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December 14 - 15, 2016
The Ritz-Carlton, Washington, DC,
Washington, DC

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

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

Key Sessions Address Critical Topics


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)


Priority Review Voucher Proliferation: Bane of FDA, Boon for Industry?


- Cameron Durrant, MD, Chairman and CEO, KaloBios Pharmaceuticals Inc

- Krista Carver, Partner, Covington & Burling LLP


Regulation in a Pandemic World

Denise Esposito, Partner, Covington & Burling LLP

Media Partners

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