December 5-6, 2017
Renaissance Washington DC Downtown,
Washington, D.C.
Marshal in the Next Era of US Regulatory Policy as it Intersects with Breakthrough Scientific Innovation
Connect with Federal Agencies for Regulatory Updates, Policies and Initiatives Impacting BioPharma
Discuss Current Trends & Developments with Industry Stakeholders and Hear What’s in the Pipeline for the Year Ahead
FDA & CDER at this year's FDA/CMS Summit
Meet with the new FDA Commissioner, Dr. Scott Gottlieb and the Director for the Center for Drug Evaluation & Research (CDER) Dr. Janet Woodcock at this year's event!
Get latest information on CDER, biosimilars, and PROs directly from decision-makers
At this year's event, hear CDER deliver a new drug update for 2018. We’ll also examine the state of biosimilars in the US, and how these medicines may impact the cost curve across healthcare. A full range of topics to be discussed include:
Know What's Coming Down the Pipeline
Hear directly from CDER on goals, trends, and new drug development for 2017 and beyond.
Biosimilars Implication
Understand the economics and impacts of biosimilars on healthcare through global case studies.
The Evolving Role of PROs
Understand the implication of a more vocal patient role in drug development and feedback through a panel of patient advocacy groups and industry and FDA leaders.
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
