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 and founding Director of the University of Washington’s Women’s Health Care Center. She was appointed Chair of the Department of Medical History (now the Department of Bioethics and Humanities) in October 2000. She is also an adjunct professor of medicine and epidemiology and a member of the Fred Hutchinson Cancer Research Center. She is a member of the Institute of Medicine and the Association of American Physicians, and is a past President of the American Society of Human Genetics. Dr. Burke’s research addresses the social, ethical, and policy implications of genetics, including responsible conduct of genetic and genomic research, genetic test evaluation, and implications of genomic health care for underserved populations. She is director of the University of Washington Center for Genomics and Healthcare Equality, a National Human Genome Research Institute Center of Excellence in Ethical, Legal, and Social Implications research, and co-director of the Northwest-Alaska Pharmacogenomic Research Network.

Nicholas Conti, Ph.D., M.B.A., is Vice President, Business Development for Quest Diagnostics. He is responsible for licensing and technology transac-



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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 Asso- ciate Director of the Internal Medicine Residency Program and founding Director of the University of Washington’s Women’s Health Care Center. She was appointed Chair of the Department of Medical History (now the Department of Bioethics and Humanities) in October 2000. She is also an adjunct professor of medicine and epidemiology and a member of the Fred Hutchinson Cancer Research Center. She is a member of the Institute of Medicine and the Association of American Physicians, and is a past President of the American Society of Human Genetics. Dr. Burke’s research addresses the social, ethical, and policy implications of genetics, including responsible conduct of genetic and genomic research, genetic test evalua- tion, and implications of genomic health care for underserved populations. She is director of the University of Washington Center for Genomics and Healthcare Equality, a National Human Genome Research Institute Center of Excellence in Ethical, Legal, and Social Implications research, and co- director of the Northwest-Alaska Pharmacogenomic Research Network. Nicholas Conti, Ph.D., M.B.A., is Vice President, Business Development for Quest Diagnostics. He is responsible for licensing and technology transac- 69

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70 GENOME-BASED DIAGNOSTICS tions as well as the development and management of strategic alliances for the company. He has led licensing efforts which have resulted in licensing dozens of new technologies that have been developed into new clinical assays. Dr. Conti joined Quest Diagnostics in 2006. Prior to joining the company, he was Vice President, Business Development, for Becton Dick- inson. Dr. Conti started his career at Union Carbide as a scientist engaged in catalysis research for their plastics division. Dr. Conti is a graduate of Notre Dame with a bachelor’s degree in chemistry. He received his Ph.D. in chemistry from the University of Florida and his M.B.A. from the Wharton School. Additionally, Dr. Conti is an Overseas Fellow of the Royal Society of Medicine. Russel K. Enns, Ph.D., is the Chief Regulatory Officer of Cepheid oversee- ing staff and departments in Regulatory, Clinical and Government Affairs and Quality Systems and Compliance. He has been at Cepheid since June 2003. From 2001 to 2003 he was Divisional Vice President of Regulatory and Clinical Affairs, Quality Systems and Medical Reimbursement at Vysis (wholly owned by Abbott Laboratories), a genomic disease management company. Prior to the Abbott acquisition he served the same functions as above since 1995. Before joining Vysis, he was Vice President, Technical Affairs of MicroProbe Corporation, from 1992 to 1995. MicroProbe was sold to Becton Dickinson in 1995. Before joining MicroProbe, he held vari- ous positions at Gen-Probe, Inc. (a biotechnology diagnostic company), in order of Director of Product Development, Clinical Programs, and Techni- cal Affairs from 1984 to 1992. Dr. Enns was the Director of Cell Biology R&D at Alpha Therapeutics Corporation from 1979 to 1984. From 1975 to 1979 he was a Senior Research Biochemist at Monsanto Corporation. He received his Ph.D. in biochemistry from the University of California, Davis, in 1976. He was a national foundation lecturer for ASM from 1988 to 1989. From 2005 to 2011 he served on the Clinical and Laboratory Stan- dards Institute Board of Directors, and he was a co-founder and chair of its Area Committee on Molecular Methods from 1992 and 1998 to 2005, respectively. Dr. Enns has helped introduce approximately 35 different molecular diagnostic products and platforms through the in vitro diagnostic process at the Food and Drug Administration (FDA) since 1985, including infectious disease, oncology, and genetic tests. Mark Gorman is Director of Survivorship Policy for the National Coalition for Cancer Survivorship (NCCS). He is a long-term survivor of metastatic melanoma. His work with NCCS focuses on advocacy for quality cancer care for all people touched by cancer. NCCS looks to the six aims of quality identified in Crossing the Quality Chasm for a framework for its advocacy. He has served on the EGAPP Stakeholders Group, the External Stakehold-

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71 APPENDIX B ers Advisory Group for the CANCERGEN project, and as consumer faculty for the Accelerating Anti-Cancer Agent Development and Validation Work- shop. He is also an FDA Patient Consultant for Melanoma. Alberto Gutierrez, Ph.D., is the Director of FDA’s Office of In Vitro Diag- nostic Device Evaluation and Safety. Dr. Gutierrez received a bachelor’s degree from Haverford College, and master and doctorate degrees in chem- istry from Princeton University. Dr. Gutierrez has over 10 years of expe- rience in research in the area of structural organic and organometallic chemistry. Dr. Gutierrez joined FDA in 1992 as researcher and reviewer in FDA’s Center for Biologics Evaluation and Research working on vac- cine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he joined the Office of In Vitro Diagnostic Device Evaluation and Safety as a scientific reviewer, becoming a Team leader for Toxicology in 2003, Director of the Division of Chemistry and Toxicology Devices in 2005, Deputy Director of the Office of In Vitro Diagnostic Devices in 2007, and Director in 2009. Daniel F. Hayes, M.D., is the Clinical Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center (UM CCC), where he is the Stuart B. Padnos Professor of Breast Cancer Research. He received a bachelor’s degree (1974) and a master’s degree (1977) at Indiana University. He received his M.D. from the Indiana Uni- versity School of Medicine in 1979, followed by a residency in internal medicine at the University of Texas Health Science Center at Dallas, Texas (hence renamed University of Texas Southwestern Medical Center at Dallas; Parkland Memorial and affiliated hospitals). He served a fellowship in med- ical oncology from 1982 to 1985 at Harvard’s Dana Farber Cancer Institute (DFCI) in Boston. In 1992, he assumed the role of the Medical Director of the Breast Evaluation Center at DFCI. He held that title until 1996, when he moved to the Georgetown University Lombardi Cancer Center. In 2001, Dr. Hayes joined the UM CCC and continues treating patients and doing research in translational science. Dr. Hayes and colleagues published the first reports concerning the development of the CA15-3 blood test, which is currently used worldwide to evaluate patients with breast cancer. He has become an internationally recognized leader in the use of this and other tumor markers, such as HER-2, circulating tumor cells, and phar- macogenomics. In 2007, he was awarded the American Society of Clinical Oncology’s (ASCO) Gianni Bonadonna Breast Cancer Award. He is Chair of the Breast Cancer Translational Medicine Committee of the Southwest Oncology Group (SWOG), Chair of the Correlative Sciences Committee of the U.S. Breast Cancer Intergroup, and co-chairs the Expert Panel for

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72 GENOME-BASED DIAGNOSTICS Tumor Marker Practice Guidelines for ASCO. In 2011, he was elected to the ASCO Board of Directors (2011-2014). Louis Hochheiser, M.D., is Medical Director for Clinical Policy Develop- ment in the Clinical Guidance Organization for Humana, Inc., in Louis- ville, Kentucky. In this position, he provides leadership for the technology assessment process, policy implementation, strategy for molecular diag- nostics, and oversight for medical director reviews. He earned his B.A. (1958) from the University of Pennsylvania in Philadelphia, and his M.D. in 1962 from the New Jersey Medical College in Newark, New Jersey. He conducted his rotating internship at the U.S. Naval Hospital in St. Albany, New York; completed his residency in pediatrics at Kaiser Hospital in San Francisco, California; and did a fellowship in community pediatrics at the University of Rochester in New York. Additionally, he served as a Lieuten- ant in the U.S. Navy. His background includes 17 years as Chairperson of Family Medicine, first at Brown University and then the University of Ver- mont, where he holds the position of professor emeritus. He has published abstracts, journal articles, and book chapters, as well as lectured extensively on the topics of pediatric health, quality of care, nurse practitioner educa- tion, and family dynamics. He is also professor emeritus at the University of Vermont and the Medical Director Clinical Policy Development for Humana, Inc., in Jackson, Wyoming. Louis B. Jacques, M.D., joined the Centers for Medicare & Medicaid Services (CMS) in 2003 and has been director of the Coverage and Analy- sis Group (CAG) since October 2009. The group reviews evidence and develops Medicare national coverage policies. From 2004 through 2009 he was Director of the Division of Items and Devices within CAG. Prior to his arrival at CMS, Dr. Jacques was the Associate Dean for Curriculum at Georgetown University School of Medicine, where he retains a faculty appointment. He served on a number of university committees including the Executive Faculty, Committee on Admissions, and the Institutional Review Board. He previously worked in the Palliative Care program at Georgetown’s Lombardi Cancer Center, where he covered the gynecologic oncology service and he made home visits as a volunteer physician for a rural hospice on the Maryland Eastern Shore. Muin Khoury, M.D., Ph.D., is the first Director of the Centers for Disease Control and Prevention’s (CDC’s) National Office of Public Health Genom- ics. The Office was formed in 1997 to assess the impact of advances in human genetics and the Human Genome Project on public health and dis- ease prevention. CDC’s National Office of Public Health Genomics serves as the national focus for integrating genomics into public health research

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73 APPENDIX B and programs for disease prevention and health promotion. Dr. Khoury joined CDC as an Epidemic Intelligence Service Officer in 1980 in the Birth Defects and Genetic Diseases Branch, and as a medical epidemiologist in 1987. In 1990, he became Deputy Chief of the same branch. In 1996, Dr. Khoury chaired a CDC-wide Task Force on Genetics and Disease Preven- tion and provided important leadership in outlining a plan delineating the future direction that CDC should take in this important area. Dr. Khoury received his B.S. degree in biology and chemistry from the American Univer- sity of Beirut, Lebanon, and his medical degree and pediatrics training from the same institution. He received a Ph.D. in human genetics and genetic epi- demiology and training in medical genetics from Johns Hopkins University. Dr. Khoury is board certified in medical genetics. Dr. Khoury has published extensively in the fields of genetic epidemiology and public health genetics and is a member of many professional societies and serves on the editorial boards of several journals. He is an adjunct professor of epidemiology at Emory’s School of Public Health and an associate in the Department of Epi- demiology at Johns Hopkins University Bloomberg School of Public Health. Debra Leonard, M.D., Ph.D., received her M.D. and Ph.D. from the New York University School of Medicine, and is currently Professor and Vice Chair for Laboratory Medicine in the Department of Pathology and Laboratory Medicine, and Director of the Clinical Laboratories for New York-Presbyterian Hospital’s Cornell campus (NYPH-WCMC). She is also Director of the Pathology Residency Training Program at NYPH-WCMC. Dr. Leonard was previously Director of Molecular Pathology at the Uni- versity of Pennsylvania School of Medicine and is a nationally recognized expert in Molecular Pathology. She has served on several national commit- tees that develop policy for the use of genetic and genomic technologies and information, including most recently the Secretary’s Advisory Committee on Genetics, Health and Society that advises the Secretary of Health and Human Services. Dr. Leonard is editor of two molecular pathology text- books and has spoken widely on various molecular pathology test services, the future of molecular pathology, and the impact of gene patents on molec- ular pathology practice. Dr. Leonard is interested in the use of genomic technologies in the practice of medicine to improve patient outcomes. Robert McCormack, Ph.D., is currently Head of Technology Innovation and Strategy for Veridex, LLC. He was formerly the Director of Technol- ogy Assessment of Ortho-Clinical Diagnostics, which focused on novel cellular and molecular cancer technology. In 2005 he assumed the role of Vice President of Scientific and Medical Affairs at Veridex, LLC, a Johnson & Johnson startup dedicated to the development and commercialization of novel cancer diagnostic tests. His group successfully conducted clinical

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74 GENOME-BASED DIAGNOSTICS trials to launch the first molecular test for assessing axillary nodal status in women diagnosed with breast cancer. Prior to this position, in 2001 he was appointed General Manager of the Cellular Diagnostics Group at Veridex. The Cellular Diagnostics Group successfully launched their first product in 2004 for the detection and enumeration of circulating tumor cells in patients with metastatic breast cancer. He joined Johnson & Johnson in 1998 as Vice President of Clinical Affairs for Ortho-Clinical Diagnostics. Under his direction, Ortho-Clinical Diagnostics became the first diagnostics company to gain FDA approval for hepatitis assay testing on random access automation for clinical laboratories. In 1995 he joined Sanofi Diagnostics Pasteur as Director of Clinical and Regulatory Affairs, and Worldwide Group Leader for cancer diagnostics. Dr. McCormack spent his early career in genetic, molecular, and cellular research at the University of Minnesota, 3M, and Hybritech. He transitioned to clinical and regulatory affairs at Hybritech and was part of the team that successfully gained FDA approval for prostate-specific antigen (PSA) in the early detection of prostate cancer. Dr. McCormack received his B.S. degree in medical technology from the University of Wisconsin, River Falls, and his M.S. and Ph.D. degrees from the University of Minnesota in hematology and immunology, respectively. Bruce Quinn, M.D., Ph.D., is a national expert on Medicare policy, the impact of health reform on innovation, and the crafting of successful busi- ness strategies within the U.S. health care reimbursement system. Dr. Quinn has worked successfully with both large and small companies in overcoming hurdles to commercialization through negotiation, understanding insightful ways to use the existing system to advantage, and the mechanisms of policy change. Since 2008, Dr. Quinn has been a full-time business strategist work- ing with attorney and policy teams for health care and life sciences clients in the firm’s Government Strategies practice. Dr. Quinn travels nationwide to speak on health reform issues and publishes actively, recently writing two peer-reviewed policy articles on advanced diagnostics. Before joining Foley Hoag LLP, he was the regional Medicare medical director for the California Part B program. Earlier in his career, Dr. Quinn was a physician executive in the Health & Life Sciences division of Accenture, working with the pharma, biotech, and genomics industries. Dr. Quinn is a board-certified pathologist. As a physician-scientist on the faculty of Northwestern University School of Medicine, he led pathology research for Northwestern’s National Institutes of Health–funded Alzheimer Research Center. Earlier, he also held academic positions at New York University School of Medicine and the UCLA Center for Health Sciences and is the author or co-author on 30 scientific publica- tions, including two 2010 publications on personalized medicine policy. He also holds an MBA from the Kellogg School of Northwestern University.

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75 APPENDIX B Steven Shak, M.D., has served as Chief Medical Officer with Genomic Health, Inc., since 2000. Under Dr. Shak’s leadership Genomic Health used innovative molecular diagnostic methods and rigorous clinical studies to develop the Oncotype DX® breast cancer and colon cancer assays and has maintained an 80 percent product development success rate. Dr. Shak has been a leader in personalized medicine for more than two decades. Prior to co-founding Genomic Health in 2000, he served for 14 years in vari- ous roles in Discovery Research and Medical Affairs at Genentech, Inc., a biotechnology company dedicated to using human genetic information to discover, develop, manufacture, and commercialize medicines to treat patients with serious or life-threatening medical conditions. He led the clini- cal team that gained approval for Herceptin®, a targeted biologic treatment for breast cancer. He also initiated the cancer clinical trials of the anti- angiogenesis agent Avastin®. In addition, Dr. Shak discovered Pulmozyme®, a mucus-dissolving enzyme that is approved worldwide for the treatment of the genetic disease cystic fibrosis. Prior to joining Genentech, he was an assistant professor of medicine and pharmacology at New York University School of Medicine. Dr. Shak holds a bachelor of arts degree in chemistry from Amherst College and an M.D. from New York University School of Medicine, and completed his postdoctoral training at the University of California, San Francisco. Susan E. Siegel, M.S., is a General Partner at Mohr, Davidow, a leading Silicon Valley venture firm. Ms. Siegel leads investments in companies involved in personalized medicine, digital health, and life sciences, tools, and molecular diagnostics. Prior to her venture capital career, Ms. Siegel spent more than 20 years as a corporate leader growing biomedical compa- nies through the commercialization of breakthrough technologies, including Bio-Rad, DuPont, Amersham (now GE), and Affymetrix. As President and Director of Affymetrix, Inc., Ms. Siegel focused on customer engagement and building shareholder value, leading Affymetrix growth to a multibil- lion-dollar market cap company. As a leading genomic company, Affyme- trix accelerated the advent of personalized medicine. Ms. Siegel serves as a board member for Pacific Biosciences, Crescendo Bioscience, Corventis, Navigenics, On-Q-ity, Newtco, Analyte Health, Personalis, and RainDance Technologies. She also serves on DELL’s Healthcare and Life Sciences Advi- sory Board. In addition, Ms. Siegel is a member of the Presidents’ Circle of the National Academies, sits on the Stanford Medical School’s ITI Council, and is a member of the Santa Clara University Center for Science, Technol- ogy, and Society Board. Ms. Siegel was elected as a Henry Crown Fellow of the Aspen Institute, is a member of the Young Presidents Organization and of Women Corporate Directors. Ms. Siegel co-founded with Stanford Hospital, Checking-In™, an organization dedicated to serving the local

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76 GENOME-BASED DIAGNOSTICS aging population. She is Board Member Emeritus of the Silicon Valley Tech Museum and of the Gladstone Advisory Council. Sean R. Tunis, M.D., M.Sc., is the Founder and Director of the Center for Medical Technology Policy (CMTP) in Baltimore, Maryland. CMTP’s main objective is to improve the quality, relevance, and efficiency of clini- cal research by providing a neutral forum for collaboration among experts, stakeholders, and decision makers. Dr. Tunis was a member of the Institute of Medicine Committee on Initial National Priorities for Comparative Effectiveness Research. He advises a wide range of domestic and interna- tional public and private health care organizations on issues of comparative effectiveness, evidence-based medicine, clinical research, reimbursement, and health technology policy. Through September 2005, Dr. Tunis was the Chief Medical Officer at CMS, where he had lead responsibility for clinical policy for the Medicare and Medicaid programs. Previously he served as the Director of the Health Program at the Congressional Office of Technol- ogy Assessment and as a health policy advisor to the U.S. Senate, where he worked on pharmaceutical and device policy issues. Dr. Tunis trained at UCLA and at the University of Maryland in internal medicine and emer- gency medicine, and holds adjunct faculty positions at the Center for Health Policy at Stanford University, the Department of Internal Medicine at the Johns Hopkins School of Medicine, and the Department of Surgery at the University of California, San Francisco. Laura J. van ‘t Veer, Ph.D., is a professor of laboratory medicine, Leader of the Breast Oncology Program, and Director of Applied Genomics with the University of California, San Francisco Department of Pathology and Laboratory Medicine. She specializes in Breast Cancer and Applied Genom- ics. Dr. van ‘t Veer cofounded Agendia B.V. in 2003 and serves as its Chief Research Officer. She served as Chief Operating Officer of Agendia B.V. until June 12, 2007. Dr. van ‘t Veer served as the Head of the DNA- diagnostic laboratory of the Netherlands Cancer Institute (NKI) and also serves as a staff member of the Department of Molecular Pathology. She has 20 years of experience in molecular oncology research. She served as the Head of the Family Cancer Clinic of NKI for 10 years. She developed Agendia’s MammaPrint® gene expression profiling service. She served as a Member of Group Counsel of Batenburg Beheer NV. She serves as a Direc- tor of the American Association for Cancer Research. She has published more than 80 papers in peer-reviewed journals.