B
Workshop Agenda, Speakers, Panelists, and Participants: June 27, 2005

Workshop Agenda

8:30

WELCOME AND OPENING REMARKS

 

Philip A.Pizzo

Chair, IOM Board on Health Sciences Policy

Dean, Stanford University School of Medicine

 

Gail Cassell

Member, IOM Council and Board on Health Sciences Policy

Vice President, Scientific Affairs and Distinguished Lilly Research

Scholar for Infectious Diseases

Eli Lilly and Company

OVERVIEW & BACKGROUND

8:45

KEYNOTE: IMPORTANCE OF THE PUBLIC TRUST

 

The Honorable John Porter

Partner

Hogan & Hartson, LLP

9:15

STATUS OF IOM BOARD ACTIVITY

 

Philip A.Pizzo

Chair, IOM Board on Health Sciences Policy

Dean, Stanford University School of Medicine



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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary B Workshop Agenda, Speakers, Panelists, and Participants: June 27, 2005 Workshop Agenda 8:30 WELCOME AND OPENING REMARKS   Philip A.Pizzo Chair, IOM Board on Health Sciences Policy Dean, Stanford University School of Medicine   Gail Cassell Member, IOM Council and Board on Health Sciences Policy Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases Eli Lilly and Company OVERVIEW & BACKGROUND 8:45 KEYNOTE: IMPORTANCE OF THE PUBLIC TRUST   The Honorable John Porter Partner Hogan & Hartson, LLP 9:15 STATUS OF IOM BOARD ACTIVITY   Philip A.Pizzo Chair, IOM Board on Health Sciences Policy Dean, Stanford University School of Medicine

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary PANEL 1: PATIENT/PUBLIC/JOURNAL EDITORS PERSPECTIVE 9:45 PATIENT/PUBLIC NEEDS   Marjorie Speers Executive Director Association for the Accreditation of Human Research Protection Programs   DISCUSSANTS: Miriam O’Day Senior Director of Public Policy Alpha-1 Foundation   Sharon Terry President and CEO Genetic Alliance   Jeanne Ireland Director of Public Policy Elizabeth Glaser Pediatric AIDS Foundation 10:00 DISCUSSION 10:15 CLINICAL TRIAL REGISTRY REQUIREMENTS: INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS   Harold Sox Editor Annals of Internal Medicine   DISCUSSANTS: Catherine DeAngelis Editor-in-Chief JAMA   Jeffrey Drazen Editor-in-Chief NEJM 10:30 DISCUSSION

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary 10:45 BREAK PANEL 2: CURRENT REGISTRY ACTIVITIES 11:00 INDUSTRY PERSPECTIVE   Alan Breier Vice President, Medical and Chief Medical Officer Eli Lilly and Company   DISCUSSANTS: Alfred Sandrock Vice President, Medical Research-Neurology Biogen Idec   Frank Rockhold Senior Vice President and Director, Biomedical Data Sciences GlaxoSmithKline Pharmaceuticals Research and Development 11:15 DISCUSSION 11:30 U.S. FOOD AND DRUG ADMINISTRATION   Robert Temple Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration 11:45 DISCUSSION 12:00 LUNCH 1:00 PERSPECTIVES FROM NIH AND SURVEY OF DATA IN CLINICALTRIALS.GOV   Deborah Zarin Director, ClinicalTrials.gov Lister Hill National Center for Biomedical Communications National Library of Medicine 1:15 DISCUSSION

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary 1:30 WORLD HEALTH ORGANIZATION CLINICAL TRIAL REGISTRY PROJECT   Metin Gulmezoglu Scientist World Health Organization 1:45 DISCUSSION PANEL 3: ACADEMIC PERSPECTIVES 2:00 PRESENTER: P.Pearl O’Rourke Director, Human Research Affairs Partners HealthCare System, Inc.   DISCUSSANTS: John Schneider Chair, Council on Scientific Affairs American Medical Association   Hugh Tilson Chair, National Steering Committee Centers for Education and Research on Therapeutics (CERTs) 2:15 DISCUSSION 3:00 BREAK PANEL 4: CONGRESSIONAL PERSPECTIVE 3:30 PRESENTER: Kate Reinhalter Legislative Assistant Office of Congressman Ed Markey U.S. House of Representatives   Rachel Sher Health Counsel Office of Congressman Henry Waxman U.S. House of Representatives

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary 3:45 DISCUSSION 4:00 GENERAL DISCUSSION/AUDIENCE PARTICIPATION 5:00 ADJOURN TO RECEPTION

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Speakers and Panelists Alan Breier Vice President, Medical and Chief Medical Officer Eli Lilly and Company Catherine DeAngelis Editor-in-Chief JAMA Jeffrey Drazen Editor-in-Chief NEJM Metin Gulmezoglu Scientist World Health Organization Jeanne Ireland Director of Public Policy Elizabeth Glaser Pediatric AIDS Foundation Miriam O’Day Senior Director of Public Policy Alpha-1 Foundation P.Pearl O’Rourke Director, Human Research Affairs Partners HealthCare System, Inc. The Honorable John Porter Partner Hogan & Hartson, LLP Kate Reinhalter Legislative Assistant Office of Congressman Ed Markey U.S. House of Representatives Frank Rockhold Senior Vice President and Director Biomedical Data Sciences GlaxoSmithKline Pharmaceuticals R&D Alfred Sandrock Vice President Medical Research-Neurology Biogen Idec John Schneider Chair, Council on Scientific Affairs American Medical Association Rachel Sher Health Counsel Office of Congressman Henry Waxman U.S. House of Representatives Harold Sox Editor Annals of Internal Medicine Marjorie Speers Executive Director Association for the Accreditation of Human Research Protection Programs Robert Temple Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. Food and Drug Administration Sharon Terry President and CEO Genetic Alliance Hugh Tilson Chair, National Steering Committee Centers for Education and Research on Therapeutics (CERTs)

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Registered Workshop Participants Margaret Anderson FasterCures Debra Aronson BIO Naomi Aronson Blue Cross Blue Shield Association Angela Bates NIH Peggy Beat Cleveland VA Annetta Beauregard Eli Lilly and Company Lisa Begg DHHS/NIH Mario Belledonne Biolab Research Douglas Boenning Children’s National Medical Center Michele Boisse American Society for Clinical Pharmacology & Therapeutics Claire Bornstein Elizabeth Glaser Pediatric AIDS Foundation Lizbet Boroughs American Psychiatric Association Lynn Bosco AHRQ Laquitta Bowers Self-Employed Steven Brotman Wyeth Pharmaceuticals Voncelia Brown Salisbury University Mario Browne University of Pittsburgh Graduate School of Public Health Suanna Bruinooge American Society of Clinical Oncology Kristin Butterfield American Academy of Pediatrics Ronald Califre Novartis Pharmaceuticals Corporation Scott Campbell American Diabetes Association Dolph Chianchiano National Kidney Foundation, Inc. Yen-pin Chiang AHRQ Anita Cicero Gardner, Carton & Douglas Michelle Cissell JDRF Mickey Clarke Washington University

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Elaine Collier National Center for Research Resources Sarah Comley International Observers Christina Copty Aspen Systems Corporation Jennifer Couzin Science Magazine Tyler C.Cymet, DO C/O Sinai Hospital of Baltimore MaryAnn D’Alessandro NPPTL Kevin Davis National Cancer Institute Patty Delaney Cancer Liaison Program, FDA Don Detmer American Medical Informatics Association Jeffrey Dickey Spriggs & Hollingsworth Barry Dickinson American Medical Association Wei Du Adolor Corporation Brenda Evelyn Food and Drug Administration Brian Feit DHHS/HRSA/HAB/DCBP Lorraine Fitzsimmons National Institute on Aging Yolanda Fleming National Medical Association MaryAnn Foote Amgen Robert Fulcher American Society of Nephrology Barbara Galen Cancer Imaging Program/NCI/NIH Roger Garceau Sanofi-Aventis Edward Garcia Washington Health Advocates Kathryn Goettge NLM Clinical Information Services Alan Goldhammer PhRMA Jennifer Gorman Office of the Director, NIH Lakshmi Grama National Cancer Institute David Grandison Meharry Medical College Donald Greene Veritas Medicine Jeffrey Grossi Johns Hopkins Medicine

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Mary Hager American Dietetic Association Kimberly Harris Education to Advance Cancer Clinical Trials Lynne Haverkos National Institute of Child Health and Human Development Anthony Hayward NIH Katerina Herodotou Novo Nordisk, Inc. Susan Herold Consumers Union Lauren Hetrick Abbott Laboratories Nick Ide National Library of Medicine Heather Jameson Research!America Lindsey Johnson U.S. PIRG Nicole Johnson Baker Director’s Council of Public Representatives, NIH Cheryl Karol Hoffmann-LaRoche Inc. Kenneth Katz University of Pennsylvania Mahin Khatami NIH/NCI Felix Khin-Maung-Gyi Chesapeake Research Review, Inc. Gary Kline FASEB Yosuke Komatsu Otsuka America Pharmaceutical, Inc. Kristin Kroeger Ptakowski American Academy of Child and Adolescent Psychiatry Steven Krosnick NIH Michel Krumenacker Sanofi-Aventis Selma Kunitz KAI Research, Inc. Theresa Lawrence Department of Health and Human Services Sue Levi-Pearl Tourette Syndrome Association, Inc. Tola Life Health Resources and Services Administration Caroline Loew PhRMA Laura Lyman Rodriguez NIH Nancy Maher Department of Veterans Affairs

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Michael Manganiello National Institutes of Health Richard Manrow National Cancer Institute Sherry Marts Society for Women’s Health Research Debra McCoy Arthritis Foundation Christopher McGowen Novo Nordisk, Inc. Paul Meade Clear Point Health David Miller GlaxoSmithKline Nancy Miller NIH Abdulaziz Mohamed Manchester Health Department Richard Mowery National Institute of Dental and Craniofacial Research Esther Myers American Dietetic Association Nancy Myers PhRMA John Neylan Wyeth Research Martha Nolan Society for Women’s Health Research Susan Norris AHRQ Laura Nufire Self-Employed Joanne Odenkirchen NIH/NINDS Sharon Olmstead Schering Plough Paul Parry Abigail Alliance for Access to Clinical Trials Carol Payne Department of Housing and Urban Development JoNell Potter University of Miami Karla Price Epilepsy Foundation Kate Reinhalter U.S. House of Representatives Stephen Rose Foundation Fighting Blindness Marcel Salive DHHS/Centers for Medicare & Medicaid Services Susan Schiffner Veterans Affairs Jeff Schomisch Thompson Publishing Group Nanette Schwann Lehigh Valley Medical Center

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Yvette Seger FasterCures Katie Senauer RTI Clarissa Agee Shavers Michigan State University J.C.Shay Department of Housing and Urban Development Sam Shekar Center for Quality, HRSA Rachel Sher U.S. House of Representatives Juliette Shih Genzyme David Silk Avalere Health Paul Sirovatka American Psychiatric Association Douglas Sporn Abbott Laboratories Linda Temple Regulatory Affairs Professionals Society Sona Thakkar Office of Education and Special Initiatives Roni Thaler The Center for Information & Study on Clinical Research Participation Susan Thaul Congressional Research Service Phil Thevenet GlaxoSmithKline Stephen Thomas University of Pittsburgh Terry Toigo FDA Cathy Tran Science Magazine Tony Tse ClinicalTrials.gov, National Library of Medicine Judith Vaitukaitis NIH William Vaughan Consumers Union Paula Squire Waterman Office of Research Oversight, Veterans Affairs Jill Wechsler Applied Clinical Trials Magazine Beat Widler Roche Products Limited Erin Williams Congressional Research Service Reginald Williams Avalere Health Marcel Willner Bristol-Myers Squibb

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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Marsha Wilson Gynecologic Cancer Foundation Kim Witherspoon National Cancer Institute Jerome Yates American Cancer Society