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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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B
Speaker Biographical Sketches

Margaret Anderson, M.S., is executive director of FasterCures/The Center for Accelerating Medical Solutions, where she defines the organization’s strategic priorities and positions on key issues, develops its programmatic portfolio, and manages its operations. Prior to her appointment as executive director, she was FasterCures’ chief operating officer for 5 years. She has extensive experience in managing biomedical and public health initiatives and facilitating multisector collaborations.

In 2011 the Clinical Research Forum recognized Anderson with an award for leadership in public advocacy, a testament to the positive impact of her leadership and FasterCures’ vital role in improving the medical research system. She is a founding board member and past-president of the Alliance for a Stronger U.S. Food and Drug Administration (FDA), co-chairs the eHealth Initiative’s Council on Data and Research, is on the board of the National Health Council, and is a member of the National Center for Advancing Translational Sciences Advisory Council, the Cures Acceleration Network Review Board, the National Health Council Board of Directors, United for Medical Research Steering Committee, and the Institute of Medicine’s Forum on Drug Discovery, Development and Translation. She served as a board member of the Council for American Medical Innovation and the Coalition for the Advancement of Medical Research.

Ms. Anderson joined FasterCures after 5 years at the Academy for Educational Development (AED) in Washington, DC. At AED she was the deputy director and a team leader in the Center on AIDS & Community Health. Her responsibilities included financial and budget oversight; management of a team, projects, and staff; and strategic planning. She managed a portfolio that consisted of grants and contracts from the Cen-

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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ters for Disease Control and Prevention, the Ford Foundation, and the Annie E. Casey Foundation.

Between 1995 and 1998 Ms. Anderson was program director for the Society for Women’s Health Research. At the society she managed grant-funded programs, including the startup planning for the multiyear campaign Some Things Only a Woman Can Do to increase women’s awareness of and participation in clinical trials, the Get Real: Straight Talk About Women’s Health campaign for college campuses to improve young women’s health, the Vive La Difference video and facilitator’s guide to provide information about sex-based biology, and the annual Scientific Advisory Meeting.

Prior to joining the society Ms. Anderson was a health science analyst at the American Public Health Association (APHA) from 1992 to 1995, where she managed a programmatic portfolio on HIV/AIDS and other sexually transmitted diseases, infectious diseases, women’s health, and public health infrastructure issues. At APHA she staffed the AIDS Working Group, the Science Board, and the Long Term Care Task Force and wrote a series of reports on emerging HIV/AIDS issues.

From 1987 to 1991 Anderson was an analyst and project director at the Congressional Office of Technology Assessment. As a staff member in the Biological Applications Program, she contributed to studies on the societal implications of genetic testing. She directed reports on genetic and medical testing in the workplace and contributed to reports on forensic uses of DNA testing, cystic fibrosis screening, and U.S. investment in biotechnology.

Ms. Anderson 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.

Krishna (Balki) Balakrishnan, Ph.D., M.B.A., serves as the senior technology manager at the National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health (NIH) that is committed to pushing the frontiers of drug discovery and development through collaborative means. Scientists at NCATS explore novel ways to incorporate the findings of the human genome into chemical starting points for disease intervention. A vast majority of these scientific projects are collaborative in nature, and Dr. Balakrishnan is actively involved in all aspects of developing these strategic alliances. Just prior to joining NCATS, Dr. Balakrishnan served as executive director at the Foundation for Advanced Education in the Sciences, a nonprofit founda-

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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tion affiliated with NIH. Dr. Balakrishnan’s earlier positions at NIH included marketing group leader at the NIH Office of Technology Transfer and senior technology development manager at the National Heart, Lung, and Blood Institute.

At the NIH Office of Technology Transfer, Dr. Balakrishnan oversaw all marketing activities. During his tenure, he promoted and widely expanded NIH’s institutional brand, sharply increasing the number of licenses issued and also the total licensing revenues. He was responsible for initiating market research studies, for making program evaluations, and for publicizing and marketing the NIH brand widely. In 2005 he obtained NIH evaluation funding, which enabled him to examine in depth the role of NIH inventors in technology transfer. For his commitment and contributions toward training postdocs for alternate careers in science, Dr. Balakrishnan was awarded the prestigious NIH Director’s Mentoring Award.

Prior to working at NIH, Dr. Balakrishnan was vice president of technology and business development and vice president of research and development at a division of Covance, formerly Berkeley Antibody Company. At Covance he led, at different times, the company’s new product development, technology licensing, manufacturing, and research and development activities. This deep industry experience in all aspects of biological product development and the wide perspectives gained by working in both for-profit and nonprofit organizations has provided Dr. Balakrishnan with the flexibility and creativity needed to negotiate complex agreements.

Dr. Balakrishnan earned a Ph.D. in biophysical chemistry from Stanford University and an M.B.A. from the University of California, Berkeley. He completed the management cadre leadership development program at NIH and has won a number of performance awards. He is the co-inventor on two U.S. patents and has published and presented globally on various technology transfer aspects and topics. He also serves on various professional boards, panels, and advisory committees.

Paul R. Billings, M.D., Ph.D., is a board-certified internist and clinical geneticist who serves as chief medical officer of Life Technologies Corporation, a new position aimed at improving patient care through expanding the use of medically relevant genomic technologies in clinical settings. Dr. Billings brings extensive expertise and health care experience in the areas of genomics and molecular medicine. Most recently he served as director and chief scientific officer of the Genomic Medicine Institute at El Camino Hospital, the largest community hospital in the

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Silicon Valley. He was a member of the U.S. Department of Health and Human Services’ Secretary’s Advisory Committee on Genetics, Health, and Society. He currently serves on the Scientific Advisory Board of the Food and Drug Administration and the Genomic Medicine Advisory Committee at the Department of Veterans Affairs. Dr. Billings has had a distinguished career as a physician and researcher. He has been a founder or chief executive officer of companies involved in genetic and diagnostic medicine, including GeneSage, Omicia, and CELLective Dx Corporation.

Henry Brem, M.D., has developed new tools and techniques that have changed the field of neurosurgery. Dr. Brem carried out the pivotal clinical study that introduced navigational imaging into the neurosurgical suite. His work led to the U.S. Food and Drug Administration’s approval of the first image-guidance computer system for intraoperative localization of tumors. Furthermore, he has changed the surgical armamentarium against brain tumors by inventing and developing Gliadel® wafers to intraoperatively deliver chemotherapy to brain tumors. His work has shown that surgeons can deliver potent therapies directly at the tumor site.

Dr. Brem is the Harvey Cushing Professor of Neurosurgery, Oncology, Biomedical Engineering, and Ophthalmology and chairman of neurosurgery at Johns Hopkins as well as chief of neurosurgery. He received his undergraduate degree from New York University and his medical degree from Harvard University, and he trained in neurosurgery at Columbia. He has built one of the largest brain tumor research and treatment centers in the world. He reinstituted the Hunterian Neurosurgery Laboratory (originally founded by Cushing) and has trained numerous researchers in brain research, particularly in intraoperative imaging, angiogenesis, immunotherapy, stem cell therapy, and targeted brain therapy. Since 2000 he has led the number-one-ranked Johns Hopkins Neurosurgery Department with a wide range of research, clinical, and teaching innovations.

Dr. Brem’s teaching was recognized by the Hopkins Professors Award for Excellence in Teaching in 1996. In 1998 he was elected to the Institute of Medicine of the National Academy of Sciences. In 2000 he was awarded the Grass Award by the Society of Neurological Surgeons for meritorious research. Under Dr. Brem’s leadership, U.S. News & World Report named Johns Hopkins Hospital as having the top ranked neurosurgery and neurology departments for 2010–2012. His trainees are leading brain tumor centers and neurosurgery departments throughout the world.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Guy M. Chisolm III, Ph.D., is a professor in the Department of Cellular and Molecular Medicine and vice chair of the Lerner Research Institute at Cleveland Clinic. He has previously served on Cleveland Clinic’s board of governors and board of trustees. He received a B.S. from the University of Pennsylvania, a Ph.D. from the University of Virginia, and postdoctoral research training from the Karolinska Institute (Stockholm) and the Massachusetts Institute of Technology.

Dr. Chisolm has published more than 100 articles on vascular cell biology and atherosclerosis. His research funding has come from the National Institutes of Health (NIH) (predominantly), the American Heart Association (AHA), and industry. He received the Research Merit Award from the AHA’s Ohio Valley Affiliate (2001) and a Special Recognition Award for Vascular Biology Research from the AHA’s (national) Council on Arteriosclerosis, Thrombosis and Vascular Biology (2006). He has served on journal editorial boards and as member or chair of multiple grant review study sections for NIH and AHA.

Dr. Chisolm is heavily involved in the Cleveland Clinic Lerner College of Medicine (CCLCM) of Case Western Reserve University (CWRU). He is director of the school’s basic science curriculum and sits on admissions, faculty appointments, student promotion, and GI curriculum committees. He received the 2007 Lerner Research Institute Award for Excellence in Education and the 2009 CCLCM Distinguished Faculty Award.

Dr. Chisolm is director of Cleveland Clinic’s Innovation Management and Conflict of Interest (IM&CoI) Program, chairman of the IM&CoI Committee, and a member of the Clinic’s board of trustees conflict of interest committee, and he helped craft the clinic’s current conflict of interest policies. He led the organizational committee for a national summit, A Dialogue on Biomedical Conflicts of Interest and Innovation Management, held at Cleveland Clinic on September 6, 2013. He is also a member of CWRU’s conflict of interest committee and served on CWRU’s President’s Committee on Conflict of Interest Policy Development. He is a member of the University of Michigan’s Committee on Institutional Conflict of Interest in Clinical Trials.

He is on the steering committee for the Association of American Medical Colleges (AAMC) Forum on Conflict of Interest in Academe (FOCIA), hosted its annual national meeting, and served on planning committees for their subsequent annual meetings He served on the joint AAMC–AAU Advisory Committee on Conflict of Interest in Human Subjects Research and the AAMC task force on financial conflicts of interest in clinical care. He is currently the chair of FOCIA and serves on

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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conflict of interest–related task forces of the Institute of Medicine and the Pew Charitable Trusts.

Neal H. Cohen, M.D., M.P.H., M.S., F.C.C.M., is a professor of anesthesia and medicine and vice dean for the University of California, San Francisco (UCSF) School of Medicine. He also serves as the medical director of the international service. Dr. Cohen received a B.A. degree from the University of Wisconsin, an M.D. from the UCSF School of Medicine, an M.P.H. from the University of California, Berkeley, and an M.S. in management from the Stanford University Graduate School of Business.

Dr. Cohen is responsible for oversight and approval of all academic and clinical affiliations between the School of Medicine and other academic and clinical institutions as well as industry, both nationally and internationally. He recently chaired the committee that developed the policy on industry relations and serves on the task force that oversees the policy. He has extensive experience in addressing ways to manage conflicts of interest while fostering collaboration between the academic community and industry.

Dr. Cohen is the recipient of the Lifetime Achievement Award from the Society of Critical Care Anesthesiologists. Dr. Cohen has authored numerous articles and given lectures on a wide array of topics related to the care of the critically ill patients, practice management, industry relations and its impact on innovations in health care, and compliance and regulatory affairs.

Mary R. Grealy, J.D., is president of the Healthcare Leadership Council (HLC), a coalition of chief executives of the nation’s leading health care companies and organizations. The HLC advocates consumer-centered health care reform, emphasizing the value of private-sector innovation. It is the only health policy advocacy group that represents all sectors of the health care industry. She was appointed to the position in August 1999.

Ms. Grealy has an extensive background in health care policy. She has led important initiatives on the uninsured, improving patient safety and quality, protecting the privacy of patient medical information, and reforming the medical liability laws. She testifies frequently before Congress and federal regulatory agencies.

She is a frequent public speaker on health issues and has been ranked many times by Modern Healthcare as 1 of the 100 Most Powerful People

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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in Healthcare and was named to Modern Healthcare’s list of the Top 25 Women in Healthcare for 2009.

Gabriela Lavezzari, Ph.D., M.B.A., joined PhRMA in July 2012 as assistant vice president, scientific affairs. In this role, Dr. Lavezzari is the primary staff lead for a variety of strategic initiatives aimed at establishing PhRMA as a valuable source of scientific expertise in innovative biopharmaceutical research and development within the scientific and regulatory affairs division of PhRMA. Dr. Lavezzari brings to PhRMA more than 10 years of combined research experience in the government and industry, with multi-disciplinary expertise in personalized medicine.

Prior to joining PhRMA, Dr. Lavezzari served as director of extramural development at the Medco Research Institute, a subsidiary of Medco Health Solutions, where she led clinical utility and cost-effectiveness research to create value-based reimbursement decisions in a variety of different therapeutic areas. Prior to working at Medco, Dr. Lavezzari spent a few years at Theranostics Health, a proteomics-based diagnostics company where she led the laboratory operations and the oncology product development. Prior to Theranostics, Dr. Lavezzari worked at Social Scientific Systems where she provided scientific support to and managed multiple AIDS clinical trials groups as well as laboratory science, laboratory technical, and specialty laboratory committees, subcommittees and working groups.

In addition to her experience in industry, Dr. Lavezzari spent almost 6 years in research at the National Institutes of Health and at Georgetown University, where she completed her postdoctoral training.

Dr. Lavezzari received her Ph.D. in biological sciences from the University of Milano (Italy) and received her M.B.A. from the New York Institute of Technology.

Allen S. Lichter, M.D., FASCO, is the chief executive officer of the American Society of Clinical Oncology (ASCO), a professional organization representing almost 30,000 physicians and health professionals in oncology. Prior to joining ASCO in 2006, Dr. Lichter was at the University of Michigan in two significant leadership roles. He served as chair and professor of radiation oncology from 1984 to 1998 and as dean of the medical school from 1998 to 2006. Dr. Lichter was named the first Isadore Lampe Professor of Radiation Oncology, an endowed chair, and also was the Newman Family Professor of Radiation Oncology. Prior to his tenure at the University of Michigan, Dr. Lichter was the director of the Radiation Therapy Section of the Radiation Oncology Branch of the

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×

National Cancer Institute. Dr. Lichter’s research and development of three-dimensional treatment planning led to a gold medal from the American Society for Therapeutic Radiology and Oncology. In 2002 he was elected to membership in the Institute of Medicine of the National Academy of Sciences. As a member of ASCO since 1980, Dr. Lichter has assumed many prominent roles in the society, including president (1998–1999) and founding chairman of ASCO’s Conquer Cancer Foundation Board. Dr. Lichter earned a bachelor’s degree (1968) and medical degree (1972) from the University of Michigan. He trained in radiation oncology at the University of California, San Francisco, before joining the faculty at Johns Hopkins University and, later, the National Cancer Institute.

Bernard Lo, M.D., is president of the Greenwall Foundation, whose mission is supporting bioethics research and young researchers in bioethics. He has been director of the Greenwall Faculty Scholars Program since 2001. He is professor emeritus of medicine and director emeritus of the Program in Medical Ethics at the University of California, San Francisco (UCSF). Dr. Lo serves on the board of directors of the Association for the Accreditation of Human Research Protection Programs and on the medical advisory panel of Blue Cross/Blue Shield. From 1996 to 2001 he served as a member of the National Bioethics Advisory Committee. From 1997 to 2001 he chaired the expert panel convened by the American College of Physicians to develop clinical, ethical, and policy recommendations regarding care near the end of life. He is a member of the Institute of Medicine (IOM) and previously served as chair of the Health Sciences Policy Board and as a member of the IOM council. He chaired an IOM committee, Conflicts of Interest in Medical Research, Education, and Practice. Dr. Lo developed a course on responsible conduct of research that 120 UCSF postdoctoral fellows and junior faculty take each year, and he is author of Resolving Ethical Dilemmas: A Guide for Clinicians (4th ed., 2010) and of Ethical Issues in Clinical Research (2010). He is a graduate of Stanford University Medical School, did his residency at both the University of California, Los Angeles, and Stanford, and completed a fellowship at Stanford as a Robert Wood Johnson Clinical Scholar.

Michelle McMurry-Heath, M.D., Ph.D., is assistant director for science of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA). Prior to joining FDA, she was the founding director of the Health, Biomedical Science, and Society Initia-

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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tive at the Aspen Institute and adjunct assistant professor of health policy at George Washington University. Her Aspen Institute team focused on creating new policy strategies for stimulating biomedical research, disseminating emerging health care technologies, and reducing health care disparities domestically and internationally. Her science diplomacy work has included projects from Rwanda to Cambodia. From 2001 to 2004, she oversaw health and social policy issues for Senator Joseph Lieberman and was the senior health policy advisor for the Lieberman for President Campaign. While on the Hill, she worked on homeland security, health disparities, health care quality, and translational research bills, including the American Center for Cures initiative and legislation (later enacted as the Cures Acceleration Network). After studying biochemistry at Harvard, Dr. McMurry-Heath went on to become the first African American to receive both M.D. and Ph.D. degrees from Duke University. She trained in pediatrics and molecular immunology.

Charles Ornstein is a senior reporter for ProPublica, an investigative news organization in New York. He is also an adjunct professor at the Columbia University Graduate School of Journalism and president of the board of the Association of Health Care Journalists. Mr. Ornstein is a graduate of the University of Pennsylvania, where he was editor of the college newspaper, the Daily Pennsylvanian. In 1999–2000, he was a media fellow with the Henry J. Kaiser Family Foundation. Prior to joining ProPublica he was a reporter for 5 years at the Dallas Morning News and for 7 years at the Los Angeles Times.

Mr. Ornstein, in collaboration with Tracy Weber, was a lead reporter on a series of articles in the Los Angeles Times titled The Troubles at King/Drew, which won the Pulitzer Prize for Public Service, the Robert F. Kennedy Journalism Award and the Sigma Delta Chi Award for public service in 2005. His ProPublica series, also with Ms. Weber, When Caregivers Harm: California’s Unwatched Nurses, was a finalist for a 2010 Pulitzer Prize for Public Service.

Heather H. Pierce, J.D., M.P.H., is senior director for science policy and regulatory counsel at the Association of American Medical Colleges (AAMC). She serves as AAMC’s staff leader for scientific issues, including clinical research, regulatory compliance, conflicts of interest, evidence-based regulation, and interactions between industry, government, and academia in biomedical research. She is also the program leader for the AAMC’s Forum on Conflict of Interest in Academe.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Ms. Pierce regularly speaks at national forums on issues related to the protection of human subjects, conflicts of interest, scientific misconduct, and the regulation of research. She has served on ad hoc committees and task forces convened by organizations, including the Institute of Medicine, the Pew Charitable Trusts, the National Dialogue on Healthcare Innovation, and Public Responsibility in Medicine and Research.

Prior to joining AAMC, Ms. Pierce was an attorney in the health care group of the law firm of Ropes & Gray LLP in New York. Her regulatory practice focused on medical research and clinical care. She received her law degree from New York University and her M.P.H. in health law from Boston University.

Sally J. Rockey, Ph.D., is the National Institutes of Health (NIH) deputy director for extramural research, leading the extramural research activities of the agency. Her role is to oversee the development and implementation of the critical policies and guidelines central to the successful conduct of NIH-supported biomedical research. Dr. Rockey works in close partnership with the biomedical research community around the world.

Dr. Rockey received her Ph.D. in entomology from Ohio State University and has spent the majority of her career in the area of research administration and information technology. In 1986 she joined the U.S. Department of Agriculture, soon becoming the deputy administrator of the cooperative state research, education, and extension service, overseeing the extramural grants program and portfolio. In 2002 she became the agency’s chief information officer, applying her breadth of government knowledge to information technology. In 2005 Dr. Rockey was appointed to the position of NIH deputy director of the Office of Extramural Research and brought her extensive experience in research administration to biomedical research. She assumed her current position as NIH deputy director for extramural research in 2008.

Dr. Rockey leads or is active on a number of federal committees related to science and research, federal assistance, and electronic government. She works most closely with other federal science and university administrators, small businesses, professional societies, and the scientific communities. In 2012 Dr. Rockey co-led a groundbreaking effort on the biomedical workforce. Dr. Rockey is a skilled public speaker, giving countless presentations on extramural research priorities and policies, grantsmanship, the competitive peer review process, workforce, scien-

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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tific integrity, and information technology. She is the author of the widely read “Rock Talk” blog.

Todd Sherer, Ph.D., is associate vice president for research administration and executive director of technology transfer at Emory University. He has worked in technology transfer for 22 years on both coasts at public and private universities. Before coming to Emory, he was the director of the Office of Technology and Research Collaborations at Oregon Health and Science University in Portland. He earned his doctorate in toxicology at Washington State University in Pullman, where he studied gene expression in the developing brain. Dr. Sherer became a registered patent agent with the U.S. Patent and Trademark Office in 1995. He continues to be an active speaker at technology transfer, economic development, and commercialization conferences across the globe. Dr. Sherer is immediate past president for the Association of University Technology Managers, where he has been an active board member and volunteer for several decades. His current efforts have been focused on encouraging and adopting positive changes in technology transfer, nationally, through creative new initiatives that reduce barriers and improve impact.

Sharon Terry, M.A., is president and chief executive officer of the Genetic Alliance, a network of more than 10,000 organizations, 1,200 of which are disease advocacy organizations. Genetic Alliance improves health through the authentic engagement of communities and individuals. It develops innovative solutions through novel partnerships, connecting consumers to smart services.

She is the founding chief executive officer of PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE). As co-discoverer of the gene associated with PXE, she holds the patent for ABCC6 and has assigned her rights to the foundation. She developed a diagnostic test and is conducting clinical trials.

Ms. Terry is also a co-founder of the Genetic Alliance Registry and Biobank. She is the author of more than 90 peer-reviewed articles. In her focus at the forefront of consumer participation in genetics research, services, and policy, she serves in a leadership role on many of the major international and national organizations, including the Institute of Medicine (IOM) Health Sciences Policy Board, the National Coalition for Health Professional Education in Genetics board, and the International Rare Disease Research Consortium Interim Executive Committee, and she is a member of the IOM Roundtable on Translating Genomic-Based Research for Health. She is on the editorial boards of several journals.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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She was instrumental in the passage of the Genetic Information Nondiscrimination Act. In 2005 she received an honorary doctorate from Iona College for her work in community engagement; the first Patient Service Award from the University of North Carolina Institute for Pharmacogenomics and Individualized Therapy in 2007; the Research!America Distinguished Organization Advocacy Award in 2009; and the Clinical Research Forum and Foundation’s Annual Award for Leadership in Public Advocacy in 2011. She is an Ashoka Fellow.

Jill Hartzler Warner, J.D., is acting associate commissioner for special medical programs at the U.S. Food and Drug Administration (FDA). She oversees FDA’s Office of Pediatric Therapeutics, Office of Orphan Products Development, Office of Good Clinical Practice, and Office of Combination Products, as well as the advisory committee oversight and management staff. In this position Ms. Warner provides leadership and direction in the coordination of internal and external review of pediatric science, safety, ethics, and international issues. She oversees the implementation of the orphan products provisions of the Federal Food, Drug, and Cosmetic Act to encourage the development of drugs of limited commercial value for use in rare diseases and conditions to advance public health. She promotes and directs good clinical practice and human subject protection regulation, policy, harmonization, and outreach activities. Ms. Warner provides leadership and direction on issues involving the regulation of combination products, the classification of human medical products, and jurisdiction over human medical products. Further, she oversees management of FDA advisory committees to provide consistent application of laws and policies applicable to such committees, and directs development of policy, procedures, and processes to maintain and improve the agency’s advisory committee program.

Prior to her current position, Ms. Warner served FDA’s Office of the Commissioner and the Center for Biologics Evaluation and Research in a variety of roles, including acting assistant commissioner for accountability and integrity, senior policy advisor and counselor, and associate chief counsel for biologics. Ms. Warner received her B.A. in environmental sciences, with distinction, from the University of Virginia and her J.D. from the University of Virginia School of Law.

Dorit Zuk, Ph.D., is the science policy advisor to the deputy director for extramural research at the National Institutes of Health (NIH). She is responsible for coordinating and disseminating policies and procedures

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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on a variety of research-related issues, such as financial conflicts of interest and the biomedical research workforce. Dr. Zuk came to NIH in 2009 after a year as a Hellman Fellow for Science Policy at the American Academy of Arts and Sciences. Before that she was an American Association for the Advancement of Science (AAAS) Science and Technology Policy Fellow in the Office of Extramural Research at NIH. From 2000 to 2007 Dr. Zuk worked as a scientific editor at Cell Press, where she was deputy editor of the journal Cell (2000–2002) and editor of Molecular Cell (2003–2007). Dr. Zuk also serves on the education and professional development committee of the American Society of Biochemists and Molecular Biologists and chairs the AAAS Fellowships Advisory Committee.

Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
×
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Page 71
Suggested Citation:"Appendix B: Speaker Biographical Sketches." Institute of Medicine. 2014. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18723.
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Page 72
Next: Appendix C: Statement of Task »
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Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together.

Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.

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