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2005 Bio-Pharmaceuticals for the 21st Century


January 10-11, 2005

About the Event
On January 10-11, 2005, the Center hosted “Bio-Pharmaceuticals for the 21st Century:  Responsibility, Sustainability, and Public Trust,” a summit involving numerous stakeholders, including industry, government, consumers, public advocates, academic investigators, healthcare scholars, hospitals and other health service institutions and the public.  The goals were to generate recommendations for a socially responsible and sustainable healthcare/research industry as well as to inform public understanding and policy on clinical trials registries.  

Learn More About the Event
Below are presentation and other materials from the event.  We hope that these materials will inform and encourage others to expand upon the important dialogue that began at our summit.

 View the Conference White Paper:

Clinical Trial Registries and Results Databases

View the article 
"Clinical Trials Results Databases:
Unanswered Questions"

by Celia Fisher, Ph.D. appearing in Science (1.13.06)

Keynote Address:  
Diana DeGette (D-Colorado)
Vice-Chair, House Committee on Energy and Commerce

An excerpt from Rep. DeGette's official homepage: "A life-long Coloradoan, Rep. DeGette is guided by traditional Western values. Rep. DeGette is one of the leading voices in the health care debate in this country. She played a vital role in the reauthorization of the State Children’s Health Insurance Program and is the author of legislation to expand stem cell research. She is also the author of the landmark Colorado Wilderness Act, which protects and preserves 1.6 million acres of pristine land across Colorado for generations to come. She has fought to expand her constituents’ access to affordable quality health care, expand mass transit, improve transportation in the Denver area, clean up environmental waste sites, and improve opportunities for small business. Finally, committed to common-sense fiscal responsibility, she is working with like-minded Members of Congress to reduce the national deficit."
Jill Guary, MS, CCRC Director, Clinical Research, Harris Interactive (PowerPoint) 
Laurence Hirsch, M.D., Executive Director, Medical Communications, Merck Research Laboratories (PowerPoint)

Bernard Schwetz, D.V.M., Ph.D., Director, Office for Human Research Protections (PowerPoint)


Theresa Toigo, RPh, MBA, Director, Office of Special Health Issues Office of External Relations - Food and Drug Administration (FDA) (PowerPoint)


Alan Milstein, Esq., Sherman, Silverstein, Kohl, Rose & Podolsky (PowerPoint)


Bill Leedom, Esq., Bennett, Bigelow and Leedom (PowerPoint)

Panel 1:   Clinical Trial Registries:  Current Models & Public Perceptions
Theresa Toigo, RPh, MBA, Director, Office of Special Health Issues, Office of External Relations, Food and Drug Administration (PowerPoint Presentation)
Alan Breier, M.D., Vice President of Lilly Medical, Chief Medical Officer, Eli Lilly and Company (PowerPoint Presentation)
Edward Campion, M.D., Senior Deputy Editor, New England Journal of Medicine

Laurence Hirsch, M.D., Executive Director, Medical Communications, Merck Research Laboratories (PowerPoint Presentation)


John Schneider, MD, Ph.D., Chair-Elect, Council on Scientific Affairs, American Medical Association; Written Presentation (Microsoft Word) and PowerPoint Presentation


Richard Barker, M.D., Director General, Association of the British Pharmaceutical Industry

Panel 2:   Current Models: Promise, Problems & Meaningful Public Access
Bernard Schwetz, DVM, Ph.D., Director, Office for Human Research Protections

Pearl O’Rourke, M.D., Director, Human Research Affairs, Partners HealthCare Systems, Inc.; Current Clinical Trials Models  (Microsoft Word)

Herbert Pardes, M.D., President and CEO, New York Presbyterian Healthcare System
Emma Sergeant, President, Clinical Trials Worldwide of Fast4wd Ogilvy
Panel 3:   Ideal Registry(ies): Panacea or Placebo?

Ken Getz, Board Chairman, Center for Information and Study on Clinical Research Participation

Malcolm Wheeler, Wheeler, Trigg & Kennedy, LLP(Microsoft Word)
Gary Cohen, Vice President, Ethics & Corporate Responsibility, Millennium Pharmaceuticals, Inc. (Microsoft Word)
Robert Rubin, M.D., Ph.D., Associate Director, Division of Infectious Disease, MIT Harvard Center for Experimental Pharmacology and Therapeutics (Microsoft Word)
Marc Wilenzick, Senior Corporate Counsel, Pfizer, Inc.
Panel 4:   Key Points & Recommendations

Debra Aronson, Esq., Director of Bioethics, BIO: Biotechnology Industry Organization

Marc Boutin, Esq. Vice President, Policy Development & Advocacy, National Health Council
Kevin Dahill, MBA, President & CEO, Nassau Suffolk Hospital Council
Lee Farrow, Esq., Vice President, ACE Medical Risk

Matthew Whalen, Ph.D., Co-Founder & Chief Development Officer, Chesapeake Research Review, Inc.



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