[Editor’s note: To tap the wisdom of our distinguished group of Xconomists, we asked a few of them to answer this question heading into 2013: “What does your gut tell you will happen this year even though you don’t have data to prove it?”]
I think there will be even more FDA approvals for New Molecular Entities in 2013 compared with 2012 and 2011, which have been “banner years” for approvals. Why? Industry has stepped up their game on innovative medicines and the FDA has now set a better balance of risk and benefit.
Author: John Maraganore
John Maraganore is the CEO of Alnylam Pharmaceuticals. John joined Alnylam in December 2002, bringing over 20 years of experience in Research and Development, and business roles with biotechnology companies. Prior to Alnylam, he served as an officer and a member of the management team for Millennium Pharmaceuticals. As Senior Vice President, Strategic Product Development for Millennium, he was responsible for the company's product franchises in Oncology, Cardiovascular, Inflammation, and Metabolic Diseases. He was previously Vice President, Strategic Planning and M&A and prior to that he was General Manager of Millennium BioTherapeutics, a former subsidiary of Millennium. Before Millennium, he served as Director of Molecular Biology and Director of Market and Business Development at Biogen, (now Biogen Idec). At Biogen, Dr. Maraganore invented and led the discovery and development of Angiomax™ (bivalirudin for injection, formerly Hirulog™) currently marketed by The Medicines Company. Prior to Biogen, Dr. Maraganore was a scientist at ZymoGenetics, and The Upjohn Company. Dr. Maraganore received his M.S. and Ph.D. in biochemistry and molecular biology at the University of Chicago. Dr. Maraganore is Chairman of Regulus Therapeutics, LLC, and a Director for Archemix, and Macrogenics. He is also a member of the Research Advisory Board of the Beth Israel Deaconess Hospital and a member of the Biotechnology Industry Organization Board.
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