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Inside the FDA

Tuesday, February 14th, 4:00pm-5:00pm

With PDUFA V reauthorization looming and the implementation of follow-on biologics legislation continuing, 2012 will be a big year for the FDA. Senior leaders from the FDA, BIO, and the industry will convene to discuss the legislative and regulatory environment, and what is in store for the FDA in the coming months and years.


  • James C. Greenwood, President & CEO, Biotechnology Industry Organization (BIO)


  • Paul J. Hastings, President & CEO, OncoMed Pharmaceuticals, Inc.
  • Jonathan S. Leff, Managing Director, Healthcare, Warburg Pincus LLC
  • Richard Pops, Chairman & CEO, Alkermes plc
  • Stephen  P. Spielberg,  MD, PhD, Deputy Commissioner for Medical Products & Tobacco, FDA

Who's Who

James C. Greenwood
President & CEO, Biotechnology Industry Organization
James C. Greenwood is President and CEO of the Biotechnology Industry Organization (BIO) in Washington, D.C., which represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. Since his appointment in January of 2005, he has markedly enhanced the trade association’s capacity – increasing both its staff and budget by nearly fifty percent. BIO is now a world class advocacy organization playing a leading role in shaping public policy on a variety of fronts critical to the success of the biotechnology industry at the state and national levels as well as internationally. Mr. Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005. A senior member of the Energy and Commerce Committee, he was widely viewed as a leader on health care and the environment. From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee's vast jurisdiction. He led hard-hitting investigations into corporate governance at Enron, Global Crossing and WorldCom; terrorist threats to our nation's infrastructure; and waste and fraud in federal government agencies. Prior to his election to Congress, Mr. Greenwood served six years in the Pennsylvania General Assembly (1981-86) and six years in the Pennsylvania Senate (1987-1992). Mr. Greenwood graduated from Dickinson College in 1973 with a BA in Sociology. From 1977 until 1980, he worked as a caseworker with abused and neglected children at the Bucks County Children and Youth Social Service Agency. Mr. Greenwood is married with three children and resides in Upper Makefield, Pennsylvania.

Paul J. Hastings
President & CEO, OncoMed Pharmaceuticals, Inc.
Paul Hastings has served as president and chief executive officer of OncoMed Pharmaceuticals, Inc. since January 2006. Prior to joining OncoMed, Mr. Hastings was president and chief executive officer of QLT, Inc. Before this role, Mr. Hastings served as president and chief executive officer of Axys Pharmaceuticals, Inc., which was acquired by Celera Corporation in 2001. Prior to Axys, Mr. Hastings was president of Chiron Biopharmaceuticals and also held a variety of management positions of increasing responsibility at Genzyme Corporation, including president of Genzyme Therapeutics Europe and president of Worldwide Therapeutics. Mr Hastings was Chairman of the Board of Proteolix ( sold to Onyx) and was a member of the board of directors of ViaCell Inc ( sold to Perkin Elmer). Mr Hastings is currently a member of the Board of directors for Pacira Pharmaceuticals, and serves as chairman of the board of the Bay Area Biosciences Association (Bay Bio) and is Vice Chair of the Emerging Companies Section of the Biotechnology Industry Organization. He received a Bachelor of Science degree in pharmacy from the University of Rhode Island.

Jonathan S. Leff
Managing Director, Healthcare, Warburg Pincus LLC
Jonathan S. Leff joined Warburg Pincus in 1996. He is a member of the firm’s healthcare team and leads the firm’s investment efforts in pharmaceuticals and biotechnology. Prior to joining Warburg Pincus, he was a consultant at Oliver, Wyman & Co. Mr. Leff received an A.B. in government from Harvard University and an M.B.A. from the Stanford University Graduate School of Business. Mr. Leff is a director of Allos Therapeutics, Archimedes Pharma, InterMune, Protox Therapeutics, ReSearch Pharmaceutical Services, Rib-X Pharmaceuticals and Talon Therapeutics. In addition, Mr. Leff serves on the boards of several industry groups and not-for-profit organizations, including the Biotechnology Industry Organization, the National Venture Capital Association, Columbia University Medical Center and the Spinal Muscular Atrophy Foundation.

Richard Pops
Chairman & CEO, Alkermes
Richard Pops serves as Chairman and Chief Executive Officer of Alkermes. He joined Alkermes as CEO in 1991. Under his leadership, Alkermes has grown from a privately held company with 25 employees to an international, publicly traded biopharmaceutical company with more than 1,200 employees and a portfolio of more than 20 commercial products. Mr. Pops currently serves on the Board of Directors of Neurocrine Biosciences, Acceleron Pharma, Epizyme, the Biotechnology Industry Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), the New England Healthcare Institute and is also a member of the Harvard Medical School Board of Fellows.

Stephen  P. Spielberg,  MD, PhD
Deputy Commissioner for Medical Products & Tobacco, FDA
Dr. Stephen P. Spielberg is Deputy Commissioner for Medical Products and Tobacco of the US Food and Drug Administration.  He received an AB (Biology) from Princeton University, an MD and PhD (Pharmacology) from the University of Chicago, did a pediatric internship and residency at Children’s Hospital, Boston, and a post-doctoral fellowship in human biochemical genetics at the National Institute of Child Health and Human Development. He then joined the faculty of Johns Hopkins University School of Medicine as Assistant Professor of Pediatrics and Pharmacology, moving to the University of Toronto, Hospital for Sick Children where he was Professor of Paediatrics and Pharmacology, Director of the Division of Clinical Pharmacology and Toxicology, and Director of the Centre for Drug Safety Research. After 15 years in academic medicine, he moved to Merck Research Laboratories as Executive Director, Exploratory Biochemical Toxicology and of Clinical and Regulatory Development in 1992, and subsequently to Johnson & Johnson from 1997 to 2003 to become Vice President for Pediatric Drug Development. He chaired the Pediatric Task Force for PhRMA, represented the pharmaceutical industry on the FDA Pediatric Advisory Subcommittee and on pediatric legislative initiatives in the US and EU, and was the Rapporteur for the Pediatric ICH Initiative (ICH E-11) to harmonize pediatric drug development regulations among Europe, Japan, and the US. He then returned to academic medicine as Dean of Dartmouth Medical School and Vice President for Health Affairs at Dartmouth College from 2003-2007. From 2007-Sept., 2011, he was the Marion Merrell Dow Chair in Pediatric Pharmacogenomics, and Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital, Kansas City, MO. He also served as Principal Investigator for the Institute for Pediatric Innovation, a non-profit organization focused on developing improved medicines and devices to meet the therapeutic needs of sick children.

He has served as Associate Editor of Drug Metabolism and Disposition, and on the editorials boards of multiple pediatric and pharmacology journals. He served on the Board of Directors of the Foundation for the National Institutes of Health, the Science Board Advisory Committee for the FDA, the Executive Board of OMOP (Observational Medical Outcomes Partnership – FDA, FNIH, PhRMA), and was President of the American Society for Clinical Pharmacology and Therapeutics (2006). 

His research interests include: mechanisms of idiosyncratic adverse drug reactions, human pharmacogenetics and personalized medicine, and pediatric clinical pharmacology; he has published over 130 papers in these areas. He is the recipient of the Rawls-Palmer Award and Lectureship from the American Society of Clinical Pharmacology and Therapeutics (1992), the first recipient of the Werner Kalow Award in Pharmacogenetics and Drug Safety (1995), the Williams B. Abrams Lectureship from FDA/ASCPT (2001), Award in Excellence in Clinical Pharmacology, PhRMA Foundation (2007), the Distinguished Service Award from the University of Chicago, Pritzker School of Medicine (2008), presented the FDA Chief Scientist’s Distinguished Lecture (2009), and received the Sumner J. Yaffe Lifetime Achievement Award in Pediatric Pharmacology and Therapeutics from the Pediatric Pharmacy Advocacy Group (2009).