December 14-15 2015
Ritz Carlton | Washington, DC




FDA/CMS Summit for Biopharmaceutical Executives 2014

FDA/CMS Summit for Biopharmaceutical Executives 2014

Innovation After Health Reform

The health insurance expansion under the Affordable Care Act is in full swing — a late enrollment surge helped the Obama Administration meet its goal of enrolling 7 million patients into the health care exchanges. Now the questions really begin. What does the first year of the exchanges mean for drug manufacturers? Who are those enrollees, and are there enough healthy participants to ensure the sustainability of the system? What will the White House do to secure its health care legacy in the final two years of the Obama Administration?

And most important of all: how can biopharmaceutical companies anticipate and shape the policy debates that will come now that the ACA expansion is done?

What will the rules for formulary access be? As industry wades through the ACA's approach to prescription drug formularies, it also faces changes to Medicare Part D. While the Centers for Medicare & Medicaid Services withdrew a controversial proposal to cut back on the protected classes of covered drugs, it's clear that CMS hasn't finished tinkering with the prescription drug benefit.

Will FDA's drug review process keep pace? At the same time, FDA and industry are gearing up for the next reauthorization of the Prescription Drug User Fee Act. At the center of the PDUFA VI negotiations will be the fate of FDA's new drug review "Program," under which FDA agreed to greater communication with sponsors in exchange for a slightly longer review period. Is the process is increasing the number of first-cycle reviews, and will FDA and industry will want to retain it?

What surprises await industry after the 2014 mid-term elections? Those PDUFA VI negotiations — and the second go-round of the Generic Drug User Fee Act and the Biosimilar User Fee Act — will kick off next year, with plenty of other hot topics on the table for discussion. Will the result be major reforms to the regulatory process for drugs and biologics, or just some minor tweaks? And with FDA getting closer to approving the first biosimilar under the abbreviated pathway, will those early products see commercial success?

Come to the tenth annual FDA/CMS Summit for Biopharma Executives to find out. Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

  • The commercial outlook for biopharma under the new health care exchanges;
  • Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program";
  • The future of drug safety at FDA — both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes;
  • What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.
  • Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit;
  • What the mid-term Congressional elections will mean for the biopharma industry.

Register now and join us at the Fairmont Washington DC, December 11-12, 2014 for this can’t-miss event.

Key Benefits for Attending FDA/CMS Summit

Key Benefits for Attending FDA/CMS Summit:

  • Hear about critical trends and changes so you can create successful strategies for dealing with FDA and CMS
  • Walk away with practical, real life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles
  • Get face-to-face access to the top regulatory thought leaders and policy makers
  • Benchmark your regulatory strategy against all the major pharmaceutical and biotech companies

Registration Homepage


Important Deadlines
Early Bird Rates - Save $200 on Registration Before:Extended thru Conference
Last Chance for Discounted Rooms (may sell out earlier):11/19/2014



Simple. Meet the most important people in the business. Only at FDA/CMS Summit can you hear from this stellar lineup:

Homepage Keynotes & Speakers


Jim Robinson
Astellas Pharma US, Inc.

John Castellani
President and CEO

Featured Speakers:

Janet Woodcock, MD
Director, Center for Drug Evaluation and Research

John K. Jenkins, MD
Director, Office of New Drugs, Center for Drug Evaluation and Research

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group (CAG)

Robert Clark
VP, US Regulatory Affairs
Novo Nordisk

Niall Brennan
Acting Director
Offices of Enterprise Management (OEM)

View a Complete List of Speakers


Feedback About FDA/CMS Summit:

"I would like to thank the whole Windhover/RPM 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

View other testimonials »»


For registration and sponsorship opportunity information, please contact:

Heej Ko
Phone: (203) 291-9576
Email: heej.ko@informa.com