilean pharmaceutical mar- ready present with a direct offce in Co- looking at biotechnological products. ket has to reinvent its business model lombia. Additionally the company is in “We are in the process of concluding every three years because today we the process of opening offces in Peru partnerships in order to launch bio- are competing against some of the and Ecuador. “Given our expertise in technological products into the market largest multinationals,” says Maurizio manufacturing products under inter- place,” Reginato adds.

Latin America. The deal will more than double its branded ge- environment for logistics and distribution services. Chile neric drug business in Latin America and establish the compa- stretches over 4,300 km along the southwest coast of South ny among the top 10 pharmaceutical companies in the region. America, a distance roughly the same as that from San Fran- cisco to New York. At the same time, its width never exceeds a paRTicuLaR maRkeT 240 km, making the country more than eighteen times longer than its widest point. It goes without saying that Chile’s Although Chile is a relatively small market, with only 17 harsh geography, typifed by the Andes mountain range, is million inhabitants, its geography makes it a challenging one of the major challenges for the distribution of drugs.

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“Reaching the outlying regions for “Since 2007 we have been work- private laboratories is very complicated ing with the Ministry of Health for to achieve,” says Edgardo Díaz Navarre- the distribution of vaccines and one of te, director of CENABAST, the public our frst customers was CENABAST,” purchasing entity and distributor for all Sánchez adds. public hospitals and clinics, and Chile’s Unlike large international logistics de facto largest purchaser. “We reach companies such as DHL and UPS, both of the whole country, either through own which are present in Chile, Peri Logistics distribution system or that of a logistics From left: Edgardo Díaz Navarrete, only works with pharmaceuticals or sup- operator,” says Navarrete. “We have director, CENABAST; Raúl Sánchez, plements. One of Peri Logistics’ strengths general manager, Peri Logistics managed to expand our reach by es- is its cold chain expertise. Peri Logistics tablishing great partnerships with third recently expanded its services to address parties that allow us to conduct our services uninterrupted.” the need for specialized temperature-controlled ground trans- But this is not the only particularity of distribution in portation services. The company’s facility accommodates seven Chile. “The Chilean market place is very particular,” ex- cold storage rooms, which allow them to successfully conduct plains Raúl Sánchez, general manager of Peri Logistics. the annual vaccination campaign. “For example, the pharmaceutical market is characterized by the vertical integration and dominance of three major pharmacy chains in the country, which control together 92 percent of the market. This is something you don’t see any- The Overview effect where else in the world. And, international logistics provid- A company specialized in homeo- ers that decide to come to Chile must take such particulari- pathic treatments, Heel has had ties into account.” to develop an innovative marketing strategy in order to compete with Western medicine in its chosen markets. Much of Heel’s success in the Chilean market can Eduardo Loyola, be attributed to Eduardo Loyola, general manager, who has been at the helm of Heel Heel’s Chilean affliate for almost a decade, and has, through his innovative view of the market, helped homeopathic treatments be introduced alongside their better-established Western counterparts. “Generally, the person taking family decisions on medicine in Chile is the mother,” Lo- zoya explains. “As a result, we focused our marketing strategy on paediatrics, which is also one of the largest if not the largest group of doctors in Chile. From the doctors we learned that mothers were often looking at a less aggressive cure for their children’s illnesses. Doctors were not able to provide such an alternative. This was a huge opportunity,” he continues. “We educated paediatricians about our products and consequently reached the doctors.” “Since I was appointed, Heel Chile has grown at a rate of over 20 percent per year. I believe that when I joined Heel, only 30 doctors were involved in alternative therapy. Today there are 3,000 doctors involved and this number is increasing.” Lozoya compares his management technique to the Overview Effect, frst described by author Frank White in 1987, an experience that transforms astronauts’ perspectives of the planet and mankind’s place upon it.

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Compliance 53

Continued from Page 44

idea of how the target company conducts its business and what are its touch points for regulatory risk. The next step should be to focus the due diligence on those issues that pose the highest degree of risk, be they antitrust, trade and customs compliance, anti-money

laundering, anti-bribery, or com- k c pliance with applicable local laws. to ks n

M&A due diligence teams often hi T : to

include anti-corruption specialists, o h for example, who concentrate on P distinct issues from the matters evidence of past wrongdoing, but deciding whether to accept a deal reviewed by the transaction due also to understand the culture of and determine the price they are diligence team. the organization and the roles, willing to pay. Each team will want to work capabilities, and attitudes of its Developing a post-acquisition alongside the legal department in people. plan to fully integrate the target drafting document requests and Determining what to do with company into the buyer’s compli- interviewing key employees of evidence of prior wrongdoing ance program may also help miti- the target company. In the often presents its own unique challeng- gate some of these concerns. The hectic days before signing a deal, es. Not all wrongdoing will be a acquiring company should ensure much of the challenge lies sim- deal breaker, of course, especially that its anti-corruption policies ply in coordinating the various if the target is already aware of the and procedures are implemented due diligence teams and ensur- problem and presents evidence within the newly merged entity ing that they are not duplicating of having conducted its own re- and that the target’s directors, of- each other’s efforts. Access to mediation. But other times, the fcers, employees, agents, consul- one common online dataroom, acquirer may unearth new issues tants, representatives, and joint for example, is practically a must- that the target was unaware of, venture partners are promptly have for M&A deals in which due which can be more troublesome trained on applicable laws and diligence teams do not share the and may even require regulatory the company’s related policies. same offce. disclosure. The target’s response All red fags raised during the What information should be and degree of transparency in pre-acquisition process should be reviewed during the investigation those situations will often dictate thoroughly explored and any em- will depend largely on the type of the tone of the deal. ployees found to have engaged in risk presented. At the very least, prior wrongdoing should be ap- the company’s legal, accounting, Beware of mines propriately disciplined. and compliance departments will In practice, however, regulatory want to analyze the target’s sales landmines rarely lie just beneath Be safe, not sorry and fnancial data, its customer the surface. Instead, M&A due In today’s heady bull market, contracts, as well as its third- diligence will usually reveal po- many will seek to exploit the party and distributor agreements. tential compliance red fags that M&A boom. But companies For certain heightened risks, com- simply evidence areas of height- would do well to be cautious of pliance may seek to audit selected ened risk. Quite often, compliance who they choose to bed with, transactions engaged in by the professionals may need to rely on lest they wake up with regrets target or conduct due diligence on a more basic, guttural reaction in the following morning. Expect the target’s primary third parties. deciding whether the company’s compliance offcers to play an The acquirer should also conduct risk is worth the cost. Done prop- increasingly important role as due diligence on the target’s key erly, pre-acquisition due diligence gatekeeper, which, in the end, is employees, looking not only for can be essential to acquirers in good news for business.

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54 Back Page

linked to Glass. There is no video player Google Glass—A User’s capability, nor can one view PDF or Of- fce documents. Glass cannot be used to complete any type of web-based form Guide in Healthcare and is without a keyboard (at the time Three medical affairs experts review the capabilities of of testing). It, therefore, cannot log into Google’s latest state-of-the-art technology for delivering private websites and enter any personal information to healthcare professionals in the feld. The information or credit card data; likewise, bottom line? It’s a work in progress. adding terms to search boxes as if you were searching the medical literature oogle Glass represents a techno- user-requested web pages as is common cannot be done. Glass does not browse Glogical advance in the form of a on a computer browser or mobile de- content well; the card user interface and wearable computer product. In the vice. Webpage text feld entry capability resolution provide severe limitations. By health sector, Google Glass is envisioned does not exist, inhibiting entry of user- default, moving from card to card re- to provide unique benefts for communi- names, passwords, and entering data quires hand gestures that require some cating medical information to healthcare on web forms. Therefore, information practice to achieve consistent results. professionals (HCPs). Private communi- presented in Glass required access to This is problematic for uses that require cation is achieved via the built-in bone information only from publicly Internet handing the device to a HCP unfamiliar conduction speaker and small screen, accessible sources. with the device. which is discernible only to the wearer; Files cannot be “downloaded” to In spite of existing limitations, Glass therefore, HCPs can privately receive Glass in the traditional sense, though still has many potential applications information when others are present. they can be accessed as attachments across the medical information land- Since the entire device is housed within to emails, SMS, or otherwise from the scape. In the commercial setting, sales a glasses-like head mounting, the hands timeline or application. At this time, reps can use Glass to access any ap- are free to take notes or perform other Google Glass has no built-in capability proved information in response to a phy- related tasks while receiving information. to display Microsoft PowerPoint slides, sician request and can hand Glass over The big question for sales professionals is which are the standard in the medical to the medical information group for whether this will work well in practice. industry. To achieve the aim of deliver- off-label requests. Glass can also direct To test Google Glass in real-world set- ing slide-based data to HCPs, we frst access to patient support services and be tings, we purchased three Google Glass converted slides into individual JPEGs used to record on HD video unsolicited units and went to work. so they could be viewed in Glass. These requests and all interactions when mak- We confgured Glass by connecting to fles were then placed on a publicly ac- ing offce visits. All sales training mate- an existing Google account and install- cessible webserver. Emails with the URL rial can be accomplished through Glass, ing the MyGlass app on an Apple iPhone were sent to a Glass attached account so and, as a hands-free device, the tool may 5. Initial confguration was straightfor- the URL could appear in the timeline. In allow people in remote areas to partici- ward and took only a few minutes. By Glass, clicking on the card and choosing pate in training. default, Glass enables reading email and “View Website” allowed the Glass wear- Potential benefts in the area of medi- SMS messages, performing voice-based er to view this information. cal affairs include recording and dis- Google searches, accessing webpages seminating presentations in real-time; via emailed URLs, recording video, and What we found posters and podium presentations at taking a picture. Additional apps like Google Glass has not yet matured to a medical congresses, especially in sharing Evernote and YouTube are enabled us- level consistent with modern comput- those with colleagues in remote areas; ing the MyGlass app via mobile device ers, tablets, and smartphones. Its current and gathering competitive intelligence, or computer web browser. functionality is limited, in the following though, here, caution is advised. Google Glass does not provide any ways. Bluetooth and Wi-Fi radios are A useful application of Glass in the mechanism for accessing private fle built-in but it lacks native cellular mobile clinical arena may be through physician- data on company servers sitting behind data capability. There is no menu option administered quality of life instruments. a frewall on the corporate network. for browser access; the browser is ac- In conclusion, given its present There is currently no browser access to cessed by emailing URLs to the account confguration, Glass merits consider- ation for some specifc information- Sean Turbeville is Senior Director, Medical and Scientifc Affairs, at Sunesis Pharmaceuticals. He can be reached at [email protected]. David A. Wells is Principal Consultant at Wells Medical Research based uses. Continued evaluation is Services. He can be reached at [email protected]. Charles Wolfus is a Biotech IT recommended. Leader. He can be reached at [email protected]. Glass is a trademark of Google Inc.

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