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Department of Health and Human Services National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH RECOMBINANT DNA ADVISORY COMMITTEE MINUTES OF MEETING September 12-13, 1994 TABLE OF CONTENTS I. Call to Order/Dr. Walters II. Chair Report on Minor Modifications to NIH-Approved Human Gene Transfer Protocols/Dr. Walters III. Chair Report on Accelerated Review of Human Gene Transfer Protocols/Dr. Walters IV. Minutes of the June 9-10, 1994, Meeting V. Data Management Update/Dr. Smith VI. Discussion Regarding Criteria for RAC Review and Approval of Human Gene Transfer Protocols/Dr. Varmus VII. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Transfer Protocol Entitled: A Phase I Study of an Adeno-Associated Virus-CFTR Gene Vector in Adult CF Patients with MildLung Disease/Dr. Flotte VIII. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Transfer Protocol Entitled: Gene Therapy for the Treatment of Metastatic Breast Cancer by In Vivo Infection with Breast-Targeted Retroviral Vectors Expressing Antisense C-Fos or Antisense C-Myc RNA/Drs. Holt and Arteaga IX. Addition to Appendix D of the NIH Guidelines Regarding a HumanGene Transfer Protocol Entitled: Evaluation of Repeat Administrationof a Replication Deficient, Recombinant Adenovirus Containing the Normal Cystic Fibrosis Transmembrane Conductance Regulator cDNA to theAirways of Individuals with Cystic Fibrosis/Dr. Crystal X. Amendments to Sections I, III, IV, V, and Appendix M of theNIH Guidelines Regarding NIH and FDA Consolidated Review of Human Gene Transfer Protocols/Drs. Wivel and Noguchi XI. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Transfer Protocol Entitled: A Pilot Study of Autologous Human Interleukin-2 Gene Modified Tumor Cells in Patients with Refractory or Recurrent Metastatic Breast Cancer/Dr. Lyerly XII. Chair Remarks XIII. Continuation of the Discussion Regarding Proposed Amendments to Sections I, III, IV, V, and Appendix M of the NIH Guidelines Regarding NIH and FDA Consolidated Review of Human Gene Transfer Protocols/Drs. Wivel and Noguchi XIV. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Transfer Protocol Entitled: Retroviral-Mediated Transfer of the Iduronate-2-Sulfatase Gene into Lymphocytes for Treatment of Mild Hunter Syndrome (Mucopolysaccharidosis Type II)/Dr. Whitley XV. Clarification on NIH/FDA Consolidated Review/Dr. Walters XVI. Report from the Working Group on Retrovirus Vectors/Dr. Wivel XVII. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Transfer Protocol Entitled: Arterial Gene Transfer forTherapeutic Angiogenesis in Patients with Page 1 Peripheral Artery Disease/Drs. Isner and Walsh XVIII.Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Transfer Protocol Entitled: Treatment of Advanced CNS Malignancy with the Recombinant Adenovirus H5.020RSVTK: A Phase I Trial/Drs. Eck and Alavi XIX. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene Transfer Protocol Entitled: Treatment of Advanced Mesothelioma with the Recombinant Adenovirus H5.020RSVTK: A Phase I Trial/Dr. Albelda XX. Closing Remarks and Future Meeting Dates of the RAC XXI. Adjournment DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH RECOMBINANT DNA ADVISORY COMMITTEE MINUTES OF MEETING September 12-13,, 1994 The Recombinant DNA Advisory Committee (RAC) was convened for its fifty-ninth meeting at 9:00 a.m. on September 12, 1994, at the National Institutes of Health, Building 31, Conference Room 6, 9000 Rockville Pike, Bethesda, Maryland 20892. Dr. LeRoy B. Walters (Chair) presided. In accordance with Public Law 92-463, the meeting was open to the public on September 12 from 9 a.m. until 5 p.m. and September 13 from 8:30 a.m. until 3:30 p.m. In accordance with Section 552 b(c)(4), Title 5, U.S.C. and Section 10(d) of Public Law 92-463, the meeting was closed to the public on September 12 from 5-5:30 p.m. to review, discuss, and evaluate proprietary information. The following were present for all or part of the meeting: Committee Members: Alexander M. Capron, University of Southern California Gary A. Chase, Georgetown University Medical Center Patricia A. DeLeon, University of Delaware Roy H. Doi, University of California, Davis Krishna R. Dronamraju, The Foundation of Human Genetics Robert P. Erickson, University of Arizona David Ginsburg, University of Michigan Abbey S. Meyers, National Organization for Rare Disorders A. Dusty Miller, Fred Hutchinson Cancer Research Center Arno G. Motulsky, University of Washington Robertson Parkman, Children's Hospital of Los Angeles Gail S. Ross, Cornell University Medical Center Bratin K. Saha, Emory University R. Jude Samulski, University of North Carolina Marian G. Secundy, Howard University College of Medicine Brian R. Smith, Yale University School of Medicine Stephen E. Straus, National Institutes of Health LeRoy B. Walters, Kennedy Institute of Ethics, Georgetown University Doris T. Zallen, Virginia Polytechnic Institute & State University Executive Secretary: Nelson A. Wivel, National Institutes of Health Page 2 A committee roster is attached (Attachment I). Ad Hoc Consultant Harold Ginsberg, National Institutes of Health/Columbia University Liaison Representative: Daniel Jones, National Endowment for the Humanities National Institutes of Health staff: Bobbi Bennett, OD Michael Blaese, NCI Diane Bronzert, NCI Sarah Carr, OD Jan Casadei, NCI Judith Castellucci-Muhlhauser, NIA Daryl Chamblee, OD John Chiorini, NHLBI Chin-Shyan Chu, NHLBI Marinee Chuah, NHLBI Corrado Cirielli , NIA Stephen Epstein, NHLBI Toren Finkel, NHLBI Judy Fradkin, NIDDK Jay Greenblatt, NCI Barry Goldspiel, CC Christine Ireland, OD Sachiko Kajigaya, NHLBI Masako Kawase, NHLBI Robert Kotin, NHLBI Becky Ann Lawson, OD Catherine McKeon, NIDDK Suzanne Medgyesi-Mitschang, OD Hiroaki Mizukami, NHLBI David Nelson, NCHGR Jay Ramsey, NCHGR Melissa Rosenfeld, NCHGR Brian Safer, NHLBI Gwen Shafer, NCI Dorothy Soew, NCRR Debra J. Wilson, OD Thomas Shih, OD Thierry Vanden, NHLBI Harold Varmus, OD Stephen Wiener, NHLBI Others: Page 3 Paul Aebersold, Food and Drug Administration Sandra Afiome, Johns Hopkins University Abass Alavi, University of Pennsylvania Jane Alavi, University of Pennsylvania Stephen Albelda, University of Pennsylvania Tom Alonzo, GenVec, Inc. Robert Anderson, Food and Drug Administration W. French Anderson, University of Southern California Carlos Arteaga, Vanderbilt University Estuardo Aguilar, Baylor College of Medicine Robert Beall, Cystic Fibrosis Foundation Bari Bialos, New York Hospital Bridget Binko, Cell Genesys John Bishop, Food and Drug Administration Gary Boch, Life Technologies, Inc. Ernst Boehnlein, Progenesys Arindam Bose, Pfizer Central Research Andrew Braun, Harvard University Gracia Buffleben, Breast Cancer Action Parris Burd, Food and Drug Administration James Bylund, Quality Biotech Ira Carmen, University of Illinois Barry Carter, Targeted Genetics Corporation Jan Chappell, Genetic Therapy, Inc. Saswati Chatterjee, City of Hope National Medical Center Yawen Chiang, Genetic Therapy, Inc. Carol Conrad, Johns Hopkins University Ronald Crystal, New York Hospital Kenneth Culver, Iowa Methodist University Karen Darcy, Magenta Corporation Wanda deVlaminck, Avigen Blythe Devlin, Duke University Lori Doyle, University of Pennsylvania Anne Driscoll, Fox, Bennett, & Turner Stephen Eck, University of Pennsylvania Jim Embree, Systemix Suzanne Epstein, Food and Drug Administration Terry Flotte, Johns Hopkins University Jeffrey Fox, Private Journalist Joyce Frey, Food and Drug Administration Ingo Georgoff, Quality Biotech Eva Giesan, French Cystic Fibrosis Association Christine Ginsberg, Georgetown University Igor Gonda, Genentech, Inc. Christine Gorman, Time Magazine Angus Grant, Food and Drug Administration Tina Grasso, GenVec, Inc. Nicolaas Groot, The Netherlands Health Department Mariann Grossman, University of Pennsylvania Page 4 Bill Guggino, Johns Hopkins University Jeff Gustavson, Act Up, Goldengate Paul Hallenbeck, Genetic Therapy, Inc. Jacqueline Hampton, Weinberg Consulting Group Elie Hanania, MD Anderson Cancer Center Rebecca Harmon, University of Pennsylvania Jeffrey Holt, Vanderbilt University Joseph Hughes, Quality Biotech Edie Irvine, Genetic Therapy, Inc. Jeffrey Isner, St. Elizabeth's Medical Center John Jaugstetter, Genentech, Inc. Alice Johnson, Virginia Breast Cancer Foundation Susan Jones, Virus Research Institute Larry Kaiser, University of Pennsylvania Katherine Kaufmann, GenVec, Inc. Connie Kirby, Canji, Inc. Steve Kradjian, Vical, Inc. Toshi Kotani, Genetic Therapy, Inc. Imre Kovesdi, GenVec, Inc. Alex Kuta, Food and Drug Administration Eugene LaBrec, E.H. LaBrec & Associates Jane Lebkowski, Applied Immune Sciences, Inc. David Levitt, University of Maryland Charles Link, Iowa Methodist University H. Kim Lyerly, Duke University Gail Maderis, Genzyme Corporation Tamie Malaska, Targeted Genetics Corporation Dan Maneval, Canji, Inc. Phillip Maples, Baxter Healthcare Corporation Tony Marcel, TMC Development Stephen Marcus, Genetic Therapy, Inc. Michael McCaughan, FDC Reports Gerard McGarrity, Genetic Therapy, Inc. R. Scott McIvor, University of Minnesota Bruce Merchant, Viagene, Inc. Andra Miller, Food and Drug Administration Ron Morales, Harvard University Richard Moscicki, Genzyme Corporation Philip Noguchi, Food and Drug Administration Sheryl Osborne, Viagene, Inc. John Park, University of California, San Francisco Virginia Parks, Project Inform Nicholas Pelliccione , Schering-Plough Research Institute Anne
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