Envisioning a Transformed Clinical Trials Enterprise for 2030 Proceedings of a Workshop (2022) / Chapter Skim
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Appendix B: Speaker and Moderator Biographies
Appendix B: Speaker and Moderator Biographies
Pages 83-106
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day-to-day functioning and directs special and high-priority, cross-cutting initiatives that impact the regulation of drugs, medical devices, tobacco, and food. As former acting chief information officer, she oversaw FDA's data and technical vision as well as its execution.
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RADM Araojo previously served as the director of the Office of Medical Policy Initiatives in FDA's Center for Drug Evaluation and Research (CDER) , where she led a variety of broad-based medical and clinical policy initiatives to improve the science and efficiency of clinical trials and enhance professional and patient labeling.
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-- the Federal Health Ministry's think tank on the digitalization of health care. As a trained lawyer and economist with a research background in medical law, health technology assessment, and medical device regulation, he is leading, among others, hih's projects on matters of access, regulation, evaluation, and reimbursement of digital technologies within the German statutory health insurance system.
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This resulted in improved diverse clinical trial recruitment, driving a formulation change to ensure wider drug usage among an appropriate rare disease population. Developed a patient advisory board to ensure ongoing patient input to business decisions.
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Howard A Burris III, M.D., serves as the president and the chief medical officer of Sarah Cannon, as well as the executive director of drug development for the research institute.
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from 2015 to 2016, and as the commissioner from 2016 to 2017. A nationally and internationally recognized leader in cardiovascular medicine, health outcomes research, health care quality, and clinical research, Dr.
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, and chairs the Patient Engagement, Health Literacy & Clinical Trials Diversity Investigator Initiated Studies Research Committee. Prior to joining Merck, Dr.
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Dr. ElZarrad currently leads multiple projects focused on exploring the potential use of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development.
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Goldsack spent several years at the Clinical Trials Transformation Initiative (CTTI) , where she led development and implementation of several projects within CTTI's Mobile Program and was the operational co-lead on the first randomized clinical trial using the U.S.
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From a clinical perspective, he focuses on treatment and research of genitourinary cancers. He has more than 50 publications in the peer-reviewed literature, continues to speak regularly on topics of medicine and technology, and serves on the American Society of Clinical Oncology cancer research committee, the Journal of Cancer Clinical Cancer Informatics editorial board, the National Quality Forum cancer committee, the Parkland Hospital Foundation Board of Directors, and the National Outdoor Leadership School Advisory Board.
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He is a research director for Health Data Research U.K., leading the national program on digitally enabled clinical trials. He leads the Good Clinical Trials Collaborative established by the Wellcome Trust, the Bill & Melinda Gates Foundation, and the African Academy of Sciences.
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Prior to BMS, Dr. Levy was a member of the Renal Division at Brigham and Women's Hospital in Boston, where he was an investigator in federally sponsored outcomes research as well as industry-sponsored clinical trials.
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Before joining Pfizer, Dr. Lewis-Hall held senior leadership positions of the chief medical officer and the executive vice president, Medicines Development at Vertex Pharmaceuticals; the senior vice president, U.S.
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These include the Medicare prescription drug benefit, Medicare and Medicaid payment reforms, FDA's Critical Path Initiative, and public–private initiatives to develop better information on the quality and cost of care. He has also previously served as a member of the President's Council of Economic Advisers and the senior director for health care policy at the White House, and as the deputy assistant secretary for economic policy at the U.S.
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Moscicki, M.D., is the executive vice president of science and regulatory advocacy and the chief medical officer at the Pharmaceutical Research and Manufacturers of America (PhRMA)
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and the PMS International Registry and the patient engagement lead at RARE-X, a collaborative platform for global data sharing and analysis in rare disease. She advocates for data sharing, collaborating with other advocacy groups, sharing resources, and streamlining institutional review board practices and policies.
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The National Institutes of Health (NIH) , as well as industry and founda tions, have continuously funded her work since 1994; she has a track record in clinical trials that impact health disparities.
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and Health 360x, a patient engagement and health coaching platform that empowers patients in their journey from health care to wellness. Health 360x platform is testing innovative approaches to integrate real-world data from electronic medical records to support research participation by patients and providers that are underrepresented in clinical trials.
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Her responsibilities encompassed areas such as human subjects protections; the organization and oversight of clinical trials; scientific, social, and ethical considerations in genetics research and human gene transfer trials; and safety and security implications of emerging new technologies. Prior to coming to NIH's Office of the Director, she served as the deputy director of the Division of Cellular and Gene Therapies and the medical officer in the Division of Clinical Trial Design and Analysis at the U.S.
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He has also served on science and technology advisory committees and in leadership roles for the American Society of Clinical Oncology, NuMedii, Precision for Medicine, the Survivor Advisory Board at the Cancer Institute of New Jersey, the K idney Cancer Association, OneMind4Research, and the Scientist- Survivor program of the American Association for Cancer Research. Internationally, he has served as the chief information officer of the King Hussein Institute for Biotechnology and Cancer in Amman, Jordan.
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Department of Defense's Congressionally Directed Medical Research Programs and traveled to Komen Global Initiative to meet with different groups that provided services to breast cancer patients and participate in a public activity of breast cancer awareness. She is the vice chair of the Steering Committee for Komen Advocates in Science and a member of the Southwest Oncology Group Cancer Research Network Patient Advocates Committee.
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Dr. Tenaerts brings more than 30 years of experience in clinical trials, as a researcher and academic, in medical device research operations, as a hospital-based site administrator, and as a physician, most recently serving as the executive director of the Clinical Trials Transformation Initiative (CTTI)
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In 2004, Dr. Woodcock became the deputy commissioner and the chief medical officer in the Office of the Commissioner.
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Sigal Advocacy Leadership Award in 2016 from Friends of Cancer Research; the Florence Kelley Consumer Leadership Award in 2017 from the National Consumers League; and the 2019 Biotechnology Heritage Award from the Biotechnology Innovation Organization and Science History Institute.
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