Windhover Information's FDA/CMS Summit for BioPharma Executives: Commercial Success in the Regulatory Environment; FDA's Janet Woodcock to Speak on Critical Path

December 4-5, 2006; JW Marriott Pennsylvania Ave., Washington, D.C.

Windhover Information has announced that Dr. Janet Woodcock, the FDA's Deputy Commissioner for Operations, will be one of the major speakers at its upcoming FDA/CMS Summit for BioPharma Executives, "Commercial Success in the Regulatory Environment."

The summit, scheduled for December 4-5 in Washington, D.C., is designed as a unique opportunity for healthcare executives to have face-to-face dialogues with top policymakers and executives on how to drive pre- and post-regulatory approval strategy.

Featured Topic to Be Personalized Medicine & Critical Path

Dr. Woodcock, a sought-after speaker on regulatory affairs, will address the topic of "Personalized Medicine and the Critical Path." Also speaking on this subject will be Peter Pitts, SVP-Global Health Affairs for Manning, Selvage & Lee, and former FDA Associate Commissioner for External Relations.

FDS Acting Commissioner Andrew von Eschenbach and CMS Administrator Mark McClellan are tentatively scheduled to address the conference. Also tentatively scheduled is CMS Senior Advisor Larry Kocot, who will address the topic of preparing for year two of Medicare Part D.

Other speakers and their topics include "Hot Topics for FDA's Center for Drugs," with Steven Galson, MD, Director, FDA Center for Drug Evaluation and Research; "Can FDA Help Drug Development?" with Scott Gottlieb, MD, FDA Deputy Commissioner for Medical and Scientific Affairs; "Drug Safety: New Ideas from FDA," with Paul J. Seligman, MD, MPH, FDA Associate Director for Safety, Policy and Communication; "Business Opportunities in Drug Safety," with Alastair J. Wood, MD, Tenured Professor of Medicine, Professor of Pharmacology & Associate Dean for External Affairs, Vanderbilt University School of Medicine; "Wall Street's View of Washington," with Rick Weissenstein, Healthcare Analyst, Stanford Washington Research Group; "Follow-On Biologics: How Soon?" with Amit Sachdev, Executive Vice President, Health, Biotechnology Industry Organization (BIO) and Former FDA Deputy Commissioner for Policy; and "Medicare Part D Compliance Issues," with Michael Loucks, First Assistant United States Attorney, U.S. Attorney District of Massachusetts.

Also scheduled to speak are Jeffrey Cossman, MD, Chief Scientific Officer, The Critical Path Institute; and Roger Longman, Managing Partner, Windhover Information.

Summit Aimed at Execs of All Responsibilities

The FDA/CMS Summit is not aimed solely at lawyers, but rather 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 the major pharmaceutical and biotechnology companies.

Among the issues to be explored at the conference are future regulatory and clinical implications to strategy, drug discovery and development; drug development and NDA approval strategies; drug safety, risk management and post-market surveillance; biogenerics; marketing and promotion regulation and enforcement; Medicaid and Medicare reimbursement; Medicare Part D; the Critical Path Initiative; and pricing strategies.

The summit is also a premier opportunity to network with hundreds of potential pharmaceutical and biotech companies.

Sponsor for the FDA/CMS Summit is The RPM Report: Regulation * Policy * Market Access, a Windhover publication.

Windhover is offering a free iPod(R) nano, plus free Windhover audio content, to attendees who register before Sept. 30. To register, contact Alexandria Riley at 203-838-4401, x113, or; or register on the FDA/CMS Summit website at

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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