December 11-12, 2018
The Westin Washington, D.C. City Center,
Washington, D.C.
Marshal in the Next Era of US Regulatory Policy as it Intersects with Breakthrough Scientific Innovation
Connect with FDA, CMS and CDRH for Regulatory Updates, Policies and Initiatives Impacting BioPharma and Medical Devices
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 2018 and beyond.
Biosimilar Development
Evaluate the economics, impact and FDA considerations in biosimilar labeling, manufacturing, and approval.
The Path Forward for PROs and Real World Evidence
Understand the evolving role of the patient voice in drug development through a panel of advocates, 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
FDA/CMS Speaker Q&A's
We asked our speakers to share their expertise on recent developments in federal drug regulations, industry changes, and the resulting impact on their work.