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EDITORIAL ADVISORY BOARD John Baldoni Chair, Leadership Development Practice N2growth Barry Eisenstein, M.D. Senior VP, Scientific Affairs Cubist Pharmaceuticals Mitchell Katz, Ph.D. Exec. Dir. of Medical Research Operations Purdue Pharma, L.P. Greg MacMichael, Ph.D. Global Head of Biologics Process R&D; Novartis Rafik Bishara, Ph.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA Heather Erickson President and CEO Life Sciences Foundation Mary Rose Keller Former VP Clinical Operations Sangart Jerold Martin Chairman Bio-Process Systems Alliance (BPSA) G. Steven Burrill CEO & Founder, Burrill & Company Jeffrey Evans, Ph.D. Life Science Entrepreneur Norman Klein Principal, Core Results Kenneth I. Moch President & CEO Chimerix, Inc. Tim Freeman Timothy Krupa Director of Operations at Freeman President, TSK Clinical Development Technology and Past Chair of the Process Analytical Technology Focus Group of AAPS John LaMattina, Ph.D. Senior Partner, PureTech Ventures Ron Cohen, M.D. Laura Hales, Ph.D. President and CEO Lynn Johnson Langer, Ph.D. Founder, The Isis Group Acorda Therapeutics , Inc. Director, Enterprise and Regulatory Affairs Program Fred Hassan Laurie Cooke Center for Biotechnology Education Chairman of the Board CEO Johns Hopkins University Healthcare Businesswomen's Association (HBA) Bausch + Lomb William F. Ciambrone EVP, Technical Operations Shire John Hubbard, Ph.D. Alan Eisenberg Senior VP & Worldwide Head Executive VP, Emerging of Development Operations, Pfizer Companies and Bus. Dev. Biotechnology Industry Organization (BIO) Maik Jornitz Founder, BioProcess Resources, LLC Immediate Past Chair, PDA Craig Lipset Head of Clinical Innovation, Worldwide Research & Development Pfizer Bernard Munos Founder, InnoThink Center for Research in Biomedical Innovation Mike Myatt Leadership Adviser, 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. Former Senior VP, CMO, Global Development Novartis Pharma AG Mark Pykett, Ph.D. President and CEO Navidea Biopharmaceuticals John Reynders, Ph.D. Chief Information Officer Moderna Therapeutics James Robinson VP, Vaccine & Biologics Technical Operations, Merck Mark Snyder, Ph.D. Former Associate Director, Purification Process Development Bayer HealthCare Leslie Williams Founder, President, and CEO ImmusanT Save The Date | 03.12.14 The CMO Leadership Awards Reception & Ceremony Join us at the W Hotel, New York City, to celebrate award recipients, network with industry leaders, and make new business contacts. For more information, email cmoawards@lifescienceleader.com. PRESENTED BY : RESEARCH CONDUCTED BY : SPONSORED BY : A LIFE SCIENCE CONNEC T BRAND ASK THE BOARD Have a response to our experts' answers or a question of your own? Send us an email to atb@lifescienceconnect.com. Q: What are chief concerns you have regarding R&D; and the regulatory environment, and what solutions can be implemented? Regulatory advances intended to speed development and availability of new treatments, such as orphan drugs, have positively impacted certain sectors of the life sciences industry. It is important to continue to accelerate the development and commercialization of drugs and biologics that treat serious, life-threatening conditions and address unmet medical needs. At Cubist, we have benefited from the Generating Antibiotic Incentives Now (GAIN) Act, allowing for incentives related to the development of new antibiotics. It is especially important at a time of escalating global public health needs. For example, in our sector (antibiotic resistance and rising hospital-acquired infections), industry continues to develop partnerships with regulators, policy makers, and other stakeholders. Together we can foster innovation through the right economic incentives and provide unique health value, and bring even more flexible regulatory approaches to bear. Barry Eisenstein, M.D., Dr. Eisenstein is senior VP of scientific affairs at Cubist Pharmaceuticals and editor of Antimicrobial Agents and Chemotherapy. 8 LifeScienceLeader.com Q: What is a costly pharma manufacturing mistake that executives fail to consistently pay attention to, and what can be done to avoid it? One of the most costly mistakes is yield losses in manufacturing due to wasteful process steps or flows. For example, excessive hold-up volumes, extended processing times, or just the wrong choice of filter membrane materials, to name a few, all create extensive yield losses. The lack of optimization in yield improvement happens far upstream in the process-development cycle where tests could support optimization of either individual process steps or the entire process. Extensive equipment and/or unit operation turnaround times represent another, though diminishing, cost driver. Current single-use technologies reduce this problem with flexibility and ready-to-use options. In addition, the industry starts recognizing that process flexibilities have to be a match with facility flexibilities. New flexible facility concepts support such efforts. Maik Jornitz Jornitz is COO of G-CON Manufacturing and founder of BioProcess Resources. He has more than 25 years of experience and supports the biopharm industry on a global basis. January 2014 Q: Do you think many companies will develop the "me-too" drugs like we had in the days of the SSRIs (selective serotonin reuptake inhibitors), especially if the burden of proving superiority is too great? Most companies are into projects before the concept behind the program has been proven in Phase 2. Thus, the decision a company will have is one of timing. To be honest, it is pretty hard to know the full profile of a drug until you have completed the Phase 3 program. While you may have a good sense of efficacy before then, it is only with Phase 3 that you begin to get a sense of the risk-benefit profile. Thus, if you are in second place with a new class of agents, unless you clearly are inferior in some way, it behooves you to move the program forward because no two compounds are identical in the clinic. John LaMattina, Ph.D. LaMattina is the former senior VP at Pfizer Inc. and the president of Pfizer Global Research and Development. In this role, he oversaw the drug discovery and development efforts of over 12,000 colleagues in the United States, Europe, and Asia.