Appendix B


Speaker Biographical Sketches

Joanne Armstrong, M.D., M.P.H., is a senior medical director for Aetna. Aetna is the nation’s third largest health benefits company, serving over 16 million members. At Aetna, Dr. Armstrong leads the areas of women’s health and genetics. In this role she is responsible for program development and implementation, quality assurance, medical cost management, and other activities. She is a board member of the Personalized Medicine Coalition. Dr. Armstrong is board certified in obstetrics and gynecology and has additional training in epidemiology and public health.

Richard E. Buller, M.D., Ph.D., is the vice president of translational oncology in the Pfizer oncology business unit. His group is responsible for development of biomarker and companion diagnostic clinical strategies as well as for proof of mechanism and pharmacology for drug candidates. The group’s recent success is reflected by the approval of critoztinib for the treatment of ALK-positive non-small-cell lung cancer. Prior to joining Pfizer, Dr. Buller was vice president of translational medicine at Exelixis, Inc., a development-stage biotechnology company dedicated to the discovery and development of novel small-molecule therapeutics for the treatment of cancer and other serious diseases. At Exelixis his group played a central role in relating cancer drug effects in patients to drug targets and host genetics. Prior to the Exelixis position, Dr. Buller was a director in the Oncology Medicine Development Centre at GlaxoSmithKline (GSK), focusing on development and implementation of clinical strategies around the company’s portfolio of oncology drug candidates. At GSK he co-led the successful supplemental new drug application for topotecan for the treatment of cervical cancer. Previously Dr.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 63
Appendix B Speaker Biographical Sketches Joanne Armstrong, M.D., M.P.H., is a senior medical director for Aetna. Aetna is the nation’s third largest health benefits company, serving over 16 million members. At Aetna, Dr. Armstrong leads the areas of women’s health and genetics. In this role she is responsible for program develop- ment and implementation, quality assurance, medical cost management, and other activities. She is a board member of the Personalized Medicine Coalition. Dr. Armstrong is board certified in obstetrics and gynecology and has additional training in epidemiology and public health. Richard E. Buller, M.D., Ph.D., is the vice president of translational oncol- ogy in the Pfizer oncology business unit. His group is responsible for devel- opment of biomarker and companion diagnostic clinical strategies as well as for proof of mechanism and pharmacology for drug candidates. The group’s recent success is reflected by the approval of critoztinib for the treatment of ALK-positive non-small-cell lung cancer. Prior to joining Pfizer, Dr. Buller was vice president of translational medicine at Exelixis, Inc., a development- stage biotechnology company dedicated to the discovery and development of novel small-molecule therapeutics for the treatment of cancer and other serious diseases. At Exelixis his group played a central role in relating cancer drug effects in patients to drug targets and host genetics. Prior to the Exelixis position, Dr. Buller was a director in the Oncology Medicine Development Centre at GlaxoSmithKline (GSK), focusing on development and imple- mentation of clinical strategies around the company’s portfolio of oncology drug candidates. At GSK he co-led the successful supplemental new drug application for topotecan for the treatment of cervical cancer. Previously Dr. 63

OCR for page 63
64 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT Buller was a professor in the departments of obstetrics and gynecology and of pharmacology at the University of Iowa College of Medicine. He received a B.S. in chemistry from the University of California, Los Angeles, and was awarded both the doctor of medicine and doctor of philosophy (Bert O’Malley Lab) degrees from Baylor College of Medicine before completing an OB/GYN residency at the University of California, San Francisco, and a fellowship with Philip DiSaia at the University of California, Irvine. Dr. Buller is a board-certified gynecologic oncologist with extensive clinical trials experience in all phases of drug development, both as an academic and in industry. He is the author of more than 140 publications and has received numerous awards and honors, including multiple year listings in the Guide to America’s Top Physicians prepared by the Consumer Research Council of America. His major laboratory research interest over the years has been the molecular genetics of ovarian cancer. 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 com- pleted 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 and Ethics (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 IOM 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, ethi- cal, and policy implications of genetics, including the 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 ethi- cal, legal, and social implications research, and she is co-director of the Northwest-Alaska Pharmacogenomic Research Network. W. Gregory Feero, M.D., Ph.D., obtained his M.D./Ph.D. from the Univer- sity of Pittsburgh School of Medicine’s medical scientist training program, with his Ph.D. in human genetics. He then completed his residency in family medicine at the Maine–Dartmouth Family Medicine Residency Program in Augusta, Maine. After 5 years in practice in Maine, Dr. Feero accepted a

OCR for page 63
APPENDIX B 65 position at the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) as senior advisor to the director for genomic medicine under Drs. Francis Collins and Alan Guttmacher. He played a key role in coordinating NHGRI’s activities related to family ­ health history and was the planning chair for the NIH Consensus Devel- opment Program’s 2009 State of the Science Conference “Family History­ and Improving Health.” He also participated in efforts to help insure the appropriate representation of family health history and genomic data in electronic health records. Additionally, as chief of the Genomic Healthcare Branch in the Office of the Director, he oversaw efforts to advance genom- ics education for health professional disciplines including nurses, physician assistants, physicians, and pharmacists. In 2012 Dr. Feero stepped down from his position at NHGRI and continued on his role as research director and member of the faculty at the Maine–Dartmouth family medicine resi- dency program. Currently he serves on the IOM Roundtable on Translating Genomic-Based Research for Health and as a contributing editor for the Journal of the American Medical Association. Dr. Feero sees patients four days a week in Fairfield, Maine, is board certified in family medicine, and holds professional licenses in Maine and West Virginia. He has authored numerous peer-reviewed and invited publications. Felix W. Frueh, Ph.D., is president of the Medco Research Institute, lead- ing Medco’s real-world, outcomes-based research in personalized medicine. Dr. Frueh was associate director for genomics at FDA, managing partner at Stepoutside Consulting, and held senior positions at Transgenomic and Protogene Laboratories. He is a member of the board of the Personalized Medicine Coalition and TcLand Expression, Inc., and is an adjunct faculty ­ member at the Institute for Pharmaco­ enomics and Individualized Therapy g at the University of North Carolina. Dr. Frueh held faculty appointments in the departments of pharmacology and medicine at Georgetown University in Washington, DC, and was a fellow at Stanford University and the Uni- ­ versity of Basel, Switzerland, where he received his Ph.D. in biochemistry. Geoffrey Ginsburg, M.D., Ph.D., is the founding director for genomic medicine at Duke University and assumed his current position in the Duke Institute for Genome Sciences and Policy in 2004. He is also the founding executive director of the Center for Personalized Medicine established in the Duke University Health System in 2010. He is currently professor of medicine and pathology at Duke University Medical Center. While at Duke, Dr. Ginsburg has pioneered translational genomics, initiating programs in genome-enabled biomarker discovery, longitudinal registries with linked molecular and clinical data, biomarker-informed clinical trials, and the development of novel practice models and implementation research for the

OCR for page 63
66 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT integration of genomic tools in heath care systems. With a strong commit- ment to interdisciplinary science he has led projects to develop predictive models for common complex diseases using high-dimensional genomic data as well as collaborations with engineering groups to develop novel point of care sensors. His work spans oncology, infectious diseases, cardiovascular disease, and metabolic disorders, and his research is addressing the chal- lenges for translating genomic information into medical practice using new and innovative paradigms and the integration of personalized medicine into health care. He is an internationally recognized expert in genomics and personalized medicine with more than 200 published papers, and funding from NIH, the Department of Defense, the Defense Advanced Research Projects Agency, the Bill & Melinda Gates Foundation, and industry. In 1990 he joined the faculty of Harvard Medical School, where he was direc- tor of preventive cardiology at Beth Israel Hospital and led a laboratory in applied genetics of cardiovascular disease at Children’s Hospital. In 1997 he joined Millennium Pharmaceuticals, Inc., as senior program director for cardiovascular diseases and was eventually appointed vice president of molecular and personalized medicine, where he was responsible for devel- oping pharmacogenomic strategies for therapeutics as well as biomarkers for disease and their implementation in the drug development process. He has received a number of awards for his research accomplishments, including the Innovator in Medicine Award from Millennium in 2004 and the Basic Research Achievement Award in Cardio­ ascular Medicine from v Duke in 2005. He is a founding member and former board member of the Personalized Medicine Coalition, a senior consulting editor for the Journal of the American College of Cardiology, an editor for The HUGO Journal, and an editorial advisor for Science Translational Medicine. In addition he is the editor of Genomic and Personalized Medicine (Elsevier), whose first edition was published in 2009. He has been a member of the Secretary of Veterans Affairs Advisory Council on Genomic Medicine and the National Advisory Council for Human Genome Research at NIH. He is currently an international expert panel member for Genome Canada; a member of the board of external experts for the National Heart, Lung and Blood Institute; a member of the IOM Roundtable on Translating Genomic-Based Research for Health; and a member of the external scientific panel for the Pharmacogenomics Research Network. He has recently been appointed to the advisory council for the newly established National Center for Advanc- ing Translational Sciences at NIH. He has recently been nominated to serve on the World Economics Forum’s Global Agenda Council on Personal- ized and Precision Medicine. Dr. Ginsburg received his M.D. and Ph.D. in biophysics from Boston University and completed an internal medicine residency at Beth Israel Hospital in Boston, Massachusetts. Subsequently, he pursued postdoctoral training in clinical cardiovascular medicine at Beth

OCR for page 63
APPENDIX B 67 Israel Hospital and in molecular biology at Children’s Hospital as a Bugher Foundation Fellow of the American Heart Association. Steven Gutman, M.D., M.B.A., is strategic advisor for Myraqa. He has more than 30 years of medical industry experience with more than 15 years at FDA, where he founded and directed the Office of In Vitro Diagnostics. Dr. Gutman holds a deep understanding of in vitro diagnostics history and regulation from developing policy and representing the agency for many years. Dr. Gutman came to Myraqa from the Blue Cross Blue Shield Association, where he extended his scope of work as an associate director, where he formed scientific valuations and policies. Dr. Gutman earned his M.D. at Cornell University Medical College, an M.B.A. with distinction from the State University of New York at Buffalo, and his B.S. from The Ohio State University. Walter H. Koch, Ph.D., has been in his current role of vice president and head of global research for Roche Molecular Systems, Inc. (RMS) since 2005. As a member of the executive leadership team, he sits on the life cycle and business development committees and chairs the research port- folio committee. Dr. Koch is responsible for all Roche Molecular Diagnos- tics research and early development activities, including research efforts associated with biomarker discovery and validation, the development of new diagnostic platform technologies such as next-generation sequencing, and continuing improvements in the performance of existing real time polymerase chain reaction (PCR) products and technologies. He joined RMS in 1998 as a research leader to evaluate the feasibility of developing microarray-based pharmacogenetic assays for clinical diagnostic use, result- ing in the launch of the AmpliChip® CYP450 assay. From 2001 to 2004 he served as the senior director of the pharmacogenetics department, leading six scientific teams and a bioinformatics group in the research and develop- ment of new genetics and genomics tests. In this role he was responsible for ­ the development of genetic and pharmacogenomic assays using Affymetrix oligonucleotide microarray, linear array, and real-time kinetic PCR technol- ogies and platforms. Prior to joining Roche he held several positions within FDA, including acting lab chief of immunochemistry and research biologist in the Center for Biologics Evaluation and Research Division of Transfusion Transmitted Disease as well as research biologist positions in the Division of Molecular Biological Research and Evaluation and the Division of Toxicol- ogy within the Center for Food Safety and Applied Nutrition. He received a B.S. in chemistry from Memphis State University and a Ph.D. in toxicology from the University of Tennessee, and he was a postdoctoral fellow within the Johns Hopkins University School of Public Health.

OCR for page 63
68 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT 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 University of Pennsylva- nia School of Medicine and is a nationally recognized expert in molecular pathology. She has served on several national committees 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, which advises the Secretary of Health and Human Ser- vices. Dr. Leonard is editor of two molecular pathology textbooks and has spoken widely on various molecular pathology test services, the future of molecular pathology, and the impact of gene patents on molecular pathol- ogy practice. Dr. Leonard is interested in the use of genomic technologies in the practice of medicine to improve patient outcomes. Elizabeth Mansfield, Ph.D., is the director of the personalized medicine staff in the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in the Center for Devices and Radiological Health of FDA, where she is developing a program to address companion and novel diagnostic devices. She was previously a senior policy analyst in OIVD, managing policy and scientific issues. Dr. Mansfield formerly served as the director of regulatory affairs at Affymetrix, Inc., from 2004 to 2006. She previously served in other positions at FDA, including scientific reviewer and genetics expert. Dr. Mansfield received her Ph.D. from Johns Hopkins University and completed postdoctoral training at the National Cancer Institute and the National Institute for Arthritis, Musculo­ keletal, and Skin Diseases. s 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 & ­ohnson start-up dedicated to the development and commercialization J of novel cancer diagnostic tests. His group successfully conducted clinical 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 Veri- dex. The cellular diagnostics group successfully launched its first product in 2004 for the detection and enumeration of circulating tumor cells in patients with metastatic breast cancer. He joined Johnson & Johnson in

OCR for page 63
APPENDIX B 69 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 in the early detection of prostate cancer. Dr. McCormack received his B.S. degree in medical technology from the Uni- versity of Wisconsin, River Falls, and his M.S. and Ph.D. degrees from the University of Minnesota in hematology and immunology, respectively. Scott D. Patterson, Ph.D., is an executive director in the medical sciences function at Amgen leading the In Vitro Diagnostic (IVD) Group, which is responsible for the identification, implementation, and management of diag- nostic partnering strategies for all Amgen therapeutics (e.g., the development of KRAS as a predictive biomarker and companion diagnostic for Vectibix® therapy). The IVD Group builds upon Amgen’s successful biomarker pro- gram, which Dr. Patterson led as head of molecular sciences for its first 8 years. He has published extensively in the field of proteomics and bio­ markers, holds editorial board positions, and is a frequent guest lecturer. He was previously vice president of proteomics at the Celera Genomics Group and the chief scientific officer of Farmal Biomedicines, LLC. While at Celera, he established the company’s initial foray into identification of cell surface targets for oncology, a number of which have been licensed. Dr. Patterson was at Amgen from 1993 to 2000, ultimately leading the Department of Biochemistry and Genetics. His academic career, which encompassed work on analytical protein chemistry applications and apoptosis, began at the ­ University of Queensland, where he received his Ph.D. and B.Sc. while hold- ing research positions of increasing responsibility over a period of 11 years, culminating in the position of senior research officer. In 1991 he joined the faculty of Cold Spring Harbor Laboratory, New York. John Pfeifer, M.D., Ph.D., is the vice chairman for clinical affairs and a pro- fessor in the Department of Pathology and Immunology at the Washington ­ University School of Medicine in St. Louis. He is board certified in anatomic pathology and subspecialty board certified in molecular genetic pathology, and he has been a practicing surgical pathologist for more than 20 years. His academic interests are primarily focused on investigating the role of molecular genetic testing in the analysis of tissue specimens, specifically on the methods and clinical settings in which molecular testing provides inde-

OCR for page 63
70 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT pendent information that increases diagnostic accuracy or provides more accurate prognostic estimates or can be used to guide therapy. Victoria M. Pratt, Ph.D., is a medical and clinical molecular geneticist board certified by the American College of Medical Genetics. She is cur- rently chief director, molecular genetics, for Quest Diagnostics. In addition to her work for Quest Diagnostics, Dr. Pratt served on the U.S. Secretary of Health and Human Services Advisory Committee on Genetics, Health, and Society for the Oversight of Genetic Testing. She also participated in the preparation of the Morbidity and Mortality Weekly Report publication on best practices in molecular genetic testing for the Centers for Disease Control and Prevention (CDC). Dr. Pratt continues to serve on the CDC’s GeT-RM program for reference materials for molecular genetics. She is cur- rently serving on the U.S. Secretary of Health and Human Services Advisory Committee on Hereditary Disorders in Newborns and Children. Dr. Pratt is past chair of the clinical practice committee and is currently a member of the professional relations committee for the Association for Molecular Pathology and is an advisory member of EurogenTest for genetic test valida- tion. She also is a member of the Quest Diagnostics best practice team for quality control. Dr. Pratt has authored more than 40 peer-reviewed manu- scripts and book chapters. She continues to be involved in genetics training and holds a faculty appointment at NIH. Dr. Pratt is the associate editor for the Journal of Molecular Pathology. Dr. Pratt graduated with a Ph.D. in medical and molecular genetics from Indiana University School of Medicine in Indianapolis in 1994. Her fellowship training was in medical and clinical molecular genetics at Henry Ford Hospital in Detroit, Michigan. Bruce Quinn, M.D., Ph.D., is the senior health policy advisor with Foley Hoag LLP. Dr. Quinn is a national expert on Medicare policy, the impact of health reform on innovation, and the crafting of successful business 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. He has writ- ten a series of authoritative white papers on evolving Medicare policy for genomic tests in 2012–2013, and he authored the reimbursement chapter in the authoritative handbook Genomic and Personalized Medicine (­Academic Press, 2012). Before joining Foley Hoag LLP, he was the regional Medicare

OCR for page 63
APPENDIX B 71 medical director for the California Part B program. Earlier in his career, Dr. Quinn was a physician executive in the health and life sciences divi- sion of Accenture, working with the pharmaceutical, biotechnology, and g ­ enomics industries. Dr. Quinn is a board-certified pathologist who held physician-scientist faculty positions at New York University and North- western University. The author or co-author of more than 30 scientific publications, he also holds an M.B.A. from the Kellogg School of North- western University. Mark Robson, M.D., is an associate attending physician of the Clini- cal Genetics and Breast Cancer Medicine Services in the Department of Medicine at Memorial Sloan–Kettering Cancer Center. He received his B.Sc. from Washington and Lee University and his M.D. from the University of Virginia. He performed residency and fellowship training at Walter Reed Army Medical Center before coming to Memorial Sloan–Kettering in 1996. He is currently the clinic director of the Clinical Genetics Service and the immediate past chair of the Cancer Genetics Subcommittee of the Cancer ­ Prevention Committee of ASCO. Dr. Robson’s research is primarily directed toward the improving the integration of genetic information into the clini- cal management of women with breast cancer. He and his colleagues have conducted a number of studies examining outcomes in women with heredi- ­ tary breast cancer to better define the risks and benefits of treatments such as breast-conserving therapy and adjuvant chemotherapy in this group. He and his coworkers have also conducted a number of studies examining the effectiveness of screening interventions such as breast magnetic resonance imaging or ovarian cancer screening in women at hereditary risk. He is currently conducting studies to evaluate the impact of intensive screening or surgical prevention upon women’s quality of life, and to develop new screening tools, such as serum peptide profiling. He is also investigating the optimal integration of new genetic technologies, such as genomic profiling, into the care of women at risk for breast cancer. Pamela L. Swatkowski, B.S., is director of regulatory affairs at Abbott Molecular, where she is responsible for strategic regulatory programs including companion diagnostics regulatory and business development sup- port, product lifecycle management, and global product registration filings for the molecular diagnostics product line. She has more than 25 years of experience in regulatory affairs, Ms. Swatkowski received a bachelor of science degree in biology in 1983 from Loyola University of Chicago. Ms. Swatkowski began her career at Abbott in the diagnostics division in research and development in 1983 and rejoined the company in 2004 with Abbott Molecular. In addition, she has worked at Nalge Nunc Interna- tional, a ThermoFisher company in several regulatory and quality leader-

OCR for page 63
72 THERAPEUTIC AND DIAGNOSTIC CO-DEVELOPMENT ship roles. Ms. Swatkowski has a passion for personalized health care and works toward communication and conveying the importance of companion diagnostics products that are beneficial to the patient. Sharon Terry, M.A., is president and chief executive officer of the Genetic Alliance, a network of more than 10,000 organizations, 1,200 of which are disease advocacy organizations. Genetic Alliance improves health through the authentic engagement of communities and individuals. It develops innovative solutions through novel partnerships, connecting consumers to smart services. Ms. Terry is the founding chief executive officer of PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE). As co-discoverer of the gene associated with PXE, she holds the patent for ABCC6 and has assigned her rights to the foundation. She developed a diagnostic test and is conducting clinical trials. Ms. Terry is also a co-founder of the Genetic Alliance Registry and Biobank. She is the author of more than 90 peer-reviewed articles. In her focus at the forefront of consumer participation in genetics research, ser- vices, and policy, she serves in a leadership role on many of the major inter- national and national organizations, including the IOM Health Sciences Policy Board, the National Coalition for Health Professional Education in Genetics board, and the International Rare Disease Research Consortium Interim Executive Committee, and she is a member of the IOM Round- table on Translating Genomic-Based Research for Health. She is on the editorial boards of several journals. She was instrumental in the passage of the Genetic Information Nondiscrimination Act. She received an honorary doctorate from Iona College in 2005 for her work in community engage- ment, the first Patient Service Award from the University of North Carolina Institute for Pharmacogenomics and Individualized Therapy in 2007, the Research!America Distinguished Organization Advocacy Award in 2009, and the Clinical Research Forum and Foundation’s Annual Award for Leader­ hip in Public Advocacy in 2011. She is an Ashoka Fellow. s Bradley M. Thompson, J.D., is a shareholder in the law firm of Epstein Becker & Green, P.C. There he counsels medical device, drug, combination product, and biotechnology companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. At the firm Mr. Thompson leads the medical device regulatory practice, the clinical trials practice, and the con- nected health practice, and he serves on the firm’s health and life sciences steering committee. For trade associations Mr. Thompson has served as counsel to AdvaMed and the Continua Health Alliance; as general counsel to the Combination Products Coalition, mHealth Regulatory Coalition, and ­ the Clinical Decision Support Coalition; and as general counsel and secre- tary for the Indiana Medical Device Manufacturers Council. Mr. Thompson

OCR for page 63
APPENDIX B 73 has taught food and drug law at Indiana University School of Law–India- napolis and at Columbia Law School. He also serves on the editorial boards for Medical Device & Diagnostic Industry (since 1993), Food & Drug Law Journal (since 2007), and BNA’s Medical Device Law & Industry Report (since 2007). Mr. Thompson also serves as co-chair of the food and drug law committee in the American Bar Association and of the medical device committee of the Food and Drug Law Institute (FDLI). Mr. Thompson has written extensively on the topics of medical device regulation, including a book titled FDA’s Regulation of Medical Devices (Interpharm Press, 1995), and has co-authored chapters in Off-Label Communications: A Guide to Sales and Marketing Compliance published by FDLI (2008–2009) and in a book titled Guide to Medicare Coverage Decision-making and Appeals published by the American Bar Association (2002). Mr. Thompson was included in 100 Notable People in the Medical Device Industry (Medical Device & Diagnostics Industry, June 2004), has earned an AV rating in Martindale-Hubbell (its highest rating), has been named a “SuperLawyer” in Indiana, has been elected as a fellow in the American Bar Foundation, and is listed in A Guide to America’s Leading Business Lawyers from Chambers USA. Mr. Thompson received his B.A. cum laude and an M.B.A. from the University of Illinois and his J.D. cum laude from the University of Michigan Law School.

OCR for page 63