Appendix B
Speaker Biographical Sketches

Wylie Burke, M.D., Ph.D., is Professor and Chair of the Department of Bioethics and Humanities at the University of Washington. She received a Ph.D. in genetics and an M.D. from the University of Washington and completed a residency in internal medicine at the University of Washington. She was a medical genetics fellow at the University of Washington from 1981 to 1982. Dr. Burke was a member of the Department of Medicine at the University of Washington from 1983 to 2000, where she served as Associate Director of the Internal Medicine Residency Program from 1988 to 1994 and as founding Director of the University of Washington’s Women’s Health Care Center from 1994 to 1999. She was appointed Chair of the Department of Medical History in October 2000. She is also an Adjunct Professor of Medicine and Epidemiology and an Associate Member of the Fred Hutchinson Cancer Research Center. She was a Visiting Scientist at the Centers for Disease Control and Prevention in 1998 and is a fellow of the American College of Physicians. She has served on the NIH National Advisory Council for Human Genome Research and the Secretary’s Advisory Committee on Genetic Testing. Dr. Burke’s research addresses the social, ethical, and policy implications of genetic information, including genetic test evaluation, the development of practice standards for genetically based services, and genetics education for health professionals. She is also the Director of the University of Washington Center for Genomics and Healthcare Equality, a center of excellence in ethical, legal, and social implications research funded by the National Human Genome Research Institute.



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Appendix B Speaker Biographical Sketches Wylie Burke, M.D., Ph.D., is Professor and Chair of the Department of Bio- ethics and Humanities at the University of Washington. She received a Ph.D. in genetics and an M.D. from the University of Washington and completed a residency in internal medicine at the University of Washington. She was a medical genetics fellow at the University of Washington from 1981 to 1982. Dr. Burke was a member of the Department of Medicine at the University of Washington from 1983 to 2000, where she served as Associate Director of the Internal Medicine Residency Program from 1988 to 1994 and as founding Director of the University of Washington’s Women’s Health Care Center from 1994 to 1999. She was appointed Chair of the Department of Medical History in October 2000. She is also an Adjunct Professor of Medicine and Epidemiology and an Associate Member of the Fred Hutchin- son Cancer Research Center. She was a Visiting Scientist at the Centers for Disease Control and Prevention in 1998 and is a fellow of the American College of Physicians. She has served on the NIH National Advisory Coun- cil for Human Genome Research and the Secretary’s Advisory Committee on Genetic Testing. Dr. Burke’s research addresses the social, ethical, and policy implications of genetic information, including genetic test evaluation, the development of practice standards for genetically based services, and genetics education for health professionals. She is also the Director of the University of Washington Center for Genomics and Healthcare Equality, a center of excellence in ethical, legal, and social implications research funded by the National Human Genome Research Institute. 

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 USING RESIDUAL NEWbORN SCREENING SAMpLES Michele Caggana, Sc.D., received her doctoral degree from the Harvard School of Public Health in cancer, cell, and radiation biology and completed postdoctoral work in clinical molecular genetics at the Mt. Sinai School of Medicine. She is board certified in clinical molecular genetics by the Ameri- can Board of Medical Genetics and a fellow of the American College of Medical Genetics. Dr. Caggana has been employed by the Wadsworth Cen- ter since 1996. She is Deputy Director of the Division of Genetics, Chief of the Laboratory of Human Genetics, and Director of the Newborn Screening Program. In addition, she serves as the Section Head for genetic testing at the Wadsworth Center. In this capacity she conducts regulatory reviews for technical and clinical validity of all genetic test methods conducted by laboratories performing testing on specimens taken in New York State. Dr. Caggana’s laboratory uses molecular genetics techniques to study frequen- cies of specific gene mutations in dried blood spots received as specimens for newborn screening. Her laboratory also performs DNA analysis in the context of newborn screening and works on new molecular technologies. She is also an Assistant Professor in the Department of Biomedical Sci- ences in the School of Public Health at the State University of New York at Albany. Dr. Caggana also serves on the institutional review board at the Department of Health and the Clinical and Molecular Devices Panel at the Food and Drug Administration. Ellen Wright Clayton, M.D., J.D., received a bachelor’s degree from Duke, a master’s degree from Stanford, her law degree from Yale, and her medi- cal degree from Harvard. A member of the Vanderbilt faculty since 1988, she is currently the Rosalind E. Franklin Professor of Genetics and Health Policy and co-Director of the Center for Biomedical Ethics and Society at the Vanderbilt University Medical Center. She is also Professor of Pediatrics and Professor of Law. At Vanderbilt, she directs the law emphasis program and teaches the Patient, Profession, and Society course in the medical school and teaches the interdisciplinary course in Bioethics and Law in four schools of the University. Dr. Clayton has focused primarily on issues surrounding the ethical, legal, and social implications of advances in genetics and genomics as both a scholar and a policy maker. She has served on Tennessee’s Genet- ics Advisory Council since the early 1990s, has participated in numerous policy and academic groups that have considered newborn screening, and is currently conducting research on the impact of false positive results in newborn screening. She has been very involved with the Human Genome Project in the United States, serving as a member of the National Advisory Council for Human Genome Research and more recently as co-Chair of the Ethical, Legal, and Social Implications Working Group of the International Haplotype Mapping Project. She has also been very involved in ethical

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 AppENDIX b issues raised by genetics and genomics research, working with investigators and deliberative bodies around the world. She has been instrumental in the development of Vanderbilt’s DNA biobank and is currently co-Chair of the Consent and Community Consultation Working Group of the eMERGE consortium, which is studying the use of electronic medical records in genome-wide association studies. She has also written about a variety of issues regarding children’s and women’s health. She is currently a member of the advisory council for the National Children’s Study. A member of the Institute of Medicine (IOM) since 2006, she has served on the Health Sci- ences Policy Board, its advisory council, and on several IOM committees, chairing committees to evaluate Title X family planning and to evaluate the safety of vaccines. Anne Comeau, Ph.D., is Deputy Director of the New England Newborn Screening Program and Associate Professor of Pediatrics at the University of Massachusetts Medical School. The principal focus of Dr. Comeau’s work has been the identification and epidemiology of disease that is detect- able in neonates through population-based newborn screening. Technical advances from her laboratory have made sophisticated molecular assays available to patients and providers working in domestic centers and inter- national centers that would otherwise be unable to access such technology. Her early publications include work on the identification of HIV sequences in infected newborns for early diagnosis, the study of mother-to-infant transmission, and evaluation of the efficacy of treatment. More recent publications include evaluations of newborn screening for cystic fibrosis, implications of expanded newborn screening on the healthcare community, and recommendations for successful implementation of newborn screen- ing programs such as cystic fibrosis and now including severe combined immunodeficiency (SCID). Dr. Comeau continues as the project leader for the HRSA-funded Priority Focus on Long-Term Follow Up in New England and is the principal investigator of one of two Centers for Disease Control and Prevention grant awards to study the feasibility of newborn screen- ing for SCID and has overseen the implementation of the pilot SCID NBS program for Massachusetts. Dr. Comeau authored the human subjects research protocols that facil- itated the 1999 Massachusetts expansion of newborn screening services and 2009 screening for SCID and additional biochemical conditions. She has presented on the special considerations for research use of data held under public health stewardship and is the author of two book chapters describing such: Newborn Screening Expansion: Massachusetts Research Models Encompass Public Health Service Responsibility in Genomics and public Health: Legal and Socio-Ethical perspecties (B. M. Knoppers, Ed., 2007) and Population-Based Research within a Public Health Service:

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4 USING RESIDUAL NEWbORN SCREENING SAMpLES Two Models for Compliance with the Common Rule in the Massachusetts Newborn Screening Program in Ethics and Newborn Genetic Screening: New Technologies, New Challenges (M. A. Bailey and T. H. Murray, Eds., 2009). With respect to the issue at hand, Dr. Comeau has been an avid advo- cate for responsible stewardship of residual newborn screening specimens. She coined the phrase “virtual repository,” proposing the model in Septem- ber 2002 at CDC meeting on use of dried blood spots. kelly Edwards, Ph.D., is an Associate Professor in the Department of Bio- ethics and Humanities at the University of Washington School of Medicine and core faculty for the Institute for Public Health Genetics. She received an M.A. in medical ethics and a Ph.D. in philosophy of education from the University of Washington, Seattle. Research and program responsibilities include serving as Director of the Ethics and Outreach Core for the NIEHS- funded Center for Ecogenetics and Environmental Health, co-Director of the Regulatory Support and Bioethics Core for the Institute for Trans- lational Health Sciences, and lead investigator with the NHGRI-funded Center for Genomics and Healthcare Equality. Special interests include community-based research practices, biobank governance, environmen- tal justice, everyday ethics in research practice, feminist and narrative approaches to bioethics, and integrating ethics into training programs, public conversations about science, and public policy. Alan R. Fleischman, M.D., is Senior Vice President and Medical Director of the March of Dimes Foundation and Clinical Professor of Pediatrics and Clinical Professor of Epidemiology and Population Health at the Albert Einstein College of Medicine in New York. Born in New York City, Dr. Fleischman graduated Phi Beta Kappa from the City College of New York and Alpha Omega Alpha from the Albert Einstein College of Medicine. He continued his education in pediatrics at the Johns Hopkins Hospital in Baltimore, Maryland, and completed a fel- lowship in perinatal physiology at the National Institutes of Health and through a Royal Society of Medicine Foundation Scholarship at Oxford University in England. He joined the faculty at the Albert Einstein College of Medicine and the Montefiore Medical Center in 1975, where he became Professor of Pediatrics and Professor of Epidemiology and Social Medicine and served as Director of the Division of Neonatology until 1994. In 1994, he became Senior Vice President of the New York Academy of Medicine, where he catalyzed the Academy’s growth into a research- intensive institution in areas related to urban health, medical education, public policy, bioethics, and public health. In 2004 Dr. Fleischman became ethics advisor to the National Children’s Study at the National Institutes

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 AppENDIX b of Health and was Chair of the federal advisory committee to the study from 2005–2010. In the academic area, he has published and lectured extensively in many areas of perinatal medicine and has been a pioneer in the field of bioeth- ics, emphasizing the rights of individual patients and the responsibilities of health-care professionals and organizations. This work has resulted in more than 150 publications in peer-reviewed journals and book chapters, includ- ing a book edited with Robert Cassidy, entitled pediatric Ethics—From principles to practice, published by Harwood Press. He was a member of the American Academy of Pediatrics Bioethics and AIDS Committees, a member of the National Human Research Protec- tions Advisory Committee for the Office for Human Research Protections of the Department of Health and Human Services, an expert advisor to the Institute of Medicine’s Committee on Ethical Conduct of Clinical Research Involving Children and a member of the National Research Council/Institute of Medicine Committee on Ethical Issues in Housing-Related Health Haz- ard Research Involving Children, Youth, and Families. He was a founding member and is currently still a member of the New York State Governor’s Task Force on Life and the Law, and a member of the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections’ Subcommittee on Research Involving Children. Alissa Johnson is a consultant with Johnson Policy Consulting (JPC) where she examines and reports on health policy issues for the public, private, and non-profit sectors. On behalf of clients, Ms. Johnson has explored policy issues around newborn screening, genetic discrimination, genetic privacy, and e-health. Prior to starting JPC in January 2008, she was a Program Principal with the National Conference of State Legislatures’ (NCSL’s) Health Program. At NCSL Ms. Johnson served state legislators and legisla- tive staff and managed the organization’s Genetic Technologies Project. Ms. Johnson holds bachelor’s and master’s degrees in political science. Sharon kardia, Ph.D., is Professor and Chair of Epidemiology at the Uni- versity of Michigan. She is Director of the Public Health Genetics Program, co-Director of the Michigan Center for Genomics and Public Health, and Director of the Life Sciences & Society Program housed in the University of Michigan School of Public Health. Dr. Kardia received her doctoral degree in human genetics from the University of Michigan, was a post- doctoral fellow in the Department of Microbiology and Immunology and continued postdoctoral work in the Department of Human Genetics. Dr. Kardia’s main research interests are in the genomic epidemiology of cardio- vascular disease and its risk factors. She is particularly interested in gene– environment, gene–gene interactions and in modeling complex relationships

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 USING RESIDUAL NEWbORN SCREENING SAMpLES among genetic variation, environmental variation, and risk of common chronic diseases. Her work also includes using gene expression and pro- teomic profiles for molecular classification of tumors and survival analysis in lung and ovarian cancers. As a part of her center’s activity, Dr. Kardia is also actively working on moving genetics into chronic disease programs in state departments of health. Dr. Kardia was a member of three National Academy of Sciences committees (Genomics and the Public’s Health in the 21st Century; Assessing Interactions Among Social, Behavioral, and Genetic Factors and Health; and Applications of Toxicogenomics Technologies to Predictive Toxicology). kenneth Pass, Ph.D., was Director of the New York State Newborn Screen- ing Program for 28 years. During that time he introduced screening for biotinidase deficiency, congenital adrenal hyperplasia (CAH), and Krabbe disease. The program was the first to use a call-in system by which physi- cians could obtain test results on any day at any time, the first to provide a portion of the specimen form for the mother to facilitate acquisition of test results, the first to implement HIV testing of all newborns, and the first to test for the lysosomal storage disorders. He has published more than 80 peer-reviewed papers and eight book chapters and has delivered lectures all over the world on many different aspects of newborn blood screening. With funding from the National Institute of Child Health and Human Development he has developed multiplex assays that screen for congenital hypothyroidism/cystic fibrosis/CAH (5-plex), severe combined immunodefi- ciency (2-plex), and autism (7-plex), all using a single 3-mm spot. Currently his laboratory is developing a multiplex assay for hemoglobin variants that can be added to each of the above, thereby allowing calculation of the hematocrit and normalization of test results. Sharon Terry is President and CEO of the Genetic Alliance, a coalition of more than 600 disease-specific advocacy organizations working to increase capacity in advocacy organizations and to leverage the voices of the millions of individuals and families affected by genetic conditions. She is the founding Executive Director of PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE). She is at the forefront of consumer participation in genetics research, services, and policy and serves as a member of many of the major governmental advisory com- mittees on medical research, including the Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee and the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children. She is a member of the board of directors of the Biotechnology Institute and on the advisory board of the Johns Hopkins Genetics and Pub- lic Policy Center funded by the Pew Charitable Trusts. She is the chair of the

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 AppENDIX b Coalition for Genetic Fairness, composed of advocates, health-care provid- ers, and industry working to enact effective federal policy to prohibit genetic information discrimination. She is also chair of the Social Issues Committee of the American Society of Human Genetics. In 2005 she received an hon- orary doctorate from Iona College for her work in community engagement and haplotype mapping. Ms. Terry is a co-founder of the Genetic Alliance Biobank and serves as president of its board. It is a centralized biological and data (consent/clinical/environmental) repository catalyzing translational genomic research on rare genetic diseases. The BioBank works in partnership with academic and industrial collaborators to develop novel diagnostics and therapeutics to better understand and treat these diseases. Along with the other co-inventors of the gene associated with PXE (ABCC6), she holds the patent for the invention. She co-directs a 19-lab research consortium and manages 52 offices worldwide for PXE International. Ann Waldo, J.D., joined Genetic Alliance in November 2009 as Senior Counsel. She advises on public policy matters, including privacy, gene pat- enting, genetic discrimination, newborn screening, and health information technology. She also serves as Partner in the law firm of Oldaker, Belair & Wittie, LLP, providing counsel and advocacy on privacy and informa- tion management, with special focus on the Health Insurance Portability and Accountability Act (HIPAA) and consumer protection health privacy. Ms. Waldo has extensive experience in privacy. She served as Global Chief Privacy Officer for Lenovo, a worldwide computer manufacturer, where she led privacy compliance in human resources, marketing, and product development and served as a public policy advocate on national and inter- national privacy issues. She was also the Chief Privacy Officer at Hoffmann- La Roche, handling privacy compliance and best practices in U.S. marketing, human relations, HIPAA, and clinical research. She was actively involved with the International Pharmaceutical Privacy Consortium. She worked in public policy at GlaxoSmithKline, providing legislative support on privacy, infectious disease, and other health policy issues. Previously she served as in-house counsel at IBM, working on consumer protection, marketing, and e-business. Before working at IBM, she had been a commercial litigator and had handled tax legislation for the Ohio Legislative Service Commission. A frequent public speaker, Ms. Waldo is active in the International Associa- tion of Privacy Professionals and the Carolina Privacy Officials Network, has consulted with foreign governments regarding privacy laws, and has represented the U.S. government in APEC privacy talks in Korea and Australia. She is a Certified Information Privacy Professional. Ms. Waldo graduated from the University of North Carolina School of Law with high honors in 1995. A member of Phi Beta Kappa, she holds a B.A. degree in religion from Ohio Wesleyan University (summa cum laude).

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