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Cancellation Policy: The last day to cancel your registration for a refund, minus a $300 processing fee, is October 30, 2009. After that, you may send another delegate from your company.

Is The Next Golden Age for Biopharma Almost Here?

Conventional wisdom says these are down times for biopharma companies. Dry pipelines, increased regulation, and payment cuts are part of the reality of today’s playing field. It may just be the opposite. Increased regulation makes for a more confident regulator that can make bolder decisions. In turn, that could precipitate innovation in areas once thought to be no-fly zones for innovative companies. And while payment cuts may prove to be collateral damage resulting from health reform, the industry will have an influx of new customers like it has never seen before.

At the FDA/CMS Summit, find out why 2010 may be the start of another Golden Age for biopharma companies. New Products. New Customers, and New Marketing.

Health Care Reform: What’s Next?

Hear from leaders in government and industry about how health care reform will affect your business, How will development programs have to change to satisfy demands for comparative research? What pricing and reimbursement models will best position you for success? And where are the real opportunities for growth as the US healthcare market continues to evolve?

Last year’s conference was standing room only! Register now to reserve your seat.

Hear from THE FDA/CMS Leaders that shape how you do business:

Dr. Margaret Hamburg
Commissioner
US Food & Drug Administration

John Jenkins, MD
Director, Office of New Drugs
US Food & Drug Administration

Robert Clark
VP US Regulatory Affairs
Pfizer

Philip Krause, MD
Acting Associate Director for Medical Policy and Vaccine Safety Office of Vaccines Research and Review
CBER

Clem Lewin
Head, Strategic Immunization Planning
Novartis
and Industry Representative
National Vaccine Advisory Committee Margaret Rennels
Executive Director, US Scientific Vaccine Policy
GlaxoSmithKline
and Industry Representative
FDA Vaccines & Related Biologicals Advisory Committee

Brian Daniels, MD,
SVP, Global Development & Medical Affairs
Bristol-Myers Squibb

Tim Cunniff
VP-Regulatory Affairs
Lundbeck

Jeffrey Kelman
Chief Medical Officer, Center for Drug and Health Plan Choice
CMS

Scott Keefer
VP Policy Development
America's Health Insurance Plans

*invited

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.

NEW for 2009! Hear directly from the industry experts and regulators on:

New Drugs Approvals: A Status Report
Regulatory Success Stories: Real World Examples of Working Well With the New FDA
FDA’s Favorites: Vaccines and Public Health Products
Health Reform: What’s Next?
New Commercial Realities: Pricing, Marketing and Product Acceptance
New Drug Development Standards
FDA’s Public Health Priorities

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

Hear the Regulators’ First-Hand Perspectives on:

Health Reform
User fees
Health care fraud prosecutions, especially in the new prescription drug benefit
Drug development and NDA approval strategies
Drug safety, risk management and post-market surveillance
Biogenerics/follow-on biologics
Personalized medicine
Pharma marketing and promotions regulation and enforcement
Marketing and promotion regulation and enforcement
Medicaid and Medicare reimbursement
Medicare Part D
Critical Path Initiative
Pricing Strategies

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

"Summit provided a rare opportunity for a broad group of life science companies and regulators to interact in a frank, yet cooperative manner. Great opportunity to learn from peers and our FDA / CMS customer."
- David McNinch, Affymax, Sr. Director of Marketing

"Nobody does it better!!! Best healthcare business policy conference of the year."
- John Kamp, Executive Director, Coalition for Healthcare Communication

"Great speakers. Slides were well done - informative, not just fluff."

"Fostered networking times very useful."

"Excellent information from the best sources with regard to what to expect in Washington under the new Obama Administration."

"When the right people are invited as speakers, it makes for an exceptional conference."

"Excellent speakers, well-organized event and widely-attended."

"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."

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)