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Appendix B Acknowledgments

TA wishes to thank the Pharmaceutical R&D: Costs, Risks and Rewards Advisory Panel, its workshop participants, contractors, and the individuals and organizations listed below for their assistance over the course of this study. OTA also wishes to express appreciation to those who provided advice and information for its background paper, Federal and Private Roles in the Development and Provision ofo Algucerase Therapy for Gaucher Disease. These individuals and organizations do not necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy of its content.

Lois Adams Wade M. Aubrey Office of Legislative Affairs Blue Cross Blue Shield of California U.S. Food and Drug Administration San Francisco. CA Rockville, MD Wiltse Bailey Reid Adler Washington, DC Office of Technology Transfer U.S. National Institutes of Health P. Etienne Barral Bethesda, MD Rhone-Poulenc Rorer Antony, France Gwynn C, Akin Public Policy Norman Barton Syntex (USA) Inc. Clinical Investigation Section Palo Alto, CA National Institute of Neurological Disorders and Strokes Fredrik Andersson Bethesda, MD Battelle MEDTAP Europe Battelle Institute, Ltd. Michael Beatrice London, England Center for Biologics Evaluation and Research U.S. Food and Drug Administration Naomi Aronson Rockville, MD Technology Evaluation Blue Cross Blue Shield Association David W. Beier Chicago, IL Government Affairs Genentech, Inc. Carolyn Asbury Washington, DC Health and Human Services The Pew Charitable Trusts Philadelphia, PA

269 270 I Pharmaceutical R&D: Costs, Risks and Rewards

Leslie Z. Benet Douglas L. Cocks Department of Pharmacy Corporate Affairs University of California Eli Lilly and Company San Francisco, CA Indianapolis, IN

Ernst Beutler Karen Cohen Department of Molecular and National Gaucher’s Foundation Experimental Medicine Gaithersburg, MD Scripps Research Institute La Jolla, CA Joseph Collier Department of Pharmacology and Douglas W. Bitz Clinical Pharmacology Sandoz Research Institute: St. Georges Hospital Medical School Sandoz Pharmaceuticals Corporation London, England East Hanover, NJ Paul Coppinger Carla Bodaghi Office of Planning and Evaluation U.S. Health Care Financing Administration U.S. Food and Drug Administration Washington, DC Rockville, MD

Charles Booth Pedro Cuatrecasas Office Payment Policy Pharmaceutical Research Division U.S. Health Care Financing Administration Warner-Lambert Company Baltimore, MD Ann Arbor, MI Joan M. Curran Alan Blostin Merck and Company, Inc. Bureau of Labor Statistics Rahway, NJ U.S. Department of Labor Washington, DC Bruce Cwalina Springfield, VA David Blumenthal Medical Practices Evaluation Center Patricia M. Danzon Massachusetts General Hospital School of Business Boston, MA University of Pennsylvania Philadelphia, PA Lawrence Brenkus Arthur D. Little, Inc. Alfred B. Engleberg Cambridge, MA Greenwich, CT

John Brosan Alain Enthoven Office of General Counsel School of Business U.S. General Accounting Office Stanford University Washington, DC Palo Alto, CA

Julie Cantor David Evans Human Resources Division World Health Organization U.S. General Accounting Office Geneva, Switzerland Washington, DC Appendix B—Acknowledgments I 271

Dee Fensterer Stephen C. Groft Generic Pharmaceutical Industry Association Office of Science Policy and Legislation New York, NY U.S. National Institutes of Health Bethesda, MD Franklin Fisher School of Management David Gross Massachusetts Institute of Technology Human Resources Division Cambridge, MA U.S. General Accounting Office Washington, DC Scott D. Freedman Pharmaceutical Division Charles Grudzinskas Miles, Inc. Medications Development Division West Haven, CT U.S. National Institute on Drug Abuse Rockville, MD Jesse Friedman Chevy Chase, MD Marlene E. Haffner Orphan Products Development Steven Garber U.S. Food and Drug Administration Rand Corporation Rockville, MD Santa Monica, CA Ronald Hansen Kevin Gaynor School of Business Administration Price Waterhouse, Inc. University of Rochester New York, NY Rochester, NY

William Glaser Edward Haas School of Management and Urban Policy Office of Planning and Evaluation New School for Social Research U.S. Food and Drug Administration New York, NY Rockville, MD

Sarah Glavin Jody Hessen Human Resources Division Pharmacy, Policy, and Education U.S. General Accounting Office Aetna Washington, DC Minneapolis, MN

Martin Glick Michelle Hiltebeitel Genentech, Inc. IMS America San Francisco, CA Plymouth Meeting, PA

Gregory Grabowski Peter Barton Hutt Children’s Hospital Medical Center Covington & Burling University of Cincinnati Medical Center Washington, DC Cincinnati, OH David Jackson Henry G. Grabowski Janssen Pharmaceuticals, Inc. Department of Economics Piscataway, NJ Duke University Durham, NC David C. Jones Chapel Hill, NC 272 ! Pharmaceutical R&D: Costs, Risks and Rewards

Robert Kaplan Nancy J.W. Lewis School of Business Administration Institute for Pharmaceutical Economics Harvard University Philadelphia College of Pharmacy and Science Boston, MA Philadelphia, PA

David Karlin Harold S. Luft Institute of Clinical Medicine Institute for Health Policy Studies Syntex Research University of California Palo Alto, CA San Francisco, CA

Alison Keith Evan Marks U.S. Pharmaceuticals MEDCO Containment Services Pfizer, Inc. Montvale, NJ New York, NY Kathleen McAvoy John V. Kelsey Office of Planning and Evaluation Office of Orphan Products Development U.S. Food and Drug Administration U.S. Food and Drug Administration Rockville, MD Rockville, MD Jack McConnell William Kennedy Hilton Head Island, SC Drug Regulatory Affairs ICI Pharmaceuticals Group Robert T. McDonough Wilmington, DE Public Policy Planning The Upjohn Company Christian L. Khung Kalamazoo, MI Policy Research and Development Blue Cross and Blue Shield of Massachusetts Peter Merrill North Quincy, MA Washington National Tax Service Price Waterhouse, Inc. Richard Kinny Washington, DC Legislative Affairs Schering-Plough Corporation Gerald Meyer Washington, DC Center for Drug Evaluation and Research U.S. Food and Drug Administration Mary C. Knipmeyer Rockville, MD Office of Women Services U.S. Substance Abuse and Mental Abbey Meyers Health Administration National Organization for Rare Disorders Rockville, MD New Fairfield, CT

Neil Kran Ann Meyers Internal Revenue Service Center for Drug Evaluation and Research U.S. Department of the Treasury U.S. Food and Drug Administration New York, NY Rockville, MD

Jacques Krasny Dann M. Michols Bogart, Delafield, and Ferrier, Inc. National Pharmaceutical Strategy Morristown, NJ Ottawa, Ontario Appendix B—Acknowledgments 273

Robert R. Miller Jonathan Peck International Finance Corporation Institute for Alternative Futures Washington, DC Alexandria, VA

Andrew Mitchell Gary Persinger Pharmaceutical Evaluation Health Care Systems Division Department of Health Housing and Pharmaceutical Manufacturers Association Community Services Washington, DC Canberra, Australia Tim Proctor John Moeller Office of General Counsel Center for General Health Services Merck & Company, Inc. Intramural Research Rahway, NJ U.S. Agency for Health Care Policy and Research Rockville, MD Lisa Raines Government Relations Melissa Moncavage Industrial Biotechnology Association Center for Drug Evaluation and Research Washington, DC U.S. Food and Drug Administration Rockville, MD Jonathan Ratner Human Resources Division Lee Mortenson U.S. General Accounting Office Association of Community Cancer Centers Washington, DC Rockville, MD James W. Rayburn Dennis Mueller Regulatory Affairs Department of Economics Bristol-Myers Squibb Company University of Maryland Evansville, IN College Park, MD Larry Reed Michael Murray Medicaid Non-Institutional Payment Policy Branch Office of the General Counsel U.S. Health Care Financing Administration U.S. House of Representatives Baltimore, MD Washington, DC Heinz Redwood Jane S. Myers Suffolk, England Patent and Trademark Office U.S. Department of Commerce Michael R. Reich Washington, DC School of Public Health Harvard University Maven Myers Boston, MA Department of Pharmacy Philadelphia College of Pharmacy and Science Bryan G. Reuben Philadelphia, PA Department of Chemical Engineering Southbank Polytechnic John O’Hare London, England Joint Committee on Taxation U.S. Congress Gerald Robertson Washington, DC Department of Policy, Planning and Evaluation Patented Medicine Prices Review Board Ottawa, Ontario 274 I Pharmaceutical R&D: Costs, Risks and Rewards

Deborah Regal Albert Teich Alpha Center Directorate for Science and Policy Programs Washington, DC American Association for the Advancement of Science Washington, DC James B. Russo Government and Public Policy Henri Termeer Smithkline Beecham Genzyme Corporation Cambridge, MA Gerald L. Salamon Department of Accounting Charles E. Van Horn Indiana University Patent and Trademark Office Bloomington, IN U.S. Department of Commerce Washington, DC Jeffrey Sanders Office of Legislation and Policy Jon E. Villaume U.S. Health Care Financing Administration Drug Regulatory Affairs Washington, DC Roche Pharmaceuticals Nutley, NJ Alice Sapienza School of Public Health Stuart Walker Harvard University Centre for Medicines Research Boston, MA Surrey, England Janet Scheren Andrew J. Webster, Ph.D. National Wholesale Druggists Association Faculty of Humanities, Arts, and Education Alexandria, VA Anglia University Cambridge, England Stuart Schweitzer Department of Health Services Roy Widdus University of California National Commission on AIDS Los Angeles, CA Washington, DC James Shuttinga Office of the Director Sidney Wolfe U.S. National Institutes of Health Health Research Group Bethesda, MD Washington, DC

Richard Sweeney Robert Wren School of Business Administration Bureau of Eligibility, Coverage and Reimbursement Georgetown University U.S. Health Care Financing Administration Washington, DC Baltimore, MD

Max W. Talbott James P. Yee Lilly Research Laboratories Institute of Clinical Medicine Eli Lilly and Company Syntex Research Indianapolis, IN Palo Alto, CA

Alison Taunton-Rigby Aki Yoshikawa Biotherapeutics Stanford University Genzyme Corporation Palo Alto, CA Cambridge, MA Appendix B—Acknowledgments I 275

OTA also acknowledges the assistance of individuals from the following pharmaceutical companies, without whom neither the survey on the size of clinical trials nor OTA’s on-site interviews of pharmaceutical executives would have been possible.

Abbott Laboratories Norwich Eaton Pharmaceuticals, Inc. Abbott Park, IL Norwich, NY

Bristol-Myers Squibb Company Parke-Davis Princeton, NJ Ann Arbor, MI

Cetus Corporation Pfizer, Inc. Emeryville, CA New York, NY

Ciba-Geigy Corporation The R.W. Johnson Pharmaceutical Summit, NJ Research Institute Raritan, NJ Genentech, Inc. San Francisco, CA Sandoz Pharmaceuticals Corporation Hanover, NJ Hoffman-La Roche, Inc. Nutley, NJ Schering-Plough Corporation Kenilworth, NJ Hoechst-Roussel Pharmaceuticals, Inc. Somerville, NJ SmithKline Beecham Corporation Philadelphia, PA ICI Pharmaceuticals Group Wilmington, DE Syntex (U.S.A.), Inc. Palo Alto, CA Janssen Pharmaceutical, Inc. Piscataway, NJ Takeda U. S. A., Inc. New York, NY Lederle Laboratories Pearl River, NY TAP Pharmaceuticals, Inc. Deerfield, IL Eli Lilly and Company, Inc. Indianapolis, IN The Upjohn Company Kalamazoo, MI Mead Johnson & Company Evansville, IN Wyeth-Ayerst Research Philadelphia, PA Merck and Company, Inc. Rahway, NJ

Miles, Inc. West Haven, CT