Appendix C
Workshop Registrants
Susan Alpert, M.D., Ph.D.
Director of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration
Margaret Anderson, M.A.
Program Director
Society for the Advancement of Women's Health Research
Mary Andrich, M.D.
Medical Reviewer, Office of Compliance
Center for Biologics Evaluation and Research
Food and Drug Administration
Suzanne Beckner, Ph.D.
Senior Study Director
Westat, Inc.
Julie Beitz, M.D.
Medical Team Leader
Division of Oncology Drug Products
Center for Drug Evaluation and Research
Food and Drug Administration
Barbara Benson
Institutional Liason
Western Institutional Review Board
Christine Haywood Bong
Clinical Trial Analyst
Malaria Vaccines Section
Laboratory of Parasitic Diseases
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Linda Borkowski
Regulatory Compliance Consulting
Debra Bower, M.T. (ASCP)
Consumer Safety Officer, Office of Compliance
Center for Biologics Evaluation and Research
Food and Drug Administration
Michael Brown, M.P.H.
Health Scientist
Office of Women's Health
Centers for Disease Control and Prevention
Suanna Bruinooge
Legislative Assistant to The Honorable Nancy Johnson
U.S. House of Representatives
Bruce Burlington, M.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
Glenn Byrd
Associate Director for Regulatory Affairs
Advanced Bioresearch Associates
Robert Califf, M.D.
Director
Duke Clinical Research Institute
Robert Canavan
Senior Clinical Compliance Specialist
Bayer Corporation Pharmaceutical Division
Dawn Carper
Project Manager
Pro-Neuron, Inc.
Roland Catherall
Vice President, Regulatory Affairs and Research Quality Assurance
Abbott Laboratories
Joy Cavagnaro, Ph.D.
Vice President Regulatory Affairs
Human Genome Sciences, Inc.
Danny Chaing
Director, Data Systems
Janssen Research Foundation
Tina Chiodo
Senior Regulatory Compliance Associate
British Biotech Inc.
Michaele Christian, M.D.
Associate Director
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Michael Clayman, M.D.
Vice President
Cardiovascular Research and Clinical Investigations
Lilly Research Laboratories
Eli Lilly & Company
Farley Cleghorn, Ph.D., M.P.H.
Assistant Professor
Division of Epidemiology and Prevention
Institute of Human Virology
University of Maryland
Mary Lou Clements-Mann, M.D.
Professor
International Health
Center for Immunization Research
Paul Conforti
Manager
Eli Lilly & Company
Rodger Currie
Majority Counsel
Committee on Commerce
U.S. House of Representatives
Eve Marie Damiano, M.S.
Director, Regulatory Affairs
U.S. Bioscience
Elizabeth D'Angelo
Assistant Director, International GCP Group
Manager, CQA European Pharmaceuticals
Zeneca Pharmaceuticals
Nancy Davidan
Senior Scientist
Office of Research Integrity
U.S. Department of Health and Human Services
Barbara Davies
Regulatory Affairs Associate
Pro-Neuron, Inc.
Jonathan R. Davis, Ph.D.
Senior Program Officer
Health Sciences Policy Division
Institute of Medicine
Mary Denham
Associate Director
Worldwide Regulatory Compliance
Bristol-Myers Squibb
Dennis Dixon
Chief, Biostatistics Research Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Katie Driscoll
Manager GCP
Cephalon, Inc.
William Duncan
Associate Director, TRP
DAIDS/NIAID
National Institutes of Health
Steve Durako, M.S.
Vice President
Westat, Inc.
Adrian Edwards, M.D.
Private Practice—Internal Medicine/Cardiology
The New York and Presbyterian Hospitals
Susan Ellenberg, Ph.D.
Director
Division of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research
Food and Drug Administration
Ronald Estabrook, Ph.D.
Professor of Biochemistry
University of Texas
Southwestern Medical Center
Susan Etheridge
Head
North American Clinical Quality Assurance
Hoechst Marion Roussel
William Fairweather, Ph.D.
Associate Director
Office of Epidemiology and Biostatistics
Food and Drug Administration
Frederick Ferris, III, M.D.
Director
Division of Biometry and Epidemiology
National Institutes of Health
Donna Francher
Clinical Operations Leader
Zeneca Pharmaceuticals
Richard Fry
Director of Pharmacy Affairs
Academy of Managed Care Pharmacy (AMCP)
Armand Girard
Clinical Project Manager
Pro-Neuron, Inc.
Paul Gittelson
President
Bio-Research Monitors, Inc.
Stephanie Gold
Research Coordinator
Florida Hospital
Gil Granados
Manager, Compliance
Forest Laboratories
Mario Guralnik, Ph.D.
Clinical Affairs Director
ASTA Medica, Inc.
Gio Gutierrez
Project Manager
Institute for Alternative Futures
William Harlan, M.D.
Associate Director for Disease Prevention
National Institutes of Health
Terry Hartnett
Contributing Writer
Clinical Trials Advisor
Patricia Hasemann, D.V.M.
Bioresearch Monitoring, Division of Inspections
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Pamela Hodges
Regulatory Affairs Manager
Human Genome Sciences, Inc.
Pat Holobaugh
Consumer Safety Officer, Office of Compliance
Center for Biologics Evaluation and Research
Food and Drug Administration
Scott Horton
Statistician
Fred Hutchinson Cancer Research Center
Richard Hunter
Director, Regulatory Affairs and Quality Assurance
Pro-Nevron/Pro-Virus
Frank L. Hurley, Ph.D.
Chief Science Officer
Quintiles Transnational Corporation
Lowell Irminger
RegConsult
Anne Jackson, M.A., R.N.
Professor Emeritus
City University of New York
Jian Johnson
Vice President, Regulatory Affairs
Neurobiological Technologies, Inc.
Suzanne Kaiser
Regulatory Affairs Manager
Advanced Bioresearch Associates
Valerie King
Manager
Clinical Auditing and Quality Assurance
Bristol-Myers Products
Thomas Kirsch
Executive Director, Regulatory Practices
The R.W. Johnson PRI
Charma Konnor
Director
Bioresearch Monitoring Division
Office of Compliance,
Center for Devices and Radiological Health
Food and Drug Administration
Todd Koser
Senior Database Analyst
Janssen Research Foundation
Judith Kramer, M.D.
Chief Medical Officer
Duke Clinical Research Institute
Kiyoshi Kuromiya
Critical Path AIDS Project
Diana Lee
Manager, Regulatory Compliance
Genentech, Inc.
David Lepay, M.D., Ph.D.
Director
Division of Scientific Investigations
Food and Drug Administration
Robert Levy, M.D.
Senior Vice President, Science and Technology
American Home Products
Wyeth-Ayerst Research
Rosemary Locke
Y-Me Washington, D.C, Liaison
Y-Me National Breast Cancer Organization
Yili Lu, Ph.D.
Senior Statistician
Elli Lilly & Company
Lorraine Lucas
Vice President, Medical and Scientific Affairs
B. Brown Medical Inc.
Murray Lumpkin, M.D.
Deputy Director for Review Management
Center for Drug Evaluation and Research
Food and Drug Administration
William Maguire
Deputy Director, Regulatory Affairs
Bayer Corporation
Martha Manning
Senior Vice President and General Council
U.S. Bioscience
Joan Mauer
Sr. Quality Assurance Coordinator
Clinical Trials Monitoring Branch
National Cancer Institute
James McCormack, Ph.D.
Bioresearch Monitoring Program Coordinator
Office of Enforcement Division of Compliance
Food and Drug Administration
Robert McCormick
Head, Quality Systems
Amgen Biopharma
Michael McGarvey, M.D.
Chief Medical Officer
Blue Cross and Blue Shield of New Jersey, Inc.
Theresa McGovern, Esq.
Executive Director
HIV Law Project
Samuel Merrill, Jr.
Investigator/Scientist
Office of Research Integrity
Office of Public Health Service
U.S. Department of Health and Human Services
Joseph Meschino
Chief
Pharmaceutical and Regulatory Affairs Branch
National Institutes of Health
Roger Meyer, M.D.
Senior Consultant
Division of Biomedical and Health Sciences Research
American Association of Medical Colleges
Hassan Movahhed
Associate Director, Clinical Affairs
Amgen Inc.
Richard Mowery, Ph.D.
Chief, Clinical Trials Monitoring Branch
Cancer Therapy Evaluation Program
National Cancer Institute
David Ng, Ph.D.
Vice President, Data Management
PPD Pharmaco, Inc.
James Nickas, Pharm.D.
Associate Director
Drug Safety, Genentech, Inc.
Stuart Nightingale, M.D.
Associate Commissioner for Health Affairs
Food and Drug Administration
U.S. Department of Health and Human Services
Chuke Nwachuku
Project Officer, Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
National Institutes of Health
Kristin O'Connor, M.P.H.
Director, Data Management
Boehringer Ingleheim Pharmaceuticals, Inc.
Pamela Olsson
Quality Assurance Specialist
Monsanto
Ing-Ming Pan
Manager, Database Applications
Janssen Research Foundation
Bernard Pardo
Director
Clinical Data Management
CV Therapeutics
Charles Paule, M.S.
Manager, Pediatric Nutritional Research and Development Biostatistics
Ross Products Division
Abbott Laboratories
Jonathan Peck
Vice President
Institute for Alternative Futures
Nicholas Pelliccione, Ph.D.
Senior Director
Worldwide Regulatory Affairs
Schering Plough
Sandy Phelan
Director, Regulatory Affairs
Animal Health Institute
Jim Phillips, Ph.D.
Senior Director for Biostatistics
Quintiles Transnational Corp.
Marlene Phillips
Director, GCP Compliance
Worldwide Regulatory Compliance
SmithKline Beecham Pharmaceuticals
Andrew Pope, Ph.D.
Director, Health Sciences Policy
Institute of Medicine
Laura Rocco
Director of Quality Insurance
The Johns Hopkins University
School of Medicine
Paul Rogers, J.D.
Senior Partner
Hogan & Hartson
Donna Saligan
Manager Research Quality Assurance
Janssen Research Foundation
Marci Schentzel, R.Ph.
Consumer Safety Officer, Office of Compliance
Center for Biologics Evaluation and Research
Food and Drug Administration
John Schultz, Ph.D.
Vice President
General Manager
Neuroclinical Trials Center
University of Virginia
Eleanor Segal, M.D.
Senior Director
Drug Safety and Clinical Quality Assurance
Chiron Corporation
Kenneth I. Shine, M.D.
President
Institute of Medicine
Jay Siegel, M.D.
Director
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
C. Grant Simmons
Associate Director
Good Clinical Practice Quality Assurance
Novartis Pharmaceuticals Corporation
Whaijen Soo, M.D., Ph.D.
Vice President, Clinical Sciences
Roche Pharmaceuticals
Hoffmann-La Roche, Inc.
Cheryl Spencer
Director, Research Quality
Abbott Laboratories
Caryn Steakley, R.N.
Director
Research Nursing and Clinical Operations
Georgetown University Medical Center
Gail Stoner
Manager, Clinical Research Programming
Centocor, Inc.
Matthew Tarosky, R.Ph.
Program Management Officer
Division of Scientific Investigations
Center for Drug Evaluation and Research
Food and Drug Administration
José Tavarez
Consumer Safety Officer
Center for Biologics Evaluation and Research
Food and Drug Administration
Christina Thacker
Research Assistant
Health Sciences Policy Division
Institute of Medicine
Michele Thomas
Global Database Manager
SmithKline Beecham Pharmaceuticals
Vince Ventimiglia
Professional Staff and Counsel
Subcommittee on Children and Families
Committee on Labor and Human Resources
U.S. Senate
William Vincek, Ph.D.
Vice President, Corporate Quality
Guilford Pharmaceuticals Inc.
Frances Visco, J.D.
President
National Breast Cancer Coalition
William Waggoner, Ph.D., FAACT
Chairman
Essex Institutional Review Board, Inc.
Jon Wallace
Vice President
Cephalon, Inc.
Anna Watson
Clinical Data Management Coordinator
Amgen
Carol Wentz
Global Database Manager
SmithKline Beecham Pharmaceuticals
Joel Wolf
Assistant Director, Regulatory Compliance
Purdue Pharma L.P.
Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
Food and Drug Administration
Stan Woollen
Deputy Director
Division of Scientific Investigations
Center for Drug Evaluation and Research
Food and Drug Administration
