December 5-6, 2017
Renaissance Washington DC Downtown,
HEAR THE LATEST DEVELOPMENTS AND UPDATES FROM REGULATORY LEADERS ON THE FDA DRUGS PROGRAM & CMS POLICIES IMPACTING BIOPHARMA
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.
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.
Speak at FDA/CMS Summit 2017
We are now accepting proposals for this year's event. Submit your abstract on the following topics:
- Understanding the Emerging Role of Patient Reported Outcomes (PRO) and FDA Use in Drug Programs
- The Opportunities and Challenges of Expanded Access: Right to Try
- The Pricing Issue in Pharma, Transparency, and Tying Value to Price Via Regulatory Oversight
- Looking Globally at The Economics and Impact of Biosimilars on Healthcare in Other Parts of the World
- Rare Tropical Diseases and Outbreaks: Addressing Pandemics, The Latest in Infrastructure Preparedness, and Accelerating Turnaround Time for Treatment and Eradication
- Addressing the Logistical Challenges of Gaining Accelerated Approval
- Manufacturers Panel: Addressing the Logistical Challenges of Gaining Accelerated Approval
- Repurposing orphan drugs
- Fast Track vs Breakthrough Therapy Designation
- Current trends/developments in Biopharma approvals
Email Nicole Hayes with your proposal by July 14, 2017.
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.
Sr. Director of Marketing
Nobody does it better!!! Best healthcare business policy conference of the year.
Coalition for Healthcare Communication