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U.S. Department of Health and Human Services National Institutes of Health Minutes of the Recombinant Dna Advisory Committee

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U.S. Department of Health and Human Services National Institutes of Health Minutes of the Recombinant Dna Advisory Committee U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH MINUTES OF THE RECOMBINANT DNA ADVISORY COMMITTEE December 3-4, 1992 TABLE OF CONTENTS I. Call to Order II. Minutes of September 14-15, 1992, meeting III. Proposed Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Therapy Protocol Entitled: Retroviral Mediated Transfer of the Human Multi-Drug Resistance -1 Gene into Hematopoietic Stem Cells During Autologous Transplantation After Intensive Chemotherapy for Breast Cancer/Dr. O'Shaughnessy IV. Discussion Regarding Cost Associated with Treatment for Non-Negligent Research-Related Injury Dr. Zallen and Ms. Meyers V. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Therapy Protocol Entitled:Gene Therapy of the Respiratory Manifestations of Cystic Fibrosis Using a Replication Deficient Recombinant Adenovirus to Transfer the Normal Human Cystic Fibrosis Transmembrane Conductance Regulator cDNA to the Airway Epithelium Dr. Crystal VI. Minor Modification and Summary Presentation of the Protocol Entitled: Ex Vivo Gene Therapy of Familial Hyper- CholesterolemiaDr. Wilson VII. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Therapy Protocol Entitled: Gene Therapy of Cystic Fibrosis Lung Diseases Using E1 Deleted Adenoviruses: A Phase I Trial Dr. Wilson VIII. Discussion Regarding Proposed RAC Review of European Human Gene Therapy Protocols Dr. Blaese IX. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Therapy Protocol Entitled: Cystic Fibrosis Gene Therapy Using an Adenovirus Vector: In Vivo Safety and Efficacy in Nasal Epithelium Dr. Welsh X. Amendment to the Points to Consider Regarding Reporting Requirements for Human Gene Transfer/Therapy Protocols XI. Amendment to the Points to Consider Regarding Safety of Delivery/Expression Systems and Report of Murine Replication-Competent (RCR) Assays Dr. Anderson XII. Discussion Regarding Costs Associated with Treatment of Non-Negligent Research-Related Injury/(Continued) XIII. Amendment to the Points to Consider Regarding Safety of Delivery/Expression Systems and Report of Murine Replication-Competent Retrovirus (RCR) Assays (Continued) XIV. Discussion Regarding Proposed Review of European Human Gene Therapy Protocol (Continued) XV. Discussion Regarding Compassionate Plea Exemptions to RAC Review Dr. Walters and Mr. Barton XVI. Future Meeting Date of the Recombinant DNA Advisory Committee XVII. Adjournment Attachment - Roster Page 1 The Recombinant DNA Advisory Committee (RAC) was convened for its fifty-first meeting at 9:00 a.m. on December 3, 1992, at the National Institutes of Health, Building 1, Wilson Hall, 9000 Rockville Pike, Bethesda, Maryland 20892. Dr. Barbara E. Murray (Chair) presided. In accordance with Public Law 92-463, the meeting was open to the public. The following were present for all or part of the meeting: Committee members: John H. Barton, Stanford Law School Nancy L. Buc, Weil, Gotshal, and Manges Ira H. Carmen, University of Illinois Gary A. Chase, Johns Hopkins University Patricia A. DeLeon, University of Delaware Roy H. Doi, University of California Krishna R. Dronamraju, Foundation for Genetic Research E. Peter Geiduschek, University of California, San Diego Susan S. Hirano, University of Wisconsin Brigid G. Leventhal, Johns Hopkins Hospital A. Dusty Miller, Fred Hutchinson Cancer Research Center Barbara E. Murray, University of Texas Robertson Parkman, Childrens Hospital of Los Angeles Leonard E. Post, Parke-Davis Pharmaceutical Division Moselio Schaechter, Tufts University School of Medicine Marian G. Secundy, Howard University College of Medicine LeRoy B. Walters, Georgetown University Doris T. Zallen, VA Polytechnic Institute & State University Executive secretary: Nelson A. Wivel, National Institutes of Health A committee roster is attached (Attachment). Ad hoc consultants: Harold Ginsberg, Columbia University Abbey S. Meyers, National Organization for Rare Disorders Non-voting agency representatives: Henry I. Miller, Food and Drug Administration Liaison Representative: Daniel Jones, National Endowment for the Humanities National Institutes of Health staff: Tyrone Banks, NHLBI Page 2 Susan Banks-Schlegel, NHLBI Bobbi Bennett, OD Michael Blaese, NCI Fred Bonkovsky, OD Bryan Brewer, NHLBI Steve Brody, NHLBI Betty Brown, NHLBI David Brown, NHLBI Mary Rose Burnham, NHLBI Jan Casadei, NCI Ronald Crystal, NHLBI Chin-Shyan Chu, NHLBI Pascal Denoby, NHLBI Evan Deremzo, OD Bassam Doujaiji , NHLBI Cindy Dunbar, NHLBI Steven Ficca, NHLBI Mary Ellen Franko, NCI Kateri Gabriele, NHLBI Barry Goldspiel, CC Jay Greenblatt, NCI Sungkoo Han, NHLBI John Hay, NHLBI Jim Higginbotham, NHLBI Joseph Higgins, NINDS Edward Hirschowitz, NHLBI Jeffery Hoeg, NHLBI Tom Horiagin, NCI Patrick Hwu, NCI Christine Ireland, OD Ari Jaffe, NHLBI Clara Jolley, NHLBI Stefan Karlssron, NINDS Shuichi Kato, NHLBI Steven Kishter, NCI Nobuyuki Kobayashi, NHLBI Robert Korst, NHLBI Becky Lawson, OD Hiroyuki Maeda, NHLBI Muneharu Maruyama, NHLBI Andree Mastreugeli, NHLBI Kevin McDonagh, NHLBI Noel McElvaney, NHLBI Kathryn McKeon, NIDDK Akira Miyashita, NHLBI Jim Mulay, NCI Arthur Neinhuis, NHLBI Brian O'Connell, NIDR Joyce O'Shaughnessy, NCI Herby Pollard, NIDDK Page 3 William Ramsey, NCI Melissa Rosenfeld, NHLBI Gene Rosenthal, NHLBI Silvia Santamarina, NHLBI Eva Scherer, NHLBI Prem Seth, NHLBI Yasuhiro Setogudri, NHLBI Brian Sorrentino, NHLBI Diane Striar, NHLBI Robert Walker, NIAID Susan Wallace, NHLBI Robert Wersto, NHLBI Debra Wilson, OD Louise Williams, NHLBI Jeehong Yoo, NHLBI Others: Paul Aebersold, Food and Drug Administration French Anderson, University of Southern California James Barrett, Genetic Therapy, Inc. Robert Beall, Cystic Fibrosis Foundation John Bishop, Food and Drug Administration Hal Broderson, Hilman Medical Richard Boucher, University of North Carolina Anthony Calandra, Amgen Barrie Carter, Targeted Genetics, Inc. Gwladys Caspar, Harvard University Yawen Chiang, Genetic Therapy, Inc. Jan Chappell, Genetic Therapy, Inc. Ed Chen, Los Angeles Times Larry Cohen, Somatix Therapy Francis Collins, University of Michigan Declan Conroy, Biotech Daily Matt Cotten, Institute for Molecular Pathology Mike Courtney, Transgene, Inc. Andrew Cuthbertson, Genentech Ann Daigle, Immune Response, Inc. Kevin Davies, Nature Genetics Brian Davis, Medicines Control Agency Albert Deisseroth, MD Anderson Cancer Research Center Ronald Dorazio, Columbia University Lori Doyle, University of Pennsylvania Medical Center Anne Driscoll, Fox, Bennett and Turner William Egan, Food and Drug Administration John Engel, University of Michigan Suzanne Epstein, Food and Drug Administration Carol Ezzell, Science News Susan Falen, Genetic Therapy, Inc. Mitchell Finer, Cell Genesys, Inc. Page 4 Mark Fischetti, Freelance Writer Stacy Fitzsimmons, Cystic Fibrosis Foundation Terry Flotte, Johns Hopkins Hospital Bernard Fox, University of Michigan Jeffrey Fox, ASM News & Biotechnology Wayne Galbright, Public Victor Garcia, St. Jude Childrens Hospital Lisa Giglio, The Pink Sheet Scott Graham, University of Iowa Richard Gregory, Genzyme Corporation Mariann Grossman, University of Michigan Bill Guggino, Johns Hopkins Hospital Kurt Gunter, Food and Drug Administration Elie Hanania, MD Anderson Cancer Research Center Ingo Hartel, Georgetown University, Kennedy Center Mark Hausmann, National Museum of American History Russell Herndon, Genzyme Corporation David Holzman, Bioworld Today Susan Jenks, Journal of the National Cancer Institute Steve Josephs, Baxter Health Care Nancy Kan, Canji, Inc. Arifa Khan, Food and Drug Administration Michael Knowles, University of North Carolina Rebecca Kolberg, United Press International Hitoshi Kotani, Genetic Therapy, Inc. Maryann Krane, Genzyme Corporation Alex Kuta, Food and Drug Administration Karen Lee, National Museum of American History Pierre Lehn, Assistance Publique, Paris Melvin Long, Abbott Laboratories Alan McClelland, Genetic Therapy, Inc. Gerard McGarrity, Genetic Therapy, Inc. Bruce Merchant, Viagene Robert Moen, Genetic Therapy, Inc. Lisa Morris, Genetic Therapy, Inc. Richard Moscicki, Genzyme Corporation Rod Morrison, Canadian Cystic Fibrosis Foundation Stephen Mueller, Genetic Therapy, Inc. David Mulligan, Abbott Laboratories Hien Nguyen, National Museum of American History Philip Noguchi, Food and Drug Administration Jeffery O'Brian, Dupont-Merck Pharmaceuticals John Olsen, University of North Carolina Jeff Ostrove, Microbiological Association, Inc. Edward Otto, Genetic Therapy, Inc. Michel Perricaudet, National Center for Scientific Research, Paris Janet Peterson, University of Maryland, Baltimore Anne Petruska, The Blue Sheet Bruce Pratt, Genzyme Corporation Raj Puri, Food and Drug Adminstration Page 5 Judy Randal, Freelance Writer Abdur Razzarque, Food and Drug Adminstration Paul Recer, Associate Press, Inc. Peter Reinecke, United States Senate staff Devra Rich, University of Iowa Steve Richieri, Immune Response, Inc. Joseph Rokovich, Somatix Therapy Ivor Royston, San Diego Cancer Center John Russick, National Museum of American History Laurence Schaffar, Association Francaise de Lutte Contre La Mucoviscidose Steven Shak, Genentech, Inc. Tomiko Shimada, Ambiance Awareness International Nina Siegler, Rock Creek Research Richard Simon, University of Michigan Jonathan Simons, Johns Hopkins University Alan Smith, Genzyme Corporation Herb Simith, Food and Drug Adminstration Patti Sowa, Dupont-Merck Pharmaceuticals Mark Stewart, University of Virginia Henri Termeer, Genzyme Corporation
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