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EDITORIAL ADVISORY BOARD John Baldoni Chair, Leadership Development Practice N2growth Heather Erickson President and CEO Life Sciences Foundation Rafik Bishara, Ph.D. Chair, Pharmaceutical Cold Chain Interest Group, PDA Norman Klein Principal, Core Results 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 G. Steven Burrill Technology and Past Chair of the Process Eric Langer CEO & Founder, Burrill & Company Analytical Technology Focus Group of AAPS President and Managing Partner BioPlan Associates Ron Cohen, M.D. Laura Hales, Ph.D. President and CEO Founder, The Isis Group Lynn Johnson Langer, Ph.D. Acorda Therapeutics , Inc. Director, Enterprise and Fred Hassan Regulatory Affairs Program Laurie Cooke Chairman of the Board Center for Biotechnology Education CEO Johns Hopkins University Healthcare Businesswomen's Association (HBA) Bausch + Lomb 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 Barry Eisenstein, M.D. Immediate Past Chair PDA Senior VP, Scientific Affairs Cubist Pharmaceuticals Mitchell Katz, Ph.D. Exec. Dir. of Medical Research Operations Purdue Pharma, L.P. Craig Lipset Head of Clinical Innovation, Worldwide Research & Development Pfizer Greg MacMichael, Ph.D. Global Head of Biologics Process R&D; Novartis CHIEF EDITOR'S BLOG John Orloff, M.D. Senior VP, CMO, Global Development Novartis Pharma AG Tina Morris, Ph.D. VP, Biologics and Biotechnology USP Division of Documentary Standards Mark Pykett, Ph.D. President and CEO Navidea Biopharmaceuticals Bernard Munos Founder, InnoThink Center for Research in Biomedical Innovation John Reynders, Ph.D. Chief Information Officer Moderna Therapeutics Mike Myatt Leadership Adviser, N2growth James Robinson VP, Vaccine & Biologics 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 U.S., Chair Int. Air Transport Assoc. Time & Temp. Task Force Leslie Williams Founder, President, and CEO ImmusanT Ann Willmoth General Manager Blue Standard Consulting MORE ONLINE CONTENT Want to find out what's on the mind of our chief editor, Rob Wright? Check out his blog on our website where he writes about a variety of topics such as recent shows attended, conversations with industry experts, and irritating business buzzwords. And don't forget about your opportunity to pick the brains of our editorial board. Send your questions for our monthly "Ask the Board" section to atb@lifescienceconnect.com. ASK THE BOARD Jerold Martin Chairman Bio-Process Systems Alliance (BPSA) Find more original content in (or submit your own to) any of the other Life Science Connect websites, such as BioresearchOnline.com, ClinicalLeader.com, and PharmaceuticalOnline.com. Have a response to our experts' answers? Send us an email to atb@lifescienceconnect.com. Q: What trend will have the biggest impact on pharma/bio? Q: Which pharma/bio companies do you think are truly being disruptively innovative? In my opinion, the use of combination therapies to treat diseases other than cancer will have the biggest impact. The types of diseases where companies could seize opportunity include Hepatitis C caused by the hepatitis C virus (HCV), Alzheimer's, and multiple sclerosis (MS). One of the companies well-practiced and best-positioned seems to be Gilead. Alternatively, companies working on harnessing the immune system to combat cancer could be an interesting growth opportunity. Big pharma seems to be leading the way. For example, a Bristol-Myers Squibb (BMS) study with the two-drug combination (Yervoy and nivolumab) resulted in nearly one-third of 52 skin cancer patients having rapid and deep tumor regressions. Roche's Genentech, Merck, and BMS dominated this year's American Society of Clinical Oncology (ASCO) meeting, though Onyx and BioMarin bear watching. We need an FDA that is equipped to handle both the pace of discovery and the pace of diagnosis. We need to create a 21st century FDA that can speed breakthrough cures and medicines to the patients who so desperately need them, while retaining its position as the global "Gold Standard" for the review and approval of safe and effective medicines. Furthermore, the reimbursement conversation must be focused on the value of providing cures and treatments. There are 10,000 baby boomers entering Medicare every day for the next 20 years. If fewer of them were sick from various diseases, Medicare costs would be driven down astronomically. We need to look at what we spend on chronic conditions. If we could delay the onset of diabetes by even five years, we would save Medicare $50 billion a year. Many pharma and bio companies are attempting individual approaches that are extremely innovative. I am particularly drawn to those companies investing in internal resources focused on bringing innovation to their clinical research. Such dedication is important as companies otherwise try to draw on existing resources already committed to their "day jobs," making innovation more of a hobby. Dedication is needed in order to bring discipline to innovation and to ensure companies are picking well-developed ideas, running intelligent experiments, and managing the necessary change in order to embed appropriate new tools and approaches in the organization. I appreciate companies willing to be transparent, enabling the entire clinical research field to move forward. Some of the companies participating at the Disruptive Innovation in Clinical Trials program (i.e. Lilly, J&J;, and Pfizer) are taking strong positions by these measures. G. Steven Burrill Burrill founded Burrill & Company as a logical extension of his 40-year involvement in the growth and prosperity of the biotechnology industry. He has been an active advisor and catalyst in some of the industry's most notable companies and transactions. 8 Q: What advice do you have for the FDA to facilitate more costeffective drug development? Alan Eisenberg Eisenberg serves as executive VP for emerging companies and business development at the Biotechnology Industry Organization (BIO). He manages and directs BIO's services and advocacy efforts for BIO's emerging companies. Craig Lipset Lipset is head of clinical innovation within worldwide R&D; at Pfizer. In this role, he works across units and stakeholders to define Pfizer's vision for the future of clinical trials and enables the initiatives and investments to create that future. LifeScienceLeader.com September 2013