Appendix B
Committee Member and Staff Biographies

COMMITTEE MEMBER BIOGRAPHIES

John Mendelsohn, M.D. (Chair), combines experience in clinical and laboratory research with administrative expertise in preparing the University of Texas M.D. Anderson Cancer Center for the next century. Since becoming president in 1996, he has recruited a visionary management team and implemented new priorities for integrated programs in patient care, research, education, and cancer prevention. For almost three decades, Dr. Mendelsohn has been at the forefront in understanding how growth factors regulate the proliferation of cancer cells by activating receptors on the surface of the cells. He developed cetuximab, a specific monoclonal antibody that blocks epidermal growth factor (EGF) and transforming growth factor-alpha binding to EGF receptors, thereby inhibiting activation of receptor tyrosine kinase and preventing the growth factors from stimulating cell growth and division. His research led to the first clinical trial with an antireceptor therapy and an anti-tyrosine kinase therapy. Dr. Mendelsohn was born in Cincinnati, Ohio, and earned a bachelor’s degree in biochemical sciences magna cum laude from Harvard College in 1958. After spending a year in Scotland as a Fulbright Scholar, Dr. Mendelsohn received a medical degree cum laude from Harvard Medical School in 1963. Between 1963 and 1970, he took residency training in internal medicine and completed a research fellowship in oncology at Washington University Medical School in St. Louis, Missouri. From 1970 to 1985, he was on the University of California-San Diego (UCSD) faculty, rising from assistant professor to professor of medicine at UCSD in less than 9 years. He was instrumental in establishing and



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Appendix B Committee Member and Staff Biographies COMMITTEE MEMbER bIOGRAPHIES john Mendelsohn, M.D. (Chair), combines experience in clinical and labo- ratory research with administrative expertise in preparing the University of Texas M.D. Anderson Cancer Center for the next century. Since becom- ing president in 1996, he has recruited a visionary management team and implemented new priorities for integrated programs in patient care, research, education, and cancer prevention. For almost three decades, Dr. Mendelsohn has been at the forefront in understanding how growth factors regulate the proliferation of cancer cells by activating receptors on the surface of the cells. He developed cetuximab, a specific monoclonal antibody that blocks epidermal growth factor (EGF) and transforming growth factor-alpha bind- ing to EGF receptors, thereby inhibiting activation of receptor tyrosine kinase and preventing the growth factors from stimulating cell growth and division. His research led to the first clinical trial with an antireceptor therapy and an anti-tyrosine kinase therapy. Dr. Mendelsohn was born in Cincinnati, Ohio, and earned a bachelor’s degree in biochemical sciences magna cum laude from Harvard College in 1958. After spending a year in Scotland as a Fulbright Scholar, Dr. Mendelsohn received a medical degree cum laude from Harvard Medical School in 1963. Between 1963 and 1970, he took residency training in internal medicine and completed a research fel- lowship in oncology at Washington University Medical School in St. Louis, Missouri. From 1970 to 1985, he was on the University of California-San Diego (UCSD) faculty, rising from assistant professor to professor of medi- cine at UCSD in less than 9 years. He was instrumental in establishing and 2

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20 A NATIONAL CANCER CLINICAL TRIALS SySTEM funding a National Cancer Institute-designated Cancer Center at UCSD, which he directed from its inception in 1976 until he went to Memorial Sloan-Kettering Cancer Center in 1985. At Memorial Sloan-Kettering, Dr. Mendelsohn chaired, reorganized, and expanded its Department of Medi- cine. He also extended the landmark research that he began at UCSD to clarify at the molecular level how cetuximab alters growth-signaling path- ways and cell functions. He also demonstrated the additive antitumor effects of EGF receptor inhibition plus chemotherapy or radiotherapy. As a result of successful clinical trials, the Food and Drug Administration approved cetuximab (Erbitux) for the treatment of colon cancer in 2004 and head and neck cancer in 2006. Dr. Mendelsohn served as the founding editor-in- chief of Clinical Cancer Research, a monthly translational research journal published by the American Association for Cancer Research, and he has been a member of the editorial boards of other leading scientific journals. He has authored more than 200 scientific papers and articles for journals and textbooks and is senior editor of The Molecular Basis of Cancer. His awards include the Joseph H. Burchenal and the Dorothy P. Landon awards from the American Association for Cancer Research and the David A. Karnofsky Prize from the American Society of Clinical Oncology. He is a member of the Institute of Medicine of the U.S. National Academies. Harold L. Moses, M.D. (Vice Chair), is director emeritus of the Vander- bilt-Ingram Cancer Center; the Hortense B. Ingram Professor of Molecular Oncology; professor of cancer biology, medicine and pathology; and the founding and current director of the Frances Williams Preston Laborato- ries. Dr. Moses graduated from Berea College in 1958 and then obtained an M.D. degree from the Vanderbilt University School of Medicine in 1962. After residency training in pathology at Vanderbilt and postdoctoral research training at the National Institutes of Health, he spent 5 years as a faculty member in pathology at Vanderbilt and 12 years at the Mayo Clinic in Rochester, Minnesota, the last 6 of which were as chair of the Depart- ment of Cell Biology. He returned to Vanderbilt 23 years ago as professor and chair of the Department of Cell Biology in the School of Medicine. Fifteen years ago he became the founding director of the Vanderbilt Cancer Center and had a concurrent appointment as the B.F. Byrd, Jr. Professor of Clinical Oncology. He resigned as chair of the Department of Cell Biology in 1998 to devote more time to the cancer center, now named the E. Bron- son Ingram Cancer Center. At the end of 2004, he became director emeritus of the Vanderbilt-Ingram Cancer Center and the Hortense B. Ingram Profes- sor of Medical Oncology. Susan G. Arbuck, M.D., M.Sc., F.A.C.P., is an independent consultant at Susan G. Arbuck MD LLC. Dr. Arbuck has been a a leader in medical oncol-

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21 APPENDIX B ogy in the pharmaceutical industry, from translational research to global drug registration. As vice-president, she led clinical development groups in the oncology therapeutic area of the research and development organiza- tions of major drug companies, most recently at Schering-Plough. During her career, she contributed to the development and registration of many approved oncology products. Before she joined the pharmaceutical industry, Dr. Arbuck worked for 10 years at the National Cancer Institute (NCI), where she led the Developmental Chemotherapy Section, directing the development of a portfolio of approximately 75 drugs through NCI grantees, contractors, and national Cooperative Groups. She worked with pharmaceutical and biotechnology companies on strategies for the development of agents such as Taxol, Taxotere, Gleevec, Iressa, Velcade, Eloxatin, Camptosar, and Topote- can. She also provided leadership in the development of standardized criteria for adverse event and tumor response reporting, which are used internation- ally in oncology clinical trials. Throughout her career, she has contributed to the development of novel trial designs and strategies to increase the effi- ciency of cancer drug development and registration. Before joining NCI, at the Roswell Park Cancer Institute, she had primary responsibility for a pharmacology-based translational drug development research program in upper gastrointestinal malignancies and was a principal coinvestigator in Cooperative Group Phase III trials. She was an associate professor of medicine at the State University of New York at Buffalo. Dr. Arbuck is a board-certified medical oncologist who has served on various committees for the American Association for Cancer Research and the American Society of Clinical Oncology. She has written more than 100 peer-reviewed publica- tions. She holds a B.Sc. from the University of Toronto, a M.Sc. in pharma- cology from the State University of New York at Buffalo, and an M.D. from McMaster University Medical School in Hamilton, Ontario, Canada. Donald A. berry, Ph.D., is an international expert in the field of biostatis- tics. He holds the Frank T. McGraw Memorial Chair for Cancer Research at the University of Texas M.D. Anderson Cancer Center, where he is head of the Division of Quantitative Sciences and chair of the Department of Biostatistics. His primary interest is the prevention and treatment of breast cancer. He serves as the faculty statistician on the Breast Cancer Commit- tee of the Cancer and Leukemia Group B (CALGB), a national oncology group. In this role, he designs and supervises the conduct and analysis of clinical trials of breast cancer treatments. A native of Massachusetts, Dr. Berry received a Ph.D. in statistics from Yale University and previously served on the faculty at the University of Minnesota and at Duke Univer- sity, where he held the Edger Thompson Professorship in the College of Arts and Sciences. The author of more than 200 published articles as well as several books on biostatistics in medical research, Dr. Berry has been

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22 A NATIONAL CANCER CLINICAL TRIALS SySTEM the principal investigator for numerous medical research programs funded by the National Institutes of Health and the National Science Foundation. A current project funded by NCI describes the use and benefits of breast cancer treatment. He was also the principal investigator of an NCI proj- ect, CISNET: Cancer Intervention and Surveillance Network. That project focused on statistical modeling to assess the relative contribution of screen- ing mammography, tamoxifen, and chemotherapy to the drop in breast cancer mortality observed in the United States since 1990. Another focus of Dr. Berry’s statistical research is designing clinical trials that utilize patients more efficiently and that treat the patients in the trials more effectively. Dr. Berry is a statistics editor for the Journal of the National Cancer Institute, associate editor for Breast Cancer Research and Treatment and Clinical Cancer Research, and is a fellow of the American Statistical Association and of the Institute of Mathematical Statistics. Michael A. Carducci, M.D., F.A.C.P., is AEGON Professor in Prostate Cancer Research, professor of oncology and urology at the Johns Hopkins University School of Medicine, Baltimore. He is co-leader of the Prostate Cancer/Genitourinary Oncology Program and co-leader of the Chemical Therapeutics Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine. A translational researcher, Dr. Carducci directs a laboratory program focused on the re-expression of epigenetically silenced genes in cancer cells via the use of small molecules targeting DNA methyltransferases and histone deacetylases, and manages a portfolio of clinical trials targeted at introducing these small molecules into cancer treatment. Overall, the focus of his laboratory and clinical research is on the development and evaluation of new therapies for urologic cancers. A fellow of the American College of Physicians, Dr. Carducci is a member of several professional organizations, including the American Association for Cancer Research, the American Society of Clinical Oncology (ASCO), and the American Urological Association. Dr. Carducci serves as the princi- pal investigator of an NCI Phase I clinical trial grant titled Phase I Clinical Trials of Anti-Cancer Agents and of a major project in the Johns Hopkins Prostate Cancer Specialized Programs of Research Excellence titled Epigen- etic Therapy: Advancing the Therapeutic Implications in Prostate Cancer. He also leads the Johns Hopkins site for the Prostate Cancer Foundation/ U.S. Department of Defense Prostate Cancer Clinical Trials Consortium grant. In addition, he has received peer-reviewed funding for his laboratory and clinical research from the U.S. Department of Defense and the Prostate Cancer Foundation. He is the chair of the Prostate Cancer Subcommittee of the Genitourinary Oncology Committee of the Eastern Cooperative Oncology Group and serves as an alternate to the Genitourinary Steering Committee for NCI. Dr. Carducci is also a full member of the Investiga-

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2 APPENDIX B tional Drug Steering Committee for NCI. Within ASCO, he is immediate past chair of the Scientific Program Committee and has previously served on the Cancer Education, Scientific Program, and Grants Selection Commit- tees. A graduate of Georgetown University, Dr. Carducci received a medical degree from Wayne State University School of Medicine. He completed an internal medicine internship, residency, and chief residency at the Univer- sity of Colorado Health Sciences Center. He went on to complete medical oncology and research fellowships at the Johns Hopkins Oncology Center at Johns Hopkins Hospital. David M. Dilts, Ph.D., M.b.A., is director of clinical research for the Knight Cancer Institute and professor of healthcare management at the Oregon Health & Science University. Formerly, he held the sole joint professorship between the Owen Graduate School of Management and the Vanderbilt University School of Engineering, where he was the founding director of the Engineering Management Program and co-director of the Center for Management Research in Healthcare (cMHRc.org). That center, supported by NCI, WebMD, and others, has as its mission the exchange of knowledge between management research and health care professionals to dramatically impact the practice of medicine. One research stream, funded by NCI, is to apply management principles to significantly reduce the time steps required to open oncology clinical trials. That research has completed in-depth examinations of four NCI-designated comprehensive Cancer Centers, two major oncology Cooperative Groups, and the NCI Cancer Therapy Evalu- ation Program and the NCI central institutional review board. Dr. Dilts’s work has been published in nearly 200 articles, conference papers and presentations, book chapters, books, and monographs, including Clinical Cancer Research, IEEE Transactions on Engineering Management, Jour- nal of Clinical Oncology, Journal of the American Medical Informatics Association, Journal of Technology Transfer, Health Economics, Journal of Supply Chain Management, Management Accounting, Medical Decision Making, and Tissue & Cell. Dr. Dilts has published on a range of topics, from complexity in supply chain networks to delays in opening oncology clinical trials and issues with business incuba-tion. Over the past 15 years, he has been a principal investigator or co-principal investigator on grants totaling over $18.5 million from sources such as NCI, the U.S. Department of Defense, and the Ontario Ministry of Health. He is a frequent speaker at national and international conferences. Susan S. Ellenberg, Ph.D., is professor of biostatistics and associate dean for clinical research at the University of Pennsylvania School of Medicine. Her research interests have focused on issues in the design and analysis of clinical trials and assessment of medical product safety. Particular areas of

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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM interest include efficient trial designs, interim monitoring and the operation of data-monitoring committees, evaluation of surrogate endpoints, ethical issues in clinical research, and special issues in trials of cancer and AIDS therapies and of vaccines. She serves as associate editor of Clinical Trials and of the Journal of the National Cancer Institute. Dr. Ellenberg is a fellow of the American Statistical Association, the Society for Clinical Trials, and the American Association for the Advancement of Science (AAAS) and is an elected member of the International Statistical Institute. She has served as president of the Society for Clinical Trials and the Eastern North American Region of the International Biometric Society, and has chaired the Statistics Section of AAAS. Her book on clinical trials data-monitoring committees, coauthored with Thomas Fleming (University of Washington) and David DeMets (University of Wisconsin), was named the WileyEurope Statistics Book of the Year for 2002. Before she joined the University of Pennsylvania, Dr. Ellenberg directed the Office of Biostatistics and Epidemiology at the Center for Biologics Evaluation and Research, Food and Drug Administra- tion (1993 to 2004), served as chief of the Biostatistics Research Branch of the Division of AIDS, National Institute of Allergy and Infectious Diseases (1988 to 1992), and served as a mathematical statistician in the Biostatistics Research Branch, Cancer Therapy Evaluation Program, National Cancer Institute (1982 to 1988). Gwen Fyfe, M.D., is an independent consultant in oncology clinical devel- opment. Until August 2009, she was a senior staff scientist in clinical hematology/oncology at Genentech. She attended Washington University Medical School and trained in pediatrics and pediatric oncology at Wash- ington University and the University of California-San Francisco. Following a postgraduate fellowship in immunology, Dr. Fyfe joined Chiron Cor- poration, where she participated in the successful approval of high-dose interleukin-2 (IL-2; aldesleukin [Proleukin]) for the treatment of meta- static renal cell cancer and subsequently studied the role of intermittent IL-2 for the treatment of HIV disease. Dr. Fyfe joined Genentech in 1997. While at Genentech, her responsibilities included overseeing the Genentech oncology pipeline, including the clinical trials that led to the approvals of trastuzumab (Herceptin), a humanized antibody for the treatment of human epidermal growth factor receptor 2-positive metastatic breast can- cer; rituximab (Rituxan), the first therapeutic antibody used for the treat- ment of non-Hodgkin’s lymphoma in the United States; and bevacizumab (Avastin) for the treatment of metastatic colon cancer, breast cancer, renal cell carcinoma, and non-small cell lung cancer (NSCLC). In addition, she worked with OSI Pharmaceuticals and Roche in the development of erlo- tinib (Tarceva), culminating in its approval for the treatment of relapsed NSCLC and newly diagnosed pancreatic cancer. She was promoted to vice-

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2 APPENDIX B president of clinical hematology/oncology in 2002 and moved to a new role in oncology strategy in May 2007. Stephen S. Grubbs, M.D., has for the past 24 years been a medical oncolo- gist in private practice in Newark, Delaware, at the Helen F. Graham Cancer Center. He is a graduate of the Thomas Jefferson University Medi- cal School and received postgraduate training in internal medicine at the Medical Center of Delaware and hematology and oncology at the Dart- mouth Hitchcock Medical Center. He serves as principal investigator of the Delaware Christiana Care Community Clinical Oncology Program, board member of the Cancer and Leukemia Group B Cooperative Group, a member of the State of Delaware Cancer Consortium Council, and chair of Colorectal Cancer Screening. He also serves on the American Society of Clinical Oncology (ASCO) Clinical Trials Committee, Exemplary Trials Site Subcommittee, and is chair-elect of the Clinical Trials Workshop. He is an assistant professor of clinical medicine of the Thomas Jefferson Medical School faculty. Dr. Grubbs is a member of the National Cancer Institute (NCI) Clinical Trials Advisory Committee and is co-chair of the Clinical Trials Subcommittee of the NCI Community Cancer Centers Program. He is the recipient of the 2007 Association of Community Cancer Centers David King Community Clinical Scientist Award. His practice, Medical Oncology Hematology Consultants, P.A., is honored as a recipient of the 2008 ASCO Clinical Trials Participation Award. Hedvig Hricak, M.D., Ph.D., is chair of the Department of Radiology at Memorial Sloan-Kettering Cancer Center. She holds a senior position within the Program of Molecular and Pharmacology Therapeutics at the Sloan-Kettering Institute and is professor of radiology at the Weill Medical College of Cornell University. Her research involves the use of a variety of imaging methods, including ultrasound, computed tomography, magnetic resonance imaging (MRI), and magnetic resonance spectroscopy, with the aim of improving cancer detection, treatment planning, and follow-up. She pioneered the use of ultrasound in kidney disease. In addition, through multidisciplinary collaborative research, she helped introduce MRI for the evaluation of prostate and gynecologic cancers and was involved in developing and validating the use of MR spectroscopy for prostate cancer. Dr. Hricak received an M.D. from the University of Zagreb and a Ph.D. in oncology from the Karolinska Institute. She has authored or coauthored 23 books, more than 300 peer-reviewed research papers, and 128 review/ editorial papers. In recognition of her many accomplishments, she has received the Marie Curie Award from the Society of Women in Radiology, the gold medals of the International Society for Magnetic Resonance in Medicine and the Association of University Radiologists, the Beclere Medal

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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM of the International Society of Radiology, and the Morocco Medal of Merit. She was named Honorary Professor, University of Zagreb, Zagreb, Croatia, and is an honorary member of the British Institute of Radiology, the German Radiological Society, the Austrian Roentgen Society, the Journées Françaises de Radiologie, and the Swedish Society of Medical Radiology. She is an honorary fellow of the Royal College of Radiologists as well as a member of the Croatian Academy of Science and Art, and she holds an honorary doctorate in medicine from the Ludwig Maximilian University of Munich. Richard kaplan, M.D., is associate director of the National Cancer Research Network and also serves as associate director for industry of the United Kingdom Clinical Research Network. He is professor of clinical cancer studies at the Leeds Institute of Molecular Medicine and senior scientist at the Medical Research Council Clinical Trials Unit. Dr. Kaplan is a medical oncologist with 30 years of experience in clinical research in the United States and was previously chief of the NCI Clinical Investigations Branch. He was program director for NCI’s national program of Cooperative Group clinical trials of cancer treatments and program director for NCI’s Brain Tumor Consortia. He has been responsible for the scientific coordination of NCI-funded or -sponsored treatment trials in brain, urological, and gastrointestinal malignancies and has served on advisory committees and panels for NCI, NIH, the Food and Drug Administration, and other gov- ernmental agencies and professional organizations, as well as for clinical trials networks in the United Kingdom, Ireland, and Europe. A major focus of Kaplan’s effort at present is in improving the research environment in the United Kingdom for collaborative efforts between the National Health Service and companies in the pharmaceutical, biotechnology, and medical device industries. Minetta C. Liu, M.D., is an associate professor of medicine and oncology and director of translational breast cancer research at Georgetown Univer- sity Hospital’s Lombardi Comprehensive Cancer Center. She also serves on the Breast Correlative Science Working Group and the Breast Commit- tee of the Cancer and Leukemia Group B Cooperative Group. Dr. Liu is heavily involved in clinical and translational research and focuses on the use of tissue- and serum-based biomarkers in identifying the molecular mechanisms responsible for determining sensitivity versus resistance to chemotherapy. Her work is currently supported by research grants from the National Cancer Institute, the U.S. Department of Defense, the Susan G. Komen for the Cure Foundation, and industry sponsors. Most importantly, she is firmly dedicated to the care and education of women with breast cancer and uses an individualized, multidisciplinary approach to patient

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2 APPENDIX B management. Dr. Liu received an A.B. from the Department of Molecu- lar Biology at Princeton University and an M.D. from Jefferson Medical College in Philadelphia, Pennsylvania. She completed residency training in internal medicine and fellowship training in hematology/oncology at Georgetown University Hospital in 1998. Lee N. Newcomer, M.D., M.H.A., is senior vice-president of oncology for United HealthCare. His unit is responsible for improving the qual- ity and affordability of care for the 111,000 cancer patients covered by United HealthCare. Before he rejoined United Health Group (UHG), Dr. Newcomer was a founding executive of Vivius, a consumer-directed ven- ture that allowed customers to create their own personalized health plans. From 1991 to 2000, Dr. Newcomer held a number of positions at UHG, including chief medical officer. His work there emphasized the development of performance measures and incentives to improve clinical care. Before he joined UHG, he was medical director for CIGNA Health Care of Kansas City, Missouri. Dr. Newcomer is a board-certified medical oncologist; he practiced medical oncology for 9 years in Tulsa, Oklahoma, and Min- neapolis, Minnesota (Park Nicollet Clinic). He is currently the chairman of Park Nicollet Health Services, an integrated system of more than 650 physicians and a 400-bed hospital. The group is nationally recognized for its leadership in quality, safety, and lean processes. Dr. Newcomer earned a bachelor of arts degree in biology from Nebraska Wesleyan University, an M.D. degree from the University of Nebraska College of Medicine, and an M.S. degree in health administration from the University of Wisconsin at Madison. He completed an internship and residency in internal medicine at the University of Nebraska Hospital and fellowships in medical oncology and administrative medicine at the Yale University School of Medicine and the University of Wisconsin at Madison, respectively. Edith A. Perez, M.D., is the deputy director, Mayo Clinic Comprehensive Cancer Center for Florida, director of the Breast Program, and a professor of medicine at Mayo Medical School. She is a cancer specialist and an inter- nationally known translational researcher at Mayo Clinic. Her roles extend nationally, including chairing the Breast Committee for the North Central Cancer Treatment Group, as well as other positions within 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 also developed stud- ies to evaluate the role of genetic markers in the development and aggres- siveness of breast cancer. Dr. Perez has authored more than 555 research articles in journals, books, and abstracts. Dr. Perez receives invitations to

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2 A NATIONAL CANCER CLINICAL TRIALS SySTEM lecture at national and international meetings frequently. She serves on the editorial boards of multiple academic journals. Dr. Perez is a recipient of the Breast Cancer Research Foundation Research Grant Award (1998–2010); the Horizon Achievement Award in Cancer Research (2002); the North Florida Hispanic of the Year Award (2003); the Mayo Clinic Outstanding Faculty Award (2002 and 2004); the Mayo Clinic Distinguished Educator Award (2003); the named Serene M. and Frances C. Durling Professorship of Medicine (2006); Honorary Doctorate of Letters, University of North Florida (2006); Mayo Clinic Distinguished Investigator (2007); the Florida State Biomedical Research Advisory Council (2009–2012) and is a member of the Alpha Omega Alpha Honor Medical Society (2009). Charles L. Sawyers, M.D., is an investigator of the Howard Hughes Medi- cal Institute and the inaugural director of the Human Oncology and Patho- genesis Program at Memorial Sloan-Kettering Cancer Center (MSKCC). He is building a program of laboratory-based translational researchers across various clinical disciplines as well as an institutional infrastructure to enhance the application of global genomics tools to clinical trials. Dr. Sawyers’ laboratory is focused on characterizing signal transduction path- way abnormalities in various cancers, including chronic myeloid leukemia and prostate cancer, with an eye toward translational implications. His research is best demonstrated through his studies of BCR-ABL tyrosine kinase function in chronic myeloid leukemia, his work with Brian Druker and Novartis in the development of the kinase inhibitor imatinib (Gleevec) as primary therapy for chronic myelogenous leukemia, and his discovery that imatinib resistance is caused by BCR-ABL kinase domain mutations. This discovery led Dr. Sawyers to evaluate second-line Abl kinase inhibi- tors, such as the dual Src/Abl inhibitor dasatinib, which received fast-track approval by the Food and Drug Administration in June 2006. His group also found that dasatinib resistance can occur through additional, novel BCR-ABL mutations that remain sensitive to imatinib, making a strong case for combined Abl kinase inhibitor treatment to prevent the emergence of resistant subclones. Dr. Sawyers has also developed a leading laboratory- based program in prostate cancer. That work is currently focused on the role of the androgen receptor in disease progression, even when tumors progress to the hormone-refractory stage. After demonstrating that higher levels of androgen receptor are necessary and sufficient to confer resistance to current antiandrogens, he collaborated with chemist Michael Jung (of the University of California-Los Angeles) to discover a small-molecule inhibitor that targets the increased levels of androgen receptor found in hormone-refractory disease by a novel mechanism. A Phase I-II trial of this compound (MDV3100), now under way at MSKCC and other sites, has shown impressive clinical responses in men with castrate-resistant prostate

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2 APPENDIX B cancer, including those who have progressed on chemotherapy. Dr. Sawyers is past president of the American Society of Clinical Investigation and serves on the National Cancer Institute’s Board of Scientific Councilors. He has won numerous honors and awards, including the Richard and Hinda Rosenthal Foundation Award from the American Association of Cancer Research and the David A. Karnofsky Award from the American Society of Clinical Oncology. He was recently elected to the Institute of Medicine of the National Academies. Richard L. Schilsky, M.D., is professor of medicine, section chief of Hema- tology-Oncology, and Deputy Director of the Comprehensive Cancer Cen- ter at the University of Chicago at the University of Chicago Medical Center. He specializes in the treatment of gastrointestinal cancers and in the development of new cancer treatments for diseases such as colorectal and pancreatic cancers. Dr. Schilsky led a groundbreaking study, which found that aspirin reduces the incidence of precancerous polyps in patients at high risk for colorectal cancer. From 1995 to April 2010, Dr. Schilsky served as chair of the Cancer and Leukemia Group B, the largest and oldest cancer clinical trials group in the United States. He is the immediate past president of the American Society of Clinical Oncology. Ellen v. Sigal, Ph.D., is chair and founder of Friends of Cancer Research (Friends), a nonprofit organization based in the Washington, DC, metropol- itan area. Friends is dedicated to accelerating the nation’s progress toward the prevention and treatment of cancer by mobilizing public support for cancer research funding and providing education on key public policy issues. Over the past 11 years, Friends has pioneered innovative public- private partnerships, organized critical policy forums, educated the public, and brought together key communities to develop collaborative strategies in the field of cancer research. Dr. Sigal is vice-chair of the inaugural board of directors of the Reagan-Udall Foundation, a partnership designed to mod- ernize medical product development, accelerate innovation, and enhance product safety in collaboration with the Food and Drug Administration. She serves on the National Cancer Institute Board of Scientific Advisors; the National Institutes of Health Foundation Board, chairing its Public- Private Partnerships Committee; and the American Association for Cancer Research Foundation Board. Dr. Sigal was recently appointed to the Stand Up To Cancer (SU2C) Advocate Advisory Council, and she is one of two council members nominated to the SU2C Scientific Advisory Committee. She holds leadership positions with a broad range of cancer advocacy and public policy organizations and leadership positions with academic health centers, including the M.D. Anderson Cancer Center External Advisory Board and the Duke University Cancer Center Board of Overseers. She

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20 A NATIONAL CANCER CLINICAL TRIALS SySTEM serves on the C-Change Research Committee and is a member of the Enter- tainment Industry Foundation Oversight Committee for the Biomarker Discovery Project. CONSuLTANT bIOGRAPHy Michaele Chamblee Christian, M.D., received an M.D. summa cum laude from Georgetown University School of Medicine, where she was first in her class. Among numerous awards, she received the Kober Award for highest academic achievement and was elected to the Alpha Omega Alpha honor medical society. She completed residency training in internal medicine and fellowships in hematology and oncology at Georgetown University. From 1997 until her retirement in 2007, she was director of the Cancer Therapy Evaluation Program (CTEP) of NCI, which maintains a major program in early drug development and collaborates with more than 50 pharmaceutical companies to develop new agents for cancer. CTEP is also responsible for coordinating NCI’s extensive program of extramural cancer treatment clini- cal trials. Before that, she worked in the Investigational Drug Branch on the clinical development of new anticancer drugs. In 1995 she established NCI’s Clinical Trials Monitoring Branch, which oversees quality assurance for hundreds of NCI clinical trials. Her personal research interests include early therapeutics development, ovarian cancer treatment, clinical trial design and methodology, and health disparities. She has authored numer- ous articles and chapters in these areas. She has been an active participant in professional societies, including the American Association of Cancer Research, where she served on the board of directors and was chair of Women in Cancer Research, and the American Society of Clinical Oncol- ogy. She has reviewed manuscripts for many medical journals and served as an associate editor of Clinical Cancer Research, Journal of Clinical Oncology, and Molecular Cancer Therapeutics. Medicine is her second career. She began in arts administration with Friends of the Kennedy Cen- ter and the Duke Ellington School of the Arts. She is active in community organizations, primarily in education and the arts, including the boards of the Black Student Fund and the Duke Ellington School of the Arts, which she chairs. STAFF bIOGRAPHIES Sharyl Nass, Ph.D., is the director of the National Cancer Policy Forum and study director at the Institute of Medicine (IOM). She has worked with the IOM Board on Health Sciences Policy, Board on Health Care Ser- vices, and National Cancer Policy Board and Forum. Her previous work at the IOM has focused on topics that include the development of cancer

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21 APPENDIX B biomarkers, strategies for large-scale biomedical science, the development of technologies for the early detection of breast cancer, improving breast imaging quality standards, the Health Insurance Portability and Account- ability Act Privacy Rule, and contraceptive research and development. Her current position at the IOM combines her dual interests in biomedical research and health science policy. With a Ph.D. in cell and tumor biology from Georgetown University and postdoctoral training at the Johns Hop- kins University School of Medicine, she has authored papers on the cell and molecular biology of breast cancer. She also earned a B.S. in genetics (with highest distinction) and an M.S. in endocrinology/reproductive physiology, both from the University of Wisconsin-Madison. In addition, she studied developmental genetics and molecular biology at the Max Planck Institute in Germany under a fellowship from Fulbright and the German Heinrich Hertz-Stiftung Foundation. Dr. Nass was the 2007 recipient of the Cecil Award for Excellence in Health Policy Research. Erin balogh, M.P.H., joined the Institute of Medicine in August 2008 as a research associate for the National Cancer Policy Forum and Board on Health Care Services. She has worked on two committee studies, the Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease and Cancer Clinical Trials and the NCI Cooperative Group Program. She completed an M.P.H. in the Department of Health Management and Policy at the University of Michigan and before that graduated summa cum laude from Arizona State University with bachelor’s degrees in microbiology and psychology. Ms. Balogh interned with AcademyHealth in Washington, DC, and worked as a research site coordinator for the Urban Institute in Topeka, Kansas. As an undergraduate, Ms. Balogh worked as a management intern with the Arizona State University Office of University Initiatives, a strategic planning group for the university. Sally Cluchey (née Robinson), M.S., is currently a research associate with the Engelberg Center for Health Care Reform at the Brookings Institution. There she is responsible for working with multiple stakehold- ers to develop the infrastructure, methods, and governance structure neces- sary to conduct active medical product safety surveillance and comparative effectiveness research. Before she joined Brookings, she was a program officer with the Institute of Medicine (IOM). At the IOM, she staffed multiple projects, including the consensus study on Comparative Effective- ness Research Prioritization, where she helped to write the report Initial Priorities for Comparative Effectiveness Research, and served for 2 years as staff to the Forum on Drug Discovery, Development, and Translation. While working on the Forum, Ms. Cluchey was responsible for several key IOM initiatives involving the science of drug safety, Food and Drug

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22 A NATIONAL CANCER CLINICAL TRIALS SySTEM Administration policy, funding models for drug development, and improv- ing the clinical research process. Before she joined the IOM in 2006, she worked for the Walter Reed Army Institute of Research’s Malaria Vaccine Development Program, where she managed the manufacture, preclinical, and Phase I development of multiple vaccine candidates and coordinated regulatory submissions. Ms. Cluchey holds a master’s of science in biomedi- cal science and regulatory compliance from Hood College and a bachelor of arts from Kenyon College. Lisa boyette, M.D., completed an M.D. at the University of Virginia in 2007 and is now working on a Ph.D. in molecular physiology and biologi- cal physics at the National Institutes of Health (NIH). Her research at NIH focuses on stem cell reprogramming techniques and how reprogramming technology can be applied to cell-based therapies and tissue engineering. Dr. Boyette studied biomedical engineering and physics as an undergraduate at Virginia Commonwealth University and the Medical College of Virginia. After the completion of her Ph.D., she plans to complete residency training in neurosurgery. Sharon Murphy, M.D., joined the Institute of Medicine (IOM) as a scholar- in-residence in October 2008, coming to Washington, DC, from Texas, where she was the inaugural director of the Greehey Children’s Cancer Research Institute and professor of pediatrics at the University of Texas Health Science Center at San Antonio. Dr. Murphy brings more than 30 years of experience in academic medicine, pediatric oncology, and clinical research to the IOM. A graduate of Harvard Medical School, she has pre- viously held positions at the Northwestern University Feinberg School of Medicine; Children’s Memorial Hospital in Chicago, Illinois; and St. Jude Children’s Research Hospital. She has served as an adviser to the National Cancer Institute and the Food and Drug Administration. At the IOM, she is working on projects relating to national cancer policy, cancer clinical trials, the oncology workforce, and the learning health care system for cancer. Michael Park is a senior program assistant for the Board on Health Care Services and the National Cancer Policy Forum. Before arriving at the Insti- tute of Medicine in September of 2007, Mr. Park worked for the National Academy of Education and the International Law Group in Washington, DC. He earned a bachelor’s in German and Italian Studies from the Uni- versity of Maryland at College Park. He is fluent in Spanish, Italian, and German and plans to pursue studies in environmental health and urban design at the University of Maryland.

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2 APPENDIX B Roger Herdman, M.D., received undergraduate and medical school degrees from Yale University. After an internship at the University of Minnesota and a stint in the U.S. Navy, he returned to Minnesota, where he completed a residency in pediatrics and a fellowship in immunology and nephrology and where he served on the faculty. He served as professor of pediatrics at Albany Medical College until 1979. In 1969, Dr. Herdman was appointed director of the New York State Kidney Disease Institute in Albany and shortly thereafter was appointed deputy commissioner of the New York State Department of Health (1969 to 1977). In 1977, he was named New York State’s Director of Public Health. From 1979 until joining the U.S. Congress’s Office of Technology Assessment (OTA), he served as a vice- president of the Memorial Sloan-Kettering Cancer Center in New York City. In December 1983, Dr. Herdman was named assistant director of OTA, where he subsequently served as director (1993 to 1996). He later joined the National Academies Institute of Medicine (IOM) as a senior scholar and directed studies on graduate medical education, organ trans- plantation, silicone breast implants, and the U.S. Department of Veterans Affairs national formulary. Dr. Herdman was appointed director of the IOM/NRC National Cancer Policy Board from August 2000 through April 2005. From May 2005 until September 2009, Dr. Herdman directed the IOM National Cancer Policy Forum, which includes federal and private- sector agencies or organizations relevant to cancer, in addition to academic/ industry members. In October 2007, he was also appointed director of the IOM Board on Health Care Services. During his time at the IOM, Dr. Herdman has worked closely with the U.S. Congress on a wide variety of health care policy issues.

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