9th Annual Biomarkers Congress
2013 FDA/CMS Summit
Ritz-Carlton

Washington, USA
http://www.elsevierbi.com/mkt/conf/fda-cms/2013Schedule
2013 FDA/CMS Summit
Elsevier Business Intelligence
http://www.elsevierbi.com/mkt/conf/fda-cms/2013Schedule
Ritz-Carlton
Washington
USA


Schedule of Presentations:

Wednesday, December 11, 2013
07:00:00 Registration and Continental Breakfast
08:00:00 Welcome and Opening Remarks Michael McCaughan
08:15:00 KEYNOTE ADDRESS: Priorities for FDA’s Drug Center in 2014 Janet Woodcock
09:00:00 FDA Roundtable Wendy Sanhai, Paul Seligman, Gerald Dal Pan, John Jenkins
10:30:00 Networking Break
11:00:00 Regulatory Gaps: What’s Left to “Fix” at FDA? Gillian Woollett, Douglas C. Throckmorton
12:15:00 Lunch
13:15:00 Health Reform in 2014: What to Expect After Jan. 1 Marc Samuels
14:30:00 Networking Break
14:45:00 Biosimilars in the US: What is Possible, and When? John Jenkins
16:00:00 Medicare Part D and Rx Regulation Cole Werble, William Shrank
17:00:00 Closing Keynote: Developing Successful Clinical, Regulatory and Patient Access Strategies in the Post Affordable Care Act Market
Thursday, December 12, 2013
08:30:00 Fireside Chat: Medicare in 2014 and Beyond Michael McCaughan, Jonathan Blum
09:15:00 Beyond the “Label”: Promotion in the Facebook Era Cole Werble, Adriane Fugh-Berman, Coleen Klasmeier
10:15:00 Networking Break
10:30:00 A Rare Opportunity: Orphan Drugs Michael McCaughan, Diane Dorman, Gayatri Rao
11:45:00 Networking Break and Working Box Lunch
12:00:00 Cancer Therapies: The Breakthrough Era Victor Sandor, Richard Pazdur
13:30:00 CMS Coverage Priorities Ramsey Baghdadi, Louis B. Jacques
14:30:00 Closing Keynote Margaret Hamburg
17:30:00 Registration and Continental Breakfast
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