• The commercial outlook for biopharma under the new health care exchanges
• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"
• The future of drug safety at FDA - both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes
• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.
• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit
• What the mid-term Congressional elections will mean for the biopharma industry.
Speakers Include:
o Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA)
o John Jenkins, MD, Director, Office of New Drugs, Food and Drug Administration (FDA)
o Leah Christl, Associate Director, Biosimilars Program, Office of New Drugs Food and Drug Administration (FDA)
o Gerald Dal Pan, MD, Director, Office of Surveillance & Epidemiology, Food and Drug Administration (FDA)
o Jim Robinson, President, Astellas Pharma US
o Sumant Ramachandra, MD, PhD, MBA, SVP & Chief Scientific Officer, Hospira
o Robert Clark, VP, US Regulatory Affairs, Novo Nordisk
o Francois Nader, MD, CEO, NPS Pharmaceuticals
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech
o Chris Garabedian, CEO, Sarepta
o David Beier, Partner, Bay City Capital
o John McHutchison, MD, Executive Vice President, Clinical Research, Gilead
o Mark McClellan, MD, PhD, Senior Fellow and Director, Health Care Innovation and Value Initiative, Brookings Institution
o Niall Brennan , Acting Director, Office of Enterprise Management, Centers for Medicare & Medicaid Services (CMS)
o Tamara Syrek Jensen, JD , Deputy Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)
o Mark McCamish, MD, PhD, Global Head Biopharm.& Oncology Injectables Development, Sandoz International GmbH
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech
o Chris Garabedian, CEO, Sarepta
o David Mott, General Partner, Biopharmaceutical Investments, New Enterprise Associates (NEA), Former CEO, MedImmune
o Steven Nissen, MD, MACC, Chairman, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation
Register now for this can't-miss event!
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