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Heritable Human Genome Editing (2020)

Chapter: Appendix B: Commissioner Biographies

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Suggested Citation:"Appendix B: Commissioner Biographies." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
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Page 193
Suggested Citation:"Appendix B: Commissioner Biographies." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
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Page 194
Suggested Citation:"Appendix B: Commissioner Biographies." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
×
Page 195
Suggested Citation:"Appendix B: Commissioner Biographies." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
×
Page 196
Suggested Citation:"Appendix B: Commissioner Biographies." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
×
Page 197
Suggested Citation:"Appendix B: Commissioner Biographies." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
×
Page 198
Suggested Citation:"Appendix B: Commissioner Biographies." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
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Page 199

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Appendix B Commissioner Biographies Kay E. Davies, DPhil., CBE, DBE, FMedSci, FRS, is Professor of Genetics in the Department of Physiology, Anatomy, and Genetics and associate head of development, impact, and equality, in the Medical Sciences Division at the University of Oxford. She established the Medical Research Council (MRC) Functional Genomics Unit in 1999 and co-founded the Oxford Centre of Gene Function in 2000. She is co-director of the Muscular Dystrophy UK (MDUK) Oxford Neuromuscular Centre. Her research interests lie in the molecular analysis and development of treatments for human genetic diseases, particularly Duchenne muscular dystrophy, and the application of genomics for the analysis of neurological disorders and gene-environment interactions. She has published more than 400 papers and won numerous awards for her work. She co-founded Summit Therapeutics and Oxstem. Dr. Davies is a founding fellow of the Academy of Medical Sciences and was elected a fellow of the Royal Society in 2003. She was appointed governor of the Wellcome Trust in 2008 and was deputy chair from 2013 to 2017. In 2008 she was made Dame Commander of the British Empire for services to science. Richard P. Lifton, M.D., Ph.D., NAS, NAM, is the 11th president of The Rockefeller University. His work uses human genetics and genomics to understand fundamental mechanisms underlying a wide range of human diseases. He is well known for his discovery that mutations with large effect on human blood pressure act by altering renal salt reabsorption, discoveries that have informed dietary guidelines and therapeutic strategies used worldwide to reduce blood pressure and prevent heart attacks and strokes, and for his development and use of exome sequencing for clinical diagnosis and disease gene discovery. Dr. Lifton graduated summa cum laude from Dartmouth College, obtained M.D. and Ph.D. degrees from Stanford University, and completed training in internal medicine at Brigham and Women’s Hospital/Harvard Medical School. Prior to Rockefeller, he was chair of the Department of Genetics and Sterling Professor at Yale University, where he founded the Yale Center for Genome Analysis. He is a member of the National Academy of Sciences and the National Academy of Medicine, and has served on the governing councils of both organizations. He currently serves on the scientific advisory boards of the Simons Foundation for Autism Research and the Chan-Zuckerberg Initiative Biohub and is a director of Roche and its subsidiary Genentech. He previously served on the advisory council to the director of the National Institutes of Health and co-chaired the National Institutes of Health Precision Medicine Working Group, which developed the plan for the “All of Us” Presidential Initiative. He has received numerous awards for his research, including the 2014 Breakthrough Prize in Life Sciences, the 2008 Wiley Prize, and the highest scientific awards of the American Heart Association, the American and International Societies of Nephrology, and the American and International Societies of Hypertension. He has received honorary doctorates from Northwestern University, Mount Sinai School of Medicine, and Yale University. Hidenori Akutsu, M.D., Ph.D., is a director of the Department of Reproductive Medicine at the National Center for Child Health and Development in Tokyo, Japan. He is a member of the Expert Panel on Bioethics, Council for Science and Technology Innovation (CSTI) of Japan and a secretary of the Committee on Genome Editing Technology in Medical Sciences and Clinical Applications of the Science Council of Japan. His research explores mechanisms of PREPUBLICATION COPY | UNCORRECTED PROOFS 193

preimplantation development and stem cell reprogramming, and he has derived human embryonic stem cells in Japan. Dr. Akutsu received his M.D. from Hirosaki University and completed his clinical training in obstetrics gynecology at Fukushima Medical University. He completed his Ph.D. at Fukushima Medical University School of Medicine. Robert Califf, M.D., MACC, NAM, is the Donald F. Fortin, M.D., Professor of Cardiology at Duke University. He is also professor of medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the commissioner of food and drugs (2016–2017) and deputy commissioner for medical products and tobacco (2015–2016). Prior to joining the Food and Drug Administration, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many clinical trials and has more than 1,200 publications in the peer-reviewed literature. Dr. Califf has served on a number of advisory committees for the Food and Drug Administration and National Institutes of Health. He has led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative, a public-private partnership co-founded by the Food and Drug Administration and Duke. Dana Carroll, Ph.D., NAS, is a distinguished professor in the Department of Biochemistry at the University of Utah School of Medicine. He was until recently Interim Director of the Public Impact Program at the Innovative Genomics Institute at the University of California, Berkeley. Dr. Carroll’s research involves genome engineering using targetable nucleases. His lab pioneered the development of zinc-finger nucleases as gene targeting tools, and he continued working with the more recent TALENs and CRISPR/Cas nucleases, with much of the effort focused on optimizing the efficiency of these reagents for targeted mutagenesis and gene replacement. Dr. Carroll’s current interests include the societal implications of genome editing. He received his Ph.D. from the University of California, Berkeley, and did postdoctoral research at the Beatson Institute for Cancer Research in Glasgow, Scotland, and at the Carnegie Institution Department of Embryology in Baltimore. Susan Golombok, Ph.D., FBA, is professor of family research and director of the Centre for Family Research at the University of Cambridge, and was a visiting professor at Columbia University in New York in 2005-06. She has pioneered research on the impact of new family forms on child development, and is one of the world’s leading experts on families created by assisted reproduction (i.e. in vitro fertilization, egg donation, sperm donation and surrogacy). She has authored more than 300 academic papers and 7 books, and her award-winning research has contributed to policy and legislation on the family both nationally and internationally. She was a member of the U.K. government’s surrogacy review committee in the late 1990s and a member of the Nuffield Council on Bioethics Working Party on Donor Conception in 2102-13. Susan Golombok is a specialist in longitudinal studies of children, an important element of the commission’s tasks of identifying ways to assess the balance between potential benefits and harms to a child produced by genome editing and of identifying and assessing mechanisms for long-term monitoring of children produced by genome editing. She received her PhD from the PREPUBLICATION COPY | UNCORRECTED PROOFS 194

University of London Institute of Psychiatry in 1982, and was elected a fellow of the British Academy in 2019. Andy Greenfield, Ph.D., has been a programme leader at the Medical Research Council’s Harwell Institute since 1996, and his lab’s research focuses on the molecular genetics of mammalian sexual development. From 2003 to 2007, Dr. Greenfield served as a member of the Wellcome Trust’s Molecules, Genes and Cells Funding Committee, and from 2009 to 2018 he was a member of the U.K. Human Fertilisation and Embryology Authority. He chaired the authority’s Licence Committee from 2014 to 2018 and was deputy chair of its Scientific and Clinical Advances Advisory Committee, for which he now serves an external advisor. In 2014 and 2016 Dr. Greenfield chaired two expert scientific panel reviews of mitochondrial donation techniques, important components of the regulatory process permitting mitochondrial replacement therapy in the U.K. He has spoken on numerous occasions about the science and ethics of genomic technologies and their application in animals and humans. From 2014 to 2020, he was a member of the Nuffield Council on Bioethics and chaired its 2016 working group that reported on ethical issues surrounding the use of genome editing in a range of organisms and contexts. Dr. Greenfield graduated with a B.A. in natural sciences from St. John’s College, University of Cambridge. He received his Ph.D. in molecular genetics from St. Mary’s Hospital Medical School, Imperial College London, and was a postdoctoral fellow at the Institute for Molecular Bioscience, University of Queensland, Australia. He has an M.A. in philosophy from Birkbeck, University of London, and is a fellow of the Royal Society of Biology. A. Rahman A. Jamal, M.D., Ph.D., MRCP, is the pro vice chancellor of the Universiti Kebangsaan Malaysia (UKM) Kuala Lumpur campus. He is also the founding director of the UKM Medical Molecular Biology Institute at the UKM, Kuala Lumpur, and a professor of pediatric oncology and hematology, and molecular biology. Dr. Jamal’s research focus is on molecular biology of cancers, other non-communicable diseases, thalassemia, and rare diseases. He and his research team have discovered gene signatures associated with the pathogenesis of colorectal cancer, glioma, and leukemias. He has pioneered personalized and precision medicine at the UKM Medical Molecular Biology Institute and is now the chairman of the Task Force for Precision Medicine under the auspices of the Academy of Sciences Malaysia. Dr. Jamal is the principal investigator for the Malaysian Cohort project, is a member of the Asia Cohort Consortium and the International Health Cohort Consortium, and has been a member of The Wellcome Trust U.K. Grant Committee for Longitudinal Population Studies since 2018. He is the chairman of the National Committee for Ethics for Cell Research and Therapy and a member of the National Committee for Clinical Research, both under the Ministry of Health Malaysia. Dr. Jamal is currently the project director for the UKM Specialist Children’s Hospital, which will be the first dedicated hospital for pediatric patients in Malaysia. He graduated from UKM in medicine in 1985 and obtained his M.R.C.P. (pediatrics) from the Royal College of Physicians Ireland in 1991. He was awarded a Ph.D. in hematology and molecular biology in 1996 from the University of London and has a graduate diploma in healthcare leadership and management from the Singapore Management University. Jeffrey Kahn, Ph.D., M.P.H., NAM, is the Andreas C. Dracopoulos Director of the Johns Hopkins Berman Institute of Bioethics, a position he assumed in 2016. He is the inaugural Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy and professor PREPUBLICATION COPY | UNCORRECTED PROOFS 195

in the Department of Health Policy and Management of the Johns Hopkins Bloomberg School of Public Health. Dr. Kahn works in a variety of areas of bioethics, exploring the intersection of ethics and health/science policy, including human and animal research ethics, public health, and ethical issues in emerging biomedical technologies. He has served on numerous state and federal advisory panels. He is currently chair of National Academies of Sciences, Engineering, and Medicine’s Board on Health Sciences Policy and has previously chaired its Committee on the Use of Chimpanzees in Biomedical and Behavioral Research (2011); Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights (2014); and Committee on the Ethical, Social, and Policy Considerations of Mitochondrial Replacement Techniques (2016). He formerly served as a member of the National Institutes of Health’s Recombinant DNA Advisory Committee. In addition to committee leadership and membership, Dr. Kahn is an elected member of the National Academy of Medicine and an elected fellow of The Hastings Center. He was the founding president of the Association of Bioethics Program Directors. Dr. Kahn’s publications include three books and more than 125 scholarly and research articles. He speaks widely on a range of bioethics topics, in addition to frequent media outreach. From 1998 to 2002 he wrote the bi-weekly column “Ethics Matters” on CNN.com. Prior to joining the faculty at Johns Hopkins, Dr. Kahn was Maas Family Endowed Professor of Bioethics and director of the Center for Bioethics at the University of Minnesota. He received his M.P.H. from the Johns Hopkins Bloomberg School of Public Health and his Ph.D. from Georgetown University. Bartha Maria Knoppers, J.D., Ph.D. (comparative medical law), is a full professor, Canada Research Chair in Law and Medicine, and director of the Centre of Genomics and Policy of the Faculty of Medicine at McGill University. She was chair of the Ethics and Governance Committee of the International Cancer Genome Consortium from 2009 to 2017, has been chair of the Ethics Advisory Panel of the World Anti-Doping Agency (WADA) since 2015, and has been co-chair of the Regulatory and Ethics Workstream of the Global Alliance for Genomics and Health since 2013. In 2015-2016, she was a member of the drafting group for the recommendation of the Organisation for Economic Cooperation and Development’s Council on Health Data Governance and gave the Galton Lecture in November 2017. She holds four doctorates honoris causa and is a fellow of the American Association for the Advancement of Science, the Hastings Center (bioethics), the Canadian Academy Health Sciences, and the Royal Society of Canada. She is an officer of the Order of Canada and of Quebec, and was awarded the 2019 Henry G. Friesen International Prize in Health Research. Eric S. Lander, Ph.D., NAS, NAM, is president and founding director of the Broad Institute of the Massachusetts Institute of Technology and Harvard, and is professor of biology at the Massachusetts Institute of Technology and professor of systems biology at Harvard Medical School. From 2009 to 2017 he also served as co-chair of the President’s Council of Advisors on Science and Technology for President Barack Obama. A geneticist, molecular biologist, and mathematician, Dr. Lander has played a pioneering role in the reading, understanding, and biomedical application of the human genome. He was a principal leader of the Human Genome Project and has done pioneering work on mapping genes underlying human diseases and traits, human genetic variation, genome architecture, genome evolution, and genome-wide screens to discover the genes essential for biological processes using CRISPR-based genome editing. Dr. Lander has received numerous honors including the MacArthur Fellowship, the Breakthrough PREPUBLICATION COPY | UNCORRECTED PROOFS 196

Prize in Life Sciences, the Albany Prize in Medicine and Biological Research, the Gairdner Foundation International Award (Canada), the Dan David Prize (Israel), the Mendel Medal of the Genetics Society (U.K.), the City of Medicine Award, the William Allan Award from the American Society of Human Genetics, the Abelson Prize from the AAAS, the Award for Public Understanding of Science and Technology from the AAAS, the James R. Killian Jr. Faculty Achievement Award from MIT, and honorary doctorates from more than a dozen universities and colleges. Jinsong Li, Ph.D., is a professor at the Shanghai Institute of Biochemistry and Cell Biology of the Chinese Academy of Sciences. Dr. Li’s lab focuses on stem cells and embryonic development, and he has made fundamental contributions through his work in mice to the establishment of androgenetic haploid embryonic stem cells that can be used as sperm replacement to efficiently support full-term embryonic development upon injection into MII oocytes, leading to the generation of semi-cloned (SC) mice. Dr. Li has shown that this technology can be used as a unique tool for genetic analyses in mice, including medium-scale targeted screening of crucial genes or essential nucleotides of a specific gene involved in a developmental process; efficient generation of mouse models carrying defined point mutations related to human developmental defects; and one-step generation of mouse models that mimic multiple genetic defects in human diseases. Most recently, Dr. Li initiated a major genome tagging project to tag every protein in mice based on artificial spermatid–mediated SC technology, which may enable the precise description of protein expression and localization patterns, and protein-protein, protein-DNA, and protein–RNA interactions. Dr. Li received his Ph.D. from the Institute of Zoology of the Chinese Academy of Sciences in 2002 followed by postdoctoral training at The Rockefeller University. Michèle Ramsay, Ph.D., is director and research chair of the Sydney Brenner Institute for Molecular Bioscience at the University of Witwatersrand, Johannesburg. The institute focuses on the development of new solutions to African health challenges by conducting biomedical molecular and genomic research. Dr. Ramsay’s research interests include the genetic basis and molecular epidemiology of single-gene disorders in South African populations and the role of genetic and epigenetic variation in the molecular etiology of diseases and traits affected by lifestyle choices. She is a member of the Academy of Science of South Africa, immediate past president of the African Society of Human Genetics, and president of the International Federation of Human Genetics Societies. Dr. Ramsay received her Ph.D. in human molecular genetics from the University of Witwatersrand. Julie Steffann, M.D., Ph.D., is director of the molecular genetics department at Necker-Enfants Malades Hospital in Paris and professor of genetics at the Paris University. She runs the Preimplantation Genetic Diagnosis Laboratory since 2003, and belongs to the mitochondrial diseases research team at the Imagine Institute in Paris. The Imagine Institute focuses on understanding the mechanisms of genetic diseases, and inventing tomorrow’s treatments for genetic diseases. Julie Steffann conducts research on mitochondrial DNA disorders and their consequences on human early embryos. She investigates the potential impacts of mitochondrial DNA mutations on human embryo/foetal development and develops methods of prevention and treatment of mitochondrial DNA disorders. She received her M.D. in 2001 and her Ph.D. in Genetics in 2006 from the Paris-Descartes University. PREPUBLICATION COPY | UNCORRECTED PROOFS 197

B.K. Thelma, Ph.D., is a professor and J.C. Bose fellow at the Department of Genetics at the University of Delhi. She has also served as a member of the Scientific Advisory Council to the Prime Minister of India from 2009-2014. From 2008, she is a team leader of the Centre of excellence on Genome Sciences and Predictive Medicine, of the Department of Biotechnology, Government of India. Thelma has made original contributions in the field of human genetics and medical genomics. Her group has identified several novel disease causal genes for familial forms of Schizophrenia, Parkinson’s disease and Intellectual disability. Her group has also been the pioneers in the identification of novel susceptibility conferring genes for rheumatoid arthritis and ulcerative colitis in the Indian population. Her current work focuses on Ayurgenomics, an innovative approach of combining the doctrines of Ayurveda, the Indian system of medicine for deep phenotyping of individuals with contemporary genome analysis tools to address the phenotypic heterogeneity limiting our understanding of the genetics of common complex disorders; and functional genomics of rare genetic variants using cellular models of disease and CRISPR-based genome editing tools. In her persistent efforts to translate benefits of science to society, Dr.Thelma established early on the DNA based diagnosis for fragile X syndrome; and more recently, newborn screening for inborn errors of metabolism to reduce the socio-economic burden of this large group of genetic disorders in the country. Dr. Thelma has been involved in a number of long-term follow up studies and has contributed to several expert committee in areas of Science and ethics. She received the Stree Shakti Science Samman award in 2012 and is a fellow of the Indian National Science Academy, Indian Academy of Sciences and the National Academy of Sciences (India). Dr Thelma obtained her Master's degree in zoology from Bangalore University and received a Ph. D in zoology from the University of Delhi. Sir Douglass Turnbull, M.D., Ph.D., FMedSci, FRS, is professor of neurology and director of the Wellcome Centre for Mitochondrial Research at Newcastle University. The Wellcome Centre for Mitochondrial Research focuses on understanding the clinical course of patients with mitochondrial disease and how this relates to the underlying disease mechanisms, identifying the molecular and genetic mechanisms causing mitochondrial disease and developing techniques to prevent the transmission of mtDNA disease and improve treatment for patients with mitochondrial disease. Dr. Turnbull was also director of the Medical Research Council (MRC) Centre for Ageing and Vitality which is focused on understanding how aging mechanisms are influenced by lifestyle interventions and carries out studies aimed at promoting healthy aging. He was the lead for the National Health Service Highly Specialised Services for Rare Mitochondrial Services for Adults and Children. This service provides optimum care for patients with mitochondrial disease throughout the U.K. with centres in Newcastle, London, and Oxford. This service was built on the back of clinical and basic research, and the Newcastle centre reviews more than 1000 patients per year. The service has developed care pathways and patient guidelines that are used worldwide. Dr. Turnbull was elected a fellow of the Academy of Medical Sciences in 2004 and elected a fellow of the Royal Society in 2019. Sir Doug Turnbull received a knighthood in the Queen’s Birthday Honours 2016 “for services to health care research and treatment, particularly mitochondrial disease.” He received his bachelor of medicine, bachelor of surgery, M.D., and Ph.D. from Newcastle University. Haoyi Wang, Ph.D., leads a research group in the State Key Laboratory of Stem Cell and Reproductive Biology at the Chinese Academy of Sciences’ Institute of Zoology. The Wang PREPUBLICATION COPY | UNCORRECTED PROOFS 198

laboratory focuses on developing novel technologies to achieve efficient and specific genome engineering, and applying them to study the function of genes and establish novel therapeutic methods. His laboratory has developed a zygote electroporation of nuclease method to generate genetically modified mouse models with high throughput and efficiency, the Casilio method to regulate gene transcription, and a method to generate CAR-T cells with multiplex gene editing. Dr. Wang previously worked on the development of a variety of genome engineering technologies, including a transposon-based “calling card” method for determining the genome- wide binding locations of transcription factors, TALEN-mediated genome editing in human pluripotent stem cells and mice, CRISPR-mediated multiplexed genome editing in mice, and CRISPR-mediated gene activation in human cells. Dr. Wang received his Ph.D. from Washington University in St. Louis. Anna Wedell, M.D., Ph.D., is head of the Centre for Inherited Metabolic Diseases at Karolinska University Hospital and professor of medical genetics at the Karolinska Institute in Stockholm, Sweden. Dr. Wedell leads an integrated translational centre combining clinical and laboratory medicine, high-throughput genomics, and basic experimental science. The centre performs nationwide clinical diagnostics of inborn errors of metabolism, including the national neonatal screening program (“PKU test”). The centre also has a strong focus on mitochondrial medicine. Dr. Wedell is affiliated with the Science for Life Laboratory, a national infrastructure for high- throughput biology. She has implemented whole-genome sequencing into health care and has discovered a number of novel monogenic diseases. She received her M.D. in 1988 and her Ph.D. in medical genetics in 1994 from the Karolinska Institute. In 2006, she became board certified in clinical genetics after training at the Karolinska University Hospital. Dr. Wedell is a member of the Nobel Assembly at Karolinska Institutet and the Royal Swedish Academy of Sciences. PREPUBLICATION COPY | UNCORRECTED PROOFS 199

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Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing.

From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.

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