October 09, 2014 09:00 ET

FDA/CMS Summit for Biopharmaceutical Executives Explores Innovation After Health Reform December 11-12, 2014, Washington, DC at the Fairmont

WASHINGTON, DC--(Marketwired - Oct 9, 2014) - 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?

Join us at FDA/CMS Summit 2014, December 11-12 in Washington, DC. 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.

Among the speakers and topics on this jam-packed two-day agenda are:

Priorities for FDA's Drug Center in 2015 by Janet Woodcock, MD, Director of Center For Drug Evaluation & Research at Food and Drug Administration (FDA)

FDA Roundtable with John Jenkins, MD, Director, Office of New Drugs, Food and Drug Administration (FDA); Gerald Dal Pan, MD, Director, Office of Surveillance & Epidemiology, Food and Drug Administration (FDA); Robert Clark, VP, US Regulatory Affairs, Novo Nordisk; Francois Nader, MD, CEO, NPS Pharmaceuticals; Karen Jones, VP, Global Head of Oncology Regulatory, Genentech; and Kate Rawson, Contributing Editor, Prevision Policy

Drug Pricing: An Honest Conversation About Innovation with Chris Garabedian, CEO, Sarepta; David Beier, Partner, Bay City Capital; John McHutchison, MD, Executive Vice President, Clinical Research, Gilead; and Mark McClellan, MD, PhD, Senior Fellow and Director, Health Care Innovation and Value Initiative, Brookings Institution

Medicare Payment Data: What's Next? with Niall Brennan, Acting Director, Office of Enterprise Management

Medicare Priorities: Part B & D with Tamara Syrek-Jensen, Acting Director, Coverage & Analysis Group Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS) and Ramsey Baghdadi, Founding Member, Prevision Policy

Drug Coverage Under The ACA with Deborah Bachrach, Partner, Healthcare Industry, Manatt, Phelps & Phillips, LLP and Mike Ryan, VP, Value & Access Team, Amgen, and Jonathan Blum EVP, Medical Affairs CareFirst.

Mass Customization: Should Healthcare Adopt This Model? with Trent T. Haywood, MD, JD, SVP, Chief Medical Officer, BlueCross BlueShield Association

Pricing and Reimbursement: The Tipping Point in the Future of Healthcare with Karen Ignagni, President and CEO, America's Health Insurance Plans

Biosimilars or Biosames: Who Cares, Who Decides and Who Pays? with Leah Christl, Associate Director, Biosimilars Program, Office of New Drugs, Food and Drug Administration (FDA); Mark McCamish, MD, PhD, Global Head Biopharm.& Oncology Injectables Development, Sandoz International GmbH; Sumant Ramachandra, MD, PhD, MBA, SVP & Chief Scientific Officer, Hospira; Richard F. Kingham, Partner, Covington & Burling LLP; and Gillian Woollett, Senior Vice President, Avalere

FDA and the First Amendment with Coleen Klasmeier, Partner, Sidley Austin LLP; Rachel Sherman, MD, MPH, FACP, Principal, Drug and Biological Drug Products, Greenleaf Health, Former Director, CDER Office of Medical Policy, Mike Ryan, VP, Value & Access Team, Amgen and Cole Werble, Founding Member, Prevision Policy

The Next FDA Reform: Looking Ahead to PDUFA VI with Ron Cohen, MD, CEO, Acorda Therapeutics; Sascha Haverfield, Vice President for Scientific and Regulatory Affairs, PhRMA; Robert Metcalf, PhD, Vice President, Global Regulatory Affairs - US and Quality, Eli Lilly and Company; Margaret Anderson, Executive Director, FasterCures; and Michael McCaughan, Founding Member, Prevision Policy

To see the full agenda or to register for this event, please visit:

Co-located with FDA/CMS Summit 2014 is FDA/CMS Summit for Payers which will bring together leaders from the Food & Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), healthplans, and pharmaceutical companies to harmonize individual interests for the benefit of patients. The FDA/CMS Summit for Payers will be held in conjunction with 10th Annual FDA/CMS Summit for Biopharmaceutical Executives, December 11-12, 2014 at The Fairmont Hotel in Washington D.C. For more information about The FDA/CMS Summit for Payers, please visit:

About FDA/CMS Summit:
FDA/CMS Summit is the only meeting to gather in one place the top regulatory thought leaders and policy makers. Hear about critical trends and changes so you can create successful strategies for dealing with FDA and CMS. Benchmark your regulatory strategy against all the major pharmaceutical and biotech companies. FDA/CMS Summit allows you to walk away with practical, real life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles.

About IIR:
The Institute for International Research (IIR) is the world's largest conference company and has been the leader in the provision of business information for over 25 years. IIR produces over 5,000 events annually through its network of offices in over 35 countries.

Contact Information

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