December 5-6, 2017
Renaissance Washington DC Downtown,
Driving Momentum Towards Approval of New Therapies
Thank you to all of those who attended FDA/CMS Summit 2016! Sign up for our email updates below for program updates and registration offers.
Be Prepared for the Wave of Public Policy Changes
At this year's FDA/CMS Summit, 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
Thank you to all of our 2016 Speakers
Selected speakers from 2016 are below. Thank you to all of our speakers!
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