B
Workshop Agenda, Speakers, Panelists, and Participants: June 27, 2005
Workshop Agenda
8:30 |
WELCOME AND OPENING REMARKS |
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Philip A.Pizzo Chair, IOM Board on Health Sciences Policy Dean, Stanford University School of Medicine |
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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 |
PANEL 1: PATIENT/PUBLIC/JOURNAL EDITORS PERSPECTIVE
9:45 |
PATIENT/PUBLIC NEEDS |
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Marjorie Speers Executive Director Association for the Accreditation of Human Research Protection Programs |
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DISCUSSANTS: Miriam O’Day Senior Director of Public Policy Alpha-1 Foundation |
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Sharon Terry President and CEO Genetic Alliance |
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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 |
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Harold Sox Editor Annals of Internal Medicine |
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DISCUSSANTS: Catherine DeAngelis Editor-in-Chief JAMA |
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Jeffrey Drazen Editor-in-Chief NEJM |
10:30 |
DISCUSSION |
10:45 |
BREAK |
PANEL 2: CURRENT REGISTRY ACTIVITIES
11:00 |
INDUSTRY PERSPECTIVE |
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Alan Breier Vice President, Medical and Chief Medical Officer Eli Lilly and Company |
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DISCUSSANTS: Alfred Sandrock Vice President, Medical Research-Neurology Biogen Idec |
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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 |
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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 |
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Deborah Zarin Director, ClinicalTrials.gov Lister Hill National Center for Biomedical Communications National Library of Medicine |
1:15 |
DISCUSSION |
1:30 |
WORLD HEALTH ORGANIZATION CLINICAL TRIAL REGISTRY PROJECT |
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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. |
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DISCUSSANTS: John Schneider Chair, Council on Scientific Affairs American Medical Association |
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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 |
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)
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
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
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
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
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