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Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington (DC): National Academies Press (US); 2011.

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Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary.

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Appendix BParticipant Biographies

Barbara Alving, M.D., M.A.C.P., is the Director of the National Center for Research Resources (NCRR), which funds the development of new technologies for basic and clinical research, supports training for researchers in the biomedical sciences, develops preclinical models, and provides health and biomedical education for the public. The NCRR is responsible for developing the new Clinical and Translational Science Award (CTSA) program that has evolved from the NIH Roadmap initiative to re-engineer clinical research. Dr. Alving received her M.D. cum laude from Georgetown University School of Medicine in Washington, DC. After an internship in internal medicine at Georgetown University Hospital, she completed a residency in internal medicine and a fellowship in hematology at the Johns Hopkins University Hospital in Baltimore, Maryland. Dr. Alving then became a research investigator in the Division of Blood and Blood Products at the FDA on the NIH campus. In 1980, she joined the Department of Hematology and Vascular Biology at the Walter Reed Army Institute of Research and became Chief of the Department in 1992. She left the Army at the rank of Colonel in 1996 to become the Director of the Medical Oncology/Hematology Section at the Washington Hospital Center in Washington, DC. In 1999, she joined the National Heart, Lung, and Blood Institute (NHLBI), serving as the Director of the extramural Division of Blood Diseases and Resources until becoming the Deputy Director of the Institute in September 2001. From September 2003 until February 1, 2005, she served as the Acting Director of the NHLBI. From October 2002 until January 2006, she served as the Director of the Women’s Health Initiative, which is funded through the NHLBI. In March 2005, she became the Acting Director, NCRR and was named Director in April 2007. Dr. Alving is a Professor of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, a Master in the American College of Physicians, a former member of the subcommittee on Hematology of the American Board of Internal Medicine, and a previous member of the FDA Blood Products Advisory Committee. She is a co-inventor on two patents, has edited three books, and has published more than 100 papers in the area of thrombosis and hemostasis.

Margaret Anderson is Executive Director of FasterCures/The Center for Accelerating Medical Solutions, defining the organization’s strategic priorities and positions on key issues, developing its programmatic portfolio, and managing its operations. Prior to her appointment, she was FasterCures’ COO for 5 years. Ms. Anderson previously served as deputy director of the Academy for Educational Development and led programs and studies at the Society for Women’s Health Research, the American Public Health Association and the Congressional Office of Technology Assessment. She serves on the boards of the Alliance for a Stronger FDA and the Council for American Medical Innovation. She holds a Bachelor’s degree from the University of Maryland and a master’s degree in science, technology and public policy from George Washington University’s Elliott School of International Affairs.

Gail H. Cassell, Ph.D., is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana. She is former Charles H. McCauley Professor and Chair of the Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from the NIH during the decade of her leadership. She obtained her B.S. from the University of Alabama in Tuscaloosa and in 1993 was selected as one of the top 31 female graduates of the twentieth century. She obtained her Ph.D. in microbiology from the University of Alabama at Birmingham and was selected as its 2003 Distinguished Alumnus. She is past President of the American Society for Microbiology (the oldest and single largest life sciences organization, with a membership of more than 42,000). She was a member of the NIH Director’s Advisory Committee and of the Advisory Council of the National Institute of Allergy and Infectious Diseases. She was named to the original Board of Scientific Councilors of the Center for Infectious Diseases, CDC, and served as chair of the board. She recently served a 3-year term on the advisory board of the Director of CDC and as a member of the Secretary of Health and Human Services’ Advisory Council of Public Health Preparedness. Currently she is a member of the Science Board of the FDA. Since 1996 she has been a member of the U.S.–Japan Cooperative Medical Science Program, responsible for advising the respective governments (U.S. State Department/Japanese Ministry of Foreign Affairs) on joint research agendas. She has served on several editorial boards of scientific journals and has authored more than 250 articles and book chapters. Dr. Cassell has received national and international awards and an honorary degree for her research in infectious diseases. She is a member of the IOM and is currently serving a 3-year term on the IOM Council, the institution’s governing board. Dr. Cassell has been intimately involved in the formulation of science policy and legislation related to biomedical research and public health. For 9 years she was chair of the Public and Scientific Affairs Board of the American Society for Microbiology; she has served as an advisor on infectious diseases and indirect costs of research to the White House Office of Science and Technology Policy, and has been an invited participant in numerous congressional hearings and briefings related to infectious diseases, antimicrobial resistance, and biomedical research. She has served two terms on the Liaison Committee on Medical Education, the accrediting body for U.S. medical schools, as well as other national committees involved in establishing policies on training in the biomedical sciences. She recently completed a term on the Leadership Council of the School of Public Health of Harvard University. Currently she is a member of the Executive Committee of the Board of Visitors of Columbia University School of Medicine, the Executive Committee of the Board of Directors of the Burroughs Wellcome Fund, Research!America, and the Advisory Council of the Johns Hopkins School of Nursing.

William Corr, J.D., was unanimously confirmed on May 6, 2009, by the Senate as Deputy Secretary of the Department of Health and Human Services. As Deputy Secretary, he is responsible for the operations of the largest civilian department in the federal government. “Bill Corr’s policy expertise and management experience will be invaluable as we work together to manage the Department and pass and implement comprehensive health reform,” Secretary Sebelius said. “Bill knows our department inside and out, and I look forward to partnering with him in the years ahead.” Mr. Corr most recently served as executive director of the Campaign for Tobacco-Free Kids. Previously, he served for 12 years as counsel to the U.S. House of Representatives’ Subcommittee on Health and the Environment. Additionally, Mr. Corr served as Chief of Staff for the Department of Health and Human Services. Mr. Corr is a graduate of the University of Virginia and the Vanderbilt University School of Law.

Representative Rosa DeLauro has worked a lifetime for the people of Connecticut. She was first elected to Congress from Connecticut’s Third District in 1990, and is currently serving her tenth term. Congresswoman DeLauro sits on the influential House Appropriations and Budget Committees. She serves as chairwoman of the Agriculture-FDA Appropriations Subcommittee and as a member of the Labor–Health and Human Services–Education and Financial Services Appropriations Subcommittees. In 1999, she was elected Assistant to the Democratic Leader by her colleagues, making her the second highest ranking Democratic woman in the House of Representatives. She was re-elected to this position in 2000. She has served as co-chair of the House Steering and Policy Committee since 2002. Congresswoman DeLauro was born and raised in New Haven’s Wooster Square, where for years her grandmother owned and operated a pastry shop. Her father, Ted DeLauro, was a New Haven Alderman whose hard work earned him the nickname “Mayor of Wooster Square.” DeLauro’s mother, Luisa, was the longest-serving member of the New Haven Board of Aldermen, serving from 1965 to 1998. Since coming to Congress, DeLauro has built a solid reputation for constituent service and hard work. In 1998, 2000 and 2002, she was recognized as one of the House of Representative’s top “Workhorses” by Washingtonian magazine, and was called a “hero for working families” by nationally syndicated columnist Tom Oliphant. DeLauro has helped Connecticut families get ahead by making economic improvement a top priority. The first bill she introduced as a Member of Congress was a middle-class tax cut. More recently, she has fought for targeted tax cuts such as a $500 per child tax credit, a tax cut for children’s health care, and education tax cuts to give every Connecticut family the chance to send their kids to college. DeLauro has authored legislation that would guarantee men and women equal pay for equal work. From her seat on the Appropriations Committee, DeLauro has successfully secured millions in vital funds for Connecticut’s defense industry. In addition, DeLauro has become a leader in the effort to protect and strengthen Social Security for today’s seniors and future generations. During her tenure in Congress, DeLauro has taken a special interest in health care issues, leading the fight for affordable, quality health care. She has worked aggressively with a bipartisan group of legislators to lower the rising costs of prescription drugs. As a result of her efforts, the U.S. House passed legislation allowing the importation of drugs from countries like Canada in the 108th Congress. A survivor of ovarian cancer, DeLauro has been a leading voice for increasing critical cancer research. Her work led to passage of “Johanna’s Law” in the 109th Congress—a law that will increase awareness of the gynecologic cancers. From her position on the Labor–Health and Human Services–Education Appropriations Subcommittee, DeLauro has fought to increase funding for breast and cervical cancer screenings and research. DeLauro has also authored legislation to ensure longer hospital stays for women undergoing breast cancer surgery that enjoys bipartisan support. She led an effort to enact national legislation to address the public health crisis of underage drinking in our country. In the 109th Congress, “The STOP (Sober Truth on Preventing) Underage Drinking Act” became law. In February 2005, DeLauro was honored to be appointed ranking member of the House Appropriations Agriculture Subcommittee and charged with overseeing what she considers the core responsibilities of our federal government. Through the position, DeLauro has worked to provide funding for a safe food supply, a healthy agricultural economy, and for the FDA to regulate thousands of products we use every day. DeLauro has made reform of the FDA a top priority to strengthen oversight of food and drugs. With rising instances of food safety and food-borne illness a concern for many Americans, DeLauro co-founded the Congressional Food Safety Caucus to explore remedies to secure the food supply. As chairwoman of the Appropriations Agriculture Subcommittee in the 110th Congress, DeLauro worked to restore the oversight functions of the subcommittee by examining the nation’s food safety system and ensuring that federal agencies such as the FDA and USDA prioritize science and the public interest. She worked to make bold investments in renewable energy technologies, expand rural development programs and support specialty crop initiatives that are important to Connecticut. DeLauro has spearheaded initiatives in Washington and Connecticut to meet the challenges facing parents and children. She has championed legislation that would make child care more affordable, and has worked to improve public education by reducing class size and modernizing public schools. In 1999, DeLauro established “Rosa’s Readers,” a program designed to increase interest in reading outside the formal classroom environment. During the first Rosa’s Readers summer program, more than 400 first graders completed the challenge of reading twenty books over the summer and were rewarded at a pizza party with their family and friends. Since she first came to Congress in 1990, DeLauro has put every pay raise she has received toward the Ted DeLauro Scholarship, which she founded in memory of her late father. To date, $478,000 has helped 478 students further their education. In 2004, DeLauro also used the Congressional pay raise to initiate the Maria Baez Perez Scholarship, established in the name of a former staff person. Since that time, 38 area students have received $1,000 scholarships as well. Prior to her election to the House of Representatives, DeLauro served as Executive Director of EMILY’S List, a national organization dedicated to increasing the number of women in elected office. She served as Executive Director of Countdown ‘87, the national campaign that successfully stopped U.S. military aid to the Nicaraguan Contras. From 1981–1987, DeLauro served as Chief of Staff to U.S. Senator Christopher Dodd. DeLauro is a graduate of Marymount College, where she received her B.A. with honors. She earned her master’s in International Politics from Columbia University, and studied at the London School of Economics. DeLauro is married to Stanley Greenberg, President of Greenberg-Quinlan Research, Inc., a public issues research and polling firm.

Jeffrey M. Drazen, M.D., was born in Missouri. He attended Tufts University with a major in physics and Harvard Medical School, and served his medical internship at Peter Bent Brigham Hospital in Boston. Thereafter, he joined the Pulmonary Divisions of the Harvard hospitals. He served as Chief of Pulmonary Medicine at the Beth Israel Hospital, Chief of the combined Pulmonary Divisions of the Beth Israel and Brigham and Women’s Hospitals, and finally as the Chief of Pulmonary Medicine at Brigham and Women’s Hospital. Through his research, he defined the role of novel endogenous chemical agents in asthma. This led to four new licensed pharmaceuticals for asthma with more than 5 million people on treatment worldwide. In 2000, he assumed the post of Editor-in-Chief of the New England Journal of Medicine. During his tenure, the journal has published major papers advancing the science of medicine, including the first descriptions of SARS and papers modifying the treatment of cancer, heart disease and lung disease. The journal, which has more than a million readers every week, has the highest impact factor of any journal publishing original research.

Susan Ellenberg, Ph.D., is Professor of Biostatistics, Center for Clinical Epidemiology and Biostatistics, and Associate Dean for Clinical Research, University of Pennsylvania School of Medicine. Dr. Ellenberg’s research has focused on practical problems and ethical issues in designing, conducting and analyzing data from clinical trials, including surrogate endpoints, data monitoring committees, clinical trial designs, adverse event monitoring, vaccine safety and special issues in cancer and AIDS trials. At Penn, in addition to her teaching and administrative duties, she serves as senior statistician for three multicenter clinical trials and directs the Biostatistics Core of the Penn Center for AIDS Research. In her role as Associate Dean for Clinical Research, she oversees the human subjects protections programs of the University of Pennsylvania School of Medicine. Prior to her appointment at Penn, Dr. Ellenberg held positions of increasing responsibility in the federal government. From 1993 to 2004 she served as Director, Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research (CBER) at the FDA; prior to that she served as the first Chief of the Biostatistics Research Branch in the Division of AIDS, National Institute of Allergy and Infectious Diseases (1988–1993), and served in the Biometric Research Branch in the Cancer Therapy Evaluation Program, National Cancer Institute (1982–1988). During Dr. Ellenberg’s tenure at FDA, she played a leading role in the development of international standards for design and analysis of clinical trials performed by the pharmaceutical industry, developed productive programs for postmarketing safety surveillance of biological products, and coordinated the development of policy for the establishment and operation of clinical trial data monitoring committees. Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute. Her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was named WileyEurope Statistics Book of the Year for 2002. Dr. Ellenberg received her undergraduate degree from Radcliffe College and her Ph.D. in Mathematical Statistics from the George Washington University.

Garret FitzGerald, M.D., is chair of Pharmacology and director of the Institute for Translational Medicine and therapeutics at the University of Pennsylvania School of Medicine. His work is focused on prostaglandins and their inhibitors and on the role of molecular clocks in cardiovascular biology and metabolism. He has previously served as chair of medicine and therapeutics at University College, Dublin, and director of Clinical Pharmacology at Vanderbilt. Besides the IOM Drug Forum, he serves on the Science Board of the FDA and the Peer Review Advisory Committee of the NIH.

Jesse Goodman, M.D., M.P.H., became Chief Scientist and Deputy Commissioner for Science and Public Health of the FDA in 2009. He has broad responsibility for and engagement in leadership and coordination of the agency’s cross-cutting scientific and public health efforts. From 2003–2009, he was Director of FDA’s Center for Biologics Evaluation and Research (CBER), which oversees medical and public health activities critical to U.S. and global preparedness concerning the development, evaluation, safety, quality, and availability of biologics. A graduate of Harvard, he received his M.D. from the Albert Einstein College of Medicine and did residency and fellowship training at the Hospital of the University of Pennsylvania and at UCLA (where he was also Chief Medical Resident). Prior to joining FDA, he was Professor of Medicine and Chief of Infectious Diseases at the University of Minnesota, where he directed the multihospital Infectious Diseases research, training, and clinical programs, and where his NIH-funded laboratory first isolated and characterized Anaplasma phagocytophilum, the infectious agent causing a new tick-borne disease, human granulocytic ehrlichiosis. He has authored numerous scientific papers and edited the book Tick-Borne Diseases of Humans published by ASM Press in 2005. Dr. Goodman has been elected to the American Society for Clinical Investigation and to the Institute of Medicine of the National Academy of Sciences, where he is a longstanding member of the Forum on Emerging Threats. He is an active clinician and teacher who is board certified in internal medicine, oncology, and infectious diseases and is Staff Physician and Infectious Diseases Consultant at both the National Naval and Walter Reed Army Medical Centers, and is Adjunct Professor of Medicine at the University of Minnesota.

Harry Greenberg, M.D., received his B.A. in History from Dartmouth College in 1966. He received his M.D. from Columbia College of Physicians and Surgeons in 1970. He did his internal medicine house staff and GI fellowship training at Bellevue Hospital and Stanford University respectively. Dr. Greenberg spent 10 years at the NIH in the Laboratory of Infectious Disease as a tenured scientist before returning to Stanford in 1983. He is currently the Joseph D. Grant Professor of Medicine and Microbiology and Immunology and the Senior Associate Dean for Research at Stanford University School of Medicine. He is also a staff physician at the Palo Alto VA hospital. Dr Greenberg is a member of a variety of scholarly societies, governmental committees, and editorial boards. He is the past President of the American Society of Virology, a consultant for a variety of vaccine manufacturing companies and the director of Stanford’s NIH-funded CTSA. He has been an active NIH-funded investigator for more than 30 years during which time his studies have focused primarily on viruses that infect the GI tract, liver, or respiratory tree. He has published more than 400 articles, chapters, and reviews. His work has spanned the spectrum from basic studies of viral:host cell interaction to translation work on the immune response to important pathogens in both animal models and humans to clinical trials of vaccine safety and efficacy. He has trained a large number of M.D. and Ph.D. postdoctoral students who are now in independent careers in science and academic medicine. He has also carried out a variety of other administrative roles at Stanford including being the Chief of the GI division of the Department of Medicine, the acting Chairperson of the Department of Medicine (twice) and the ACOS for research at the Palo Alto VA. During a 2-year leave of absence from Stanford, Dr. Greenberg was the Chief Scientific Officer at a biotechnology company called Aviron (now MedImmune Vaccines) where he played a key role in bringing the live attenuated influenza vaccine to licensure.

Steven Grossman, J.D., is the President of HPS Group, LLC, a public affairs consulting firm that specializes in health policy and FDA regulatory issues. His clients include patient and research advocacy groups, professional societies, and FDA-regulated companies. Mr. Grossman is also the author of the blog: FDA Matters, In 2007, he was a founder of Alliance for a Stronger FDA, the only multi-stakeholder group advocating on behalf of increased appropriations for FDA. He continues to serve as the group’s Deputy Executive Director. Earlier in his career, Mr. Grossman was a Deputy Assistant Secretary for Health at DHHS and Health Staff Director and Counsel to the Senate Labor and Human Resources Committee. He was one of the chief Senate negotiators on the Orphan Drug Act and on the Patent Term Restoration and Drug Price Competition Act (Hatch-Waxman). He received his B.A. from Oberlin College and his J.D. from Georgetown University School of Law.

Margaret Hamburg, M.D., was confirmed on May 18, 2009, by a unanimous Senate voice vote to become the 21st Commissioner of Food and Drugs. The second woman to be nominated for that demanding position, Dr. Hamburg is exceptionally qualified for her new job by her training and experience as a medical doctor, scientist, and public health executive. Dr. Hamburg graduated from Harvard Medical School, and completed her residency in internal medicine at what is now New York Presbyterian Hospital–Weill Cornell Medical Center, one of the top-ten hospitals in the nation. She conducted research on neuroscience at Rockefeller University in New York, studied neuropharmacology at the National Institute of Mental Health on the NIH campus in Bethesda, Maryland, and later focused on AIDS research as Assistant Director of the National Institute of Allergy and Infectious Diseases. In 1990, Dr. Hamburg joined the New York City Department of Health and Mental Hygiene as Deputy Health Commissioner and within a year was promoted to Commissioner, a position she held until 1997. During her tenure she was widely praised for her initiatives, decisive leadership, and significant public health measures she carried out despite severe budget constraints and while holding academic positions at Columbia University School of Public Health and Cornell University Medical College. Dr. Hamburg’s accomplishments as New York’s top public health official included improved services for women and children, needle-exchange programs to reduce the spread of HIV (the AIDS virus), and initiation of the first public health bioterrorism defense program in the nation. Her most celebrated achievement, however, was curbing the spread of tuberculosis. In the 1990s, TB resurged as a major public health threat, largely because many patients did not complete the full course of the treatment and the disease became resistant to standard drugs. Dr. Hamburg confronted the problem by sending health care workers to patients’ homes and taking other steps to make sure they completed the drug regimen. Thanks to this program, in a five-year span, the TB rate in New York City fell by 46 percent overall, and 86 percent for the most drug-resistant strains. Dr. Hamburg’s innovative approach has become a model for health departments world-wide. In 1994, Dr. Hamburg was elected to the membership in the IOM, one of the youngest persons to be so honored. Three years later, at the request of President Clinton, she accepted the position of Assistant Secretary for Policy and Evaluation in the U.S. Department of Health and Human Services (HHS). In 2001, Dr. Hamburg became Vice President for Biological Programs at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. In that position, she advocated broad reforms in public health infrastructure and policy, from local health departments to the national agency, in order to meet the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu. Beginning in 2005, Dr. Hamburg served as the initiative’s Senior Scientist. President Barack Obama nominated her for the FDA Commissioner on March 25, 2009. Upon Dr. Hamburg’s confirmation by the U.S. Senate, HHS Secretary Kathleen Sebelius has praised her as “an inspiring public health leader with broad experience in infectious disease, bioterrorism, and health policy,” and added that “Personally, I have been impressed by the calm and confidence Dr. Hamburg has shown in the face of a wide variety of challenges.”

Peter K. Honig, M.D., M.P.H., is Head of Global Regulatory Affairs at AstraZeneca Pharmaceuticals. He was executive vice president for Worldwide Regulatory Affairs and Product Safety within Development at Merck Research Laboratories since March of 2002. In this role, he was responsible for Global Regulatory Affairs, Worldwide Product Safety and Quality Assurance, Preclinical Pharmacology/Toxicology as well as Worldwide OTC Development. He is former Director of the Office of Drug Safety in FDA’s Center for Drug Evaluation and Research (CDER). He received his baccalaureate, medical, and public health degrees from Columbia University in New York. He has postgraduate training and is board certified in internal medicine and clinical pharmacology and is a Fellow of the American College of Physicians. Dr. Honig retains faculty appointments at the Uniformed Services University of the Health Sciences and Georgetown University Medical School. He recently served as President-Elect of the American Society of Clinical Pharmacology and Therapeutics and has previously served as a Vice President and Chair of its section on Pharmacoepidemiology, Drug Safety and Outcomes Research. He is the PhRMA representative to the International Conference on Harmonization (ICH) Steering Committee. Dr. Honig joined CDER as a medical officer in the Division of Oncology and Pulmonary Drug Products in 1993. He also served as the FDA representative to the CERTs Steering Committee (Centers for Education and Research on Therapeutics), CDER liaison to the Harvard Clinical Investigators fellowship training program, CDER representative to the MedDRA Management Board, and the ICH E2B Expert Working Group.

Sangtae Kim, Ph.D., brings a unique combination of academic, industry, and government agency experience to bear on the problem of drug discovery and development. He came to the Morgridge Institute in 2008 from Purdue University, where he was the Donald W. Feddersen Distinguished Professor of Mechanical Engineering and Distinguished Professor of Chemical Engineering. During his six years in industry, Dr. Kim led research and development efforts at the pharmaceutical giants Eli Lilly and Pfizer. He also served the National Science Foundation as director of the division of shared cyberinfrastructure in 2004–2005, while on loan from Purdue University. In 2001, Dr. Kim was named a member of the National Academy of Engineering for his contributions to microhydrodynamics, protein dynamics, and drug discovery through the application of high-performance computing. After earning a master’s degree from the California Institute of Technology, Dr. Kim received a doctorate in chemical and biological engineering from Princeton University in 1983. He joined the UW-Madison faculty in 1983 and served as chair of the Department of Chemical Engineering from 1995–1997. During that time, he also was granted a rare “courtesy appointment” in the Department of Computer Sciences.

Judith Kramer, M.D., has a broad background in both pharmacy and medicine, having worked in roles as practitioner, clinical researcher, scientific administrator, and policy advisor. Currently, she is Associate Professor of Medicine in the Division of General Internal Medicine at Duke University Medical Center, where she is involved full time in research-related activities. From 2000–2007, she was the principal investigator for Duke’s Center for Education and Research on Therapeutics (CERTs), focused on cardiovascular disease. She continues as a co-investigator of the Duke CERTs and is currently chairperson of the FDA’s Drug Safety and Risk Management (DSaRM) Advisory Committee. In 2008, Dr. Kramer was named Executive Director of the Clinical Trials Transformation Initiative, (CTTI), a public private partnership under FDA’s Critical Path Program aimed at improving the quality and efficiency of randomized clinical trials. Dr. Kramer received her B.S. and M.S. in pharmacy and M.D. from the University of North Carolina at Chapel Hill and is board-certified in internal medicine. She did her residency in primary care internal medicine at Massachusetts General Hospital in Boston, and a senior residency in internal medicine at UNC Chapel Hill. After 5 years in practice of internal medicine in rural North Carolina, Dr. Kramer worked for 10 years at Burroughs Wellcome Co. where she became VP of Medical, directing U.S. Clinical Research. She continued in the merged GlaxoWellcome as International Director of Cardiovascular/Critical Care Clinical Research before leaving to work at Duke in 1996. At Duke she served as Chief Medical Officer of the Duke Clinical Research Institute from 1997–2006, and regulatory consultant to the Duke Translational Medicine Institute from 2006–2008. From 1999–2001, Dr. Kramer also served as the Founding Director of the Master’s Program in Clinical Research at Campbell University, in Research Triangle Park, North Carolina. Dr. Kramer’s research interests have focused on finding safe and effective cardiovascular therapies, assuring persistent use of life-saving medications, and using new methods to study postmarketing safety of drugs and devices.

Michael Manganiello has more than 15 years of experience in patient advocacy and public health with a strong background in formulating policy, building coalitions, managing nonprofits, and organizing grass-roots campaigns. Diagnosed as HIV positive in 1988, he was an early participant in NIH clinical trials that eventually led to treatments that have benefited many people today. In 1996, he helped establish the Christopher Reeve Foundation, a patient advocacy organization dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for people living with paralysis through grants, information, and advocacy. At the Reeve Foundation, Mr. Manganiello authored and secured introduction of the Christopher Reeve Paralysis Act and raised $22.5 million for the Christopher and Dana Reeve Paralysis Resource Center. He was chair of the Paralysis Task Force, in collaboration with the Centers for Disease Control and Prevention and the Hope Network, which connects more than 50,000 advocates across the country. Mr. Manganiello is a founding member and president emeritus of the Coalition for the Advancement of Medical Research (CAMR), which unites more than 100 diverse organizations, universities, scientific societies, and foundations in a bipartisan call for breakthrough medical research. Mr. Manganiello and CAMR were instrumental in the U.S. Congress’ passage of the Stem Cell Research Enhancement Acts in 2006 and 2007. He continues to serve on CAMR’s board. Today, CAMR and its 25,000 grassroots members conduct education, outreach, and advocacy about stem cell research, somatic cell nuclear transfer, and other technologies. This alliance strengthens the voices of families who cope with life-threatening illnesses, such as cancer, diabetes, Parkinson’s, and Alzheimer’s, as well as spinal cord injuries and other conditions. Mr. Manganiello also served for three years on the NIH Director’s Council of Public Representatives, a group that advises the NIH director about policy issues in biomedical research from the public perspective. He currently serves on several boards and advisory panels, including the Whitman-Walker Clinic, the National Association for Biomedical Research, the Prevent Cancer Foundation, and the National Symposium on Health Care Reform through the Mayo Clinic. In 2008, Mr. Manganiello and his two partners, Terrell Halaska and Kristin Conklin, established HCM Strategists, a consulting firm specializing in health care and education based on the belief that sound public policy drives progress and the results ensure that good ideas spread boldly to effect change in our communities. Their goals of achieving policy change in a reasonable time frame takes a combination of high-level government experience, a network of strong relationships, and the ability to find a fresh, creative approach to addressing the issues. When you can enlighten all participants by capturing their attention, finding common ground, and building strong alliances, success is within reach. Mr. Manganiello has a master’s degree in public administration from Columbia University and a bachelor’s degree in political science from Villanova University.

Mark McClellan, M.D., Ph.D., is Director of the Engelberg Center for Healthcare Reform at Brookings Institution. Dr. McClellan is former Administrator for the Centers for Medicare and Medicaid Services (CMS) and former Commissioner of the FDA. He has had a highly distinguished tenure of public service. In the George W. Bush administration, he served as a member of the President’s Council of Economic Advisers and Senior Director for Health Care Policy at the White House (2001–2002), FDA commissioner (2002–2004), and CMS Administrator. In these positions, he developed and implemented major reforms in health policy. In the Clinton administration, Dr. McClellan was Deputy Assistant Secretary of the Treasury for Economic Policy from 1998 to 1999, supervising economic analysis and policy development on a range of domestic policy issues. He subsequently directed Stanford’s Program on Health Outcomes Research, and was a Research Associate of the National Bureau of Economic Research and a visiting scholar at the American Enterprise Institute. Additionally, he was Associate Editor of the Journal of Health Economics and co-principal investigator of the Health and Retirement Study, a longitudinal study of the health and economic well-being of older Americans. A graduate of the University of Texas at Austin, he earned his MPA from Harvard’s Kennedy School of Government in 1991, his M.D. from the Harvard-MIT Division of Health Sciences and Technology in 1992, and his Ph.D. in economics from MIT in 1993. He completed his residency training in internal medicine at Brigham and Women’s Hospital, Boston. Dr. McClellan has been board certified in internal medicine and has been a practicing internist during his academic career. His academic research has been concerned with the effectiveness of medical treatments in improving health, the economic and policy factors influencing medical treatment decisions and health outcomes, the impact of new technologies on public health and medical expenditures, and the relationship between health status and economic well-being. He has twice received the Kenneth J. Arrow Award for Outstanding Research in Health Economics.

Dale Nordenberg, M.D., is a principal with Novasano Health and Science. He is a physician executive who leverages his experience as a pediatrician, medical epidemiologist, and informatician to deliver strategic, operational, and scientific services to clients in the healthcare and health information technology arena. Clients include both private and public sector institutions that are engaged in challenging activities such as new operational or business model development, novel information infrastructure development, collaborative/open innovation activities that are dependent on complex information supply chains, and the development of funding strategies. Client activities are both domestic and international. Recent projects include the development of a public–private partnership to build laboratory capacity for multidrug resistant TB across diverse international settings which he is currently leading, development of governance structures for the National Biosurveillance System for Human Health, development of a multi-institutional collaboration to revise FDA regulatory processes to more effectively establish laboratory data standards for national laboratory data exchange, and the evaluation of emerging diagnostics related to the gut microbiome from both the scientific and clinical perspectives. For the past few years, Dr. Nordenberg has been working as a healthcare consultant first with PricewaterhouseCoopers and then with Novasano. From 2002 through 2007, Dr. Nordenberg held various positions at CDC including Associate Director and Chief Information Officer (CIO), National Center for Infectious Diseases (NCID) and Senior Advisor for Strategic Planning, Office of the CIO, CDC. During this time, Dr. Nordenberg led the development of the CDC’s agency-wide IT strategic plan (2008–2012) and he was responsible for informatics for the agency’s infectious disease center where he initiated the implementation of a single laboratory platform for NCID’s labs and launched the Public Health Laboratory Interoperability Project (PHLIP) in collaboration with the Association of Public Health Labs to create a standards-based national laboratory data sharing network. Dr. Nordenberg led and participated in many disease surveillance, outbreak response, and bioterrorism preparedness and response activities and associated informatics initiatives. He has worked extensively in the arena of pandemic influenza preparedness and response. He was detailed part time to the Office of the National Coordinator for Health Information Technology in 2004–2005 to catalyze a national strategy for children’s health information technology. Dr. Nordenberg has been a member of the Science and Technology Subcommittee of the Science Advisory Board of the FDA in 2007 and 2009, which was tasked with the evaluation of science and technology at the FDA. Prior to CDC, Dr. Nordenberg was a founding executive of a company that launched VeriSign affiliates in Latin America and Asia and prior to that he was faculty in the Emory School of Medicine where founded and directed the Office of Medical Informatics for the Emory University Children’s Center. Dr. Nordenberg has served on the boards of numerous companies. Most recently he was a member of the board for Coventry Health Care of Georgia. Dr. Nordenberg is a board certified pediatrician. He received a B.S. in Microbiology from the University of Michigan, his M.D. from Northwestern University, and completed his training in pediatrics at McGill University, Montreal Children’s Hospital. He completed his fellowship in epidemiology and public health in the Epidemic Intelligence Service Program at the CDC.

Philip A. Pizzo, M.D., became dean of the Stanford School of Medicine in April 2001. Before joining Stanford, he was the physician-in-chief of Children’s Hospital in Boston and chair of the Department of Pediatrics at Harvard Medical School from 1996–2001. Dr. Pizzo is recognized for his contributions as a clinical investigator, especially in the treatment of children with cancer and HIV. Dr. Pizzo received his undergraduate degree from Fordham University and an M.D. from the University of Rochester School of Medicine. He completed an internship and residency at Children’s Hospital Medical Center in Boston, a teaching fellowship at Harvard Medical School, and a clinical and research fellowship in pediatric oncology at the National Cancer Institute. Dr. Pizzo served as head of the institute’s infectious disease section, chief of the NCI’s pediatric department, and acting scientific director for NCI’s Division of Clinical Sciences between 1973 and 1996. Dr. Pizzo devoted much of his distinguished medical career to the diagnosis, management, prevention, and treatment of childhood cancers and the infectious complications that occur in children whose immune systems are compromised by cancer and AIDS. Dr. Pizzo and his research team pioneered the development of new treatments for children with HIV infection, lengthening and improving the quality of life for children with this disease. His research soon led to important clues about how to treat HIV-positive children and adults, and how to manage life-threatening infections. He is the author of more than 500 scientific articles and 15 books. Dr. Pizzo has received several awards from the U.S. Public Health Service, including the Outstanding Service Medal in 1995. He was awarded the Ronald McDonald Charities “Award of Excellence” in 2009, has been cited in Best Doctors of America since 1995, and in 1990 was declared “Washingtonian of the Year” by Washingtonian magazine for helping to found the Children’s Inn, a temporary home for children undergoing treatment at the NIH and their families. In 2004, he was the first person named to the Independent Citizens’ Oversight Committee, which oversees the California Institute for Regenerative Medicine. He is a member of a number of prestigious organizations. He currently serves on the Council of the IOM of the National Academy of Sciences, is Chair of the Association of Academic Health Centers and Chair of the Council of Deans of the Association of American Medical Colleges. In 2009, he was elected to the Board of Trustees of the University of Rochester and Koc University in Istanbul, Turkey.

Allen D. Roses, M.D., was one of the first clinical neurologists to apply molecular genetic strategies to neurological diseases. His laboratory at Duke reported the chromosomal location for more than 15 diseases, including several muscular dystrophies and Lou Gehrig’s disease. He led the team that identified apolipoprotein E4 [APOE4] as the major susceptibility gene for common late-onset Alzheimer’s Disease (AD) in 1992. Dr. Roses was the Jefferson Pilot Professor of Neurobiology and Neurology and the Division Chief Neurology. Dr. Roses became Senior VP for Genetic Research at GlaxoSmithKline and a leader in applied pharmacogenetics. His teams completed the first efficacy pharmacogenetic clinical trial, identifying the responsive and non-responsive patients in a clinical trial of rosiglitazone for the treatment of AD. Dr. Roses’ GSK teams also identified the first highly accurate predictive test for a drug allergy using genomic technology. A pioneer in the application of whole genome analyses for several common diseases, Dr. Roses returned to Duke to initiate the Deane Drug Discovery Institute. In 2009, he reported the identification of a polyT variable repeat in the TOMM40 gene in AD, based on the first phylogenetic demonstration of multiple independent mutations at the same locus for AD co-dominant inheritance. Dr. Roses established Zinfandel Pharmaceuticals, Inc. to design and sponsor a combination Alzheimer’s Disease diagnostic validation and clinical trial to test delay of age of onset in a pharmacogenetic-assisted clinical trial of normal individuals stratified by variable TOMM40 polyT polymorphism and age at entry.

Ellen V. Sigal, Ph.D., is Chairperson and Founder of Friends of Cancer Research (“Friends”), a non-profit organization based in the Washington, DC metropolitan area. For more than 12 years, Friends has convened leading cancer advocates and researchers to create strategic consensus; educated policy makers and the general public about new research opportunities and existing obstacles; pioneered valuable public–private partnerships to maximize resources; and created an effective dialogue between researchers and regulators to minimize institutional barriers and ensure safety. Dr. Sigal is Vice Chair of the inaugural board of directors of the Reagan-Udall Foundation, a partnership designed to modernize medical product development, accelerate innovation, and enhance product safety in collaboration with the U.S. FDA. She serves on the NIH Foundation Board chairing its Public–Private Partnerships Committee, the American Association for Cancer Research Foundation Board, and on the board of several national cancer centers. 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 served on the National Cancer Institute Board of Scientific Advisors from 2003–2009, and the NIH Director’s Council of Public Representatives from 2003–2006. She was a Presidential Appointee to the National Cancer Advisory Board from 1992–1998 chairing its Budget and Planning Committee, which oversees the federal cancer budget.

Paul B. Watkins, M.D., is the Verne S. Caviness Distinguished Professor of Medicine, and also Professor of Pharmacology and Experimental Therapeutics, and Professor of Toxicology at the University of North Carolina in Chapel Hill (UNC-CH). He attended medical school at Cornell and completed his residency in internal medicine at New York Hospital–Cornell Medical Center. He received subspecialty training in hepatology at the Medical College of Virginia. He was on faculty at the University of Michigan from 1986–1999 when he moved to North Carolina. There he became the Director of the General Clinical Research Center and more recently director of the UNC Translational and Clinical Sciences (TraCS) Institute. In June of 2009, he became the director of a new Institute for Drug Safety Sciences, which represents a collaboration between UNC-CH and the Hamner Institutes. The Hamner Institutes is a not-for-profit organization based in Research Triangle Park. It was formerly called the Chemical Institute for Industrial Toxicology [CIIT] and has a three-decade history of leading research into the health effects of environmental chemicals. Dr. Watkins is an accomplished basic and translational investigator in the fields of drug metabolism and hepatotoxicity. He is the recipient of numerous honors and awards including the Therapeutic Frontiers Award from the American College of Pharmacy and election to the Association of American Physicians. He is one of the most frequently cited authors in the field of pharmacology according to He serves as the chair of both the Steering and Genetics Committees for the national Drug Induced Liver Injury Network (DILIN) (U01DK065201).

Mary Woolley is the president of Research!America, the nation’s largest not-for-profit alliance working to make research to improve health a higher national priority. Under her leadership, Research!America’s publications and initiatives have been honored by leading communications and advocacy organizations. Dr. Woolley is an elected member of the IOM and serves on its Governing Council. She is a Fellow of the American Association for the Advancement of Science and serves on the National Academies Board on Life Sciences. She is a Founding Member of the Board of Associates of the Whitehead Institute for Biomedical Research. She has served as president of the Association of Independent Research Institutes, as editor of the Journal of the Society of Research Administrators, as a reviewer for the National Institutes of Health and National Science Foundation, and as a consultant to several research organizations. Dr. Woolley has a 30-year editorial and publication history on science advocacy and research-related topics. She is a sought-after speaker and is frequently interviewed by science, news, and policy journalists.

Copyright © 2011, National Academy of Sciences.
Bookshelf ID: NBK54402
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