National Academies Press: OpenBook

Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop (2022)

Chapter: Appendix B: Speaker and Moderator Biographies

« Previous: Appendix A: Health Affairs Blog Posts
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Appendix B

Speaker and Moderator Biographies

Amy Abernethy, M.D., Ph.D., is an oncologist and an internationally recognized clinical data expert and clinical researcher. As the former principal deputy commissioner of food and drugs, Dr. Abernethy helped oversee the U.S. Food and Drug Administration’s (FDA’s) 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. She has held multiple executive roles at Flatiron Health and was a professor of medicine at the Duke University School of Medicine, where she ran the Center for Learning Health Care and the Duke Cancer Care Research Program. Dr. Abernethy received her M.D. at Duke University, where she did her internal medicine residency, served as the chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University and her B.A. from the University of Pennsylvania and is boarded in palliative medicine.

Anita LaFrance Allen, J.D., Ph.D., is an internationally renowned expert on privacy law and ethics and is recognized for her contributions to legal philosophy, women’s rights, and diversity in higher education. In 2013, Dr. Allen was appointed the University of Pennsylvania’s vice provost for faculty, and, in 2015, the chair of the Penn Provost’s Advisory Council on Arts, Culture and the Humanities. From 2010 to 2017, she served on President Obama’s Presidential Commission for the Study of Bioethical

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Issues. She was presented the Lifetime Achievement Award of the Electronic Privacy Information Center in 2015 and elected to the National Academy of Medicine in 2016.

In 2017, Dr. Allen was elected the vice president/president-elect of the Eastern Division of the American Philosophical Association. In 2015, Dr. Allen was on the summer faculty of the School of Criticism and Theory at Cornell University. A 2-year term as an associate of the Johns Hopkins Humanities Center concluded in 2018. Her books include Unpopular Privacy: What Must We Hide (Oxford, 2011); Privacy Law and Society (Thomson/West, 2017); The New Ethics: A Guided Tour of the 21st Century Moral Landscape (Miramax/Hyperion, 2004); and Why Privacy Isn’t Everything: Feminist Reflections on Personal Accountability (Rowman & Littlefield, 2003).

Margaret Anderson, M.S., is a managing director at Deloitte Consulting, serving clients at the intersection of the nonprofit sector, federal health agencies, and the life sciences industry. She is also the leader of diversity, equity, and inclusion for Deloitte’s Strategy & Analytics. Her career as a strategist has traversed roles in a variety of settings, always putting patients at the center. She joined Deloitte from FasterCures, where she helped set up the organization and served as the executive director. She began at the Congressional Office of Technology Assessment, studying the impact of the mapping of the human genome on our lives. She currently sits on a number of boards, including Act for the National Institutes of Health, Allen Institute, FasterCures, Friends of Cancer Research, and the Melanoma Research Alliance.

RADM Richardae Araojo, Pharm.D., M.S., serves as the associate commissioner for minority health and the director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA). In this role, RADM Araojo provides leadership, oversight, and direction on minority health and health disparity matters for FDA. 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. RADM Araojo joined FDA in 2003, where she held several positions in CDER. RADM Araojo received her Pharm.D. from Virginia Commonwealth University, completed a pharmacy practice residency at the University of Maryland, and earned an M.S. in pharmacy regulation and policy from the University of Florida.

Christopher P. Austin, M.D., joined Flagship Pioneering in 2021 as a chief executive officer (CEO) partner. Dr. Austin is part of the broader Flagship

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

senior leadership team, participating in Flagship leadership meetings, serving on selected Flagship company boards, and providing his experience across the ecosystem. Dr. Austin will also serve as the CEO of a Flagship-founded company currently in stealth, to be announced at a later date. He is a trained clinician and geneticist, with more than 20 years of experience in translational research in the public and private sectors. He joins Flagship from the National Institutes of Health (NIH), where he served as the founding director of the National Center for Advancing Translational Sciences (NCATS). In this role, he led NCATS’s work to transform translation—the process by which interventions that benefit patients are developed and deployed—from an empirical process into a predictive science. Dr. Austin previously served as the senior advisor to the director for translational research at NIH’s National Human Genome Research Institute, implementing research programs to derive scientific insights and therapeutic benefits from the results of the Human Genome Project. He also founded and directed NIH’s Chemical Genomics Center, Therapeutics for Rare and Neglected Diseases program, Toxicology in the 21st Century initiative, and Center for Translational Therapeutics. Before joining NIH, Dr. Austin worked at Merck, where he directed programs on genome-based discovery of novel targets and drugs, with a particular focus on treatments for schizophrenia and Alzheimer’s disease. He is a member of the National Academy of Medicine and earned his M.D. from Harvard Medical School and his A.B. in biology from Princeton University. He completed a research fellowship in developmental neurogenetics at Harvard University and trained in internal medicine and neurology at the Massachusetts General Hospital.

Jan Benedikt Brönneke, LL.M., is the director of law and economics of health technologies of the German health innovation hub (hih)—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. In this position he was closely supporting the development and implementation of the German Digital Healthcare Act, the Patient Data Protection Act, and other legislative activities regarding digitalization of the German health care system. Before joining hih, he worked for the Federal Joint Committee on quality assurance in hospitals and private practices and was a manager for a Berlin-based law firm specializing in the law of medical devices and pharmaceuticals. With this background, he bridges the gaps among disciplines as well as regulatory authorities and private actors, such as technology developers, doctors, and hospitals.

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Dyan Bryson, M.B.A., is a life science industry sales and marketing veteran who has consistently developed innovative initiatives that have helped to propel the industry forward. In the past decade, Ms. Bryson’s mantra has been that patients should be part of the drug development process from before the Investigational New Drug stage through commercialization, years ahead of the U.S. Food and Drug Administration’s Patient-Focused Drug Development effort.

Examples of the initiatives Ms. Bryson has led include

  • For Merck–Medco, developed one of the industry’s first patient services hubs.
  • For Merck, led the Vioxx launch outside the United States; developed all branding, messaging, and promotional materials.
  • For Pfizer Inc. and the American Pain Association, developed the industry’s first digital Congress delivery, including Continuing Medical Education accreditation.
  • For Sanofi, developed the Community Health Partnership, the industry’s first enterprisewide, patient-focused initiative that resulted in a positive change in behavior for both patients and physicians. This initiative was focused on supporting diverse patient populations; all materials were translated and acculturated. On a $3.4 million investment, Ms. Bryson and her team returned $406 million to the brands.
  • For Retrophin, ensured patient insights were part of business decisions across the entire company. 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.
  • Ms. Bryson has worked with technology to collect patient-reported outcomes/real-world data to help people manage their health better, help companies go “beyond the brand,” and enhance diversity in clinical trials.

Ms. Bryson has won numerous industry awards for her efforts, including being honored as part of the PharmaVoice 100 as a life sciences industry innovator.

Silas Buchanan, B.A., is a passionate and experienced underserved community outreach and engagement strategist. He is dedicated to building partnerships and crafting Web-based ecosystems that solve for known failure points. Mr. Buchanan has worked with various health care payer, provider, government, and academic stakeholders across the United

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

States and has expertise in recruiting, activating, and connecting with trusted faith- and community-based organizations.

Mr. Buchanan works closely with public and private stakeholders to identify actionable ehealth and mhealth engagement opportunities that also support sustainable broadband adoption and digital inclusion efforts for underserved populations. He has testified before the U.S. Department of Health and Human Services’ Health Information Technology Policy Committee, Meaningful Use Workgroup. He was selected as a member of the White House Summit to Achieve eHealth Equity, selected as the co-chair of the Awareness Committee for Region V of the National Partnership for Action to End Health Disparities, and recently selected as an inaugural National Advisory Board member of the Morehouse School of Medicine’s National COVID-19 Resiliency Network. In addition, he is an inaugural member of the National eHealth Collaborative Consumer Committee and a member of the Ohio Patient-Centered Primary Care Collaborative.

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. He is an associate of Tennessee Oncology, PLLC, where he practices medical oncology. Dr. Burris’s clinical research career has focused on the development of new cancer agents, with an emphasis on first-in-human therapies, having led the trials of many novel antibodies, small molecules, and chemotherapies that are now approved by the U.S. Food and Drug Administration, including ado-trastuzumab emtansine, everolimus, and gemcitabine. In 1997, he established in Nashville the first community-based, early-phase drug development program, which grew into the Sarah Cannon Research Institute. He has authored more than 400 publications and 700 abstracts. Sarah Cannon has now dosed more than 350 first-in-human anticancer therapies and enrolls more than 3,000 patients per year into clinical trials. Dr. Burris served as the elected president of the American Society of Clinical Oncology (ASCO) in 2019–2020. He also currently serves on the Board of ASCO’s Conquer Cancer Foundation. Additionally in 2014, Dr. Burris was selected by his peers as a Giant of Cancer Care for his achievements in drug development.

Dr. Burris completed his undergraduate education at the U.S. Military Academy at West Point, his M.D. at the University of South Alabama, and his internal medicine residency and oncology fellowship at Brooke Army Medical Center in San Antonio. While in Texas, he also served as the director of clinical research at the Institute for Drug Development of the Cancer Therapy and Research Center and The University of Texas Health Science Center. He attained the rank of lieutenant colonel in the U.S. Army, and

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

among his decorations he was awarded a Meritorious Service Medal with oak leaf cluster for his service in Operation Joint Endeavor.

Robert Califf, M.D., MACC, is the head of clinical policy and strategy for Verily Life Sciences and Google Health for Verily and Google Health. Prior to this Dr. Califf was the vice chancellor for health data science for the Duke University School of Medicine; the director of Duke Forge, Duke’s center for health data science; and the Donald F. Fortin, M.D. Professor of Cardiology. He served as the deputy commissioner for medical products and tobacco in the U.S. Food and Drug Administration (FDA) 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. Califf is a graduate of the Duke University School of Medicine. Dr. Califf was the founding director of the Duke Clinical Research Institute and is one of the most frequently cited authors in biomedical science.

Janice Chang, M.B.A., is the chief operating officer at TransCelerate BioPharma Inc. She has been involved with the organization since its inception. In her current position, Ms. Chang works closely with the chief executive officer and the Board of Directors to shape the long-term strategic vision and priorities for the organization and its more than 30 initiatives. She defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries. She has accountability for overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio.

Chang also actively participates in various cross-stakeholder global discussions to help evolve its research and development paradigm. Most recently she joined the Advisory Council for HL7 International’s Vulcan Accelerator. Vulcan is a global strategic effort to bring together stakeholders across the translational and clinical research community to align on data exchange standards to bridge existing gaps between clinical care and clinical research, enabling more effective acquisition, exchange, and use of health care data in translational and clinical research.

With a background of more than 20 years of experience leading initiatives in large pharma and biotech companies, Ms. Chang has experience spanning across regulatory, clinical, and manufacturing. She is passionate about driving meaningful change across our ecosystem and not settling for the status quo. She believes in reimagining the way we advance innovative medicine and advocates for the power of open collaboration across stakeholder groups.

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Luther T. Clark, M.D., is the deputy chief patient officer and the global director of scientific medical and patient perspective in the Office of the Chief Patient Officer at Merck. In this role, he is responsible for (1) gathering internal and external scientific and medical information to assist with decision making at the highest levels; (2) collaborating across Merck to increase the voice of patients, directly and indirectly, in decision making; (3) collaborating with key internal and external stakeholders in the development of a systematized approach for collecting and incorporating patient insights across the patient journey and product life cycle; and (4) representing Merck externally, expanding bidirectional exchange with key patient and professional leaders and organizations.

Dr. Clark leads Merck’s Patient Insights Team, is the co-leader of the team that champions Health Care Equities (including the promotion of health literacy and research diversity), and chairs the Patient Engagement, Health Literacy & Clinical Trials Diversity Investigator Initiated Studies Research Committee.

Prior to joining Merck, Dr. Clark was the chief of the Division of Cardiovascular Medicine at the State University of New York Downstate Medical Center (SUNY Downstate) and the founding director of the National Institutes of Health–funded Brooklyn Health Disparities Research Center. Dr. Clark earned his B.A. from Harvard College and his M.D. from Harvard Medical School. He is a fellow of the American College of Cardiology and the American College of Physicians, and a past member of the Board of Directors of the Founders Affiliate of the American Heart Association. He is a nationally and internationally recognized leader in cardiovascular education, clinical investigation, cardiovascular disease prevention, and health equity. He has authored more than 100 publications and edited and was principal contributor to the textbook Cardiovascular Disease and Diabetes (McGraw-Hill).

Dr. Clark has received numerous awards and honors, including the Harvard University Alumni Lifetime Achievement Award for Excellence in Medicine. He is the current president of the Health Science Center at Brooklyn Foundation, SUNY Downstate Medical Center.

Andy Coravos, M.B.A., is the co-founder and the chief executive officer of HumanFirst (previously known as Elektra Labs), building a digital medicine platform with a focus on digital biomarkers for decentralized clinical trials. She is a member of the Harvard–Massachusetts Institute of Technology’s Center for Regulatory Sciences. Formerly, Coravos served as an entrepreneur in residence in the digital health unit at the U.S. Food and Drug Administration, focusing on the pre-certification program and policies around software and artificial intelligence/machine learning. Previously, she worked as a software engineer at Akili Interactive Labs, a

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

leading digital therapeutic company. Ms. Coravos also worked at KKR, a private equity firm, and McKinsey & Company, a management consulting firm, where she focused on the health care industry. She serves on the Board of the Digital Medicine Society, and she is an advisor to the Biohacking Village at DEF CON.

M. Khair ElZarrad, Ph.D., M.P.H., is the deputy director of the Office of Medical Policy at the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. 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. Dr. ElZarrad is the rapporteur for the International Council for Harmonisation’s ongoing work to revise the international Good Clinical Practice Guideline (ICH-E6(R2)). Prior to joining FDA, he served as the acting director of the Clinical and Healthcare Research Policy Division with the Office of Science Policy at the National Institutes of Health (NIH). At NIH, he worked on policies related to human subject protections; the design, conduct, and oversight of clinical research; and the enhancement of quality assurance programs at pharmaceutical development and production facilities. He earned a doctoral degree in medical sciences with a focus on cancer metastases from the University of South Alabama and an M.P.H. from the Johns Hopkins Bloomberg School of Public Health.

Steven K. Galson, M.D., M.P.H., retired from Amgen Inc. in July 2021 nearly 12 years in senior research and development roles as the senior vice president of global regulatory affairs and safety. He joined Amgen in 2010 as the vice president of global regulatory affairs. Prior to Amgen, Dr. Galson was the senior vice president for civilian health operations and the chief health scientist at the Science Applications International Corporation. Dr. Galson spent more than 20 years in government service, including 2 years as acting Surgeon General of the United States. Previously, he served as the director of the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, where he provided leadership for the center’s broad national and international programs in pharmaceutical regulation. Dr. Galson began his U.S. Public Health Service (PHS) career as an epidemiological investigator at the Centers for Disease Control and Prevention after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He also held senior-level positions at the U.S. Environmental Protection Agency (EPA); the U.S. Department of Energy, where he was the chief medical officer; and the U.S. Department of Health and Human Services. Prior to his arrival

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

at FDA, Dr. Galson was the director of EPA’s Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances. Dr. Galson holds a B.S. from Stony Brook University, an M.D. from the Icahn School of Medicine at Mount Sinai, and an M.P.H. from the Harvard T.H. Chan School of Public Health. In 2008, he received an honorary doctor of public service degree from the Drexel University School of Public Health, and, in 2015, he received the Jacobi Medallion Award from the Icahn School of Medicine at Mount Sinai. In 2018, Dr. Galson was named the Health Leader of the Year from the Commissioned Officers Association of PHS. Dr. Galson is a member of the Clinical Trials Transformation Initiative Executive Committee and on the Board of Trustees for the Keck Graduate Institute in Claremont, California.

Jennifer Goldsack, M.A., M.B.A., is the executive director at the Digital Medicine Society, a new professional organization promoting the adoption of digital technologies for health. Previously, Ms. 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. Food and Drug Administration’s Sentinel System. Ms. Goldsack spent 5 years working in research at the Hospital of the University of Pennsylvania, first in outcomes research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Ms. Goldsack earned her master’s degree in chemistry from the University of Oxford, England; her master’s degree in history and sociology of medicine from the University of Pennsylvania; and her M.B.A. from The George Washington University. Additionally, she is a Certified Professional in Healthcare Quality.

Tara Hastings, M.A., is the senior associate director of patient engagement at The Michael J. Fox Foundation for Parkinson’s Research (MJFF). Ms. Hastings works with both the Parkinson’s disease community and key stakeholders across the research and drug therapeutic landscape to ensure the patient perspective is present. She guides MJFF’s efforts to foster collaboration and provide guidance on how to meaningfully capture and include patient insights, experiences, desires, and preferences at all phases of development, through mechanisms such as innovative technology platforms, precompetitive consortia, and education initiatives. Ms. Hastings holds a B.A. from Columbia University and an M.A. from the University of Virginia.

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Bradford Hirsch, M.D., M.B.A., is the co-founder and the chief executive officer of SignalPath Research, a company leveraging technology to make clinical trials more efficient, effective, and available. He is also a medical oncologist and a principal investigator. Prior to his current focus, he held leadership roles in technology companies and academics, including Flatiron Health and the Duke University School of Medicine. Across all of his roles, he has focused on the use of data and novel technologies to advance the frontier in medicine.

He received his B.A. from the University of Pennsylvania, M.D. from the University of Texas Southwestern, and completed his fellowship and M.B.A. at Duke University. 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.

Terris King, Sc.D., D.D., M.S., is the senior pastor of Liberty Grace Church of God, the executive director of the Grace Foundation, and a retired federal government senior executive. He is a second-generation ordained Baptist preacher of a growing and vibrant ministry.

Dr. King is the former director and the client executive at AT&T. He was the lead executive for all AT&T services within the U.S. Department of Health and Human Services. These services exceeded $50 million. He previously served as the deputy director of the Office of Information Systems at the Centers for Medicare & Medicaid Services (CMS). The innovation initiatives Dr. King is establishing are CMS’s future payment and health care coordination models. Prior this role, Dr. King was the founder of the Office of Minority Health for CMS. In this role, he focused on the establishment of the new office with the mission to improve the health of racial and ethnic minority populations. For 6 years, Dr. King served as the deputy director of the Office of Clinical Standards and Quality (OCSQ), a division of the U.S. Department of Health and Human Services.

Dr. King is a proud alumnus of Walbrook Senior High School in Baltimore, Maryland, from which he graduated and received a scholarship in football. He completed both his scientific doctorate in occupational science and his undergraduate degree in mass communications from Towson University. He completed his master’s in behavioral science from Johns Hopkins University and was a Harvard University executive fellow. He received his doctorate in divinity from Saint Thomas College.

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Esther Krofah, M.P.P., is the executive director of FasterCures, a center of the Milken Institute. She has deep experience in the government, nonprofit, and for-profit sectors, where she has led efforts to bring together diverse stakeholder groups to solve critical issues and achieve shared goals that improve the lives of patients. Most recently, Ms. Krofah was the director of public policy leading GlaxoSmithKline’s (GSK’s) engagement with the U.S. Department of Health and Human Services (HHS) and relevant Executive Branch agencies on broad health care policy issues, including leadership in improving vaccinations and care for people living with HIV. Prior to GSK, Ms. Krofah served as the deputy director of HHS’s Office of Health Reform, where she led the development of policy positions for significant regulator priorities, including the health insurance marketplaces. Prior to HHS, she served as a program director at the National Governors Association (NGA) health care division, working directly with governors’ health policy advisors, state Medicaid directors, and state health commissioners on health insurance, health workforce, and Medicaid coverage issues. Before joining NGA, Ms. Krofah worked in consulting at Deloitte Consulting, LLP, where she worked with public-sector and commercial clients, including assisting states in developing state-based exchanges. Ms. Krofah earned a B.A. from Duke University and an M.P.P. from the Harvard University John F. Kennedy School of Government.

Martin Landray, M.B.Ch.B., Ph.D., FRCP, FHEA, FASN, FBPHS, FESC, is a professor of medicine and epidemiology in the Nuffield Department of Population Health and the deputy director of Oxford’s Big Data Institute in the Li Ka Shing Centre for Health Information and Discovery at the University of Oxford. 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. His research seeks to further understand the determinants of common life-threatening and disabling diseases through the design, conduct, and analysis of efficient, large-scale epidemiological studies (including clinical trials) and the widespread dissemination of both the results and the scientific methods used to generate them. The results of his previous trials of treatments for cardiovascular and kidney disease have changed regulatory drug approvals, influenced clinical guidelines, and changed prescribing practice to the benefit of patients. His work on Big Data focuses on the large-scale analysis and interpretation of clinical phenotype through analysis of routine health care data, participant-oriented devices (e.g., smartphones, sensors) and imaging.

Since March 2020, Dr. Landray has been the co-chief investigator of the RECOVERY trial, the national priority platform trial of potential treat-

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

ments for patients hospitalized with COVID-19 in the United Kingdom. The trial was established at a fast pace, moving from first draft protocol to first patient enrolled in 9 days and randomizing more than 12,000 patients in the first few months. Within the first 100 days, the trial produced three practice-changing results: neither hydroxychloroquine nor lopinavir–ritonavir improve clinical outcomes for hospitalized patients with COVID-19; by contrast, dexamethasone reduces mortality by about one-third for patients requiring invasive mechanical ventilation and by one-fifth for those requiring oxygen. The trial has now enrolled more than 39,000 patients, providing clear evidence that the immunomodulatory drug, tocilizumab, further reduces mortality (and that convalescent plasma, colchicine, and azithromycin do not). The protocol is deliberately streamlined, making extensive use of routine health care data to minimize the burden on clinicians and patients in the context of the ongoing pandemic.

Dr. Landray completed his medical training at University of Birmingham (United Kingdom) and specialist training in clinical pharmacology and therapeutics, and general internal medicine at the University of Birmingham. He continues to practice clinical medicine as an honorary consultant physician in the Department of Cardiology at Oxford University Hospitals National Health Service Trust.

Elliott Levy, M.D., is the senior vice president of research and development (R&D) strategy and operations at Amgen Inc., where he is responsible for delivering the operational and transformational capabilities essential to executing Amgen’s R&D strategy. Dr. Levy joined Amgen in 2014 and was the senior vice president of global development, responsible for the clinical development of Amgen’s pipeline.

Before joining Amgen, Dr. Levy served as the senior vice president and the head of specialty development at Bristol Myers Squibb (BMS). Prior to that role, he held the position of the senior vice president of global pharmacovigilance and epidemiology. Dr. Levy joined BMS in 1997, and during his 17 years at the company he held a range of senior positions in cardiovascular clinical development, immunoscience clinical research, and global clinical research operations.

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. Dr. Levy is a graduate of the Yale School of Medicine, where he was chief medical resident and trained in internal medicine and nephrology. He completed fellowship training in clinical research through the Robert Wood Johnson Foundation Clinical Scholars Program at Yale University.

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Freda Lewis-Hall, M.D., DFAPA, MFPM, has been on the frontlines of health care as a clinician, educator, researcher, and leader in the bio-pharmaceuticals and life sciences industries during her 35-year career in medicine. She served as Pfizer Inc.’s chief medical officer and executive vice president until the end of 2018 and as the chief patient officer and the executive vice president during 2019.

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. Pharmaceuticals at Bristol Myers Squibb; the vice president, research and development, product development at Pharmacia Corporation; and the product team leader and the director at Eli Lilly and Company. Dr. Lewis-Hall currently serves on the Board of Fellows of Harvard Medical School, the Board of Advisors of the Dell Medical School, and the Board of Governors for the Patient-Centered Outcomes Research Institute. She also serves on the corporate boards of Milliken and Company, a global diversified industrial manufacturer; 1Life Healthcare, Inc., a health services company; Exact Sciences, Inc., a molecular diagnostics company; and SpringWorks Therapeutics, a biopharmaceutical company.

Prior to joining the biopharmaceutical industry, Dr. Lewis-Hall served as the vice chair and an associate professor in the Department of Psychiatry at the Howard University College of Medicine and was an advisor to the National Institute of Mental Health. She earned a B.A. in natural sciences from Johns Hopkins University and an M.D. from the Howard University College of Medicine. She launched her medical career as a practicing physician and then focused her academic research on the effects of health care disparities and the impact of mental illness on families and communities.

Dr. Lewis-Hall is a distinguished fellow of the American Psychiatric Association and the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. She is a frequent speaker on issues such as improving patient safety and health outcomes, reducing stigma and health care disparities, women’s health, public health, corporate leadership, and diversity. Dr. Lewis-Hall is an accomplished developer of consumer education and medical outreach programs, including national television and radio shows such as segments on Dr. Phil, The Doctors, The Real, TEDMed, The Urban Health Report, and multiple online sites.

Mark McClellan, M.D., Ph.D., is the Robert J. Margolis Professor of Business, Medicine, and Policy, and the founding director of the Duke–Margolis Center for Health Policy at Duke University. With offices in Durham, North Carolina, and Washington, DC, the center is a univer-

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

sitywide Duke initiative that is nationally and internationally recognized for research, evaluation, implementation, and educational initiatives to improve health policy and health, most recently in its COVID-19 response. The center integrates Duke’s expertise in the social, clinical, and analytical sciences alongside engagement with health care leaders and stakeholders, to develop and apply policy solutions that improve health, health equity, and the value of health care locally, nationally, and worldwide.

Dr. McClellan is a doctor and an economist who has addressed a wide range of strategies and policy reforms to improve health care, including payment reform to promote better outcomes and lower costs, methods for development and use of real-world evidence, and strategies for more effective biomedical innovation.

At the center of the nation’s efforts to combat the pandemic, Dr. McClellan is the co-author of a roadmap that details the steps needed for a comprehensive COVID-19 response and safe reopening of our country. His current work on responding to the COVID-19 public health emergency spans virus containment and testing strategies, reforming health care toward more resilient models of delivering care, and accelerating the development of therapeutics and vaccines.

Before coming to Duke, he served as a senior fellow in economic studies at the Brookings Institution, where he was the director of the Health Care Innovation and Value Initiatives and led the Richard Merkin Initiative on Payment Reform and Clinical Leadership. He also has a highly distinguished record in public service and academic research.

Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services and the former commissioner of the U.S. Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy. 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. Department of the Treasury.

Dr. McClellan is the founding chair and a senior advisor of the Reagan–Udall Foundation for FDA, serves on the Institute for Clinical and Economic Review Advisory Board, and is a member of the National Academy of Medicine (NAM). He chairs the NAM’s Leadership Council for Value and Science-Driven Health Care, co-chairs the Guiding Committee of the Health Care Payment Learning and Action Network, and is a research associate at the National Bureau of Economic Research. He is also a senior advisor on the faculty of the University of Texas Dell Medical School and an independent director on the boards of Johnson &

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Johnson, Cigna, Alignment Healthcare, and PrognomIQ. He was previously an associate professor of economics and medicine with tenure at Stanford University, and has twice received the Kenneth Arrow Award for Outstanding Research in Health Economics.

Marilyn A. Metcalf, Ph.D., leads GlaxoSmithKline’s (GSK’s) Oncology Patient Council, involving patients in the work of GSK’s largest and fastest-growing therapy area. Together they enhance the development and use of innovative treatments and promote understanding of these medicines. As a member of GSK’s Global Safety Board, she provides oversight of the safety and benefit–risk balance of GSK’s pharma portfolio from First Time in Human through Lifecycle Management. She is a lead author for Council for International Organizations of Medical Sciences (CIOMS) Working Group XI’s guidance on patient involvement in the development and safe use of medicines, co-chaired U.S. Patients as Partners 2020, and co-chaired the National Academies of Sciences, Engineering, and Medicine’s Science of Patient Input Action Collaborative.

Previously Dr. Metcalf was Family Health International’s project director of the National Institutes of Health’s master contract for HIV vaccine research focusing on the United States and lower- and middle-income countries. At the former GlaxoWellcome, she studied the safety and efficacy, health economics, and quality of life effects of HIV, oncology, and respiratory therapies. In 2001, she moved with her family to the United Kingdom to rebuild GSK’s international Decision Sciences team. After returning to the United States in 2003, she went to Centocor to lead its Decision Sciences and R&D Portfolio Management team. She returned to GSK in 2006 and formed the Benefit–Risk Evaluation team, then led GSK’s Pharmacovigilance Centre of Innovation. She began her current role in 2017.

Richard A. 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). Dr. Moscicki came to PhRMA in 2017 after serving as the deputy center director for science operations for the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as the chief medical officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as a senior vice president and the head of clinical development at Sanofi-Genzyme from 2011 to 2013.

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Dr. Moscicki received his M.D. from the Northwestern University Feinberg Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency in internal medicine, followed by a fellowship at Massachusetts General Hospital (MGH) in clinical immunology and immunopathology. He remained on staff at MGH and on the faculty of Harvard Medical School from 1979 until 2013.

Megan O’Boyle, B.S., is the parent of a 20-year-old daughter with Phelan-McDermid Syndrome (PMS). She is also the principal investigator for the PMS Data Network (PMS_DN, PCORnet) 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. As the patient engagement lead, she brings her decade of experience in advocacy to help patient groups develop and govern their new data collection efforts within RARE-X. Ms. O’Boyle knows firsthand about the challenges that patients and patient communities face collecting and sharing their data. She is passionate about the need for the rare disease community as a whole to collect standardized data (ask the same questions) to allow for cross-disease research. She believes that having data collection developed and maintained at no cost to the patients and patient communities is imperative to removing the barriers to finding treatments and cures for rare disease. Keeping the patient at the center of all decisions and efforts of RARE-X is Ms. O’Boyle’s priority and mission. She serves as a patient advisor on the National Institutes of Health’s Council of Councils and the Simons Foundation–SPARK project, is a former advisor to the National Center for Advancing Translational Sciences Advisory Council, and has won several awards, including from FasterCures and Academy Health.

Anaeze Chidiebele Offodile II, M.D., M.P.H., is the executive director for clinical transformation and an assistant professor in the Department of Plastic Surgery at the MD Anderson Cancer Center. Collaborating with key clinical and operational leaders throughout the institution, he is helping to define, align, and implement a high-level roadmap for clinical and economic transformation in support of MD Anderson’s vision to deliver high-value cancer care. He is also a non-resident scholar in domestic health policy at the Baker Institute, a non-partisan think tank on the campus of Rice University. His scholarship is focused on examining the subjective and material impacts of patient-borne treatment-related costs (“financial toxicity”) and the interaction between vertical integration and the delivery

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

of high-value care. He has received several national awards for his research as well as competitive funding from the Doris Duke Charitable Foundation, the University Cancer Foundation, and the Blue Cross Blue Shield Affordability Cures Consortium. He is currently the 2019–2021 Gilbert Omenn Fellow at the National Academy of Medicine.

A graduate of the Columbia University College of Physicians and Surgeons, he completed surgical training at Brigham & Women’s Hospital (general surgery), the Lahey Clinic (Plastic Surgery), and the MD Anderson Cancer Center (microvascular fellowship). Dr. Offodile also received an M.P.H. in health policy from the Johns Hopkins Bloomberg School of Public Health. He previously served as a senior advisor to the director of the Patient Care Models Group (Christina Ritter) at the Center for Medicare & Medicaid Innovation.

Elizabeth Ofili, M.D., M.P.H., FACC, is a professor of medicine at the Morehouse School of Medicine and a practicing cardiologist with Morehouse Healthcare in Atlanta. She serves as the chief medical officer of the Morehouse Choice Accountable Care Organization, a Centers for Medicare & Medicaid Services’ Shared Savings Program.

She is a nationally and internationally recognized clinician scientist with particular focus on cardiovascular disparities and women’s health. The National Institutes of Health (NIH), as well as industry and foundations, have continuously funded her work since 1994; she has a track record in clinical trials that impact health disparities. In 2002, as the president of the Association of Black Cardiologists, she led the initiative to implement the landmark African American Heart Failure Trial, whose findings led to a change in practice guidelines for the treatment of heart failure in African Americans. She leads or co-leads multi-institutional and national networks funded by NIH to address health disparities and diversity in the biomedical workforce, including the National Research Mentoring Network, an NIH Diversity Program Consortium. She has led collaborative efforts to establish and grow the clinical research infrastructure and training programs at the Morehouse School of Medicine with awards totaling more than $175 million. She has a track record of facilitating cross-institutional research collaborations and community partnerships. These activities include acting as multiple principal investigator (PI) of the Georgia Clinical and Translational Science Alliance, the statewide collaboration at Emory University, the Morehouse School of Medicine, the Georgia Institute of Technology, and the University of Georgia, and partnering with health systems and statewide research organizations totaling more than 1,558 investigators, 49 scholars, 112 trainees, and 110 other career development students. She serves as contact PI for the Research Centers at Minority Institutions (RCMI) Coordinating

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Center, which works with all 21 National Institute on Minority Health and Health Disparities–funded RCMI U54 Centers at Historically Black, Hispanic/Minority Serving, and Native Hawaiian/Pacific Islander Serving Institutions to support investigator development, and data standards for evaluation across the consortium. She was lead author of a publication on models of partnerships between Historically Black Colleges and Universities/Minority Serving Institutions (HBCUs/MSIs) and research-intensive institutions.

Dr. Ofili has delivered more than 700 scientific presentations and published more than 150 scientific papers in national and international journals. As the American Association of Medical Colleges 2007 Council of Dean Fellow, Dr. Ofili led a project on best practices to sustaining the biomedical and physician workforce.

Dr. Ofili brings her knowledge of health and medicine to technology and innovation. She is the founder and the chief science officer of AccuHealth Technologies Inc. (www.Myaccuhealth.com) 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. Dr. Ofili holds a patent for “A system and method for chronic illness care,” and has received more than 50 national awards, including “Changing the Face of Medicine: The Rise of America’s Women Physicians” Exhibit at the National Library of Medicine. She is an elected member of the National Academy of Medicine (2015). She is an elected member of the Association of University Cardiologists (2007) and the American Clinical and Climatological Association (2016). She has advised NIH on diversity in the biomedical research workforce, and served on the board of directors of the National Space Biomedical Research Institute. Dr. Ofili currently serves as the chair of the Board of Directors of the Association of Black Cardiologists, whose motto is “Saving the Hearts and Minds of a Diverse America” (www.abcardio.org).

Amy Patterson, M.D., is the chief science advisor and the director of scientific research programs, policy, and strategic initiatives in the Immediate Office of the Director of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH). In this role, she provides leadership and strategic coordination of trans-NHLBI efforts and manages a broad portfolio of issues germane to the conduct of clinical research, research oversight, policy development, major new scientific initiatives, and relationships with organizations within and external to the Institute.

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

Prior to joining NHLBI in 2015, Dr. Patterson served as the NIH associate director for science policy and as the NIH associate director for bio-security and biosafety policy. 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. Food and Drug Administration’s Center for Biologics Evaluation and Research. Dr. Patterson received her B.A. (cum laude) in biology from Harvard University and her M.D. (Alpha Omega Alpha) from the Albert Einstein College of Medicine. She conducted her internship and residency in internal medicine at New York Hospital and Memorial Sloan Kettering and completed her postdoctoral clinical research fellowships in adult and pediatric endocrinology and metabolism at NIH.

Eric Perakslis, Ph.D., is the chief science and digital officer at the Duke Clinical Research Institute. He was previously a Rubenstein Fellow at Duke University, where his work focused on collaborative efforts in data science that spanned medicine, policy, engineering, computer science, information technology, and security. Immediately prior to his arrival at Duke, Dr. Perakslis served as the chief scientific advisor at Datavant, a lecturer in the Department of Biomedical Informatics at Harvard Medical School, and a strategic innovation advisor to the Médecins Sans Frontières.

Dr. Perakslis was the senior vice president and the head of the Takeda R&D Data Science Institute, where he built an integrated institute of more than 165 multidisciplinary data scientists serving all aspects of biopharmaceutical research and development (R&D) and digital health. Prior to Takeda, Dr. Perakslis was the executive director of the Center for Biomedical Informatics and the Countway Library of Medicine, an instructor in pediatrics at Harvard Medical School (HMS), and a faculty member of the Children’s Hospital Informatics Program at Boston Children’s Hospital.

During his time at HMS, Dr. Perakslis focused on the approval of the Department of Biomedical Informatics as a full academic department, the development of the National Institutes of Health’s Undiagnosed Diseases Network, industry collaborations, leading the technology efforts for multiple Ebola response programs, and building active research programs in medical product development, regulatory science, and cybersecurity.

Prior to HMS, Dr. Perakslis served as the chief information officer and chief scientist (informatics) at the U.S. Food and Drug Administration

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

(FDA). In this role, he authored the first information technology (IT) Strategic Plan for FDA and was responsible for modernizing and enhancing the IT capabilities as well as in silico scientific capabilities at FDA.

Prior to his time at FDA, Dr. Perakslis was the senior vice president of R&D information technology at Johnson & Johnson (J&J) Pharmaceuticals R&D and a member of the Corporate Office of Science and Technology. While at J&J, he created and open-sourced the tranSMART clinical data system, which is now being freely used by hundreds of health care organizations. During his 13 years at J&J, he also held the posts of the vice president of R&D informatics, the vice president and the chief information officer, the director of research information technology, and the director of drug discovery research. Prior to working at J&J, Dr. Perakslis was the group leader of scientific computing at ArQule Inc.

Dr. Perakslis has served on the editorial board of Cancer Today magazine and as the associate editor for novel communications for the Journal of Therapeutic Innovation and Regulatory Science. 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 Kidney 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. Dr. Perakslis has a Ph.D. in chemical and biochemical engineering from Drexel University. He also holds a B.S.Ch.E. and an M.S. in chemical engineering.

Eliseo Pérez-Stable, M.D., is the director of the National Institutes of Health’s (NIH’s) National Institute on Minority Health and Health Disparities, which seeks to advance the science of minority health and health disparities research through research, training, research capacity development, public education, and information dissemination. Dr. Pérez-Stable practiced general internal medicine for 37 years at the University of California, San Francisco (UCSF), before moving to NIH in 2015. He was a professor of medicine at UCSF and the chief of the Division of General Internal Medicine for 17 years. His research interests include improving the health of racial and ethnic minorities and underserved populations, advancing patient-centered care, improving cross-cultural communication skills among clinicians, and promoting diversity in the biomedical research workforce. For more than 30 years, Dr. Pérez-Stable led research on Latino smoking cessation and tobacco control policy in the United States and Latin America, addressing clinical and prevention issues in cancer screening, and mentoring more than 70 minority investigators. He

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

has published more than 250 peer-reviewed articles and was elected to the National Academy of Medicine in 2001.

Sam Roosz, M.B.A., is the chief executive officer and the co-founder of Crescendo Health, a health care technology company that supports trial sponsors in integrating real-world evidence into their study designs. Mr. Roosz previously co-founded Datavant, the leading vendor of privacy preserving record linkage, where he served as the general manager of life sciences. Mr. Roosz previously held roles at Natera, Element Science, and Putnam Associates. He holds a degree in molecular and cellular biology from Harvard University and an M.B.A. from Stanford University.

Bárbara Segarra-Vázquez, D.H.Sc., has been a faculty member at the University of Puerto Rico for 30 years. She is the dean of the School of Health Professions and one of the principal investigators of the Hispanic Clinical and Translational Research Education and Career Development program (R25MD007607) funded by the National Institutes of Health. Dr. Segarra-Vázquez was diagnosed with breast cancer Stage IIB on 2003 and was in remission for 13 years. In 2017, she had a recurrence of metastatic breast cancer to the skin. A volunteer for Komen Puerto Rico since 2006, she was the board president for 4 years. She is a member of the Puerto Rico Cancer Control Coalition, currently serving as the leader of the survivor-ship committee. She has served several times as a consumer reviewer for the Breast Cancer Research Program of the U.S. 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. She is the founder and the co-investigator of Hispanics Increasing Diversity to Enhance Advocacy in Science.

Brian Southwell, Ph.D., is the senior director of the Science in the Public Sphere Program in RTI International’s Center for Communication Science. He also is an adjunct professor and Duke–RTI Scholar with Duke University and a graduate faculty member and an adjunct associate professor at the University of North Carolina at Chapel Hill. In more than 100 articles, chapters, and books, including Misinformation and Mass Audiences and Social Networks and Popular Understanding of Science and Health, Dr. Southwell has explored public understanding of science. At Duke, he has been involved with a series of year-long faculty–student projects on topics such as residential energy use behavior and public engagement regarding

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

air pollution. Dr. Southwell hosts WNCU’s The Measure of Everyday Life, speaks at events such as the Aspen Ideas Festival, and advises for NOVA Science Studio.

Pamela Tenaerts, M.D., M.B.A., is the chief scientific officer at Medable, where she directs research to help identify, implement, and make ubiquitous responsible decentralized trial strategies. 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), a multi-stakeholder public–private partnership to improve quality and efficiency in clinical trials at Duke University. She sits on the boards of the Society of Clinical Trials and the Scientific Leadership Council of the Digital Medicine Society, participates in the Good Clinical Trial Collaborative, and is a member of the National Academies of Science, Engineering, and Medicine’s Forum on Drug Discovery, Development, and Translation. She received her M.D. from Catholic University in Leuven, Belgium, and her M.B.A. from the University of South Florida.

Jonathan Watanabe, Pharm.D., Ph.D., BCGP, is a professor of clinical pharmacy and an associate director and the founding associate dean of assessment and quality at the University of California, Irvine, Samueli College of Health Sciences and a National Academy of Medicine Emerging Leader in Health and Medicine scholar. He was a contributor to the National Academies of Sciences, Engineering, and Medicine’s Making Medicines Affordable: A National Imperative consensus study report and is a current member of the National Academies’ ad hoc Committee on Implications of Discarded Weight-Based Drugs. Dr. Watanabe employs real-world data to develop policy solutions to improve patient care, augment population health, and reduce medical costs. Dr. Watanabe focuses on improving access to evidence-driven medication use and pharmacist-directed patient care. He serves as an advisor to the California Health Benefits Review Program for the California State Legislature. His research on safe and effective medication use has been cited in enacted legislation efforts. He served as an investigator, faculty, and fellowship director for the federal Health Resources and Services Administration–funded San Diego Geriatrics Workforce Enhancement Program and is a current investigator for the California Tobacco-Related Disease Research Program. Dr. Watanabe was the inaugural recipient of the University of Washington (UW)/Allergan Global Health Economics and Outcomes Research Fellowship. He served as a clinical consultant at the San Diego Program of All-inclusive Care for the Elderly Clinic. He is an advisor to

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

the Joint Commission on pain management and assessment standards in long-term care. He received his B.S. from UW. He received a Pharm.D. from the University of Southern California. He received an M.S. and a Ph.D. from UW’s Comparative Health Outcomes, Policy, and Economics Institute. He is a board-certified geriatric pharmacist.

Janet Woodcock, M.D., was named the acting commissioner of food and drugs on January 20, 2021. As the acting commissioner, Dr. Woodcock oversees the full breadth of the U.S. Food and Drug Administration (FDA) portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation; and the regulation of tobacco products.

Dr. Woodcock began her FDA career in 1984, joining the Center for Biologics Evaluation and Research (CBER) as the director of the Division of Biological Investigational New Drugs, as well as serving as CBER’s acting deputy director for a period of time. She later became the director of the Office of Therapeutics Research and Review in CBER, which included the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis during her tenure.

In 1994, Dr. Woodcock was named the director of FDA’s Center for Drug Evaluation and Research (CDER), overseeing the center’s work that is the world’s gold standard for drug approval and safety. There she led many of FDA’s drug initiatives, including introducing the concept of risk management as a new approach to drug safety; modernizing drug manufacturing and regulation through the Pharmaceutical Quality for the 21st Century Initiative; advancing medical discoveries from the laboratory to consumers more efficiently under the Critical Path Initiative; and launching the Safety First and Safe Use initiatives designed to improve drug safety management within and outside FDA, respectively.

In 2004, Dr. Woodcock became the deputy commissioner and the chief medical officer in the Office of the Commissioner. Later she took on other executive leadership positions in the Commissioner’s Office, including the deputy commissioner for operations and the chief operating officer.

In 2007, Dr. Woodcock returned as the director of CDER until she was asked to lend her expertise to Operation Warp Speed for developing therapeutics during the COVID-19 pandemic, such as evaluating the potential benefits of monoclonal antibody treatments for certain COVID-19 patients. From late 2020, she split her time advising Operation Warp Speed on advancing COVID-19 therapeutics with serving as the

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×

principal medical advisor to the commissioner on key priorities on behalf of the Office of the Commissioner.

Dr. Woodcock holds a B.S. in chemistry from Bucknell University and an M.D. from the Northwestern University Feinberg School of Medicine. She also completed further training and a fellowship in rheumatology and held teaching appointments at The Pennsylvania State University and the University of California, San Francisco. She is board certified in internal medicine. Dr. Woodcock has been bestowed numerous honors over her distinguished public health career, most notably: a Lifetime Achievement Award in 2015 from the Institute for Safe Medication Practices; the Ellen V. 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.

Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 83
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 84
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 85
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 86
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 87
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 88
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 89
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 90
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 91
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 92
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 93
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 94
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 95
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 96
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 97
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 98
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 99
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 100
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 101
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 102
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 103
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 104
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 105
Suggested Citation:"Appendix B: Speaker and Moderator Biographies." National Academies of Sciences, Engineering, and Medicine. 2022. Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26349.
×
Page 106
Next: Appendix C: Workshop Agendas »
Envisioning a Transformed Clinical Trials Enterprise for 2030: Proceedings of a Workshop Get This Book
×
Buy Paperback | $30.00 Buy Ebook | $24.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands.

Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!