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Issue link: https://lifescienceleadermag.epubxp.com/i/437789
LSL LIFESCIENCELEADER.COM JANUARY 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 Former VP Clinical Operations, Sangart 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 KEVIN O'DONNELL Senior Partner, Exelsius Cold Chain Mgt. Consultancy U.S., Chair, Int. Air Transport Assoc. Time & Temp. Task Force JOHN ORLOFF, M.D. Head of Global Clinical Development Merck Serono SANDRA POOLE Sr. Vice President, Technical Operations ImmunoGen, Inc. 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 SUSTAINABLE DEVELOPMENT REQUIRES A STREAMLINED CLINICAL TRIAL PATH, better diagnostics, and pricing and reimbursement that value these assets. Gaining approval for new drugs typically requires that at least two large noninferiority clinical trials have been run. More feasible trial designs are crucial. Currently, no tests can tell physicians which drug may be most useful in treating an infection. We must ensure we have rapid point-of-care tests across therapeutic areas to help medical staff quickly select the right therapies for the right patients at the right time. For antibiotics, the reimbursement process needs to evolve. The model centered on a diagnosis-related group (DRG, or bundled payment system) assuming all patients will respond to the same medicine poses a signif cant barrier to capturing fair value for antibiotics. BARRY EISENSTEIN Barry Eisenstein, MD, FACP, FIDSA, FAAM, is senior VP of scientif c affairs at Cubist Pharmaceuticals and editor of Antimicrobial Agents and Chemotherapy . Q Q Q What do you think the Internet of Things (IoT) means as applied to pharma? A THE INTERNET OF THINGS TO ME refers to everything being connected, and that can be an interesting opportunity in clinical trials. Researchers are increasingly exploring the concept of deep digital phenotyping and the ability to capture robust streaming data from patients. This is starting today with a range of wearables and sensors that are of increasing interest. It is extending into tomorrow to other devices in the home and around the lives of patients to passively capture data and extend the concept of patient-reported outcomes. From medication adherence to quality of life, from activity to physiologic parameters and environmental factors – IoT brings exciting new data. As with all new and large data sources, the ultimate challenge will be in extracting value. The next challenge will be identifying what new analytics capabilities are needed to fully use this new data. CRAIG LIPSET Craig Lipset is head of clinical innovation within worldwide R&D; at Pf zer. In this role, he works across units and stakeholders to def ne Pf zer's vision for the future of clinical trials and enables the initiatives and investments to create that future. A I RECOMMEND ASSURING YOU ARE ALIGNED with the mission of the advocacy organization. Also, do a "reputation check" to avoid pairing with a group in the center of a storm. Then, seek to f nd common ground where working together furthers the goals of both entities in a faster, stronger, and better fashion than going it alone. The biggest mistakes I have seen are not gaining suff cient clarity about your desired advocacy outcomes and what you're agreeing to do. There will be a time commitment, so get clarity early on about what is expected of you. Ask for full details about events you need to attend, speeches you're expected to deliver, media in which you may be quoted, and publications in which your writing may appear. This clarity will serve both sides well. LAURIE P. COOKE Laurie P. Cooke, BS, RPh, PGDip, CAE, is the CEO of the Healthcare Businesswomen's Association (HBA), a global nonprof t professional association. What best practices have you seen applied by life science executives when engaging with advocacy organizations, and what practices would you advise them to avoid? What is the most valuable lesson you have learned from the shortage of antibiotics in the pipeline, and what can executives and regulators learn and apply to other therapeutic areas?