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Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine (2016)

Chapter: Appendix A: Committee Member and Staff Biographies

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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
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Appendix A

Committee Member and Staff Biographies

COMMITTEE MEMBER BIOGRAPHIES

Harold L. Moses, M.D. (Chair), was chair of the Department of Cell Biology at Vanderbilt for 13 years. He is now the acting chair of the Department of Cancer Biology. He was the founding director of the Vanderbilt-Ingram Cancer Center, which he led for 12 years; he is now director emeritus. He has served as president of the American Association for Cancer Research (AACR), president of the Association of American Cancer Institutes, chair of the National Institutes of Health Chemical Pathology Study Section, chair of the Molecular Oncogenesis Study Section, a member of the Integration Panel for the U.S. Army Breast Cancer Program, co-chair of the Breast Cancer Progress Review Group for the National Cancer Institute (NCI), and chair of the NCI Cancer Centers review panel. He is a member of the National Academy of Medicine and was founding chair of the National Academies of Sciences, Engineering, and Medicine’s National Cancer Policy Forum, 2005 to 2011. Dr. Moses is a graduate of Berea College and Vanderbilt University School of Medicine.

Trained as a pathologist, Dr. Moses has devoted much of his career to basic research on growth factors and tumor suppressor genes and has received many awards for his research. These include two Outstanding Investigator Awards from the NCI, the Esther Langer Award for Meritorious Cancer Research from the University of Chicago, the Rous-Whipple Award from the American Association of Pathologists, the John H. Exton Award for Research Leading to Innovative Biological Concepts, the Harvey Branscomb Distinguished Professor Award, the Nakahara

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
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Memorial Lecture Award from the Princess Takamatsu Cancer Research Fund, the T.J. Martell Foundation Lifetime Medical Research Award, the Earl Sutherland Prize for Achievement in Research, the Grant W. Liddle Award for Promoting an Interest in Research Among Physicians, the T.J. Martell Lifetime Scientific Achievement Award, and the AACR Lifetime Achievement in Cancer Research Award. He also has been elected Fellow of the AACR Academy. He is chair the Board of Trustees of Berea College, a position he will hold for the next 2 years.

John M. Carethers, M.D., is the John G. Searle Professor and Chair of the Department of Internal Medicine at the University of Michigan. As chair, he oversees more than 700 paid faculty in their academic, clinical, and teaching roles as they relate to the overall integration with the health system’s missions of clinical excellence, education, and discovery. Dr. Carethers is a trained gastroenterologist and physician–scientist who focuses his research in the area of hereditary colon cancer genetics.

Dr. Carethers received his B.S. in Biological Sciences with a minor in Chemistry from Wayne State University, and his M.D. with high distinction from the same institution. Dr. Carethers did his internship and residency in Internal Medicine at Massachusetts General Hospital, followed by a fellowship in gastroenterology at the University of Michigan. He was then recruited to the University of California, San Diego (UCSD), where he grew his laboratory-based research in the area of DNA mismatch repair and colorectal cancer pathogenesis; and he saw medicine and gastroenterology patients, including serving as the main physician for hereditary colon cancer referrals in Southern California. He served in leadership roles, including the gastroenterology fellowship director, the gastroenterology section chief for the San Diego Veterans Affairs Hospital, then division chief for UCSD, before being recruited to Michigan. He was the founding director of the National Institutes of Health (NIH)-funded UCSD Gastroenterology Center grant, and was the director of the gastroenterology T32 training grant. His laboratory research continues to be funded by NIH. Dr. Carethers also has interests in colorectal cancer disparities as they relate to genetics and outcomes. He is the former Principal Investigator of the San Diego State University/UCSD Cancer Center Comprehensive Partnership U54 grant, which addresses cancer disparities.

Dr. Carethers has published more than 150 manuscripts and book chapters. He is a senior associate editor for Gastroenterology, the highest impact gastroenterology journal. He completed a 2-year appointment on the National Commission for Digestive Diseases, a U.S. Congressional Commission, after his appointment by Elias Zerhouni, M.D., then director of NIH. He was elected a member of the American Society for Clinical

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
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Investigation and the American Association of Physicians (AAP), and serves on the AAP Council. He was elected a member of the National Academy of Medicine in 2012.

Molly Cooke, M.D., professor of medicine, is the inaugural director of education for Global Health Sciences across the five schools (Medicine, Dentistry, Pharmacy, Nursing, and the Graduate Division) at the University of California, San Francisco (UCSF). She is charged with developing a portfolio of high-impact educational programs for UCSF students, residents, fellows, post-docs, and faculty members and devising innovative and high-value ways to share UCSF’s expertise in discovery science, health care delivery, professional education, and basic science with international partners.

Dr. Cooke has been active in medical education program development and educational research throughout her career. A distinguished teacher, Dr. Cooke has received numerous teaching awards including, in 2006, the AOA/Robert J. Glaser Distinguished Teacher Award from the Association of American Medical Colleges. As a senior scholar of the Carnegie Foundation for the Advancement of Teaching, she co-directed a national study of medical education. This work culminated in the text, Educating Physicians: A Call for Reform of Medical School and Residency (2010). Dr. Cooke has used education and faculty development to address the health problems of underserved populations throughout her career. A founding faculty member of the internal medicine residency at San Francisco General Hospital–UCSF, she developed graduate medical education curricula focused on the care of the urban underserved. She serves on the Training Advisory Committee of the University of Zimbabwe Medical Education Partnership Initiative and is a member of the Scientific Advisory Board of Accordia Global Health Foundation and the Infectious Diseases Institute of Makerere University, Kampala.

Dr. Cooke is a practicing internist with a special interest in HIV and other complex chronic illnesses. She has been repeatedly selected by her peers as one of “America’s Best Doctors.” She is active in the American College of Physicians, serving as governor of the Northern California chapter of the American College of Physicians from 2004 to 2009, regent from 2009 to 2014, president-elect from 2012 to 2013, and president of the College from 2013 to 2014. Dr. Cooke is a graduate of Stanford University and received her M.D. from Stanford University School of Medicine. She did her residency training at UCSF, where she also served as chief resident in medicine and did a Henry J. Kaiser Family Foundation Fellowship focusing on ethics. She was elected to the National Academy of Medicine in 2013.

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

Garret A. FitzGerald, M.D., professor of medicine and pharmacology, is the McNeil Professor in Translational Medicine and Therapeutics at the Perelman School of Medicine at the University of Pennsylvania, where he chairs the Department of Pharmacology and directs the Institute for Translational Medicine and Therapeutics. Dr. FitzGerald’s research has been characterized by an integrative approach to elucidating the mechanisms of drug action, drawing on work in cells, model organisms, and humans. His work contributed substantially to the development of low-dose aspirin for cardioprotection. Dr. FitzGerald’s group was the first to predict and then mechanistically explain the cardiovascular hazard from non-steroidal anti-inflammatory drugs (NSAIDs). He has also discovered many products of lipid peroxidation and established their utility as indexes of oxidant stress in vivo. Dr. FitzGerald’s laboratory was the first to discover a molecular clock in the cardiovascular system and has studied the importance of peripheral clocks in the regulation of cardiovascular and metabolic function.

Dr. FitzGerald has received the Boyle, Coakley, Harvey, and St. Patrick’s Day medals; the Lucian, Scheele, and Hunter Awards; and the Cameron, Taylor, Herz, Lefoulon-Delalande, and Schottstein Prizes. He is a member of the National Academy of Medicine and a Fellow of the American Academy of the Arts and Sciences and of the Royal Society.

Felix W. Frueh, Ph.D., is a respected thought leader in personalized medicine with 20 years of research and development, management, and policy experience. Dr. Frueh is executive partner at Opus Three, LLC, a position he has held since 2012. He provides strategic consulting to pharmaceutical and diagnostic companies on scientific, regulatory, and reimbursement strategies for medical products in the personalized health care space.

From 2014 to July 2015, Dr. Frueh was chief scientific officer (CSO) of Human Longevity, Inc. (HLI). As CSO, Dr. Frueh led all genomic operations, including nonclinical microbiome testing, high throughput, next-generation genomic sequencing, and research collaborations and partnerships, including the program with the University of California, San Diego/Moores Cancer Center. Dr. Frueh was also instrumental in guiding HLI’s collaborations and partnerships with the pharmaceutical and diagnostic industry.

Previously, Dr. Frueh was an entrepreneur-in-residence at Third Rock Ventures, a Boston-based venture capital firm, where he provided scientific and strategic input for the formation of new and the advancement of existing portfolio companies. Before joining Third Rock, Dr. Frueh was president of the Medco Research Institute, leading Medco’s real-world, health economics and outcomes research-oriented initiatives and collaborations after having formed Medco’s personalized medicine research and

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

development organization. Before joining Medco, he was the first associate director for genomics at the Food and Drug Administration (FDA), where he built and led the core genomics review team in the Center for Drug Evaluation and Research, and chaired the first FDA-wide, interdisciplinary pharmacogenomics review group.

Dr. Frueh has been a member of various working groups on genetics and genomics at FDA and the Department of Health and Human Services. He is the recipient of numerous awards, including the FDA Commissioner’s Special Citation. He serves on the board of the Personalized Medicine Coalition and is also a board member at Enterome Biosciences. Dr. Frueh is a Fellow of the American College of Clinical Pharmacology, adjunct faculty member at the Institute for Pharmacogenomics and Individualized Therapy at the University of North Carolina, and held faculty appointments in the Departments of Pharmacology and Medicine at Georgetown University. Dr. Frueh was a Postdoctoral Fellow at Stanford University and the University of Basel in Switzerland, where he also received his Ph.D. in Biochemistry (magna cum laude).

Debra Leonard, M.D., Ph.D., is professor and chair of the Department of Pathology and Laboratory Medicine at the University of Vermont College of Medicine and the University of Vermont Medical Center. Dr. Leonard is a leading expert in molecular pathology and genomic medicine, applying our understanding of the human genome and pathogen genomes to the diagnosis and treatment of human diseases, including inherited disorders, cancers, and infectious diseases. Dr. Leonard is certified by the American Board of Pathology in Anatomic Pathology and by the American Boards of Pathology and Medical Genetics in Molecular Genetic Pathology. She is a member of the National Academies of Sciences, Engineering, and Medicine’s Roundtable on Translating Genomic-Based Research for Health. She is past chair of the Personalized Healthcare Committee of the College of American Pathologists. She previously served as a member of the Advisory Committee on Genetics Health and Society to Secretary of Health and Human Services Michael O. Leavitt, and was chair of the Stakeholders Group of the Centers for Disease Control and Prevention Program Evaluating Genomic Applications in Practice and Prevention. She has spoken widely on various molecular pathology testing services, the future of molecular pathology and the impact of gene patents on molecular pathology practice.

Dr. Leonard did her undergraduate education at Smith College and her medical and scientific training at New York University School of Medicine. She started her faculty career at Case Western Reserve University School of Medicine, where she was director of the Molecular Diagnostics Laboratory, and moved to the University of Pennsylvania

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

School of Medicine as director of the clinical Molecular Pathology Laboratory and director of the Molecular Diagnosis and Genotyping Core Facility at the Abramson Cancer Center. Prior to joining the University of Vermont, Dr. Leonard was at Weill Cornell Medical College and New York-Presbyterian Hospital-Weill Cornell Medical Center, where she was professor and vice chair for Laboratory Medicine in the Department of Pathology and Laboratory Medicine and director of Clinical Laboratories. She also served as chief diversity officer for Weill Cornell Medical College from 2009 through 2012. Dr. Leonard was a 2003 Fellow at the Executive Leadership in Academic Medicine Program at Drexel University. She is a member of the College of American Pathologists and a founding member of the Association for Molecular Pathology, serving as president in 2000 and receiving its Leadership Award in 2009. She is editor of 2 textbooks of molecular pathology and has published more than 80 peer-reviewed articles, book chapters, and reviews.

Gary H. Lyman, M.D., M.P.H., is co-director of the Hutchinson Institute for Cancer Outcomes Research and member of the Public Health Sciences and Clinical Research Divisions at the Fred Hutchinson Cancer Research Center. He is also an adjunct professor in the School of Pharmacy and the School of Public Health at the University of Washington as well as professor of medicine in the Department of Medicine in the University of Washington School of Medicine. Dr. Lyman is a medical oncologist and hematologist and a member of the Breast Cancer Program at the Seattle Cancer Care Alliance. He was most recently director of Comparative Effectiveness and Outcomes Research–Oncology at Duke University and the Duke Cancer Institute, where he also served as professor of medicine in the Duke University School of Medicine and a Senior Fellow at the Duke Center for Clinical Health Policy Research. In addition to his training in Internal Medicine at University of North Carolina at Chapel Hill and Hematology/Oncology at Roswell Park Cancer Institute, Dr. Lyman was a Postdoctoral Fellow in Biostatistics at the Harvard School of Public Health.

Dr. Lyman is active with the American Society of Clinical Oncology (ASCO), serving on the ASCO Board of Directors, co-chair of the Breast Cancer and Survivorship Guideline Advisory Groups as well as chair of the Guideline Methodology Committee and several individual clinical practice guidelines. Dr. Lyman is also a member of the ASCO Research Committee, Biomarkers Guideline Working Group, the Comparative Effectiveness Research Task Force, the Global Oncology Leadership Task Force, and the Value of Cancer Care Task Force, contributing to development of ASCO’s Top Five as a part of the American Board of Internal Medicine Choosing Wisely Campaign. He is a member of the Committee

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

on Educational Affairs for the American Society of Hematology. He is editor-in-chief of Cancer Investigation and on the editorial board of the Journal of Clinical Oncology and several other specialty journals. He is an active grant reviewer for the National Cancer Institute, Conquer Cancer Foundation, American Association for Cancer Research, and Canadian Institute of Health Research.

Dr. Lyman’s research interests include comparative effectiveness and outcomes research related to targeted therapies and biomarkers, efforts to integrate health economics into evidence-based medicine, health policies, and real-world research paradigms. His research group is also engaged in advanced methods of evidence synthesis in support of clinical practice guidelines and population studies of patterns of cancer treatment and the impact of health disparities on the quality of cancer care. Dr. Lyman has authored or edited more than 15 books and more than 450 articles in scientific literature.

Robert L. Nussbaum, M.D., joined Invitae, a genetic information and testing company based in San Francisco, as Chief Medical Officer in August 2015. Previously, he was co-director of the Program in Cardiovascular Genetics at the University of California, San Francisco (UCSF), Heart and Vascular Center and Medical Director of the Cancer Risk Program of the Helen Diller Family Comprehensive Cancer Center. He is a member of the UCSF Institute for Human Genetics, where he is studying if and how genetic and genomic information can be used to improve health care by improving outcomes, reducing adverse reactions, lowering costs, and promoting health through risk education.

Dr. Nussbaum is one of the leading medical geneticists in the nation. The focus of his expertise in genomics medicine is on the interpretation of genomic data and its use for patient care decision making in the clinical setting. As the director of the UCSF Genomic Medicine Initiative, he is exploring ways of applying genomics to clinical care at UCSF. For example, he launched and supports a project at UCSF Medical School to sequence DNA from tumors and use the genomic data to identify patients most likely to benefit from targeted therapies. He also helped establish an undiagnosed diseases clinic in which whole exome sequencing is being used to make diagnoses in patients with puzzling, likely genetic disorders. Dr. Nussbaum is interested in establishing partnerships among clinics, laboratories, and institutions that create and maintain electronic medical records regarding the collection and storage of genomics data.

Dr. Nussbaum also conducts research on Parkinson’s disease to understand what causes the disorder and to develop treatments to prevent, slow, or stop its progression. A member of the National Academy of Medicine and a former president of the American Society of Human

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

Genetics, Dr. Nussbaum was co-discoverer of the first inherited form of Parkinson’s disease. Prior to joining UCSF, he was chief of the Genetic Disease Research Branch of the National Human Genome Research Institute. Dr. Nussbaum served a full term as a member of the National Academies of Sciences, Engineering, and Medicine’s Roundtable on Translating Genomic-Based Research for Health.

Rebecca D. Pentz, Ph.D., is professor of research ethics, Emory University School of Medicine. She specializes in empirical ethics research on genetic testing, confidentiality, biobanking, return of results, duty to warn, and informed consent ethical issues in early drug development. She has a special interest in pediatric bone marrow transplant and the effect on the family. Before coming to Atlanta, she designed and directed the clinical ethics program at The University of Texas MD Anderson Cancer Center.

Dr. Pentz received her Ph.D. in Philosophy from the University of California. During the early part of her career, she served as a clinical ethicist, helping patients, families, and the health care team at the bedside to resolve ethical dilemmas, working first in the community setting in Yakima, Washington, and then as the sole clinical ethicist at The University of Texas MD Anderson Cancer Center for a decade.

Edith A. Perez, M.D. joined Genentech in August 2015 as vice president and head of all BioOncology US Medical Affairs. Previously, she served as the deputy director at-large for the Mayo Clinic Cancer Center, group vice chair of the Alliance for Clinical Trials in Oncology, and chair of the Breast Cancer Specialty Council formed in 2012; she retains her academic appointment as a professor of medicine at Mayo Medical School and chair of the Mayo Clinic Breast Cancer Translational Genomics Program started in 2009. She is a cancer specialist and an internationally known translational researcher at Mayo Clinic. Her roles extend nationally, including positions with the American Association for Cancer Research, the American Society of Clinical Oncology, and the National Cancer Institute.

Dr. Perez has developed, and is involved in, a wide range of clinical trials exploring the use of new therapeutic agents for the treatment and prevention of breast cancer. She leads and has helped develop basic research studies to evaluate the role of genetic markers in the development and aggressiveness of breast cancer. She has authored more than 700 research articles in journals, books, and abstracts. Dr. Perez is invited frequently to lecture at national and international meetings and serves on the editorial boards of multiple academic journals.

A select list of awards Dr. Perez has received includes Breast Cancer Research Foundation Research Grant Award; Horizon Achievement Award in Cancer Research; Mayo Clinic Outstanding Faculty Award;

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

North Florida Hispanic of the Year Award; Mayo Clinic Distinguished Educator Award; Serene M. and Frances C. Durling Professorship of Medicine; Honorary Doctorate of Letters, University of North Florida; Mayo Clinic Distinguished Investigator; Florida State Biomedical Research Advisory Council; Alpha Omega Alpha Honor Medical Society; Mayo Clinic Outstanding Course Director; EVE Award for Lifetime Achievement; NFL Hispanic Heritage Leadership Award; 1 of the 75 Most Influential People in Jacksonville Healthcare from Jacksonville Magazine’s 904 (2012); The Girls Inc. Woman of Vision Award; Jacksonville University Woman of the Year; the Susan G. Komen® Brinker Award for Scientific Distinction in Clinical Research; the Claude Jacquillat Award; and the OncLive’s Giants of Cancer Care Award.

Jane Perlmutter, Ph.D., M.B.A., is a long-term cancer survivor and has been involved in a number of organizations committed to educating the public about cancer, supporting people affected by it, and eradicating the disease. She is an advocate representative in several clinical trials consortia, multi-institutional grants, clinical guideline committees, grant review panels, and National Cancer Institute working groups. She has also been an active member of the Clinical Trials Transformation Initiative. She is especially committed to training less experienced patient advocates, has written articles and tutorials on this topic, and is often involved in advocate training.

Dr. Perlmutter started her career as an experimental cognitive psychologist at the University of Texas in Austin, and spent most of her career at Bell Labs. She has run the Bell Technical Training Center and held an officer position in DeVry Inc., a publicly traded for-profit higher education company. She currently runs her own consulting company—Gemini Group. Her consulting focuses on process improvement for small businesses, not-for-profits, and institutions of higher learning. She has a Ph.D. in Cognitive Psychology, a master’s in educational psychology, a master’s in computer and information science, and an M.B.A.

Victoria M. Pratt, Ph.D., FACMG, is a medical and clinical molecular geneticist board-certified by the American College of Medical Genetics. She is currently director of the Pharmacogenomics Laboratory at Indiana University School of Medicine. Prior to joining Indiana University, she was chief director, Molecular Genetics, for Quest Diagnostics Nichols Institute. Dr. Pratt served on the Secretary of Health and Human Services Advisory Committee on Genetics, Health, and Society for the Oversight of Genetic Testing, and the Advisory Committee on Hereditary Disorders in Newborns and Children. She also participated in the preparation of the Morbidity and Mortality Weekly Report for Best Practices in Molecular

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

Genetic Testing for the Centers for Disease Control and Prevention (CDC). Dr. Pratt continues to serve on CDC’s GeT-RM program for reference materials for Molecular Genetics. She is now serving on the National Academies of Sciences, Engineering, and Medicine’s Roundtable on Translating Genomic-Based Research for Health.

Dr. Pratt is past chair of the Clinical Practice Committee and currently a member of the Professional Relations committee for the Association of Molecular Pathology. She is an advisory member of EurogenTest for genetic test validation. Dr. Pratt serves on the American Medical Association’s Molecular Pathology Current Procedural Terminology Advisory Committee. Dr. Pratt has authored more than 40 peer-reviewed manuscripts and book chapters. She is also an associate editor for the Journal of Molecular Pathology. She graduated with a Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine. Her fellowship training was in Medical and Clinical Molecular Genetics at Henry Ford Hospital in Detroit.

Yu Shyr, Ph.D., received his Ph.D. in Biostatistics from the University of Michigan (Ann Arbor) and subsequently joined the faculty at Vanderbilt University School of Medicine. At Vanderbilt, he has collaborated on numerous research projects; assisted investigators in developing clinical research protocols; collaborated on multiple grants funded through external peer-reviewed mechanisms; and developed biostatistical and bioinformatic methodologies for clinical trial design, high-dimensional data analysis, and other statistical and bioinformatic approaches, published in journals such as Statistics in Medicine, Bioinformatics, and Clinical Trials in the past 3 years.

Dr. Shyr is a Fellow of the American Statistical Association, an associate editor of JAMA Oncology and a Food and Drug Administration (FDA) advisory committee voting member. He has delivered more than 200 abstracts at professional meetings and has published more than 340 peer-reviewed papers. Dr. Shyr has served on numerous National Institutes of Health (NIH)/National Cancer Institute (NCI) Specialized Program of Research Excellence (SPORE), P01, and Cancer Center Support Grant (CCSG) review panels/committees and has been a member of the invited faculty at the American Association of Cancer Research (AACR)/American Society of Clinical Oncology (ASCO) Methods in Clinical Cancer Research Vail Workshop since 2004. He currently serves on the external advisory board for a dozen national cancer centers, and directs the biostatistics and bioinformatics cores for the NCI-funded Vanderbilt University Breast Cancer SPORE, Gastrointestinal Cancer SPORE, and other program projects. In addition, Dr. Shyr is the Principal Investigator of a U01 grant for the Barrett’s Esophagus Translational Research Network Coordinating

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

Center (BETRNetCC). Dr. Shyr’s current research interests focus on developing statistical bioinformatic methods for analyzing next-generation sequencing data, including a series of papers on estimating the sample size requirements for studies conducting RNA sequencing analysis.

Sean Tunis, M.D., M.Sc., is the founder and director of the independent, nonprofit Center for Medical Technology Policy (CMTP) in Baltimore. CMTP’s main objective is to improve the quality, relevance, and efficiency of clinical 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 collaborates with a wide range of domestic and international public and private health care organizations on issues of comparative effectiveness, health technology assessment, evidence-based medicine, clinical research, reimbursement, and medical technology policy.

Through September 2005, Dr. Tunis was the chief medical officer at the Centers for Medicare & Medicaid Services, where he had lead responsibility for clinical policy and quality for the Medicare program. Previously, he served as the director of the Health Program at the Congressional Office of Technology 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 Stanford University, the University of California, Los Angeles, and the University of Maryland in Internal Medicine, Emergency Medicine, and Health Services Research. He holds adjunct faculty positions at the schools of medicine of Johns Hopkins, Tufts, and the University of California, San Francisco.

Tracey F. Weisberg, M.D., is president of New England Cancer Specialists. Dr. Weisberg joined New England Cancer Specialists (formerly Maine Center for Cancer Medicine) in 1990 and began to establish a breast cancer–specific practice. In the early part of her career, she had a basic science research lab at Maine Medical Center Research Institute and studied tumor biology in severe combined immunodeficiency (SCID) mice. Dr. Weisberg was the medical director of the Maine Medical Breast Care Center from 1994 to 2013.

Dr. Weisberg serves as the president of her regional American Society of Clinical Oncology (ASCO) society, Northern New England Cancer Society. She also sits on the ASCO State Affiliates council and has been asked to serve on the Executive Board. New England Cancer Specialists is a “Vanguard” practice for ASCO’s CancerLinQ project and Dr. Weisberg serves as the representative. New England Cancer Specialists is also a COME HOME practice. Dr. Weisberg currently serves on the Board of Directors of the Hospice of Maine.

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
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INSTITUTE OF MEDICINE (IOM) STAFF BIOGRAPHIES

Laurie Graig, M.A., is a program officer for the National Academies of Sciences, Engineering, and Medicine’s Board on Health Care Services. She is currently the study director for the Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies. Ms. Graig has worked on a broad range of health care systems research and policy issue areas, within for-profit and not-for-profit consulting organizations. Most recently, she participated in an evaluation of state-level improvement partnerships as a consultant to AcademyHealth. Previously, she managed a large, multifaceted project designed to improve the operational efficiency of community health centers using the Lean process improvement methodology. She has contributed to studies and reports in the area of public health planning and emergency preparedness, such as mass casualty events and pandemic influenza. She also worked for more than 10 years in the research and information center of a worldwide management consulting firm and conducted research and analysis of health and retirement issues. Ms. Graig is the author of three editions of Health of Nations: An International Perspective on U.S. Health Care Reform published by CQ Books (1991, 3rd edition). She is a former Peace Corps volunteer, having served in Burkina Faso, West Africa. Ms. Graig received her B.S. from Georgetown University and M.A. from the University of Virginia.

Jonathan Phillips is a research associate for the National Academies of Sciences, Engineering, and Medicine’s Board on Health Care Services. Previously, he worked in clinical research at The University of Texas MD Anderson Cancer Center, providing clinical trial and translational research support for Principal Investigators in the Department of Gastrointestinal Medical Oncology and the Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy. He received a B.A. in Anthropology from Texas A&M University in 2008, and plans to receive his M.P.H. from The George Washington University in 2017.

Sarah E. De Leo, Ph.D., is an American Association for the Advancement of Science Science & Technology Policy Fellow with the Department of Defense. Her primary interests are intellectual property and regulatory issues surrounding state-of-the art technologies in the defense and health care spaces.

She served as a Mirzayan Fellow and then as a Research Associate for the Board on Health Care Services at the National Academies of Sciences, Engineering, and Medicine. Dr. De Leo’s doctoral work focused on determining optimal conditions for lymphocyte activation and designing a targeted T cell expansion platform for use in adoptive immunotherapy. During her graduate studies, Dr. De Leo worked in the Columbia Ventures Technology fellows program where she assessed the economic feasibil-

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
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ity and impact of scientific advancements and researched the landscape of relevant markets for technology transfer. Dr. De Leo holds a Ph.D., M.Phil., and M.S. in Biomedical Engineering from Columbia University and a B.S. in Biological Engineering from Louisiana State University.

Celynne Balatbat is a senior program assistant for the National Academies of Sciences, Engineering, and Medicine’s Board on Health Care Services. She received her B.A. in Neuroscience and Behavior from Vassar College in 2013. Previously, she interned in the advocacy department at AARP California and worked as a laboratory assistant in a medical microbiology lab at the University of California, Davis.

Sharyl Nass, Ph.D., M.S., is director of the National Academies of Sciences, Engineering, and Medicine’s Board on Health Care Services and director of the National Cancer Policy Forum of the Academies. The work of the board is helping to shape the direction of health care in the United States and abroad. The board considers the entire health care system in order to ensure the best possible care for all patients. Its activities pertain to the organization, financing, effectiveness, workforce, and delivery of health care. The Cancer Forum examines policy issues pertaining to the entire continuum of cancer research and care.

For more than 15 years at the Academies, Dr. Nass has worked on a broad range of topics that includes the quality of care, clinical trials, oversight of health research, developing biomarkers and omics-based tests to guide patient care, technologies and quality standards for breast imaging, strategies for large-scale biomedical science, and contraceptive research and development. In addition, she studied developmental genetics and molecular biology at the Max Planck Institute in Germany under a fellowship from the Heinrich Hertz-Stiftung Foundation. She was the 2007 recipient of the Cecil Award for Excellence in Health Policy Research, the 2010 recipient of a Distinguished Service Award from the Academies, and the 2012 recipient of the Institute of Medicine staff team achievement award (as the team leader). With a Ph.D. in Cell and Tumor Biology from Georgetown University and postdoctoral training at the Johns Hopkins University School of Medicine, she has published papers on the cell and molecular biology of breast cancer. She also holds a B.S. in Genetics and an M.S. in Endocrinology/Reproductive Physiology, both from the University of Wisconsin–Madison.

Adam C. Berger, Ph.D., joined the Food and Drug Administration’s Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health in July 2015 as Senior Staff Fellow on the Personalized Medicine Staff. Previously, he was a senior program officer and director of the Roundtable on Translating Genomic-Based Research for Health

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×

in the Board on Health Sciences Policy at the National Academies of Sciences, Engineering, and Medicine. His primary interests focus on policy issues relating to translational medicine, including the development of biologic, drug, diagnostic, and clinical and public health applications. In his capacity at the Academies, Dr. Berger has facilitated numerous policy discussions on innovative, new health care technologies and applications, helped establish collaborative projects among stakeholder groups, and planned and conducted many public workshops and written resulting reports, such as Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings; The Economics of Genomic Medicine; Genome-Based Diagnostics: Clarifying a Pathway to Clinical Use; Integrating Large-Scale Genomic Information into Clinical Practice; Genome-Based Therapeutics: Targeted Drug Discovery and Development; Assessing Genomic Sequencing Information for Health Care Decision Making; and The Value of Genetic and Genomic Technologies. Dr. Berger received his doctorate from Emory University in the Biochemistry, Cell and Developmental Biology Program and his B.S. in Molecular Genetics from The Ohio State University. He completed his postdoctoral training at the National Cancer Institute of the National Institutes of Health (NIH). He is the recipient of the NIH Fellows Award for Research Excellence and a Ruth L. Kirschstein National Research Service Award.

Andrew M. Pope, Ph.D., is director of the Board on Health Sciences Policy at the National Academies of Sciences, Engineering, and Medicine. He has a Ph.D. in Physiology and Biochemistry from the University of Maryland and has been a member of the Academies staff since 1982 and of the Institute of Medicine (IOM) staff since 1989. His primary interests are science policy, biomedical ethics, and environmental and occupational influences on human health. During his tenure at the Academies, Dr. Pope has directed numerous studies on topics that range from injury control, disability prevention, and biologic markers to the protection of human subjects of research, National Institutes of Health priority-setting processes, organ procurement and transplantation policy, and the role of science and technology in countering terrorism. Since 1999, Dr. Pope has served as Director of the Academies’ Board on Health Sciences Policy, which oversees and guides a program of activities that is intended to encourage and sustain the continuous vigor of the basic biomedical and clinical research enterprises needed to ensure and improve the health of the public. Ongoing activities include Forums on Neuroscience, Genomics, Drug Discovery and Development, and Medical and Public Health Preparedness for Catastrophic Events. Dr. Pope is the recipient of the IOM’s Cecil Award and the National Academy of Sciences President’s Special Achievement Award.

Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
Page 232
Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
Page 234
Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
Page 235
Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
Page 236
Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
Page 237
Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Suggested Citation:"Appendix A: Committee Member and Staff Biographies." National Academies of Sciences, Engineering, and Medicine. 2016. Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine. Washington, DC: The National Academies Press. doi: 10.17226/21860.
×
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Every patient is unique, and the evolving field of precision medicine aims to ensure the delivery of the right treatment to the right patient at the right time. In an era of rapid advances in biomedicine and enhanced understanding of the genetic basis of disease, health care providers increasingly have access to advanced technologies that may identify molecular variations specific to an individual patient, which subsequently can be targeted for treatment. Known as biomarker tests for molecularly targeted therapies, these complex tests have the potential to enable the selection of the most beneficial treatment (and also to identify treatments that may be harmful or ineffective) for the molecular underpinnings of an individual patient’s disease. Such tests are key to unlocking the promise of precision medicine.

Biomarker tests for molecularly targeted therapies represent a crucial area of focus for developing methods that could later be applicable to other areas of precision medicine. The appropriate regulatory oversight of these tests is required to ensure that they are accurate, reliable, properly validated, and appropriately implemented in clinical practice. Moreover, common evidentiary standards for assessing the beneficial impact of biomarker-guided therapy selection on patient outcomes, as well as the effective collection and sharing of information related to those outcomes, are urgently needed to better inform clinical decision making.

Biomarker Tests of Molecularly Targeted Therapies examines opportunities for and challenges to the use of biomarker tests to select optimal therapy and offers recommendations to accelerate progress in this field. This report explores regulatory issues, reimbursement issues, and clinical practice issues related to the clinical development and use of biomarker tests for targeting therapies to patients. Properly validated, appropriately implemented biomarker tests hold the potential to enhance patient care and improve outcomes, and therefore addressing the challenges facing such tests is critical.

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