Life Science Leader Magazine

MAR 2015

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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LSL LIFESCIENCELEADER.COM MARCH 2015 8 EDITORIAL ADVISORY BOARD EAB ASK THE BOARD Have a response to our experts' answers? Send us an email to atb@lifescienceconnect.com . JOHN BALDONI Chair, Leadership Development Practice, N2growth RAFIK BISHARA, PH.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA ALEX CHANG, PH.D. Director, Global Licensing & Business Development, Glenmark WILLIAM CIAMBRONE EVP, Technical Operations, Shire RON COHEN, M.D. President and CEO Acorda Therapeutics, Inc. LAURIE COOKE CEO, Healthcare Businesswomen's Association (HBA) TOM DILENGE General Counsel & Head of Public Policy BIO BARRY EISENSTEIN, M.D. Senior VP, Scientif c Affairs Cubist Pharmaceuticals HEATHER ERICKSON President and CEO Life Sciences Foundation TIM GARNETT CMO, Eli Lilly RON GUIDO President, Lifecare Services, LLC LAURA HALES, PH.D. Founder, The Isis Group ANU HANS VP & CPO Enterprise Supply Chain, J&J; FRED HASSAN Managing Director, Warburg Pincus JOHN HUBBARD, PH.D. Independent Director and Board Member, Agile Therapeutics MAIK JORNITZ Founder, BioProcess Resources, LLC Immediate Past Chair, PDA MITCHELL KATZ, PH.D. Exec. Dir. of Medical Research Operations, Purdue Pharma, L.P. MARY ROSE KELLER Vice President, Clinical Operations Tocagen, Inc. TIMOTHY KRUPA President, TSK Clinical Development JOHN LAMATTINA, PH.D. Senior Partner, PureTech Ventures CRAIG LIPSET Head of Clinical Innovation, Worldwide Research & Development, Pf zer JEROLD MARTIN Chairman Bio-Process Systems Alliance (BPSA) KENNETH MOCH Former CEO, Chimerix BERNARD MUNOS Founder, InnoThink Center for Research in Biomedical Innovation MIKE MYATT Leadership Advisor, N2growth CAROL NACY, PH.D. CEO, Sequella, Inc. SESHA NEERVANNAN, PH.D. VP Pharmaceutical Development Allergan JOHN ORLOFF, M.D. Vice President of BioScience R&D; Baxter International SANDRA POOLE Sr. Vice President, Technical Operations ImmunoGen, Inc. DENNIS J. PURCELL Aisling Capital LLC Founder and Senior Advisor MARK PYKETT, PH.D. President and CEO Agilis Biotherapeutics JOHN REYNDERS, PH.D. Chief Information Off cer Moderna Therapeutics JAMES ROBINSON VP, Vaccine & Biologics Technical Operations, Merck ANDREW SKIBO EVP Operations, MedImmune RVP, AstraZeneca LESLIE WILLIAMS Founder, President, and CEO, ImmusanT A MICHAEL JAHARIS has made three fortunes in pharmaceuticals. The f rst was when he and dermatologist Phillip Frost bought Key Pharmaceuticals in 1972. Jaharis was CEO until 1986 when it merged with Schering-Plough in an $836 million deal. Number two came when he founded Kos Pharmaceuticals in 1988 and sold it to Abbott Labs in 2006 for $4.2 billion. The third home run for Jaharis was when AstraZeneca purchased Pearl Therapeutics for $1.15 billion in 2013. At the time, Vatera Healthcare Partners, the VC f rm cofounded by Jaharis, was the controlling investor in Pearl. As a biopharmaceutical entrepreneur, I think readers would be enlightened by his wisdom. LESLIE WILLIAMS Leslie Williams is president, CEO, and founder of ImmusanT, Inc., an early-stage company focused on peptide treatments for autoimmune diseases. She has more than 20 years of industry experience. Q Q Q What advantages will personalized medicine bring to patients, and what is its overall public health benefi t? A PERSONALIZED MEDICINE could trump the current one-size-f ts-all approach to pharmaceutical interventions in certain cases. Some individuals fall on one side of the bell-shaped curve, and the rest will be okay with a general therapy. The closer to the top of the curve, and to the right (high responders), the greater chance the therapy will be successful. The outliers on the left will benef t the most from individualized therapy. For example, knowing specif c tumor genotypes can focus chemotherapy on agents effective for such tumors. Understanding personal genetics will enable physicians to tailor therapy based on ability to respond to a specif c chemotherapy and avoid treating individuals whose genetics make them poor responders. People metabolize drugs differently based on liver enzymes (Cyps), so understanding patient Cyp genotypes could help physicians tailor drug therapy to those with the ability to correctly metabolize prodrugs. CAROL NACY, PH.D. Dr. Nacy is CEO of Sequella, Inc., a private company that develops new anti- infective drugs. She was formerly CSO at Anergen and EVP/CSO at EntreMed. Prior to her business experience, she directed research in tropical infectious diseases at Walter Reed Army Institute of Research, Washington, D.C. A A RECENT LABOR STATISTIC NOTED 2015 as the year the millennial generation will become the majority in both the workforce and consumer space. I feel the shift. The things that motivated my staff 10 years ago do not resonate with current workers. Although I have no metrics to cite, I feel we are not training and developing enough clinical trialists. It takes me much longer to f nd a suitable hire. In a few instances, I have had positions open for months with only a trickle of applicants, and few of them qualif ed. It seems fewer and fewer have been adequately educated in the discipline of drug development. We need to ensure a steady stream of top talent is coming into our industry. MARY ROSE KELLER Mary Rose Keller, VP clinical operations at Tocagen, has 30+ years of industry experience in clinical development strategy and execution of global Phase 1 to 4 clinical trials for drug, biologic, and diagnostic products. What macro trend have you noticed beginning to impact the way you do business? Who would you be most interested in reading about in Life Science Leader ?

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