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Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
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C

Committee Biographies

Lawrence O. Gostin, J.D. (Chair), is University Professor, Georgetown University’s highest academic rank, conferred by the university’s president. Dr. Gostin directs the O’Neill Institute for National and Global Health Law and was the founding O’Neill Chair in Global Health Law. He served as associate dean for research at Georgetown Law from 2004 to 2008. He is a professor of medicine at Georgetown University, a professor of public health at the Johns Hopkins University, and director of the Center for Law and the Public’s Health at Johns Hopkins and Georgetown universities. Dr. Gostin holds a number of international academic professorial appointments. He is a visiting professor (faculty of medical sciences) and research fellow (Centre for Socio-Legal Studies) at the University of Oxford, United Kingdom. Dr. Gostin is the Claude Leon Foundation Distinguished Scholar and visiting professor at the University of Witwatersrand, Johannesburg, South Africa. He serves as secretary and a member of the governing board of directors of the Consortium of Universities for Global Health. Dr. Gostin is the director of the World Health Organization (WHO) Collaborating Center on Public Health Law and Human Rights. He also serves on the WHO director-general’s Advisory Committee on Reforming the World Health Organization. In 2007, the WHO director-general appointed Dr. Gostin to the International Health Regulations Roster of Experts and the Expert Advisory Panel on Mental Health. Dr. Gostin holds numerous editorial appointments in prestigious academic journals throughout the world. His principal position is as health law and ethics editor, contributing writer, and columnist for the Journal of the American Medical Association. He is also founding editor-in-chief of Laws, an international open-access law journal. He was formerly the editor-in-chief of the Journal of Law,

Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
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Medicine & Ethics. He is an elected member of the Institute of Medicine (IOM) and serves on the IOM’s Board on Health Sciences Policy, the Human Subjects Review Board, and the Committee on Science, Technology, and Law. He recently chaired the IOM Committee on Global Solutions to the Challenge of Counterfeit Medicines. He has also chaired National Academies committees on national preparedness for mass disasters, health informational privacy, public health genomics, and human subject research on prisoners. In 2006, the IOM awarded Dr. Gostin the Adam Yarmolinsky Medal for distinguished service to further its mission of science and health. He received the Public Health Law Association’s Distinguished Lifetime Achievement Award “in recognition of a career devoted to using law to improve the public’s health,” presented at the Centers for Disease Control and Prevention.

Kenneth I. Berns, M.D., Ph.D., is director of the University of Florida (UF) Genetics Institute and distinguished professor, department of molecular genetics and microbiology, College of Medicine, University of Florida. He has served as a member of the composite committee of the U.S. Medical Licensing Examination, chairman of the Association of American Medical Colleges, president of the Association of Medical School Microbiology and Immunology Chairs, president of the American Society for Virology, president of the American Society for Microbiology, and vice president of the International Union of Microbiological Societies. He is a member of the National Academy of Sciences and the Institute of Medicine. Dr. Berns’ research examines the molecular basis of replication of the human parvovirus and adeno-associated viruses and the ability of an adeno-associated virus to establish latent infections and be reactivated. His work has helped provide the basis for use of this virus as a vector for gene therapy. Dr. Berns’ M.D. and Ph.D. in biochemistry are from the Johns Hopkins University.

R. Alta Charo, J.D., is the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin–Madison (UW), where she is on the faculty of the law school and the department of medical history and bioethics of the medical school. Dr. Charo is an elected member of the World Technology Network (2004) and the Wisconsin Academy of Sciences, Arts and Letters (2005). In 2006, she was elected to membership in the Institute of Medicine (IOM). Dr. Charo served on President Obama’s transition team, focusing her attention particularly on transition issues related to the National Institutes of Health (NIH), the U.S. Food

Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×

and Drug Administration (FDA), bioethics, stem cell policy, and women’s reproductive health. She was on leave from 2009 to 2011 to serve as a senior policy advisor on emerging technology issues in the Office of the Commissioner at FDA. Dr. Charo offers courses on public health law, bioethics, biotechnology law, food and drug law, reproductive rights, torts, and legislative drafting. In addition, she has served on the UW Hospital clinical ethics committee, the UW institutional review board, and the UW bioethics advisory committee. Her federal advisory committee service includes the 1994 NIH Human Embryo Research Panel and President Clinton’s National Bioethics Advisory Commission (1996 to 2001). From 2001 to 2008, she was a member of the National Academies’ Board on Life Sciences, and from 2006 to 2012, she was a member of the IOM Board on Population Health and Public Health Practice.

Howard J. Federoff, M.D., Ph.D., is executive vice president for health sciences at Georgetown University and executive dean of the School of Medicine. Dr. Federoff is responsible for Georgetown University Medical Center. He is a professor of neurology and neuroscience. Prior to his time at Georgetown, he held appointments as senior associate dean for basic research; professor of neurology, medicine, microbiology, and immunology; and professor of oncology and genetics at the University of Rochester School of Medicine and as founding director of the Center for Aging and Development Biology at the Aab Institute of Biomedical Sciences and founding division chief of molecular medicine and gene therapy. After joining the Rochester faculty in 1995, he also served as director of the university’s Interdepartmental Neuroscience Program. Dr. Federoff’s research interests include gene therapy and neurodegenerative diseases such as Parkinson’s and Alzheimer’s. His research has received support from the National Science Foundation, the National Institutes of Health, and the Department of Defense. He has published widely in peer-reviewed journals and served as a reviewer for many journals, and currently serves on the editorial boards of the Journal of Parkinson’s Disease, Open Genomics Journal, and the Journal of Experimental Neurology. He is a fellow of the American Association for the Advancement of Science and National Academy of Inventors. Before joining the Rochester community, he was associate professor of medicine and neuroscience at Albert Einstein College of Medicine, from which he received M.S., Ph.D., and M.D. degrees. He completed his internship, residency, and clinical and research fellowships at Massachusetts Gen-

Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×

eral Hospital/Harvard Medical School and practiced medicine at the Albert Einstein College of Medicine and University of Rochester.

Jeffrey P. Kahn, Ph.D., M.P.H., is the inaugural Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy at the Johns Hopkins University Berman Institute of Bioethics. Prior to joining the faculty at Johns Hopkins in 2011, Dr. Kahn was director of the Center for Bioethics and the Maas Family Endowed Chair in Bioethics at the University of Minnesota, positions he held from 1996 to 2011. Earlier in his career, Dr. Kahn was director of the graduate program in bioethics and assistant professor of bioethics at the Medical College of Wisconsin and associate director of the White House Advisory Committee on Human Radiation Experiments. Dr. Kahn works in a variety of areas of bioethics, exploring the intersection of ethics and public health policy, including research ethics, ethics and genetics, and ethical issues in public health. He has served on many advisory panels, including for the National Institutes of Health, the Centers for Disease Control and Prevention, the Institute of Medicine, and others, and speaks nationally and internationally on a range of bioethics topics. He has published 3 books and more than 125 articles in the bioethics and medical literature. From 1998 to 2002, he wrote the biweekly column Ethics Matters for CNN.com. Dr. Kahn earned his B.A. in microbiology from the University of California, Los Angeles, his M.P.H. from Johns Hopkins University, and his Ph.D. in philosophy/bioethics from Georgetown University.

Terry Magnuson, Ph.D., is vice dean for research of the School of Medicine, S.G. Kenan Professor and chair of the department of genetics, and director of the Cancer Genetics Program of the Lineberger Comprehensive Cancer Center at the University of North Carolina (UNC) at Chapel Hill. Dr. Magnuson was recruited to UNC in 2000 as founding chair of the department of genetics and director of the newly established Carolina Center for Genome Sciences. He also created the Cancer Genetics Program in the UNC Lineberger Comprehensive Cancer Center. He was appointed vice dean for research in the School of Medicine in July 2010. The work in Dr. Magnuson’s laboratory focuses on the role of mammalian genes in unique epigenetic phenomena such as genomic imprinting, X-chromosome inactivation, and stem cell pluripotency. The laboratory also studies the tumor suppressor role of the BAF/PBAF chromatin remodeling complexes and has developed a novel genome-wide mutagene-

Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×

sis strategy. Dr. Magnuson received his Ph.D. from Cornell University and was a postdoctoral fellow at the University of California, San Francisco.

Joseph G. Perpich, M.D., J.D., is principal and senior medical adviser at JBS International, Inc., a behavioral health consulting firm in North Bethesda, Maryland. He joined JBS in 2012 and is responsible for overseeing the ongoing development and management of behavioral health research networks developed at JGPerpich, LLC. As president of JGPerpich, LLC (2001–2012), he led the development of digital interactive collaborative research and training programs by facilitating network building, establishing work groups, providing training and mentoring programs, producing 508-compatible webinar series, promoting capacity-building activities in developing countries, and organizing scientific conferences and workshops. The virtual collaborations that Dr. Perpich supports for the National Institutes of Health (NIH) focus on international drug abuse, suicide prevention, and behavioral health services; they reach more than 2,000 scientists. During the past 35 years, Dr. Perpich has held key leadership positions in biomedical research and education, including as associate director for program planning and evaluation at NIH, where he directed government-wide activities related to rDNA research and regulatory policies (1976 to 1981). Before founding JGPerpich, LLC, in 2002, Dr. Perpich was vice president for grants and special programs at the Howard Hughes Medical Institute, where he created and managed the grants program for science education and international biomedical research.

Sharon F. Terry, M.A., is president and CEO of Genetic Alliance, a network of more than 10,000 organizations, of which 1,200 are disease advocacy organizations. Genetic Alliance enables individuals, families, and communities to reclaim their health and become full participants in translational research and services. She is the founding CEO of PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE). As co-discoverer of the gene associated with PXE, she holds the patent for ABCC6 to act as its steward and has assigned her rights to the foundation. She developed a diagnostic test and conducts clinical trials. Ms. Terry is also a co-founder of the Genetic Alliance Registry and Biobank. She is the author of more than 100 peer-reviewed articles. In her focus at the forefront of consumer participation in genetics research, services, and policy, she serves in a leadership role on many of the major international and national organizations, including the Institute of Medicine (IOM) Health Sciences Policy Board, the IOM

Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×

Roundtable on Translating Genomic-Based Research for Health, the National Coalition for Health Professional Education in Genetics Board, the International Rare Disease Research Consortium Executive Committee, Map My Genome (India), and the EspeRare Foundation (as president). She is on the editorial boards of several journals. She was instrumental in the passage of the Genetic Information Nondiscrimination Act. She received an honorary doctorate from Iona College for her work in community engagement in 2005; the first Patient Service Award from the University of North Carolina Institute for Pharmacogenomics and Individualized Therapy in 2007; the Research!America Distinguished Organization Advocacy Award in 2009; and the Clinical Research Forum and Foundation’s Annual Award for Leadership in Public Advocacy in 2011. In 2012, she became an honorary professor of Hebei United University in Tangshan, China, and also received the Facing Our Risk of Cancer Empowered (FORCE) Spirit of Empowerment Advocacy Award. She was named one of the Food and Drug Administration’s “30 Heroes for the Thirtieth Anniversary of the Orphan Drug Act” in 2013. She is an Ashoka Fellow.

Inder M. Verma, Ph.D., is a professor in the Laboratory of Genetics and American Cancer Society Professor of Molecular Biology at the Salk Institute and is one of the world’s leading authorities on the development of viruses for gene therapy vectors. Dr. Verma uses genetically engineered viruses to insert new genes into cells that can then be returned to the body, where they produce the essential protein whose absence causes disease. Dr. Verma and Salk colleagues developed a gene therapy vector based on a stripped-down version of HIV that can deliver genes to non-dividing cells, which constitute the majority of the cells in our bodies. They have used this vector successfully to deliver the clotting factor gene to laboratory animals and to transfer a therapeutic gene to retinal cells to mice with an inborn deficiency. Dr. Verma’s group is also studying two genes implicated in familial breast cancer, BRCA1 and BRCA2, and recently demonstrated that their action is linked to the cell’s division cycle and that BRCA1 regulates gene activity.

John E. Wagner, M.D., is a professor of pediatrics at the University of Minnesota Medical School. He is the first recipient of the Children’s Cancer Research Fund/Hageboeck Family Chair in Pediatric Oncology and holds the University of Minnesota McKnight Presidential Chair in Cancer Research. He is the director of the division of pediatric blood and

Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×

marrow transplantation, scientific director of clinical research of the UMN Stem Cell Institute and co-director of the Center for Translational Medicine. Dr. Wagner is a member of numerous societies, including the American Society of Hematology, the International Society of Experimental Hematology, and the American Society of Blood and Marrow Transplantation. He is a member of several honorary societies, including Alpha Omega Alpha (1980), the American Society of Clinical Investigation (2000), and the Association of American Physicians (2006). Dr. Wagner holds a patent on the isolation of the pluripotential quiescent stem cell population. Dr. Wagner holds a B.A. in biological sciences and a B.A. in psychology from the University of Delaware and an M.D. from Jefferson Medical College. Dr. Wagner’s research has focused on the development of novel cellular therapies for tissue repair and suppression of the immune response using subpopulations of neonatal umbilical cord blood and adult bone marrow and peripheral blood. His projects are funded by the National Institutes of Health and industry, and he is the principal investigator of a National Cancer Institute program project grant entitled “Stem Cell Biology and Transplantation.” Dr. Wagner was the recipient of the 2009 Simon Gratz Research Prize from the Jefferson Medical College, which is awarded to an alumnus who has furthered the advancement of medical/surgical treatments. Dr. Wagner has written more than 275 articles and book chapters in the field of hematopoietic stem cell transplantation. He previously served as a member of the scientific board of directors of the National Marrow Donor Program, the Institute of Medicine’s Committee on Establishing a National Cord Blood Stem Cell Banking Program, and the National Academies’ Human Embryonic Stem Cell Research Advisory Committee. He is currently a member of the Scientific and Medical Accountability Standards Working Group of the California Institute of Regenerative Medicine.

Lt. Col. Daniel J. Wattendorf, M.D., joined the Defense Advanced Research Projects Agency as a program manager in the defense sciences office in 2010. His interests focus on applying methodological advances in genomics and biotechnology to optimize health and prevent disease—specifically to achieve simple solutions that improve health care at the point of care. He holds a B.S. in microbiology from Cornell University and an M.D. with distinction from George Washington University. He completed a residency in family medicine at the National Capital Consortium; a residency in clinical genetics at the National Institutes of Health’s (NIH’s) National Human Genome Research Institute (NHGRI);

Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×

a fellowship in clinical cytogenetics at Georgetown University; and a fellowship in health policy from the NHGRI Office of the Director. Dr. Wattendorf previously served as director, Air Force Medical Genetics Center, and program manager for an advanced-concept technology demonstration integrating advanced diagnostics and informatics with surveillance systems to rapidly detect natural and hostile pathogens in the Office of the Air Force Surgeon General. In addition to Defense Advanced Research Projects Agency programs, he is a geneticist at the National Naval Medical Center and the Cancer Genetics Branch, National Cancer Institute, NIH.

Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×
Page 109
Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×
Page 110
Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×
Page 111
Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×
Page 112
Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×
Page 113
Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×
Page 114
Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×
Page 115
Suggested Citation:"Appendix C: Committee Biographies." Institute of Medicine. 2014. Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press. doi: 10.17226/18577.
×
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Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion.

Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.

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