Appendix B

Biographical Sketches of the Workshop Planning Committee and Speakers

PLANNING COMMITTEE BIOSKETCHES

FREDA LEWIS-HALL, M.D. (Chair), is the former executive vice president and chief medical officer at Pfizer. Trained as a psychiatrist, she has held leadership roles in academia, medical research, frontline patient care, and global biopharmaceutical companies, including Vertex, Bristol Myers Squibb, and Eli Lilly. Before her work in industry, she led research projects for the National Institutes of Health (NIH) and was vice chair of the Department of Psychiatry at Howard University College of Medicine. In 2010, Dr. Lewis-Hall was appointed by the Obama administration to the inaugural board of governors for the Patient-Centered Outcomes Research Institute; in 2012, she was appointed chair of the Cures Acceleration Network Review Board and a member of NIH’s National Center for Advancing Translational Sciences Advisory Council. She also serves on the executive committee of the Clinical Trials Transformation Initiative and on numerous other boards, including those of Harvard Medical School, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation, and Save the Children. Dr. Lewis-Hall received a B.A.S. from Johns Hopkins University and her Ph.D. from Howard University Hospital and College of Medicine. Dr. Lewis-Hall was named one of Savoy’s Top Influential Women in Corporate America in 2012 and selected as the Healthcare Businesswomen’s Association’s 2011 “Woman of the Year.”

BARBARA BIERER, M.D., is a hematologist-oncologist and professor of medicine at Harvard Medical School (HMS) and the Brigham and Women’s

Hospital (BWH). Dr. Bierer is the faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University, a collaborative effort to improve standards for planning and conducting international clinical trials. She is also the director of the Regulatory Foundations, Ethics, and Law program at the Harvard Catalyst and principal investigator and director of SMART IRB. She serves as faculty in the Center for Bioethics, HMS, and affiliate faculty in the Petrie-Flom Center for Health Law at Harvard Law School. She is a cofounder of COVID-19 Collaboration Platform and of the nonprofit Vivli, a global clinical research data-sharing platform. From 2003 to 2014, Dr. Bierer served as senior vice president, research, BWH, where she founded the Brigham Research Institute and the Brigham Innovation Hub. She is a past chair of the Secretary’s Advisory Committee on Human Research Protections and has served or serves on the board of directors of Association for Accreditation of Human Research Protection Programs, Inc., Public Responsibility in Medicine and Research, Management Sciences for Health, Vivli, North Star IRB, and the Edward P. Evans Foundation. She has authored more than 275 publications. Dr. Bierer received her B.S. from Yale University and her MD.D. from HMS.

SILAS BUCHANAN is the founder and CEO of the Institute for eHealth Equity, a social impact consulting firm. He is an experienced underserved community engagement strategist, dedicated to building equitable partnerships and crafting Web-based ecosystems that solve for known, outreach, and engagement failure points. He partnered with the AME Church (2,000 congregations and 2 million members) to build and launch www.amechealth.org as its official health information sharing and data collecting website. He then led the development of strategic partnerships with health care, wellness, and pharma organizations. He is working with the start-up OurHealthyCommunity to redevelop the platform to better engage underserved communities both secularly and nonsecularly. He has contributed thought leadership to the National Academies, Milken Institute’s FasterCures, Clinical Trials Transformation Initiative, Morehouse School of Medicine, Duke Clinical Research Institute, Healthcare Information and Management Systems Society, Accenture, American Telemedicine Association, Digital Medicine Society, and Kraft Precision Medicine Accelerator at Harvard Business School, among many others.

LUTHER CLARK, M.D., is deputy chief patient officer and global director, scientific, medical, and patient perspective in the Office of the Chief Patient Officer at Merck; 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 developing a systematized approach for collecting and incorporating patient insights across the patient journey and product lifecycle; 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 coleader of the team that champions Health Care Equities (including promoting health literacy and research diversity), and chairs the Patient Engagement, Health Literacy, and Clinical Trials Diversity Investigator Initiated Studies Research Committee. Before Merck, Dr. Clark was chief of the Division of Cardiovascular Medicine at the State University of New York Downstate Medical Center (SUNY Downstate) and 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 American College of Physicians and 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 president of the Health Science Center at Brooklyn Foundation, SUNY Downstate.

MARIANNE HAMILTON LOPEZ, Ph.D., M.P.A., is a senior research director, adjunct associate professor, and core faculty at the Duke-Margolis Center for Health Policy at Duke University. Dr. Hamilton Lopez was a senior program officer at the National Academy of Medicine, where she oversaw the Leadership Consortium for a Value and Science-Driven Health System’s Science and Technology portfolio and directed the Clinical Effectiveness Research Collaborative and Digital Health Collaborative. She held senior positions at Academy Health, the U.S. Cochrane Center, and National Institutes of Health. Her work focuses on facilitating a more efficient, affordable, and equitable biomedical pathway. She leads the Duke-Margolis Biomedical Innovation program, which focuses on medical product development and regulation, clinical trials, real-world evidence, digital health, payment and coverage, and drug pricing and competition. She recently oversaw the development of the Advancing Clinical Trials at the Point-of-Care coalition, which aims to drive the implementation of representative clinical trial networks to support rapid evidence development. Dr. Hamilton Lopez earned a Ph.D. from University of Maryland,

Baltimore Campus, an M.P.A. from George Washington University, and a B.A. from Earlham College. She is also a graduate of the Department of Health and Human Services (HHS) Emerging Leaders Program.

MORGAN HANGER, M.P.P., is the executive director of Clinical Trials Transformation Initiative (CTTI), a public–private partnership between Duke University and the U.S. Food and Drug Administration. She has deep experience convening organizations to solve complex problems related to evidence generation and is passionate about data ethics and transparency. Before CTTI, she worked at health technology companies focused on patients. Ms. Hanger served as vice president of the online patient research network PatientsLikeMe, where she led partnerships to use patient-generated health data in life sciences and regulatory settings. Before that, she worked in advisory services for Avalere Health, where she helped pharma, biotech, and professional societies create more effective research strategies. She has also held positions within the Health Outcomes Group at Memorial Sloan Kettering Cancer Center and Congressional Budget Office. Ms. Hanger graduated summa cum laude from New York University with a B.A. in politics and holds an M.A. in public policy from the University of California, Berkeley.

ESTHER KROFAH, M.P.P., is the executive vice president for health at the Milken Institute, leading FasterCures, Public Health, the Future of Aging and Feeding Change. She has extensive experience managing efforts to unite diverse stakeholders to solve critical issues and achieve shared goals that improve patients’ lives. Most recently, she was the director of public policy at GlaxoSmithKline, where she led engagement with U.S. Department of Health and Human Services (HHS) and relevant executive branch agencies on broad health care policy issues. Before that, she was a deputy director of HHS Office of Health Reform. She also served as program director at the National Governors Association health care division and worked at Deloitte Consulting, LLP. She received a B.A. from Duke University and an M.A. in public policy from the Harvard University John F. Kennedy School of Government.

MARTIN MENDOZA, Ph.D., serves as the chief health equity officer at the Centers for Medicare & Medicaid Services (CMS) and Director of the CMS Office of Minority Health (OMH); he leads OMH in its mission toward the advancement and integration of health equity in the development, evaluation, and implementation of CMS’s policies, programs, and partnerships. Before CMS, Dr. Mendoza served as the first director of health equity for the National Institutes of Health (NIH) All of Us Research Program, where he provided leadership and high-level expertise to improve

inclusion and equity in precision medicine. Before All of Us, Dr. Mendoza led extramural research for minority health in the Office of the Commissioner at U.S. Food and Drug Administration (FDA). He is a recognized expert in clinical trial diversity and has testified on it before Congress. He is also the primary author of the pivotal FDA guidance recommending that clinical trial sponsors submit a diversity action plan. His idea and recommendation became federal public law in December 2022. Dr. Mendoza has also served as director of the Division of Policy and Data in the OMH in HHS Office of the Secretary and in multiple NIH Institutes, including the National Institute of Neurological Disorders and Stroke, National Cancer Institute, and National Human Genome Research Institute, where he assisted in the genetic mapping of the Human Genome Project. Dr. Mendoza is a graduate of the University of Maryland, Baltimore County, and received his Ph.D. in cancer biology from Johns Hopkins University.

CARLA RODRIGUEZ-WATSON, Ph.D., M.P.H., is the director of research for the Reagan-Udall Foundation for U.S. Food and Drug Administration. Earlier, she was an investigator at Kaiser Permanente Mid-Atlantic Research and at the University of Washington. Her heart lies where it all began, in service of public health. She devoted over a decade to that in the New York City, San Francisco, and Seattle-King County Health departments in communicable disease and environmental epidemiology and surveillance. Her exposure to and love for the complexity of real-world-data and its potential was born in public health. Today, she is focused on continuously developing and enhancing a portfolio of work to advance and leverage real-world data (RWD) and experiences to inform and conduct clinical and postmarket drug safety and effectiveness studies, including improving the quality and relevance of RWD (including data needed to advance health equity), developing and advancing frameworks and tools to systematically describe data sources and methods for pre- and postmarket studies of product safety and effectiveness, and the Innovation in Medical Evidence, Development and Surveillance Program—where such tools can be leveraged and tested for regulatory and nonregulatory studies. She brings her extensive background in public health surveillance, health outcomes research, and pharmacoepidemiology to this work.

MICHELLE TARVER, M.D., Ph.D., is a board-certified ophthalmologist and epidemiologist and deputy director for transformation at the Center for Devices and Radiological Health (CDRH); she facilitates the development, implementation, and direction of its transformative projects and initiatives. Under her leadership, CDRH is advancing efforts to include underserved and underrepresented populations in the evaluation of medical devices, including people across diverse age, sex, gender, racial, and ethnic

backgrounds; those living with rare diseases and physical limitations; and those living in rural areas. Her CDRH career has included many leadership roles, most recently as the deputy director of the Office of Strategic Partnerships and Technology Innovation and program director of patient science and engagement. She has received numerous awards, including the American Academy of Ophthalmology’s Secretariat Award, and is widely published in peer-reviewed journals. Dr. Tarver received a B.S. in biochemistry from Spelman College in Atlanta, GA, and completed the M.D./Ph.D. program at the Johns Hopkins University School of Medicine and Bloomberg School of Public Health. After her internal medicine internship, she completed a residency in ophthalmology with fellowship training in ocular inflammation (uveitis) at the Wilmer Eye Institute (Johns Hopkins). She has worked on laboratory-based and epidemiological studies, clinical trials, registries, and patient-reported outcome measures and surveys to capture patient preferences. As a dedicated clinician, she continues to care for people living with eye disease.

ROBERT A. WINN., M.D., is the director of Virginia Commonwealth University Massey Comprehensive Cancer Center, a National Cancer Institute (NCI)-designated center that provides advanced care, conducts groundbreaking research to discover new therapies, offers high-quality education and training, and engages with the community to make advancements in treatment and prevention equally available to all. He is leading the nation in establishing a 21st-century model of equity for cancer science and care, in which the community is informing and partnering with Massey on its research to best address the cancer burden and disparities of those the cancer center serves, with a local focus but global impact. His current basic science research, which has been supported by multiple National Institutes of Health (NIH) and Department of Veterans Affairs (VA) Merit awards, focuses on the molecular mechanisms and novel therapeutic approaches for human models of lung cancer. He has authored or coauthored more than 80 manuscripts in peer-reviewed academic journals. As a pulmonologist, he is committed to community-engaged research centered on eliminating health disparities. He is a principal investigator on several community-based projects funded by NIH and NCI, including the All of Us Research Program. He has nearly 20 years’ commitment to VA health services and held appointments at the Denver VA and Jesse Brown VA in Chicago, where he established the first multidisciplinary pulmonary nodule clinic. Dr. Winn is the president of the Association of American Cancer Institutes (AACI); the chair of the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine; a fellow of the American Association for Cancer Research (AACR) Academy; and a member of the board of directors for the American Cancer Society and LUNGevity Foundation.

He has received numerous awards and honors, including the NCI Center to Reduce Cancer Health Disparities CURE Program Lifetime Achievement Award; AACR Minorities in Cancer Research Jane Cooke Wright Lectureship; AACI Cancer Health Equity Award; and Prevent Cancer Foundation Cancer Prevention and Early Detection Laurel Award for Increasing Health Equity. In 2022, the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program was renamed the “Robert A. Winn Diversity in Clinical Trials Award Program (Winn Award),” for increasing diversity and training the new generation of community-oriented clinical researchers. Dr. Winn holds a B.A. from the University of Notre Dame and an M.D. from the University of Michigan Medical School in Ann Arbor. He completed an internship and residency in internal medicine at Rush-Presbyterian-St. Luke’s Medical Center in Chicago and a fellowship in pulmonary and critical care medicine at the University of Colorado Health Sciences Center in Denver.

SPEAKER AND MODERATOR BIOSKETCHES

STACEY J. ADAM, Ph.D., is a vice president of science partnerships at the Foundation for the National Institutes of Health (FNIH), leading many public–private partnerships, such as Accelerating COVID-19 Therapeutic Interventions and Vaccines; the Biomarkers Consortium (Cancer and Metabolic Disorders Steering Committees) and their projects; Accelerating Medicines Partnerships—Common Metabolic Diseases and Heart Failure, Partnership for Accelerating Cancer Therapies; Pediatric Medical Device Testing; and the Lung-MAP clinical trial. Before FNIH, Dr. Adam was a manager at Deloitte Consulting in the Federal Life Sciences and Healthcare Strategy practice, where she supported many federal and nonprofit client projects. Before Deloitte, Dr. Adam conducted her postdoctoral fellowship at Stanford University School of Medicine, where she was both an NIH and American Cancer Society supported fellow, and she earned her Ph.D. in pharmacology with a certificate in mammalian toxicology from Duke University.

MONICA M. BERTAGNOLLI, M.D., is the 17th director of the National Institutes of Health (NIH). She was nominated by President Joe Biden on May 15, 2023, was confirmed by the U.S. Senate on November 7, 2023, and took office on November 9, 2023. She is the first surgeon and second woman to hold the position. Dr. Bertagnolli oversees the work of the largest funder of biomedical and behavioral research in the world. She served as the 16th director of the National Cancer Institute (NCI), the Richard E. Wilson Professor of Surgery in surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital (BWH), and a member

of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. Throughout her career, Dr. Bertagnolli has been at the forefront of the field of clinical oncology. Her laboratory focused on advancing understanding of the genetic drivers of gastrointestinal cancer development and the role of inflammation as a promoter of cancer growth. As a physician-scientist, she led translational science initiatives from 1994 to 2011 within the NCI-funded Cooperative Groups Program (now NCI’s National Clinical Trials Network [NCTN]) and from 2011–2022, served as group chair of the Alliance for Clinical Trials in Oncology, an NCTN member organization. In addition, 2007–2018, she served as the chief of the division of Surgical Oncology for the Dana-Farber Brigham Cancer Center. Dr. Bertagnolli has championed collaborative initiatives to transform the data infrastructure for clinical research and is the founding chair of the minimal Common Oncology Data Elements executive committee. She also is a past president and chair of the board of directors of the American Society of Clinical Oncology and has served on the board of directors of the American Cancer Society and the Prevent Cancer Foundation. In 2021, she was elected to the National Academy of Medicine, having served on its National Cancer Policy Forum. The daughter of first-generation Italian and French Basque immigrants, Dr. Bertagnolli grew up on a ranch in southwestern Wyoming. She graduated from Princeton University with a B.S. in engineering and attended medical school at the University of Utah. She trained in surgery at BWH and was a research fellow in tumor immunology at the Dana-Farber Cancer Institute.

JAMIE BREWER, M.D., is a medical oncologist and clinical team lead in the Division of Oncology 3 in the Office of Oncologic Diseases at the U.S. Food and Drug Administration (FDA). Dr. Brewer joined FDA in 2018 and earlier served as a clinical reviewer on the Genitourinary Cancer team. Dr. Brewer serves as the Oncology Center of Excellence Scientific Liaison for Cancer Disparities; she actively engages with FDA colleagues and external stakeholders to promote inclusion and representation of diverse patient populations in clinical trials. Dr. Brewer completed her medical training at the University of Illinois–Chicago as well as her residency and a joint fellowship in Medical Oncology and Clinical Pharmacology and Pharmacogenomics at the University of Chicago.

NAMANDJÉ N. BUMPUS, Ph.D., is the U.S. Food and Drug Administration’s (FDA) principal deputy commissioner as of February 2024. Dr. Bumpus began her career at FDA as chief scientist in August 2022. She works closely with the Commissioner of Food and Drugs to develop and implement key public health initiatives and oversee FDA’s day-to-day functions. Before FDA, Dr. Bumpus was on the faculty at Johns Hopkins for

12 years, where she quickly rose through the ranks to become the E.K. Marshall and Thomas H. Maren Professor and chair of the Department of Pharmacology and Molecular Sciences at its School of Medicine and also served as associate dean for basic research. Dr. Bumpus is recognized as an international expert in pharmacology, and her research has expanded knowledge of drug metabolism, pharmacogenetics, bioanalytical chemistry, infectious disease pharmacology, and single-cell biology. Before Johns Hopkins, she completed a postdoctoral fellowship at the Scripps Research Institute in La Jolla, CA. Dr. Bumpus earned a Ph.D. in pharmacology from the University of Michigan and a B.S. in biology from Occidental College. She serves as the elected president of the American Society for Pharmacology and Experimental Therapeutics, a 4,000-member scientific society founded in 1908. She was chair of the National Institutes of Health (NIH) Xenobiotic and Nutrient Disposition and Action study section. A lauded teacher and mentor, Dr. Bumpus was awarded the Johns Hopkins University Professor’s Award for Excellence in Teaching Biomedical Sciences. Her scientific contributions and impact have been recognized through numerous national and international awards, including the Presidential Early Career Award for Scientists and Engineers, Leon I. Goldberg Award and Abrams Award from the American Society for Clinical Pharmacology and Therapeutics, James Gillette Award from the International Society for the Study of Xenobiotics, and John J. Abel Award in Pharmacology from the American Society for Pharmacology and Experimental Therapeutics. In 2022, she was selected by NIH to deliver the annual Rolla E. Dyer in Infectious Disease Lecture. Dr. Bumpus is an honorary member of the Society of Toxicology, an honor bestowed upon one scientist each year who embodies outstanding and sustained achievements in the field. She has been elected by her peers as a fellow of the American Association for the Advancement of Science and a member of the National Academy of Medicine, which is one of the highest honors in the field of medicine.

ROBERT M. CALIFF, M.D., was confirmed as the 25th commissioner of the U.S. Food and Drug Administration (FDA). He oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring 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 the food supply, cosmetics, dietary supplements, and products that give off electronic radiation; and the regulation of tobacco products. Dr. Califf has had a long and distinguished career as a physician, researcher, and leader in the fields of science and medicine. He is a nationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research and a leader in the growing

field of translational research, which is key to ensuring that advances in science translate into medical care. This is Dr. Califf’s second stint as commissioner (his first was in 2016 as the 22nd commissioner). Before that, he was FDA’s deputy commissioner for medical products and tobacco. Before rejoining FDA in 2022, Dr. Califf was head of medical strategy and senior advisor at Alphabet Inc., contributing to strategy and policy for its health subsidiaries Verily Life Sciences and Google Health. He joined Alphabet in 2019, after serving as a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and was the founding director of the Duke Clinical Research Institute. Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.

NATALIA CHALMERS, D.D.S., M.H.SC., Ph.D., is a board-certified pediatric dentist, oral health policy expert, and public health advocate who brings more than 20 years of clinical, research, industry, and regulatory experience to the Centers for Medicare & Medicaid Serivces in her role as chief dental officer in the Office of the Administrator. She was a dental officer at U.S. Food and Drug Administration. Dr. Chalmers has devoted her career to transforming scientific and health care data and information into actionable insights to address equity, improve care, and better inform policy and funding. She completed her Ph.D. in surgery at the Faculty of Dental Medicine of the Medical University of Sofia, a residency in pediatric dentistry at the University of Maryland School of Dentistry, and a Ph.D. in oral microbiology from the Graduate Partnerships Program of the University of Maryland School of Dentistry and the National Institute for Dental and Craniofacial Research at the National Institutes of Health (NIH), postdoctoral fellowship at the Forsyth Institute, and clinical research fellowship at the National Institute for Dental and Craniofacial Research, NIH. Dr. Chalmers holds an M.S. in clinical research from Duke Medical University and a certificate in Drug Development and Regulatory Science from the University of California, San Francisco School of Pharmacy. Her research has translated into action, improving oral care and advocating for the role health policy can play across the lifespan—particularly when it embraces dental well-being as a facet of care for the whole person.

MEGAN COYLEWRIGHT, M.D., is a structural interventional cardiologist whose clinical practice includes minimally invasive options to treat congestive heart failure and prevent stroke. She is a frequent lecturer on technical and procedural topics and the intersection of health policy and patient-centered shared decision making and known for her advocacy to broaden access to

cardiovascular therapies in clinical trials to women and patients of color. Dr. Coylewright is the editor of the American College of Cardiology CardioSmart/Patient Voice Program and coleads the Heart Valve Collaboratory Lifetime Management of Valvular Heart Disease task force. Her work as a middle school Teach for America teacher in the South Bronx continues to inform her perspectives on the intersections of social determinants of health. She completed her medical school, residency, and M.P.H. training at Johns Hopkins and served as health disparities coordinator at the Baltimore City Public Health Department. Five years of cardiovascular training were spent at the Mayo Clinic in her home state of Minnesota.

U. MICHAEL CURRIE, M.P.H., M.B.A., hails from Washington, DC, and served as the chief health equity officer at UnitedHealth Group until October 2023; he led the coordination of health equity efforts since June of 2010. He was responsible for the development and execution of enterprise efforts, initiatives, and interventions to identify health disparities, and the enhancement or implementation of programs, services, and strategies to address identified health disparities. He has held roles in both the public and private sectors with responsibilities related to disease prevention, wellness, and health benefits and spent nearly 30 years focused on population health management. He has contributed to numerous health equity and health disparities articles and publications and been a guest lecturer at public and private organizations and numerous academic institutions. He serves on various local and national boards and committees focused on addressing barriers to health care and improving health outcomes, including the Maryland Department of Health Advisory Committee on Minority Health, American Telemedicine Association Advisory Board on Eliminating Health Disparities, Health Care Payment Learning & Action Network Health Equity Advisory Team, Howard Community College Educational Foundation board, Johns Hopkins Howard County Medical Center Foundation board, and Creating Healthier Communities board of directors. He has a B.A. from Morehouse College, an M.P.H. from George Washington University, and an M.B.A. from Johns Hopkins University.

GWEN DARIEN is a longtime patient advocate who has played leadership roles in some of the country’s preeminent nonprofit organizations. As executive vice president for patient advocacy, engagement, and education at Patient Advocate Foundation, she leads programs that link Patient Advocate Foundation’s direct patient service programs to the national system change initiatives, with the goal of improving access to affordable, equitable quality health care. Called “a bit of a renegade” by People Magazine, she has long insisted on pushing boundaries while maintaining a safe space for patients. As editor and publisher of Mamm, a magazine for women with breast or

reproductive cancer, she published features on taboo subjects, such as dating after a mastectomy, along with the more expected academic features on news and policy analysis. Her media leadership was recognized by the Avon Foundation, which honored her as one of “the most powerful women in breast cancer.” As a three-time cancer survivor herself, she came into cancer advocacy expressly to change the experiences and outcomes for those who came after her and change the public dialogue about cancer and other life-threatening illnesses. With these goals in mind, in 2005, she started the first stand-alone advocacy entity in a professional cancer research organization at the American Association for Cancer Research, causing outside observers to note the organization’s “progressive commitment to patient advocacy.” At the American Association for Cancer Research, she launched CR magazine—a magazine for people with cancer and those who care for them. Later, she served as the executive director of the Samuel Waxman Cancer Research Foundation; director of the Pathways Project; and executive vice president of programs and services at the Cancer Support Community. In each role, she championed placing patients at the center of health system change, whether it is for research, public policy or direct services. She serves on a wide range of program committees and workshop faculties. She is the past chair of Patient Centered Outcomes Research Insitute’s Patient Engagement Advisory Panel and founding chair of Community Engagement in Genomics Working Group of the National Human Genome Research. She is on the board of trustees of the U.S. Pharmacopeia and a member of the National Cancer Policy Forum. She also writes about her experiences as an advocate and cancer survivor. A recent piece, “Transformation: My Experience as a Patient and an Advocate in Three Chapters,” appeared in the National Academy of Medicine Perspectives. She is a graduate of Sarah Lawrence College, where she also served as an advisor for its Health Advocacy program.

DECHANE L. DORSEY, J.D., is the executive director of Accel. It represents small and midsized companies and works to address concerns specific to this group of companies that comprise more than 70 percent of its overall membership. She also leads its health equity and women’s health workstreams. Earlier, she was a vice president in the Payment and Health Care Delivery Department at AdvaMed; her responsibilities included policy development and analysis of regulatory issues affecting the medical technology industry, including the hospital outpatient prospective payment system, reimbursement for ambulatory surgical centers, advanced wound healing and tissue regeneration, coding, and physician payment issues. Before joining AdvaMed in June 2006, she was the director of health policy for the American Academy of Ophthalmology, where she managed issues affecting coverage and reimbursement for ophthalmology procedures. Before

that, she was a senior counsel with the U.S. Department of Health and Human Services’ Office of Counsel to the Inspector General, as a litigator on a variety of fraud and abuse issues. including enforcement of exclusion authorities, the Emergency Medical Treatment and Active Labor Act statute, civil monetary penalties, and compliance monitoring. She holds a B.A. in political science from Syracuse University and a J.D. from the Georgetown University Law Center.

AMY FLOWERS, Ph.D., is director of policy research at the National Association of Community Health Centers (NACHC). She leads its policy research department, ensuring that it is informed by health centers’ rapidly evolving policy and advocacy needs, and focused on health equity and the diverse communities served by community health centers. Her experience includes developing both qualitative and quantitative research methodologies that address each arm of the quintuple aim: equity, patient and provider experience, cost efficiency, and care quality. Before joining NACHC, she served as a consultant on hundreds of projects for government agencies at the federal, state, and local levels; she developed a sense for the importance of early stakeholder engagement, a deep understanding of the costs of health disparities, and a sense of purpose for improving health equity and access to care. Dr. Flowers earned her Ph.D. from the University of Southern California and is a RIVA Institute–trained focus group moderator.

QUITA HIGHSMITH, M.B.A., is vice president at Genentech, a member of the Roche Group. In addition, she was selected as the first chief diversity officer (CDO) in the 46-year history of the company and reports to the CEO. She is responsible for enterprise-wide strategic initiatives that drive business impact by investing in commercial efforts, stakeholder engagement, research innovation, and community relations. Outside of diversity and inclusion knowledge, she brings brand marketing, business development, and a global leadership perspective. Before becoming the CDO, she held leadership roles in commercial and government affairs of several companies (Genentech, Sanofi, Aventis), where she impacted and improved revenues. Because she recognized the need to diversify clinical research, she cofounded Advancing Inclusive Research, an initiative to embrace equitable access. She is routinely requested to address members of Congress, speak at national and international forums, and give media interviews with both large and small outlets, such as WSJ, STAT, Atlantic, and Essence Magazine. She has coauthored numerous publications regarding health disparities in peer-reviewed journals. In 2024, she was chosen as a Top 15 Chief Diversity Officer by Diversity Global Magazine and selected by Savoy Magazine as one of the Most Influential Black Executives in Corporate America. She is an advisor to Cerebral, a mental health start-up company, and Artis

Ventures. She is also committed to community service by working with nonprofit boards, such as Congressional Black Caucus Foundation, Northwest Kidney Centers, Delta San Francisco—Peninsula Scholarship Foundation, and Genentech Patient Foundation. She received both an M.B.A. and an advanced diversity and inclusion certificate from Cornell University and an undergraduate degree from the University of Kentucky.

STEPHEN KONYA serves as the senior advisor to the deputy national coordinator and innovation portfolio lead for the Office of the National Coordinator for Health IT (ONC), U.S. Department of Health and Human Services. In addition to shaping the agency’s long-term strategy, he also serves as the primary liaison to the White House Office of Science and Technology Policy and the external health care, startup care, and investor community. Furthermore, he leads the Digital Health Innovation Workgroup under the federal Health IT Coordinating Council, an interagency collaboration community composed of innovation representatives from 40 other federal agencies. In addition to serving as the primary federal government lead and cofounder for CancerX, Mr. Konya led several other key federal projects, including the HHS PandemicX Innovation Accelerator, national Health IT Playbook, ONC Patient Engagement Playbook for Providers, SMART App Gallery, and Fast Healthcare Interoperability Resources at Scale Taskforce Initiative, and is a founding cochair of the Together.Health Collaborative.

SHARI M. LING, M.D., serves as the deputy chief medical officer for Centers for Medicare & Medicaid Services (CMS). Dr. Ling’s committed focus is on achieving meaningful health outcomes for patients and families through the delivery of high-quality, person-centered care, across all care settings. Her clinical focus and scientific interest are in the care of persons with dementia, multiple chronic conditions, and functional limitations. Dr. Ling leads the CMS Behavioral Health Strategy implementation. She also represents CMS on several U.S. Department of Health and Human Services’ efforts, including the workgroups for the National Alzheimer’s Project Plan and on eliminating and preventing health care–associated infections, the National Strategy to Combat Antimicrobial Resistance. Dr. Ling earned an M.A. in gerontology in direct service at the Leonard Davis School of Gerontology and an MD.D. at Georgetown University School of Medicine; she completed a rheumatology fellowship at Georgetown University Hospital followed by a geriatric medicine fellowship at Johns Hopkins University School of Medicine. She continues her clinical work serving veterans as a volunteer dementia care provider and has retained her appointment as part-time faculty in the Division of Geriatrics and Gerontology, Johns Hopkins University School of Medicine.

MICHELLE MCMURRY-HEATH, M.D., Ph.D., is the founder and CEO of BioTechquity Clinical, a novel clinical research organization (CRO) designed to help drug and device innovators enroll and conduct diverse clinical trials. It ends the conflation of race and poverty to find untapped diverse middle-class patient partners better equipped to complete trials and lower the average 40 percent attrition rate seen in most modern trials. Earlier, she was the CEO of the Biotechnology Innovation Organization, where she launched the industry-wide BIOEquality Agenda. She is a former regulatory and clinical leader at both the U.S. Food and Drug Administration and Johnson & Johnson, where she led a global team responsible for trials and regulatory approvals in 150 countries. She has experience on Capitol Hill and was the founding director of the Aspen Institute health program. Dr. McMurry-Heath has committed her career to the belief that medical innovation can improve lives and unlock opportunity for all people if inclusively conducted and equitably distributed and that it will take market savvy innovations and breakthrough business models to achieve meaningful biotech equity.

KATHY MICKEL serves as the learning solutions lead at the Society for Clinical Research Sites, where she plays a pivotal role in shaping and executing its events and educational programs. She spearheads initiatives such as its IncluDE (Inclusivity, Diversity, & Equity) Program and Oncology Program, contributing to the advancement of the clinical research community. With a rich background in the pharmaceutical industry, she has excelled in clinical operations, demonstrating her expertise in site-facing roles across diverse therapeutic areas. Her adeptness in connecting with others, coaching, and leadership has been instrumental in her success, extending into impactful human resources roles within pharmaceutical organizations. Drawing from her extensive experience across sites, contract research organizations, and pharmaceutical companies, she curates engaging learning experiences and fosters collaboration within the clinical research sphere. She also showcases her versatile leadership by actively supporting her family’s industrial landscape business. Additionally, she serves as a yoga teacher trainer, offering training, coaching, and mentorship to inspire personal and professional growth. Through her endeavors, she instills a commitment to excellence and encourages individuals to pursue their talents and passions relentlessly.

KRISTEN NWANYANWU, M.D., M.B.A., M.H.S., is a National Institutes of Health (NIH)-funded, board-certified ophthalmologist, practicing vitreoretinal surgeon, and expert in health equity research and implementation science. She is the PI for the NIH-funded Sight-Saving Engagement and Evaluation in New Haven Program, a multimethod approach to identifying and addressing health disparities in diabetic retinopathy. She leads the implementation science team for the Equitable Breakthroughs in Medication

Development pilot, an innovative collaboration to increase diversity in clinical trials. She lectures nationally on health equity, access to care, and the surgical management of diabetic retinopathy. She received the National Eye Institute Director’s Award and Secretariat Award from the American Academy of Opthamology. She is proud to participate in the growing advocacy to advance diversity in clinical trials.

MARY NWOKEDI-NWANERI, PHARM.D., has a diverse work experience starting from 2010. They worked as a summer research intern in ophthalmic at Emory University School of Medicine in 2010. From 2013 to 2015, they served as a lab manager focusing on cardiovascular research at Temple University, where they managed grants, ensured compliance, and collaborated with international research labs. In 2017, Dr. Nwokedi-Nwaneri was a campus ambassador and later a clinical pharmacology-oncology intern at Genentech. In 2018, they worked as a regulatory affairs extern in advertising and promotion immunology/dermatology at AbbVie and as a clinical pharmacology extern at the U.S. Food and Drug Administration. Dr. Nwokedi-Nwaneri also had a role as a global public health policy extern at Howard University Global Health Initiative South Africa. From 2019 to 2020, they worked as a visiting scientist in U.S. regulatory policy & strategy and global policy & intelligence at Eli Lilly and Company. In 2020, they joined Merck as a global labeling lead in oncology. Currently, since 2021, they are serving as the director of health equity in clinical trials, science, and regulatory advocacy at Pharmaceutical Research and Manufacturers of America.

Dr. Nwokedi-Nwaneri earned their Phram.D. from Howard University and a B.S. in biology from Allegheny College. Currently, they are pursuing a degree in global health systems with a focus on public health at the University of Maryland, Baltimore. In addition to their formal education, Dr. Nwokedi-Nwaneri has obtained certifications in comparative health systems and global health equity from the University of Pennsylvania.

BRIAN RIVERS, Ph.D., M.P.H., is professor and director of the Cancer Health Equity Institute at Morehouse School of Medicine (MSM). Dr. Rivers is nationally and internationally recognized as a thought leader in health disparities research and a retired appointed member of the National Institutes of Health (NIH) National Advisory Council on Minority Health and Health Disparities. He is an active member in the AACR community and has served in several leadership capacities, such as on the steering committee for the inaugural Cancer Disparities Progress Report, the chair for Minorities in Cancer Research Council, conference cochair for the 11th Conference on Cancer Health Disparities, and cochair for the Think Tank on Cancer Health Disparities. Dr. Rivers is chair of the Science Education

and Career Advancement Committee and cochair for the Georgia Cancer Control Consortium, a state-funded entity responsible for developing the state’s cancer plan and maintaining the prevention and control infrastructure. Dr. Rivers has endeavored to expand the application of population-based intervention/implementation/dissemination science to address cancer health disparities and advance cancer health equity in clinical and community-based settings, using multilevel/multidomain/multisectoral approaches, such as novel technological platforms and iterations of the Patient Navigation model. He is leading several large randomized controlled trials, funded by NIH’s National Institute on Minority Health and Health Disparities (R01), to evaluate and characterize the impact of multilevel, digital health psychosocial interventions, targeting African American men diagnosed with prostate cancer, and the NCI (R01), to examine the interplay of social and molecular determinants in lung cancer disparities. Dr. Rivers is lead multiple-principal investigator (MPI) for the NCI-funded Partnerships to Advance Cancer Health Equity U54 Cancer Research Partnership between MSM, Tuskegee University, and the University of Alabama-Birmingham O’Neil Comprehensive Cancer Center and MPI of the inaugural NIH Faculty Institutional Recruitment for Sustainable Transformation Coordination and Evaluation Center. He is the PI of two recent American Cancer Society initiatives, Diversity in Cancer Research Institutional Development Program (Health Equity Research Career Advancement Program) and Cancer Health Equity Research Centers (Georgia Cancer Health Equity Research Center). He has presented his novel and innovative research findings in diverse settings, including the First Congress on Oncology Clinical Trials (Lagos, Nigeria); Movember International Prostate Cancer Consortium (Queensland, Australia); Atlantic Magazine, The People vs Cancer; South by Southwest conferences; and the National Press Foundation.

JONI RUTTER, Ph.D., is the acting director of National Center for Advancing Translational Science (NCATS) at the National Institutes of Health. Dr. Rutter oversees the planning and execution of the center’s complex, multifaceted programs that aim to overcome scientific and operational barriers impeding the development and delivery of new treatments and other health solutions. Under her direction, NCATS supports innovative tools and strategies to make each step in the translational process more effective and efficient, thus speeding research across a range of diseases, with a particular focus on rare diseases. By advancing the science of translation, NCATS helps turn promising research discoveries into real-world applications that improve people’s health. Earlier, as the NCATS deputy director, Dr. Rutter collaborated with colleagues from government, academia, industry and nonprofit patient organizations to establish robust interactions with NCATS programs. Before NCATS, Dr. Rutter served as the director

of scientific programs within the All of Us Research Program, where she led the scientific programmatic development and implementation efforts to build a national research cohort of at least 1 million U.S. participants to advance precision medicine. During her time at the National Institutes of Health, she also led the Division of Neuroscience and Behavior at the National Institute on Drug Abuse; she developed and coordinated research on basic and clinical neuroscience, brain and behavioral development, genetics, epigenetics, computational neuroscience, bioinformatics, and drug discovery and coordinated its Genetics Consortium and biospecimen repository. Dr. Rutter has earned a national and international reputation for her diverse and unique expertise via more than 50 publications in journals and received several scientific achievement awards, including a SmithKline Beecham Student Award in Pharmacology, Janssen Research Foundation Young Investigator Award, and National Cancer Institute (NCI) Fellowship Achievement Award. Dr. Rutter received her Ph.D. from the Department of Pharmacology and Toxicology, Dartmouth Medical School, Hanover, New Hampshire, and completed a fellowship at NCI within the Division of Cancer Epidemiology and Genetics.

SARAH HUDSON SCHOLLE, Ph.D., M.P.H., is a principal at Leavitt Partners, an HMA company based in Washington, DC, specializing in supporting multisector alliances to promote improvement in quality, equity, and person-centered health care. Earlier, Dr. Scholle was vice president of research and analysis at the National Committee for Quality Assurance (NCQA). She led a portfolio of quantitative and qualitative research that contributed to national thought leadership in quality and equity, contributed to program development and policy action, and resulted in numerous peer-reviewed studies. Specifically, she led projects to develop and test quality measures, including those adopted into national programs. Her content expertise includes mental health, substance use, child health, care coordination, and patient-reported outcomes. She has served on national panels for the National Academies of Sciences, Engineering, and Medicine; Centers for Medicare & Medicaid Services; and the National Quality Forum. Before NCQA, she was an associate professor at the University of Pittsburgh School of Medicine and an assistant professor at the University of Arkansas. Dr. Scholle earned a B.A. in history and an M.P.H. from Yale University and a Ph.D. in public health from the Johns Hopkins Bloomberg School of Public Health.

MARY T. THANH HAI, M.D., is an internist/endocrinologist. She has been with U.S. Food and Drug Administration since 1998 and is the deputy director for clinical science in the Office of New Drugs (OND)/Center for Drug Evaluation and Research (CDER). She directly oversees the Office of

Drug Evaluation Sciences responsible for the drug development tool qualification programs, OND’s research program, clinical outcomes assessment program, and, more recently, the Drug Trials Snapshot program. Her positions include director of the Division of Metabolism and Endocrinology Products 2006–2013, deputy office director for the Office of Drug Evaluation 2013–2018, and acting director for the current office. Over her more than 26 years at the U.S. Food and Drug Administration, Dr. Thanh Hai has served on several internal and external committees on a wide range of issues, including as rapporteur for an ICH expert work group, participating in Prescription Drug User Fee Act VI and VII reauthorization negotiations, and representing CDER in several tobacco cessation initiatives. She received her M.D. from Georgetown University.

VINDELL WASHINGTON, M.D., M.S., is the chief clinical officer and head of the Health Equity Center of Excellence at Verily; he leads clinical and data innovation teams across its care delivery and research solutions and also cross-functional teams focused on advancing health equity through its people and products. He served as chief medical officer and executive vice president at Blue Cross Blue Shield of Louisiana, where he oversaw network operations and contracting, medical policy and quality, disease management, and pharmacy benefits. Before that, he was National Coordinator for Health Information Technology (ONC), where he provided high-level executive direction and leadership for programs, operations, and policies. He received his M.D. from the University of Virginia and MS.S. in health care management from the Harvard University School of Public Health.

MATTHEW WATLEY, M.DIV., M.A., is a dynamic and dedicated pastor, renowned speaker, author, professor, entrepreneur, leadership consultant, and visionary “kingdom builder.” As the founder and senior pastor of Kingdom Fellowship AME Church, Reverend Watley leads and spiritually guides a thriving community of more than 7,000 members. In a remarkable testament to his leadership, the church recently transitioned to a cutting-edge facility, the Kingdom Worship Center, valued at $45,000,000. Reverend Watley’s community involvement extends beyond the church. As the chair of the Black IDEA Coalition, he is dedicated to achieving Black parity in employment, investment, and contracting. He also leads the Kingdom Global Community Development Corporation, which provides comprehensive support services to address food insecurity, health, and outreach to those in various communities. Reverend Watley frequently speaks on issues of economy, culture, leadership, and health equity. He has spoken for Ch2Mhill, Prudential, Industrial Bank, American Institute of CPAs, U.S. Department of Transportation, and Milken Institute. He founded the Kingdom Network, a leadership program that supports

national clergy development. He is a member of the board of trustees of Wiley University, advisory board of the Museum of the Bible, Board of Visitors of the Howard University School of Divinity, and Sub-Saharan Africa Advisory Committee of EXIM and an at-large member of the general board of the African Methodist Episcopal Church. He has served as an adjunct professor at Georgetown University and lectured at various higher-learning institutions, including Howard University, Alabama State University, Cornell University, Wesley Theological Seminary, and Wilberforce University. Reverend Watley also has a B.A. in political science and an M.Div. from Howard University, an executive M.A. in leadership from Georgetown University, and an M.A. in education and human development from George Washington University. In May 2021, he was awarded an honorary doctorate of humane letters from Wiley College, where he delivered the commencement address. Reverend Watley is a doctoral candidate at Fuller Theological Seminary. He also received a Lifetime Achievement Award from President Joseph R. Biden, Jr., for his commitment to building a stronger nation through volunteer service. He is the author of several books and articles; Ignite is his most recent book. Reverend Watley professes that among his most significant roles are husband, father, and son. He is married to Shawna Francis Watley, senior policy advisor with Holland and Knight LLC, and has one daughter, Alexandra Elizabeth Watley. The family resides in the metropolitan Washington area.

KARRIEM S. WATSON, D.H.SC., M.S., M.P.H., is the chief engagement officer for the All of Us Research Program. He leads its efforts to foster relationships with participants, communities, researchers, and providers across the United States and territories through equitable engagement to help build one of the largest and most diverse health datasets of its kind to advance precision medicine research. Before joining the National Institutes of Health, Dr. Watson spent more than 15 years conducting cancer disparities research. He completed his postdoctoral training in cancer center leadership under Dr. Robert A. Winn at the University of Illinois at Chicago Cancer Center and went on to become an independently funded researcher with funding from the National Cancer Institute, National Institute on Minority Health and Health Disparities, and National Heart, Lung, and Blood Institute. Dr. Watson’s work spans community-engaged research, community based participatory research, and implementation and dissemination science, including engaging community members as citizen scientists to improve diversity, equity, and inclusion in clinical trials. He also served as a health care administrator overseeing community-based research and the associate executive director for a network of Federally Qualified Health Centers. Dr. Watson has been recognized by many organizations for his

commitment to training and education, including with the Innovator in STEM award by the Chicago Urban League.

CHERYL L. WILLMAN, M.D., serves as the enterprise executive director of Mayo Clinic Cancer Programs and director of the Mayo Clinic Comprehensive Cancer Center. She also holds the rank of professor and consultant of laboratory medicine and pathology in the Mayo Clinic College of Medicine and Science. An internationally renowned physician-scientist and cancer center leader, Dr. Willman leads the National Cancer Institute (NCI)-designated Mayo Clinic Comprehensive Cancer Center across three national sites: Rochester, MN, and the Mayo Clinic Health System, a rural health care delivery system across the Upper Midwest; Phoenix and Scottsdale, AZ; and Jacksonville, FL. In 2023, these sites provided care for greater than 130,000 unique, diverse cancer patients. Dr. Willman is a pioneer in the field of cancer genomics and cancer precision medicine with a track record of innovation and successful translation of discoveries to clinical trials. She served as the director of the University of New Mexico Comprehensive Cancer Center, which developed into one of the nation’s preeminent NCI-designated Cancer Centers serving the region’s diverse, underserved, and underrepresented patients. She has led or coled several key NCI initiatives that are improving the lives of patients with cancer and addressing disparities in cancer care, incidence, and mortality among diverse and underserved populations. She serves as PI of one of the five NCI-funded Participant Engagement Cancer Genome Sequencing Centers: Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing. This program is deeply engaging tribal leaders, communities, and cancer patients to deliver state-of-the-art comprehensive clinical genomic sequencing, cancer genetic counseling, and navigation to care for tribal cancer patients. The overall goal is to identify the spectrum of cancer-associated genomic mutations and mutational signatures in this understudied population, enhance access to state-of-the-art diagnostics and care, and drive cancer health equity. Dr. Willman has been continuously funded by National Institutes of Health (NIH), NCI, and the Leukemia & Lymphoma Society for more than 35 years. She is a highly cited physician-scientist who has published more than 290 papers, reporting her work in the highest-quality medical and scientific journals. She also holds or has pending 11 patents. Dr. Willman has served in many leadership roles at NCI, including the Board of Scientific Advisors and the Scientific Advisory Board of the Frederick National Laboratory for Cancer Research, overseeing NCI science and investments in cancer genomics, drug discovery, nanotechnologies, computing and large-scale data analysis, and relationships and collaborations between NCI and the Department of Energy laboratories. She also has held many national leadership positions in professional

organizations, including the American Association of Cancer Research, American Society of Hematology, and Leukemia and Lymphoma Society. She was a founder of the field of molecular diagnostic pathology and president of the Association of Molecular Pathologists. She is an elected fellow of the National Academy of Inventors. Dr. Willman received her M.D. at Mayo Medical School, now Mayo Clinic Alix School of Medicine, which included a medical student fellowship in immunology at NIH. She completed her residency and postdoctoral training in pathology and cancer research at Mayo Clinic, University of New Mexico, and University of Washington.