SOURCE: Elsevier Business Intelligence

Elsevier Business Intelligence

September 17, 2013 10:10 ET

Prepare for the Next Wave of Public Policy Changes at the Ninth Annual FDA/CMS Summit for Biopharma Executives

BEDMINSTER, NJ--(Marketwired - Sep 17, 2013) -  Join us at The Ritz-Carlton Washington DC, December 11-12 for the Ninth Annual FDA/CMS Summit for Biopharma Executives, the leading conference on regulatory and reimbursement policies impacting the biopharma industry. This year's conference will explore all aspects of the emerging new regulatory models, including conversations with key FDA officials and industry stakeholders on their experience thus far, as well as broader discussions of the role of "Breakthrough" in shaping drug development and reimbursement policies.

FDA's new "Breakthrough Therapy" designation is off to a fast start, with more than 25 products deemed worthy of the status in the first year since the program took effect. FDA and sponsors both seem energized and excited by the new pathway, but there are still plenty of questions about how the pathway works. As FDA and industry gain experience, of course, it will become much easier to explain the nuts and bolts of the process: how to apply; how FDA decides what makes the cut; and how "Breakthrough" changes the process of engagement with FDA going forward.

But there are much more important questions in the background: What will the new designation really mean for drug development? Will the new pathway (and other changes in the regulatory process) mean more new therapies reach the market more quickly? Will those therapies succeed -- medically and commercially -- once they get there? And will the "Breakthrough" focus mean other products get left behind, languishing for lack of regulatory attention and/or management support?

Among the speakers and topics on the jam packed two-day agenda are:

Keynote Address: Priorities for FDA's Drug Center in 2014 by Janet Woodcock, Director of Center For Drug Evaluation & Research at Food and Drug Administration (FDA).

Fireside Chat: Medicare in 2014 and Beyond with Jonathan Blum, Deputy Administrator and Center for Medicare Director at Centers for Medicare & Medicaid Services (CMS).

FDA Roundtable with John Jenkins, MD, Director of Office of New Drugs at Food and Drug Administration (FDA); Gerald Dal Pan, MD, Director of Office of Surveillance & Epidemiology at Food and Drug Administration (FDA); Richard Pops, CEO at Alkermes; and Paul Seligman, MD, Executive Director of Regulatory Affairs at Amgen Global Government Affairs.

CMS Coverage Priorities with Louis Jacques, MD, Director of Coverage & Analysis Group Office of Clinical Standards and Quality at Centers for Medicare & Medicaid Services (CMS) and Tamara Syrek Jensen, JD, Deputy Director of Coverage & Analysis Group Office of Clinical Standards and Quality at Centers for Medicare & Medicaid Services (CMS).

A Rare Opportunity: Orphan Drugs with Francois Nader, MD, Chairman, President and CEO at NPS Pharmaceuticals; Diane Dorman, Vice President for Public Policy at National Organization for Rare Disorders; Gayatri Rao, MD, Director of Office of Orphan Products Development at Food and Drug Administration (FDA); and Chris Garabedian, CEO at Sarepta Therapeutics.

Cancer Therapies: The Breakthrough Era with Jeff Allen, PhD, Executive Director at Friends of Cancer Research; Sandra Rattray, MD, VP and Head of Global Regulatory Affairs, Oncology at Johnson & Johnson; Richard Pazdur, MD, Director of Office of Hematology and Oncology Products, Center for Drug Evaluation & Research at Food and Drug Administration (FDA); Victor Sandor, MD, CM, Group Vice President, Clinical Development at Incyte Corporation; and Joseph Leveque, MD,
Vice President, US Medical - Oncology at Bristol-Myers Squibb.

To see the full agenda or to register for this event, please visit:

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