The publications on this site are part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726

Informa
Skip to Page Content

FDA CMS Banner

 

2012 FDA/CMS Summit Preliminary Agenda

December 10 & 11, 2012

Mayflower Hotel
1127 Connecticut Avenue NW
Washington, DC 20036

Click on a speaker's name to view their biography.

Monday, December 10, 2012

7:00-8:00am

Registration and Continental Breakfast

8:00am

Welcome and Opening Remarks

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

8:15-9:00am

KEYNOTE ADDRESS: Priorities for FDA’s Drug Center in 2012

Douglas Throckmorton, MD
Deputy Director
Center for Drug Evaluation & Research
Food & Drug Administration (FDA)

9:00-10:30am

The New Rules of New Drug Reviews: A Roundtable

FDA’s top new drug and drug safety officials join industry leaders to discuss trends in the new drug review process and the changes enacted by the Prescription Drug User Fee Act reauthorization.

John Jenkins, MD
Director
Office of New Drugs
Food & Drug Administration (FDA)

Gerald Dal Pan, MD
Director
Office of Surveillance & Epidemiology
Food & Drug Administration (FDA)

Richard Pops
CEO
Alkermes

Francois Nader, MD
President and CEO
NPS Pharmaceuticals

Kay Holcombe
Senior Policy Advisor
Genzyme

Moderator:
Kate Rawson
The RPM Report
Prevision Policy

10:30-11:00am

Networking Break

11:00-12:00pm

2012 Elections: Implications for Pharma

What to expect from the new Administration and the new Congressional line-up for 2013.

John McManus
President
The McManus Group

Tracy Spicer
Partner
Avenue Solutions

Jeff Forbes
Partner
Forbes-Tate 

Presenter/Moderator:

Marc Samuels
Founding Member & President
Hillco Health

12:00-1:00 pm

Lunch

 

1:15-2:00pm

 

Fireside Chat

Jonathan Blum
Principal Deputy Administrator
Centers for Medicare & Medicaid Services (CMS)

 

2:00pm-3:30 pm

 

Hot Topics in Health Reform

The politics of health care reform aside, biopharma companies need to prepare for changes in the US health care system that emphasis quality and affordability of care. This session will feature presentations on different aspects of the upcoming changes in payment and delivery of care and how they will affect pharma.

Health Reform and The Climate for Innovation

Ron Cohen, MD
President and CEO
Acorda Therapeutics, Inc.

What is Essential in Essential Health Benefits?

Ian Spatz
Senior Advisor
Manatt Health Solutions

Medication Adherence in the Context of Health Reform 

William Shrank, MD, MSHS
Director
Rapid-Cycle Evaluation Group
Centers for Medicare & Medicaid Services (CMS)

Commercial Implications of Health Reform

Will Suvari
Vice President
Campbell Alliance

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

3:30-4:00pm

Networking Break

4:00-4:30pm

Keynote: Implementing Reform

Joshua Sharfstein
Secretary
Maryland Department of Health
Former Deputy Commissioner
Food & Drug Administration (FDA)

4:30-5:00pm

Closing Keynote: Reimbursable Labeling

Chuck Stevens
Vice President
PAREXEL

5:30-7:30pm

Cocktail Reception

Tuesday, December 11, 2012

7:00-8:00am

Registration and Continental Breakfast

8:00-8:30am

KEYNOTE ADDRESS

Robert J. Hugin
Chairman and CEO
Celgene Corporation

8:30-9:45am

Biosimilars Update

Joerg Windisch
Chief Science Officer
Sandoz

Diem Nguyen
General Manager, Biosimilars
Emerging Markets/Established Products Business Unit
Pfizer Inc.

Leah Christl, PhD
Associate Director for Biosimilars
Office of New Drugs
Center for Drug Evaluation & Research
Food & Drug Administration (FDA)

Moderator:
Kate Rawson
The RPM Report
Prevision Policy

9:45-10:00am

Networking Break

10:00-11:15am

Reinventing the Approval Pathway

PDUFA V makes important changes in drug regulation, but it doesn’t fundamentally change the standard for new drug approvals. Is it time for the US to consider moving to new models like progressive approval/adaptive licensing?

Mary Ellen Cosenza
Executive Director Regulatory Affairs and North America Regulatory Head
Amgen, Inc.

Steven Nissen, MD, MACC
Chairman, Department of Cardiovascular Medicine
The Cleveland Clinic Foundation

Barry Sickels, Ph.D.
Vice President, Regulatory Affairs and Wilmington R&D Site Leader
AstraZeneca

Gregory W. Daniel, PhD, MPH, RPh
Fellow, Economic Studies
Managing Director, Engelberg Center for Health Care Reform
The Brookings Institution

Moderator:
Cole Werble
Editor, The RPM Report
Founding Member, Prevision Policy LLC

11:15-12:00pm

A Regulator's Perspective

Robert Temple, MD
Deputy Director for Clinical Science
Center for Drug Evaluation & Research
Food & Drug Administration (FDA)

Moderator
Ramsey Baghdadi
The RPM Report
Founding Member, Prevision Policy

12:00-1:00pm

Lunch - Sponsored by

1:00-1:45pm

CMS Coverage Priorities: CED, NCDs and Parallel Reviews

The Medicare agency is moving forward with innovative models to use coverage policy to encourage development of better evidence for new technologies. Devices are the primary focus, but drugs won’t be far behind.

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)

Moderator
Ramsey Baghdadi
The RPM Report
Founding Member, Prevision Policy

1:45-3:00pm

Right-Sizing the Demands for Evidence

FDA’s pre-market and post-market regulatory demands are increasing, and so are the expectations of public and private payors for “real world” comparative effectiveness data. How can policy makers and biopharmaceutical companies work together to assure that the need for evidence doesn’t overwhelm the capacity of innovators?

Jonathan Leff
Managing Director, Healthcare
Warburg Pincus

Martin Marciniak
Vice-President, US Health Outcomes
GlaxoSmithKline

Scott Gottlieb, MD
Resident Fellow
AEI

Moderator:
Gillian Woollett

Vice President
Avalere Health

3:00-3:15pm

Networking Break

3:15-4:30pm

The New Generic Drug Era

The Generic Drug User Fee Act will usher in a new era for the generic drug industry, one with greater emphasis on global production quality and tough-to-copy products. What will the new era bring?

Gregory Geba
Director
Office of Generic Drugs
Food & Drug Administration (FDA)

David Gaugh
VP-Regulatory Sciences
Generic Pharmaceutical Association

Gary Buehler
Vice President-Regulatory Strategic Operations
Teva Pharmaceuticals

Lara Ramsburg
VP-Government Relations
Mylan

Moderator:
Nancy Myers
President
Catalyst Healthcare Consulting

4:30-5:00pm

A Fireside chat with:

Geno Germano
President
Pfizer Specialty Care and Oncology

 *invited

Back to Top