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Hear from THE Leaders of the FDA/CMS world that shape
how you do business:
NEW! Keynote Address: Health Reform's Impact on the Pharmaceutical Industry
Kenneth Frazier
President, Global Human Health, Merck and Company
Keynote Address: FDA’s Priorities for 2009
Frank M. Torti, MD, MPH
Principal Deputy Commissioner and Chief Scientist, FDA
Opening Keynote: Priorities for 2009
Janet Woodcock MD
Director, FDA
Center for Drug Evaluation & Research
The Reagan-Udall Foundation
Mark McClellan
Director of the Engelberg
Center for Health Care Reform
Senior Fellow in Economic Studies
Former CMS Administrator
Keynote Address: Restoring the FDA: What Needs to be Done
Steven E. Nissen, MD, FACC
Chairman of Cardiology, The Cleveland
Clinic Foundation
Don’t miss these presentations that will help you prepare for the NEW
rules in 2009 and beyond:
New Drug Approvals: A Status Report
John Jenkins, MD, Director, Office of New Drugs, U.S. Food & Drug Administration
Preparing for the New FDA in 2009 and Beyond
Robert Clark, VP-US Regulatory Affairs, Pfizer
D. Bruce Burlington MD, Independent Consultant Former Executive Vice President
and Worldwide Head of Regulatory Affairs, Human Safety & Quality, Wyeth
Former Head, Center for Devices and Radiological
Health, U.S.
Food & Drug Administration
What Health Care Reform Means for the Pharmaceutical Industry
Rod Cavin, Managing Director, Health Strategies Group LLC
Ian Spatz, VP-Public Policy, Merck
Big Pharma R & D: Can you Handle the Truth?
John LaMattina, Former President, Pfizer Global R & D Author of Drug Truths:
Dispelling the Myths about Pharma R & D
REMS and The New Rules of Drug Safety
Gerald J. Dal Pan, M.D., MPH, Director, Office of Drug Safety, FDA
Scott Gottlieb, MD, Resident Fellow, American Enterprise Institute, AEI Former
Deputy Commissioner for Medical and Scientific Affairs, FDA
Florence Houn, VP, Regulatory Policy
and Strategy, Celgene
Valuing Medicine in an Era of Cost Containment
Josh Ofman, MD, MSHS, Vice President, Reimbursement and Payment Policy, Amgen
David Meeker, MD, Executive Vice President, Therapeutics, Biosurgery &
Transplant, Genzyme
Robert Seidman, former Wellpoint Chief Pharmacy Officer
Doing Well By Doing Good: R&D For Neglected Diseases
Christopher Earle, President & CEO, Bioventures for Global Health
Reforming Medicare Part D: Options and Implications
Brian Cohen, House Oversight Committee Staff
Tom Paul, Chief Pharmacy Officer, Ovations
How Will the New Regulatory &
Reimbursement Environments Affect Where Investors Put
Their Money – and How Much They Put In?
Brian Atwood, Partner, Versant Ventures
Rick Weissenstein, SVP, Healthcare Analyst, Stanford Financial Group
* invited
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If you make FDA/CMS Summit an annual must-attend like hundreds of other pharmaceutical and biotech leaders, keep ahead of the curve and mark your calendars NOW.
Key Benefits for Attending FDA/CMS Summit:
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Hear the critical trends and changes that affect your regulatory strategy successful strategies for dealing with FDA and CMS
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Walk away with practical, real life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles
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Get face-to-face access to the top regulatory thought leaders and policy makers
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Benchmark your regulatory strategy against all the major pharmaceutical and biotech companies
Hear the Regulators’ First-Hand Perspectives on:
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User fees
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Health care fraud prosecutions, especially in the new prescription drug benefit
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Drug development and NDA approval strategies
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Drug safety, risk management and post-market surveillance
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Biogenerics/follow-on biologics
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Personalized medicine
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Pharma marketing and promotions regulation and enforcement
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Marketing and promotion regulation and enforcement
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Medicaid and Medicare reimbursement
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Medicare Part D
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Critical Path Initiative
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Pricing Strategies
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Here is what your peers have to say 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
“A very valuable conference, showcasing great insights into the framework of US regulatory bodies.”
“All the up to date information on emerging trends in FDA and CMS policy presented in one place at one time by the people that make the policy.”
“An important opportunity to step back and take an integrated look at the macro trends that will affect industry activity next year and beyond.”
“From a European perspective and without being a regulatory expert, the summit certainly provided great insights into the current and future challenges related to FDA and CMS.”
“I found the agenda to be comprehensive and balanced and was happy with the high caliber list of speakers.”
“The agenda covered all the important background as well as "breaking news" in the key regulatory areas affecting our industry.”
“The conference really showed that these two organizations have more in common than differences.”
“The Summit was an impressive gathering of current and former FDA and CMS officials who provided valuable perspectives on policy slated for debate in 2006.”
“Topics were of high relevance and speakers very impactful. A timely and informative conference.”
“Valuable curriculum and great line-up of speakers. A great program for regulatory, government and marketing personnel.”
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Gold Sponsor:
Association Sponsor:
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A small sample of companies sending their teams to FDA/CMS Summit include:
Affymax, Inc.
Allergan, Inc.
Amgen Inc.
Amylin Pharmaceuticals, Inc.
AstraZeneca
Bayer Schering Pharma AG
Boehringer Ingelheim Corp.
Bristol-Myers Squibb Company
Cell Therapeutics Inc. (CTI)
Cephalon
CGI Pharmaceuticals Inc.
Dendreon
Eli Lilly and Company
EMD Serono, Inc.
Endo Pharmaceuticals, Inc
F. Hoffmann La Roche
FDA - CDER
Genentech Inc.
Johnson & Johnson
McKesson Corp.
Merck & Co Inc.
Neurocrine Biosciences Inc.
Novartis Pharmaceuticals
Novexel Inc
Ovation Pharmaceuticals Inc.
Pfizer, Inc.
PTC Therapeutics
Purdue Pharma LP
Sanofi Aventis
Schering-Plough Corp.
Sepracor Inc.
Takeda Pharmaceuticals North American LTD.
Teva Neuroscience
UCB Pharma
Vertex Pharmaceuticals Inc.
Wyeth
XenoPort Inc
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