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

Prepare for the Next Wave of Public Policy Changes at the Ninth Annual FDA/CMS 
Summit for Biopharma Executives 
BEDMINSTER, NJ -- (Marketwired) -- 09/17/13 --   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:
www.fdacms-summit.com 
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