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So Long, Old Friend: The End of the Blockbuster Drug Era? What 2008 Holds for Bringing Drugs to Market

Hoffmann-La Roche Inc. CEO George Abercrombie, Pfizer R&D Head Martin Mackay, HHS Deputy Secretary Tevi Troy, Former CMS Administrator & FDA Commissioner Mark McClellan Headline Agenda at FDA/CMS Summit 2007

WASHINGTON, Nov. 15 /PRNewswire-USNewswire/ -- It's shaping up to be a record year for drug approvals. Unfortunately for the biopharma sector and investors, it's a record low. The Food and Drug Administration is on track to grant marketing approval to 18 or fewer new drugs in 2007, and pipelines are not looking better in the coming years. For the research and development and marketing executives responsible for getting new drugs to customers, the level of unpredictability may be unprecedented. And Washington lawmakers and regulators are driving the uncertainty. Yesterday's blockbuster will not be the prototype for future drug development. Sweeping new legislation is reforming the FDA and changing how drugs are developed; Medicare is radically altering product economics; and Wall Street is looking for the next big thing.

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The FDA/CMS Summit, taking place December 6-7 in Washington, D.C., will feature the key decision makers from government and industry to help biopharmaceutical executives understand what regulatory and policy developments mean for research and commercial success.

"Today may look a lot like yesterday, but the rules of the game have fundamentally changed," said Cole Werble, editor-in-chief of The RPM Report, the lead sponsor of the conference. "Industry needs to learn what recent changes to FDA law mean and what the impact might hold for drug development and marketing. The FDA/CMS Summit provides leaders in industry key insight from policy-makers who have been involved in these changes."

The FDA/CMS Summit provides health care executives with an exclusive opportunity to have face-to-face dialogues with top policymakers and executives. The Summit is aimed at industry executives in all areas of responsibility who want to create successful strategies for dealing with FDA and CMS. Attendees will get practical, real-life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles, and will also be able to benchmark their regulatory strategy against all other pharmaceutical and biotechnology companies.

Among the panels and participants scheduled for the Summit are:

- Did FDA Kill the Blockbuster? The Impact of FDA Changes on Research

and Development

-- Pfizer President, Global R&D Martin Mackay

-- Bristol-Myers Squibb SVP R&D Brian Daniels

-- Novartis SVP Global Clinical Development & Medical Affairs Glenn


- Personalized Medicine: How Industry and Government can Make it Happen

-- Hoffmann La-Roche Inc. CEO George Abercrombie

- FDAAA and the New Active Surveillance System: What Does Data Mining

Mean for the Pharmaceutical Industry?

-- Engelberg Center for Health Care Reform Director, Former CMS

Administrator & FDA Commissioner Mark McClellan

-- FDA Assistant Commissioner for Policy Jeffrey Shuren

-- i3 Drug Safety SVP Alec Walker

- Paying for Innovation: CMS' Approach to Coverage

-- CMS Coverage & Analysis Group Director Steve Phurrough

- How the Government and Payors will Impact the Rx Market

-- CMS Center for Beneficiary Choices Chief Medical Officer Jeffrey


-- Former CMS Senior Advisor Larry Kocot;

-- Former Wellpoint Chief Pharmacy Officer and Founder of Doc Rock

Presents Robert Seidman

- Pharma in the Crosshairs: What are the Boundaries for Acceptable


-- First Assistant US Attorney, Boston Michael Loucks

-- Sidley Austin Partner and Former FDA Chief Counsel Daniel Troy

-- King & Spalding Partner John Bentivoglio

Complete agenda and registration information are available at

The RPM Report is a unique Windhover publication that examines FDA and CMS from a business perspective, designed to deliver not only the news from FDA and CMS but to tell executives what it all means to their companies. Register for a free online trial or a complimentary issue at

Sponsors for the FDA/CMS Summit are Foley Hoag LLP, Ogilvy Public Relations Worldwide, Avalere Health, the Personalized Medicine Coalition and PR Newswire.

Media sponsors are, and

About Windhover Information

Windhover Information Inc. has led the field in providing analysis of the healthcare industry to decision-makers at all levels since the founding of its flagship publication, IN VIVO, The Business & Medicine Report, in 1983. Windhover provides its information and analysis in many formats, including print, electronic databases, international conferences and audio conferences. For more on the company's products and services, please see

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