Speaker biographies

David S. Alberts, M.D., is the director of the Arizona Cancer Center at the University of Arizona and the Regents Professor of Medicine, Pharmacology, and Public Health at the university’s BIO5 Institute. After serving on the faculty at the National Cancer Institute and the University of California, San Francisco, Dr. Alberts moved to the Arizona Cancer Center, where he led the Pharmacology Program from 1978 to 1989 and the Cancer Prevention and Control Program from 1989 to 2005. From 1988 to 1996, he was the deputy director of the center, and from 1996 to 2002, he was the associate dean for research in the College of Medicine. Dr. Alberts has been funded by the National Cancer Institute yearly since 1971 for laboratory and clinical research related to the clinical pharmacology of cancer chemotherapy and chemopreventive agents, as well as the development of research strategies for the prevention of breast, cervical, colon, prostate, and skin cancers. Between 1982 and 1984, Dr. Alberts chaired the Oncologic Advisory Committee of the Food and Drug Administration. Since 1995, he has chaired the Cancer Prevention and Control Committee in the Gynecologic Oncology Group.

John E. Calfee is a resident scholar at AEI. He previously worked on the economics of consumer protection—including advertising and marketing, the tort liability system, tobacco, and other topics—at the Bureau of Economics at the Federal Trade Commission. He later taught marketing and consumer behavior at the business schools of the University of Maryland at College Park and Boston University, and spent a year as a visiting senior fellow at the Brookings Institution. Mr. Calfee’s op-eds have appeared in the Wall Street Journal, the Philadelphia Inquirer, the Los Angeles Times, and numerous newspapers and magazines. His recent scholarly publications have appeared in Clinical Pharmacology and Therapeutics, The American, and Health Affairs. He has published three short books: Fear of Persuasion: A New Perspective on Advertising and Regulation (Agora, 1997), Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000), and Biotechnology and the Patent System: Balancing Innovation and Property Rights (with Claude Barfield; AEI Press, 2007). He has also testified before Congress and federal agencies on various topics, including alcohol advertising, biodefense vaccine research, international drug prices, the Vioxx episode, and, most recently, Food and Drug Administration oversight of drug safety.

Ken Carson, M.D., is a hematology/oncology fellow at Northwestern University’s Feinberg School of Medicine. Before starting his clinical fellowship at Northwestern, he was a health services research fellow at the Institute for Healthcare Studies at Northwestern University, where he worked in the area of adverse drug events. After completing his internship and residency in internal medicine at Duke University, Dr. Carson joined the faculty at Duke, where he practiced general internal medicine for one year. His research interests include health economics and pharmaceutical safety.

Bruce D. Cheson, M.D., has been professor of medicine, head of hematology, and the director of hematology research at Georgetown University Hospital since 2002. From 1977 to 1984, he was an assistant professor of medicine in hematology/oncology at the University of Utah. In 1984, he came to the National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program (CTEP) and from 1986 to 2002 was the head of the Medicine Section at CTEP. He has also been a senior staff physician in the lymphoma clinic at NCI. Dr. Cheson has authored over three hundred medical publications and abstracts and has contributed to more than fifty texts. He is on the editorial board of numerous journals. He has also been the editor of the Medical Knowledge Assessment Program in Oncology for the American College of Physicians and the American Society of Clinical Oncology (ASCO). Dr. Cheson was on several ASCO committees and its board of directors, and he edited ASCO News. He is on the executive committee of the Lymphoma Research Foundation and is currently president-elect of the Scientific Advisory Board. He was also on the Oncologic Drug Advisory Committee of the Food and Drug Administration. He currently chairs the lymphoma committee of the Cancer and Leukemia Group B and is the co-chair of the International Harmonization Project in Lymphoma. Dr. Cheson’s clinical interests focus on the development and evaluation of new therapeutic approaches for hematologic malignancies.

James H. Doroshow, M.D., has been the director of the Division of Cancer Treatment and Diagnosis at the National Cancer Institute (NCI) since 2004. From 1983 to 2004, Dr. Doroshow was the chairman of the City of Hope Comprehensive Cancer Center’s Department of Medical Oncology and Therapeutics Research. From the time of his first research grant in 1980, he was continuously funded by the NCI until he moved to the National Institutes of Health in 2004. He is the author of over three hundred publications in the areas of anthracycline antibiotic molecular pharmacology, the role of oxidant stress in tumor cell signal transduction, and novel therapeutic approaches to solid tumors. Dr. Doroshow was from 1995 to 2001 a member of the Subspecialty Board on Medical Oncology of the American Board of Internal Medicine, from 1999 to 2000 the chair of NCI’s Scientific Review Group A–Cancer Centers, and from 2004 to 2007 a member of the Food and Drug Administration’s Oncologic Drugs Advisory Committee. From 2004 to2005, he chaired NCI’s Clinical Trials Working Group, which developed a comprehensive set of initiatives to restructure the national cancer clinical trials enterprise.

Richard A. Epstein is the James Parker Hall Distinguished Service Professor of Law at the University of Chicago, where he directs the John M. Olin Program in Law and Economics. He is also the Peter and Kirsten Bedford Senior Fellow at the Hoover Institution. He was interim dean of the University of Chicago Law School from February to June 2001. He has been a member of the American Academy of Arts and Sciences since 1985 and a senior fellow at the Center for Clinical Medical Ethics at the University of Chicago Medical School since 1983. He edited the Journal of Legal Studies from 1981 to 1991 and the Journal of Law and Economics from 1991 to 2001. His books include Antitrust Consent Decrees in Theory and Practice (AEI Press, 2007), Federal Preemption (edited with Michael S. Greve; AEI Press, 2007), How Progressives Rewrote the Constitution (Cato, 2006), Skepticism and Freedom: A Modern Case for Classical Liberalism (University of Chicago Press, 2003), Cases and Materials on Torts (Aspen Law & Business; 8th ed., 2004), Torts (Aspen Law & Business 1999), Principles for a Free Society: Reconciling Individual Liberty with the Common Good (Perseus Books, 1998), Mortal Peril: Our Inalienable Rights to Health Care? (Addison-Wesley, 1997), Simple Rules for a Complex World (Harvard, 1995), and Bargaining With the State (Princeton University Press, 1993). He has written numerous articles on a wide range of legal and interdisciplinary subjects.

Gwen Fyfe, M.D., is a senior staff scientist in clinical hematology/oncology at Genentech. Before joining Genentech, she worked at the Chiron Corporation, participating in the successful approval of high-dose IL-2 (aldesleukin [Proleukin]) for the treatment of metastatic renal cell cancer and subsequently studying the role of intermittent IL-2 in the treatment of HIV. She joined Genentech in 1997. While there, her responsibilities have 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 HER2-positive metastatic breast cancer; rituximab (Rituxan), the first therapeutic antibody for the treatment of non-Hodgkin lymphoma in the United States; and bevacizumab (Avastin) for the treatment of metastatic colon cancer and non–small cell lung cancer. She has also worked with OSI Pharmaceuticals and Roche in the development of erlotinib (Tarceva), which is approved for the treatment of relapsed NSCLC and newly diagnosed pancreatic cancer. Recently, she has concentrated her efforts on the further development of bevacizumab. She was promoted to vice president of clinical hematology/oncology in 2002 and moved to her current role in May 2007.

Scott Gottlieb, M.D., is a practicing physician and a resident fellow at AEI. From 2005 to 2007, Dr. Gottlieb was deputy commissioner of the Food and Drug Administration (FDA), and before that, from 2003 to 2004, he served as a senior advisor to then–FDA commissioner Mark McClellan and as the FDA’s director of medical policy development. He left the FDA in 2004 to work on implementation of the new Medicare Drug Benefit as a senior adviser to the administrator of the Centers for Medicare & Medicaid Services, where he supported the agency’s policy work on quality improvement and coverage and payment decision-making, particularly related to new medical technologies. Dr. Gottlieb is the author of more than three hundred articles that have appeared in leading medical journals, as well as the Wall Street Journal, the New York Times, USA Today, and Forbes. He has held editorial positions on the British Medical Journal and the Journal of the American Medical Association. Previously, Dr. Gottlieb worked as a health care analyst for the investment bank Alex Brown & Sons and authored the Forbes-Gottlieb Medical Technology Letter and the Gilder Biotech Report. He practices medicine as an attending physician at Stamford Hospital in Connecticut, where he is an internist on the hospital’s inpatient medical wards.

The Honorable David A. Kessler, M.D., is a professor of pediatrics and epidemiology and biostatistics at the School of Medicine at the University of California, San Francisco (UCSF). He was the dean of the School of Medicine and the vice chancellor for medical affairs at UCSF from 2003 to 2007, the dean of the Yale University School of Medicine from 1997 to 2003, and commissioner of the Food and Drug Administration from 1990 to 1997. Dr. Kessler also serves on the board of various organizations, including the Elizabeth Glaser Pediatric AIDS Foundation, of which he is the chairman; the National Center for Addiction and Substance Abuse at Columbia University; and Amherst College. He is a member of the Institute of Medicine and the recipient of the 2001 National Academy of Sciences Public Welfare Medal. His many honors include the American Cancer Society’s Medal of Honor, the American Heart Association’s National Public Affairs Special Recognition Award, the American Federation for AIDS Research Sheldon W. Andelson Public Policy Achievement Award, the American Academy of Pediatrics Excellence in Public Service Award, the March of Dimes Franklin Delano Roosevelt Leadership Award, and the Jacobs Institute of Women’s Health Excellence in Women’s Health Award. Dr. Kessler has published numerous articles in the New England Journal of Medicine, the Journal of the American Medical Association, and other major medical journals. He is also the author of A Question of Intent (PublicAffairs, 2001).

Anup Malani is a professor of law and the Aaron Director Research Scholar at the University of Chicago. He is also a research affiliate at the Joint Center for Poverty Research at Northwestern University and the University of Chicago and an editor of the Journal of Law and Economics. Malani teaches health law, food and drug law, insurance law, corporations, and bankruptcy. His health-related research examines the control of infectious disease, placebo effects, antibiotic resistance, medical malpractice liability, and the conduct of and inferences from medical trials. His legal and economic research examines methods for valuing legal reforms. He clerked for the Judge Stephen F. Williams of the D.C. Circuit Court of Appeals and for former Supreme Court Justice Sandra Day O’Connor. From 2002 to 2006, He was an associate professor at the University of Virginia Law School and the Health Evaluation Sciences Department of the University of Virginia Medical School.

Richard A. Miller, M.D., is a clinical oncologist and biotech entrepreneur with over twenty-five years of experience developing new treatments for cancer. He is currently the president and CEO of Pharmacyclics, a California-based biotechnology company specializing in drug development and research in oncology, which he cofounded in 1991. Before Pharmacyclics, he was vice president and a director at IDEC Pharmaceuticals Corporation, another public biotechnology company, which he cofounded in 1984. At IDEC, he pioneered the development of rituximab, now widely used for the treatment of most lymphomas and several autoimmune diseases such as rheumatoid arthritis, and notably the second-most-commonly-used cancer treatment overall. Dr. Miller is also a clinical professor of medicine (oncology) at Stanford University Medical Center. He has been published in the Wall Street Journal, Scientific American, and the Huffington Post and has authored or coauthored over one hundred peer-reviewed articles in scientific journals.

Tomas Philipson is a visiting scholar at AEI and a professor in the Harris School, the Department of Economics, and the Law School at the University of Chicago. He served in the Bush administration as the senior economic adviser to the commissioner of the Food and Drug Administration from 2003 to 2004 and subsequently as the senior economic advisor to the administrator of the Centers for Medicare & Medicaid Services from 2004 to 2005. He is currently a member of the Advisory Committee to the University of Chicago’s Office of Intellectual Property and Technology Transfer. Mr. Philipson is a coeditor of Forums for Health Economics & Policy and is on the editorial board of Health Economics. His honors and awards include the Kenneth Arrow Award from the International Health Economics Association in 2000 and 2006, the Garfield Award from Research America in 2007, the Prêmio Haralambos Simeonidis from the Brazilian Economic Association in 2006, and the Distinguished Economic Research Award from the Milken Institute in 2003. Mr. Philipson was the cofounder of Precision Health Economics LLC, a board member of MedErr Inc. and the Center for Medicine in the Public Interest, an adviser to the Gerson-Lehrman Group, and a consultant for Lexecon and Analysis Group.

Richard Simon is the chief of the biometric research branch of the National Cancer Institute (NCI). He has published over four hundred papers and developed many of the statistical methods used today in cancer clinical trials. Mr. Simon is an elected member of the American Statistical Association, a former member of both the Oncologic Drug Advisory Committee of the Food and Drug Administration and the National Research Council Committee on Theoretical and Applied Statistics. He is on the editorial boards of several cancer and bioinformatics journals. Mr. Simon also leads the Molecular Statistics and Bioinformatics Section of NCI and has published widely on the design and analysis of DNA microarray studies, serving as lead author of a book on that topic published by Springer. He has also developed integrated software (BRB-ArrayTools) for the analysis of microarray data, with over 7,000 registered users in 65 countries. Most recently, his research has included the development of clinical trial designs and analysis plans to facilitate the development of new drugs in targeted populations.

Douglas Throckmorton, M.D., is the deputy director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). In this role, he shares responsibility for overseeing the regulation of research, development, manufacture, and marketing of prescription, over-the-counter, and generic drugs. Dr. Throckmorton was the founding chair of CDER’s Drug Safety Oversight Board and served until recently as the CDER liaison to the FDA Human Subjects Research Review Board. He currently serves on the FDA Bioinformatics Board, helping coordinate FDA efforts in information technology. Dr. Throckmorton began his career at the FDA in the Division of Cardio-Renal Drug Products in 1997, first as a medical reviewer, then as deputy division director, and, from 2002 to 2005, as division director.

Mark van der Laan is a professor of biostatistics and statistics at the University of California, Berkeley. His research interests include statistical methods for clinical trials and adaptive designs, statistical methods in genomics (that is, computational biology), survival analysis, censored data, semiparametric models and causal inference, machine learning, and multiple testing. He is currently the associate editor of the Electronic Journal of Statistics, Statistics Surveys, Statistical Applications in Genetics and Molecular Biology, Annals of Statistics, the Journal of the American Statistical Association, and the Journal of Statistical Methods in Medical Research. He is also the founding editor of the International Journal in Biostatistics. Mr. van der Laan received the Mortimer Spiegelman Award in 2004, the van Dantzig Award in 2005, the 2005 COPPS Snedecor Award, and the 2005 (COPSS) Presidential Award. He presented the 2005 Lefkopoulou Distinguished Lectureship at Harvard University and has been awarded the UC Berkeley Chancellor Endowed Chair for 2005–2008, as well as the long-term Jiann-Ping Hsu/Karl E. Peace Endowed Chair in Biostatistics, beginning in 2005.

The Honorable Andrew C. von Eschenbach, M.D., is the twentieth commissioner of the Food and Drug Administration. He is also a former director of the National Cancer Institute (NCI) and a nationally recognized urologic surgeon and oncologist. Before being appointed to lead NCI in January 2002, Dr. von Eschenbach was the executive vice president and chief academic officer of the University of Texas’s M. D. Anderson Cancer Center in Houston. At M. D. Anderson, he was also vice president for academic affairs, and he held the Roy M. and Phyllis Gough Huffington Clinical Research Distinguished Chair in Urologic Oncology. He was also the founding director of the Prostate Cancer Research Program, the director of the Genitourinary Cancer Center, a faculty member beginning in 1977, and the chairman of the Department of Urology beginning in 1983. Dr. von Eschenbach, himself a cancer survivor, is a founding member of C-Change and was president-elect of the American Cancer Society at the time of his appointment to NCI. He has published more than two hundred articles, books, and book chapters. He has also been an editorial board member of several leading journals and served on several organizational boards. Dr. von Eschenbach has received the 2003 Carpe Diem Award from the Lance Armstrong Foundation, the Achievement Award from the 100 Black Men of Metropolitan Houston, the Julie Rogers Spirit of Love Award; and the American Radium Society Janeway Medal. In 2006, Time magazine named him one of the world’s hundred most influential people. 

Robert C. Ward is a second-year medical student at the George Washington University School of Medicine and Health Sciences, where he is chair of the Oncology Interest Group. He spent two summers working in cancer vaccine research at the University of Pittsburgh Medical Center, and he has published a review article in International Reviews of Immunology.

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