The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.
Issue link: https://lifescienceleadermag.epubxp.com/i/118943
EDITORIAL ADVISORY BOARD John Baldoni Executive Coach, Leadership Educator Baldoni Consulting LLC Jeffrey Evans, Ph.D. Life Science Entrepreneur Timothy Krupa President, TSK Clinical Development John LaMattina, Ph.D. Tim Freeman Senior Partner, PureTech Ventures Director of Operations at Freeman Technology and Past Chair of the Process Analytical Technology Focus Group of AAPS Eric Langer President and Managing Partner BioPlan Associates Laura Hales, Ph.D. G. Steven Burrill Founder, The Isis Group CEO & Founder, Burrill & Company Lynn Johnson Langer, Ph.D. Director, Enterprise and John Hubbard, Ph.D. Ron Cohen, M.D. Regulatory Affairs Program Senior VP & Worldwide Head President and CEO Center for Biotechnology Education Acordia Therapeutics , Inc. of Development Operations, Pfizer Johns Hopkins University Laurie Cooke Maik Jornitz Craig Lipset CEO Founder, BioProcess Resources, LLC Healthcare Businesswomen's Association (HBA) Immediate Past Chair PDA Head of Clinical Innovation, Worldwide Research & Development Alan Eisenberg Mitchell Katz, Ph.D. Pfizer Executive VP, Emerging Exec. Dir. of Medical Research Operations Companies and Bus. Dev. Greg MacMichael, Ph.D. Purdue Pharma, L.P. Biotechnology Industry Organization (BIO) Global Head of Biologics Process R&D; Norman Klein Novartis Barry Eisenstein, M.D. Principal, Core Results Senior VP, Scientific Affairs Jerold Martin Chairman Cubist Pharmaceuticals Bio-Process Systems Alliance (BPSA) Rafik Bishara, Ph.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA Tina Morris, Ph.D. VP, Biologics and Biotechnology USP Division of Documentary Standards John Orloff, M.D. Senior VP, CMO, Global Development Novartis Pharma AG Bernard Munos Founder, InnoThink Center for Research in Biomedical Innovation Mark Pykett, Ph.D. President and CEO Navidea Biopharmaceuticals Mike Myatt Leadership Advisor, N2growth James Robinson VP, Vaccine Product & Technical Operations, Merck Carol Nacy, Ph.D. CEO, Sequella, Inc. Mark Snyder, Ph.D. Former Associate Director, Purification Process Development Bayer HealthCare Sesha Neervannan, Ph.D. VP Pharmaceutical Development Allergan Kenneth Newman, M.D. CMO, Exec. VP, Clinical Dev. and Medical Affairs, Acton Pharmaceuticals Kevin O'Donnell Senior Partner, Exelsius Cold Chain Mgt. Consultancy US, Chair Int. Air Transport Assoc. Time & Temp. Task Force Leslie Williams Founder, President, and CEO ImmusanT Ann Willmoth General Manager Blue Standard Consulting Angela Yochem Chief Technology Officer AstraZeneca Congratulations to all of the winners of the CMO Leadership Awards, sponsored by Life Science Leader and Nice Insight. To get more information about the winners and to see photos from the CMO Leadership Awards Reception & Ceremony held on Wednesday March 13, 2013 at the W New York Hotel, go to www.CMOLeadershipAwards.com. The awards at the March 13, 2013 ceremony ASK THE BOARD Have a response to our experts' answers? Send us an email to atb@lifescienceconnect.com. Q: What is your biggest concern with the U.S. life sciences industry, and what should be done to address it? There are real threats to the U.S. life sciences industry, including increasing pressures on reimbursement for innovative new medicines, a scaling back of investment in early-stage biopharmaceutical companies, and a drain of scientific and entrepreneurial talent to rising powers such as China. To address these threats, we need to first educate political leadership and the public that continued medical innovation is worth the price, as innovative medicines actually reduce net healthcare costs over time. Second, we need to use the tax code more effectively, enacting laws that allow start-ups to appropriately retain and use nonoperating losses (NOLs) while providing other tax incentives. Third, we need an immigration policy that allows the brightest scientific minds to remain in the U.S., offering green cards to foreign nationals who receive an advanced U.S. degree. Ensuring product quality and consistency is, of course, an overriding objective. This requires effective technology transfer but is equally dependent on securing a reliable supply chain. It is important to recognize that there are significant differences between India and China, which will impact outsourcing decisions. The maturity of the pharma industry is quite different in each. Issues such as infrastructure and language may also play an important part in the success of an outsourcing exercise, and there will need to be work with local regulators and a focus to ensure the quality systems employed meet the high standards required. Finally, it is important to recognize that any equipment used may well be sourced locally so its suitability, integrity, and reliability all need to be considered. The pharmaceutical and biotechnology industries are dominated by scientists, even on the commercial side of the business. Scientists become uniquely excited and personally engaged by new technologies. Yet, the regulated nature of the industry means that scientists' personal desire to adopt better, more effective and efficient technologies are seriously hobbled by the need to consider how they will affect regulatory submissions, reviews, and ultimately revenue flow for their areas of responsibility. The hurdles to adoption are as varied as the innovations themselves, times the number of regulators potentially involved. Though scientists are attracted to new technologies, the industry is very risk-averse, and thus why you have a significant difference between what bio/pharma decision makers say they want and need and what actually gets implemented. If you want to speed up adoption, be sure to address their regulatory concerns about your new technological innovation proactively. Ron Cohen, M.D. Cohen is president, CEO, and founder of Acorda Therapeutics, Inc., a public biotechnology company developing therapies for spinal cord injury, multiple sclerosis, and other nervous system disorders. 8 Q: What are the top 3 challenges (and possible solutions) faced by U.S. companies outsourcing to India/China? Tim Freeman Freeman is director of operations for powder characterization company Freeman Technology. He has 10 years of experience in understanding and characterizing powder behavior and works closely with the pharmaceutical and powder processing industries. Eric Langer Langer has more than 20 years of experience in biotech and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. LifeScienceLeader.com April 2013 Q: Why does it seem the pharmaceutical industry is slow to adopt new technologies?