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PPCO Twist System Connect. Collaborate. Contribute. NOVEMBER 2016 Sanofi Genzyme: Expanding Beyond Rare Disease Into Specialty Care p. 18 David Meeker, executive VP and head, Sanofi Genzyme Clinical Trials 26 Allergan R&D 30 Biopharma 32 DC Insider 10 How A Chief Medical Officer Why The Company Women In Bio: Looking CEO Corner 12 Changed The Data-sharing Is Focusing On An Through The Glass Ceiling Culture At J&J And Across “Open-Science Platform” Companies To Watch 16 The Industry Global Update 48 Bringing together the best of When it’s YOUR compound, every step matters. www.pfizercentreone.com API DRUG PRODUCT PC1-16-0005-8.25x10.875 in-Mar., 2016 © 2016 Pfizer Inc. All rights reserved. inVentiv Health. Genetically engineered for success in the new pharmaceutical world. inVentiv Health processes and capabilities can accelerate business performance. The fact is, getting a new drug across the fi nish line is hard work every day. But lately, the challenges have increased exponentially. Today, it’s not enough to simply obtain regulatory approval; market success is now as mission-critical as trial success. Smart outsourcing partners begin with the end in mind. That’s why inVentiv purpose-built an organization in which both clinical and commercial work together under one roof as teammates and colleagues, not distant relatives. From early development through product launch, they share knowledge capital, data and insights. Our superior clinical trial design combined with highly effective commercial launch capabilities creates a unique environment in which processes and systems are constantly being challenged and evolved with an eye towards greater effi ciency, higher quality and, of course, getting to market faster. Most importantly, however, is the fact that when you partner with inVentiv, you will be working with people who understand each and every step along the way — people who always see the big picture. Your picture. TM Learn more at inVentivHealth.com/success Shortening the distance from lab to life. contents Welcome to Life Science Leader NOVEMBER 2016 VOL. 8 NO. 11 @LifeSciLeader1 linkedin.com/company/life-science-leader facebook.com/LifeScienceLeader WWW.LIFESCIENCELEADER.COM Columns: Insights: 6 32 BIOPHARMA Editor’s Note Women In Bio: Looking Through The Glass Ceiling 8 10 12 16 Editorial Advisory Board / Capitol CEO Companies DRUG DEVELOPMENT Ask The Board Perspectives Corner To Watch 38 Why An Investment Banker Returned To Drug Development GROWTH MARKETS 42 What’s Luring Pharma Cover Story: Back Into Antibiotic R&D? 18 SANOFI GENZYME CLINICAL TRIALS David Meeker, executive VP and head of Sanofi 46 Clinical Trials In China: Genzyme, discusses how Genzyme moved from A Model for Advancing its autonomous heritage to corporate integration Cancer Therapies as Sanofi’s new specialty-care business unit. GLOBAL UPDATE 48 The MENA Pharma Market: An Untapped Opportunity Features: INDUSTRY LEADER 26 30 52 Active Targeting: A New Clinical Trials Allergan R&D Wave In Drug Delivery How A Chief Medical Officer Changed Why The Company Is Focusing The Data-sharing Culture At J&J On An “Open-Science Platform” And Across The Industry INDUSTRY LEADER 53 The Space Squeeze: One Challenge In Building A Biopharm Lab LEADERSHIP LESSONS 54 Management Is Dead. Stop Managing And Start Coaching! LIFE SCIENCE LEADER (ISSN: 21610800) Vol. 8, No. 11 is published monthly by Jameson Publishing, Inc. at Knowledge Park, 5340 Fryling Road, Suite 300, Erie, PA 16510-4672. Phone (814) 897-9000, Fax (814) 899-5580. Periodical postage paid at Erie, PA 16510 and additional mailing offices. Copyright 2016 by Peterson Partnership. All rights reserved. Printed in the USA. SUBSCRIPTION RATES For U.S. based subscribers, $295 for one year. If your mailing address is outside the U.S. the subscription price is $445 for one year. POSTMASTER: Send address corrections (Form 3579) to Life Science Leader, Knowledge Park, 5340 Fryling Road, Suite 300, Erie, PA 16510-4672. PUBLICATIONS AGREEMENT: No. 40722524 c/o AIM, 7289 Torbram Road, Mississauga, ON L4T 1G8. 4 NOVEMBER 2016 LIFESCIENCELEADER.COM making tomorrow HEALTHIER together. EMD Millipore + Sigma-Aldrich have come together to tackle life science’s toughest challenges in collaboration with the global scientific community. GLOBAL 1 global force across 66 countries EXPERTISE A wealth of experience in solving the toughest challenges COMPLETE Enhanced tools, resources, and customer service Learn more at milliporesigma.com The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada EMD Millipore, MilliporeSigma and the vibrant M are trademarks of Merck KGaA, Darmstadt, Germany and its affiliates. Sigma-Aldrich is a trademark of Sigma-Aldrich Co. LLC and its affiliates. Copyright © 2016 EMD Millipore Corporation. All Rights Reserved. LSL EDITOR’S NOTE @RfwrightLSL facebook.com/LifeScienceLeader linkedin.com/in/robertfwright Despite Public Sentiment, NOVEMBER 2016 VOL. 8 NO. 11 LIFE SCIENCE LEADER Biopharma Has Many Bright Spots 5340 Fryling Rd., Suite 300 / Erie, PA 16510-4672 Telephone: 814 897 7700 / Fax: 814 899 4648 WWW.LIFESCIENCELEADER.COM working with Cuba. When learning that the SVP OF PUBLISHING/PRODUCT DEVELOPMENT country’s Center of Molecular Immunology Jon Howland / Ext. 203 [email protected] (CMI) had developed a lung cancer vaccine (CIMAvax), he and colleagues didn’t let a EDITORIAL DIRECTOR Dan Schell / Ext. 284 54-year-old trade embargo stand in the way [email protected] of bringing this innovation to patients in the CHIEF EDITOR states. Roswell anticipates beginning U.S. Rob Wright / Ext. 140 clinical trials soon, perhaps before the end of [email protected] next year. EXECUTIVE EDITOR It was on the last day of the 2016 Wayne Koberstein ROB WRIGHT Chief Editor International Society for Pharmaceutical [email protected] Engineering (ISPE) annual meeting that I EDITORS identified my next bright spot. Presenter Dr. Louis Garguilo ired of the biopharma pessimism? [email protected] Before writing this month’s Editor’s Frank Gupton, Ph.D., a professor at Virginia Commonwealth University (VCU), spent 30 Ed Miseta Note, I reflected on what had [email protected] been written in this column over years in industry before embarking on his T second career. Since “retiring” he has given a Anna Rose Welch the past 10 months. While I’ve delved into a [email protected] wide variety of topics (e.g., activist investors, TEDx talk, published numerous articles, and breakthroughs, Brexit), 40 percent of the received grants totaling nearly $10 million VP OF AUDIENCE DEVELOPMENT Michael Bennett columns touched on drug pricing (a rather from the Bill & Melinda Gates Foundation. [email protected] polarizing subject). When thinking about One of his teaching projects seeks cheaper and more efficient ways to manufacture DIRECTORS OF STRATEGIC PARTNERSHIPS all the hostility heaped on our industry — Tim Bretz / 724-940-7555 / Ext. 123 especially now during a U.S. presidential medicines. The first drug tackled, nevirapine, [email protected] is an HIV/AIDS compound for which Gupton campaign — I couldn’t bear entering November Cory Coleman / Ext. 108 on note of negativity. So, I started thinking (while in industry) developed the commercial [email protected] about some of the “bright spots” that have process. By making a few simple changes, the Tracy Tasker / Ext. 297 occurred in this industry recently. Medicines for All Initiative team reduced: [email protected] First, consider the fact that, as of this writ- Perry Rearick / Ext. 263 ing, we have seen 58 FDA drug approvals this the manufacturing process by nearly [email protected] year, with 17 being for novel compounds. Of two-thirds Derek Van Slyke / Ext. 217 course, this drug-approvals bright spot isn’t material costs by more than half [email protected] free of controversy, as was evident by the recent raw material waste by 93 percent. PUBLISHER/BIOPHARM & LAB approval of Sarepta’s Exondys 51 (eteplirsen), Shannon Primavere / Ext. 279 indicated for Duchenne muscular dystrophy. They did all of this while increasing the yield [email protected] from 59 to 92 percent. But most telling is the Janet Woodcock, M.D., director for the FDA’s GROUP PUBLISHER/OUTSOURCING CDER, pushed for the drug’s approval despite increased number of patients who can now be Ray Sherman / Ext. 335 heated internal opposition. Dr. Luciana Borio, treated more cost-effectively. It is estimated [email protected] acting agency chief scientist, argued that its that just a 10 percent improvement would BUSINESS DEVELOPMENT MANAGER approval would lower agency standards, while achieve a savings of $75 million and allow the Mike Barbalaci / Ext. 218 [email protected] Ellis Unger, M.D., director of the office of drug Gates initiative to treat 150,000 more patients. evaluation, called the compound a “scientifi- Following this success, Gupton’s team SR. ACCOUNT EXECUTIVE received another $5 million to investigate Scott Moren / Ext. 118 cally elegant placebo.” Time will tell who’s right. [email protected] But I admire Woodcock for her willingness improving two additional HIV/AIDS drugs (i.e., tenofovir, darunavir). DIRECTOR OF DATA ANALYTICS to take a risk, which in my opinion is another Kevin
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