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FDA CMS Summit

  October 03, 2013  
Elsevier Business Intelligence, Ritz-Carlton Washington DC
December 11-12, 2013

Wednesday, December 11, 2013


Registration and Continental Breakfast


Welcome and Opening Remarks

Michael McCaughan
Editor, The RPM Report
Founding Member, Prevision Policy LLC



KEYNOTE ADDRESS: Priorities for FDA’s Drug Center in 2014

Janet Woodcock, MD
Director, Center For Drug Evaluation & Research
Food and Drug Administration (FDA)




FDA Roundtable

Hear the latest on the implementation of PDUFA V from the Office of New Drugs, Office of Safety & Epidemiology and from industry stakeholders.

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)

Paul Seligman, MD
Executive Director Global Regulatory Policy
Amgen Global Regulatory Affairs
Former Director, Office of Pharmacoepidemiology and Statistical Sciences, FDA

Richard Pops


Kate Rawson
The RPM Report
Prevision Policy LLC



Networking Break


Regulatory Gaps: What’s Left to “Fix” at FDA?

With each round of user fees, stakeholders discuss ways to improve the regulatory review and approval process for new medicines at FDA. Do we still need multiple UFAs revised every 5 years, or have we reached the point of diminishing returns? Has the recent glut of expedited programs taught us anything we can generalize to medicines for popular diseases? Are we chasing too much technology of less and less relevance to clinical outcomes? How can we focus on actionable data that is timely and truly pertinent? And how do we allow for patient input, learnings from ex-USA settings, and on-going iterative scientific developments while still making decisions that allow access to good medicines? These topics will be discussed from the perspective of the industry, the patient, and the regulator by recognizing shared aspirations but also the distinct responsibilities of each to better and more efficiently contribute to the protection and the promotion of US public health.

Freda Lewis-Hall
EVP and Chief Medical Officer
Pfizer Inc.




Gillian Woollett, MA, DPhil
Vice President
Avalere Health


12:15-1:15 pm







CMS KEYNOTE: Priorities for 2014

Marilyn Tavenner*
Centers for Medicare & Medicaid Services (CMS)


1:45pm-2:45 pm



Health Reform in 2014: What to Expect After Jan. 1
Expert panelists look ahead to the insurance expansion of 2014, and what to expect in Medicaid, the new exchanges, and ongoing budget battles.


Marc Samuels
President & CEO




Networking Break


Biosimilars in the US: What is Possible, and When?

Heidi Hunter
Head Global Department Biosimilars Business
Boehringer Ingelheim Biopharmaceuticals GmbH

Sumant Ramachandra
Chief Scientific Officer
Hospira Inc.



Ramsey Baghdadi
The RPM Report
Founding Member, Prevision Policy



Medicare Part D and Rx Regulation

The Medicare drug benefit has been a rousing success for beneficiaries and for pharma. However, there is growing pressure for CMS to exert more control of Rx utilization—to curtail overuse, but also to encourage adherence. How might a more active role by Medicare change the commercial dynamics for prescription drugs?

Lori Reilly
Executive VP-Policy and Research
Pharmaceutical Research & Manufacturers of America

William Shrank
Harvard Medical School/Brigham & Women’s Hospital
Former Director of Evaluation, CMMI


Cole Werble
The RPM Report
Founding Member, Prevision Policy


Closing Keynote

Chuck Stevens
Vice President & General Manager, Commercialization Strategy
PAREXEL International


Cocktail Reception

Thursday, December 12, 2013


Registration and Continental Breakfast


Fireside Chat: Medicare in 2014 and Beyond

Jonathan Blum
Deputy Administrator and Center for Medicare Director



Michael McCaughan
Editor, The RPM Report
Founding Member, Prevision Policy LLC
9:15-10:15am Beyond the “Label”: Promotion in the Facebook Era

A landmark first amendment ruling raises questions about the scope of FDA’s authority to prohibit “off-label” promotion. In an era of comparative effectiveness research and social media is it time to think beyond the label?

Mit Spears
Executive VP and General Counsel
Pharmaceutical Research & Manufacturers of America

Coleen Klasmeier
Sidley Austin LLP


Cole Werble
The RPM Report
Founding Member, Prevision Policy


Networking Break





A Rare Opportunity: Orphan Drugs

Thirty years after the Orphan Drug Act, interest in rare disease research has never been higher. This session will explore how well the Orphan Drug model is operating in a world of evolving science and business, including an update from FDA’s Orphan Products Office, and perspectives from industry and patients on the interplay of regulation, reimbursement and unmet need for patients with rare diseases.

Gayatri Rao, MD
Director, Office of Orphan Products Development

Chris Garabedian
President & CEO
Sarepta Therapeutics

Francois Nader, MD
Chairman, President and CEO
NPS Pharmaceuticals

Diane Dorman
Vice President for Public Policy
National Organization for Rare Disorders


Michael McCaughan
Editor, The RPM Report
Founding Member, Prevision Policy LLC


Networking Break and Working Box Lunch



Cancer Therapies: The Breakthrough Era

There has never been more excitement about the potential for therapeutic advances in cancer. But breakthroughs bring challenges of their own, as regulators, sponsors and payors all need to adapt to the new realities of hyper-fast development—and very high prices.

Richard Pazdur, MD
Director, Office of Hematology and Oncology Products
Center for Drug Evaluation & Research, FDA

Jeff Allen, PhD
Executive Director
Friends of Cancer Research

Sandra Rattray, MD
VP and Head, Global Regulatory Affairs, Oncology
Johnson & Johnson

Victor Sandor MD CM
Group Vice President, Clinical Development
Incyte Corporation

Joseph Leveque, MD
Vice President, US Medical – Oncology
Bristol-Myers Squibb



Kate Rawson
Prevision Policy and The RPM Report




CMS Coverage Priorities


Hear from Medicare’s Part B coverage team on priorities for 2014, including the evolution of coverage with evidence development and potential hot topics for coverage review.

Louis Jacques, MD
Director, Coverage & Analysis Group Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)

Tamara Syrek Jensen, JD
Deputy Director
Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)


Ramsey Baghdadi
The RPM Report
Founding Member
Prevision Policy LLC



Closing Keynote

Margaret Hamburg, MD
Food and Drug Administration (FDA)

Organized by: Elsevier Business Intelligence
Invited Speakers:


Various, see program

Deadline for Abstracts: none



E-mail: h.ko@elsevier.com
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