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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
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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
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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)
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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
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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.
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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
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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
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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
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Sumner Yaffe, M.D. Director, Center for Research for Mothers and Children National Institute of Child Health and Human Development National Institutes of Health Kathryn Zoon, Ph.D. Director Center for Biologics Evaluation and Research Food and Drug Administration
Representative terms from entire chapter: