December 14 - 15, 2016
Ritz-Carlton Washingtion, D.C.,
Washington, D.C.
Driving Momentum Towards Approval of New Therapies
Join THE biopharma event that facilitates direct dialogue between biopharma executives, investors and FDA/CMS regulators to explain complex regulatory and reimbursement policy.
Be Prepared for the Wave of Public Policy Changes
As we convene for the 11th Annual FDA/CMS Summit, election year rhetoric will have transitioned to the realities confronting a new Administration. We’ll discuss what the future holds for the Affordable Care Act and health reform more broadly in a post-Obama landscape. We’ll examine the state of biosimilars in the US, and how these medicines may impact the cost curve for biologics as more reach the market and uptake becomes measurable. Transparency around pricing – even for the most innovative drugs – remains a contentious issue, with multiple state-level initiatives designed to limit drug spend. A full range of topics to be discussed include:
Updates Directly From CDER and CMS
- Regulatory Updates from Center for Drug Evaluation and Review (CDER) and the Insights into 2017
- Updates on the Breakthrough Designation Program from the Office of New Drugs
- Updates from CMS on Medicare Part B and Value-Based Pricing
Regulatory & Reimbursement Expertise
- Biosimilar Review Timeless and Revisions to BSUFA
- Priority Review Voucher Proliferation
- Influence of Patient Advocacy Groups on Drug Review Processes
Drug Development Innovation
- Global Regulatory Strategies in the Midst of Pandemics like Ebola and Zika
- Challenges in Pediatric Drug Development
- Regulatory Processes for Experimental Therapies
Regulatory Thought Leaders Convene at FDA/CMS Summit
Key Sessions Address Critical Topics
OPENING KEYNOTE
Priorities for FDA’s Drug Center in 2017
The head of CDER will highlight the drug center’s 2016 accomplishments, as well as challenges the drug center face’s for next year.
- Janet Woodcock, MD, Director, Center for Drug Evaluation & Research (CDER), US Food & Drug Administration (FDA)
PANEL
Priority Review Voucher Proliferation: Bane of FDA, Boon for Industry?
Panelists:
- Cameron Durrant, MD, Chairman and CEO, KaloBios Pharmaceuticals Inc
- Krista Carver, Partner, Covington & Burling LLP
REGULATORY INSIGHTS
Regulation in a Pandemic World
Denise Esposito, Partner, Covington & Burling LLP
The Best Networking in the Business
For over a decade, FDA/CMS Summit continues to be THE meeting place for the industry’s top regulatory thought leaders and policy makers. This two-day summit gives you direct access to:
- 250 + Senior Level Biopharma Executives
- FDA, CDER, & CMS Policy & Decision Makers
- 4 Dedicated Networking Opportunities
I would like to thank the whole event team for putting together this conference. Conferences are made by its participants and the group assembled here today is so diverse and truly experienced.
Mark McClellan, MD/PhD
Former FDA Commissioner and CMS Administrator
Summit provided a rare opportunity for a broad group of life science companies and regulators to interact in a frank, yet cooperative manner. Great opportunity to learn from peers and our FDA / CMS customer.
David McNinch
Sr. Director of Marketing
Affymax
Nobody does it better!!! Best healthcare business policy conference of the year.
John Kamp
Executive Director
Coalition for Healthcare Communication