Reaching Clinical Trial Excellence
Practical Strategies for Achieving Generalizable and Transportable Data
Friday, December 5th, 2025
7:00 - 10:00 AM EST
ASH Annual Meeting
Orange County Convention Center, Orlando
The Initiative
A DRIVE for Clinical Trial Excellence
D.R.I.V.E. is our strategic framework for promoting representative enrollment in clinical trials. This initiative addresses the inherent safety and efficacy concerns that arise when studies are conducted in populations that do not reflect the different patient groups these treatments are intended to serve. Generalizability, the ability to infer treatment effects for the entire population from a study population, and transportability, the ability to apply treatment effects from one group to another, are critical for ensuring equitable and effective care. To uphold these principles, we define “clinical trial excellence” as studies that successfully meet these diversity and representation benchmarks.
Despite growing awareness of these issues, most clinical trials remain unrepresentative, leading to data gaps that disproportionately impact minoritized populations. Historical migration patterns, systemic inequities, and biological factors such as genetic polymorphisms and microbiome diversity all contribute to varied treatment responses among different racial and ethnic groups. However, current trial designs often fail to account for these differences, resulting in regulatory approvals based on non-generalizable data. The D.R.I.V.E. Initiative 2025 aims to establish measurable standards for representation, advocate for policy changes, and promote inclusive research practices that improve clinical outcomes for all patients, regardless of background.
DRIVE Score Calculator
Our 2025 Speakers
-
Hematology Oncology of Indiana, a Division of American Oncology Network
Partner
Indy Hematology Education Inc.
President and CEO
Marian University: Wood College of Osteopathic Medicine
Clinical Professor
Ruemu E. Birhiray, MD is an attending physician in medical oncology, hematology, and hematopoietic stem cell transplantation at Hematology-Oncology of Indiana, and at St. Vincent Hospital in Indianapolis, Indiana. After completing his internal medicine residency at Columbus Hospital in Chicago where he also served as Chief Medical Resident in 1994, he was a postgraduate fellow in bone marrow transplant at Johns Hopkins University in Baltimore and in medical oncology at the National Cancer Institute, National Institutes of Health in Bethesda, Maryland where his research included gene therapy and adoptive cellular immunotherapy strategies in bone marrow transplantation. Dr. Birhiray’s professional experience has also included serving as an attending physician, and Director of bone marrow transplantation and a member of Marshfield Clinic, Wisconsin and a Clinical Assistant Professor at the University of Wisconsin from 1998 to 2001. Additionally Dr. Birhiray was appointed an Associate Professor of bone marrow transplantation at Rush University, Chicago, Illinois in 2001, prior to joining Hematology Oncology of Indiana. Subsequently, Dr. Birhiray, served as and director of Bone Marrow Transplantation and Institutional Principal Investigator for the National Surgical Adjuvant Breast and Bowel Project of the National Cancer Institute at St. Vincent’s Hospital, Indianapolis. Currently, he is also, Clinical Professor, Marian University School of Osteopathic Medicine, Indianapolis, Indiana, and an Editorial Board Member of The Journal of Blood Transfusion and Hematopathology. Projects for which Dr. Birhiray is principal investigator include reduced intensity allogeneic transplantation in hematologic malignancies, and a trial of Interferon A, CHOP, and rituximab therapy in advanced-stage follicular lymphoma, and neoadjuvant chemotherapy for breast cancer. Additional collaborations have included major phase III clinical trials. Additionally Dr. Birhiray founded the Clinical research program at Hematology Oncology of Indiana. His awards include, “Intern of the year” from Columbus Hospital, Hope award from the Indiana Wellness community and named “best physician” by the Indianapolis monthly magazine and “top doctor” by Castle Connelly. In 2002, Dr. Birhiray founded and has served as Chair of the annual “Indy Hematology Review”, a nationally respected program providing education for hematologists and oncologists nationally and regionally, and he is also President and CEO of Indy Hematology Education, Inc. A member of the American Society of Clinical Oncology, the American Society of Hematology, and the American Medical Association, Dr Birhiray has published in the Journal of Clinical Oncology, Leukemia, Gene Therapy and Therapeutic Apheresis, Journal of Blood Transfusion and Hematopathology, Human Immunology, Familial Cancer, Annals of Pharmacotherapy, American Journal of Health System Pharmacists, Pharmacotherapy, in addition to multiple abstracts. Dr. Birhiray is married to Donna Marie (nee Baynard) since 1995, and they are blessed with 3 children, a daughter, Maya, born in 1999, and a son, Dirin, born in 2003, and an older daughter Meaghan who was born in 1990.
-
Executive Director
Professor of Radiation Oncology
Ingram Professor of Cancer Research
Vanderbilt-Ingram Cancer Center
Associate Director of Community Outreach & Engagement
Meharry Medical College - School of Global Health
Professor of Health Policy and Head of Research & Innovation
Karen Winkfield, MD, PhD is the Executive Director of the Meharry-Vanderbilt Alliance and Associate Director for Community Outreach & Engagement at the Vanderbilt Ingram Cancer Center. She is a Professor of Radiation Oncology at Vanderbilt University Medical Center with expertise in the management of hematologic malignancies. Her work is focused on the design and implementation of programming to reduce sociocultural and economic barriers that contribute to disparate health outcomes. In 2021, Dr. Winkfield was appointed to serve a six-year term on the National Cancer Advisory Board and currently chairs the Ad hoc Subcommittee on Population Science, Epidemiology and Disparities.
-
Dana-Farber Cancer Institute and the HMS Center for Bioethics
Faculty Member
Assistant Professor of Medicine
Andrew Hantel, MD, MPH is an Assistant Professor of Medicine at Harvard Medical School and faculty member in the Divisions of Leukemia and Population Sciences at Dana-Farber Cancer Institute and the HMS Center for Bioethics. He received his MD from Loyola University Chicago; trained in internal medicine, adult hematology/oncology, and medical ethics at the University of Chicago; and completed a post-doctoral fellowship in cancer population sciences at the Dana-Farber/Harvard Cancer Center. Dr. Hantel's lab leverages health services and care delivery methods to address ethical dilemmas in cancer discovery and delivery. His current work focuses on equity in the contexts of research participation, artificial intelligence, and climate change.
-
University of Pennsylvania: Perelman School of Medicine
Advisory Dean, Dr. Helen O. Dickens House
Ruth C. and Raymond G. Perelman Professor of Medicine
Professor of Biostatistics and Epidemiology
Carmen Guerra, MD, MSCE is the Ruth C. and Raymond G. Perelman Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania. She is also the Vice Chair of Diversity and Inclusion for the Department of Medicine and the Associate Director of Diversity and Outreach for the Abramson Cancer Center. Dr. Guerra leads Community Outreach and Engagement for the Abramson Cancer Center. In this role, she leads partnerships with community organizations to design, implement, and evaluate research and interventions to increase the participation of underrepresented populations in cancer screening research and clinical trials at the center.
Dr. Guerra is the PI of several studies aimed at increasing the participation of Black and Hispanic patients in cancer clinical trials, including the development and evaluation of the Abramson Cancer Center Clinical Trials Ambassador Program which provides peer-to-peer education to newly diagnosed breast cancer patients (funded by Bristol Myers Squibb Foundation and Genentech). She is a PI for a multi-site implementation study of the Lazarex Foundation’s Improving Patient Access to Cancer Clinical Trials (IMPACT), a patient financial reimbursement program for cancer clinical trial related travel expenses being conducted at the ACC, MD Anderson and UT Southwestern cancer centers. Dr. Guerra also co-led a national initiative by ASCO and ACCC that produced the first unconscious bias training for cancer researchers, Just Ask, and a site self-assessment instrument to support equity, diversity, and inclusion in clinical trials. Dr. Guerra is currently determining the impact of the Just Ask unconscious bias training in the recommendation of trials by breast cancer research teams.
-
Indy Hematology Education, Inc.
Medical Science Liaison
Samuel Ranger, MS supports oncology education initiatives with a focus on equity, inclusion, and community-centered care. His professional interests include increasing diversity in clinical trials, advancing patient advocacy, and ensuring accessible, evidence-based cancer education for both providers and patients. Samuel holds both a Master’s and Bachelor’s degree in biology and is based in Fort Collins, Colorado, where he enjoys hiking, rock climbing, and exploring national parks.
-
Indy Hematology Education, Inc.
Medical Science Liaison
Indiana University School of Medicine
First Year Medical Student
Maya N. Birhiray holds a Bachelor of Science in Biomedical Health Sciences from Purdue University—West Lafayette and a Master of Science in Anatomy, Cell Biology, and Physiology from the Indiana University School of Medicine. Maya continues to pursue her medical education as a first year medical student at Indiana University School of Medicine. Serving as a Medical Science Liaison for Indy Hematology Education Inc. (IHE), Maya collaborates with IHE faculty and external organizations to plan and execute impactful educational events.
In addition to her liaison responsibilities, Maya is the co-author and creator of IHE’s DRIVE initiative, which aims to promote diversity, inclusion, and equity within cancer clinical research. Through this work, she is committed to fostering a more equitable healthcare environment and enhancing educational opportunities for all.
-
Medical Director of Oncology Research
Deputy Editor
Dr. Thaker is a renowned radiation oncologist, scientific researcher, informaticist, and health policy expert who works at the intersection of clinical oncology, technology, and value-based cancer care delivery. He is the medical director of stereotactic radiosurgery at Capital Health.
He received his undergraduate degree in biology with summa cum laude from The College of New Jersey and his medical degree with junior Alpha Omega Alpha status from Rutgers University – New Jersey Medical School, receiving both degrees through the highly competitive 7-year accelerated combined medical program. During medical school, he helped develop novel therapeutic combinations for
glioblastoma brain tumors and was awarded a clinical and translational research fellowship through the Doris Duke Charitable Foundation at the University of Pittsburgh Medical Center.
Upon graduating medical school, Dr. Thaker completed a transitional internship at the Crozer-Chester Medical Center, then completed residency training in Radiation Oncology at the prestigious University of Texas MD Anderson Cancer Center in Houston, Texas - the #1 ranked cancer center in the country by US News and World Report. In an effort to improve the quality of cancer care in patients’ communities, Dr. Thaker also completed a fellowship in healthcare management, where he worked with national leaders in quality improvement and healthcare innovation at the MD Anderson Cancer Center and the Harvard Business School.
Dr. Thaker is double-board certified in radiation oncology and clinical informatics, holds Master’s degrees in healthcare and business administration, has attained Project Management Professional (PMP) and Certified in Medical Quality (CMQ) professional certifications, and is a Fellow of the American Brachytherapy Society (FABS). He works with leading experts in all aspects of radiation oncology and has helped develop cutting-edge cancer therapies. He has expertise in treating a wide range of cancers, including gastrointestinal, lung, gynecologic, breast, head and neck, genitourinary, and central nervous system malignancies. Dr. Thaker also holds several national leadership positions in the American Society for Radiation Oncology (ASTRO) and the American Brachytherapy Society (ABS). He has co-founded multiple companies in the areas of technology, digital transformation, and healthcare delivery for underserved communities.
Dr. Thaker has a strong devotion to delivering world-class, academic-level cancer care to patients close to their homes. He is deeply passionate about helping patients and their families navigate their cancer journey, and he believes in patient-centered care, where he combines each patient’s personal values with
strong multidisciplinary collaboration and the most cutting-edge standards of cancer care. When at home, Dr. Thaker enjoys swimming, running, programming, watching movies, and singing Bollywood songs. He especially enjoys spending time with his wife and three young children.
-
UI Health Mile Square Health Center
Chief Executive Officer
Dr. Watson comes from immediate experience as the chief engagement officer for the All of Us Research Program at the National Institutes of Health. In this role, he led the program’s efforts to foster relationships with participants, communities, researchers, and providers across the United States to help build one of the largest, most diverse health databases of its kind to study health and illness. His focus was on connecting with people and populations underrepresented in scientific research while inviting them to participate in the development and discovery of new therapeutics and models of care.
Prior to this role, Watson spent over 15 years as a community-engaged research scientist with the Mile Square Health Center Federally Qualified Health Center network and the Chicagoland area. previously, he was the associate executive director at Mile Square Health Center while also serving as the associate director of community outreach and engagement for the University of Illinois Cancer Center and as a research assistant professor at the UIC School of Public Health. Beyond his work with UIC, he has served as co-lead of the All of Us Engagement Core at the Meharry-Vanderbilt Alliance, cultivating positive relationships with the program’s participant ambassadors.
-
Elsie de R. and Samuel P. Orlando Distinguished Professor
Professor of Law
Medical-Legal Partnership Clinic
Founding Director
Department of Public Health Sciences, Penn State College of Medicine
Assistant Professor
Medha D. Makhlouf is a professor of law and the founding director of the Medical-Legal Partnership Clinic at Penn State Dickinson Law. She is also an assistant professor (by courtesy) in the Department of Public Health Sciences at Penn State College of Medicine.
Professor Makhlouf’s research interests lie at the intersection of health law, immigrants’ rights, and poverty law and policy. Her current work focuses on immigrant access to health care and the many ways in which immigration status functions as a social determinant of health. Professor Makhlouf’s scholarship has been published or is forthcoming in the New York University Law Review, the Boston University Law Review, California Law Review Online, the Yale Journal of Health Policy, Law & Ethics, and several other academic journals. Professor Makhlouf was selected as a Health Law Scholar by the American Society of Law, Medicine & Ethics and the Saint Louis University Center for Health Law Studies based on the originality of the thesis of her article, “Health Justice for Immigrants,” and its contribution to the scholarly literature. Her work on changes to public charge policy has been cited by litigants and amici curiae in four federal lawsuits challenging the 2019 regulations expanding the scope of public charge inadmissibility.
As director of the Medical-Legal Partnership Clinic, Professor Makhlouf supervises law students in direct representation of individuals who have health-harming legal needs. The Clinic aims to reduce health disparities and improve health in vulnerable communities through collaboration with medical providers and public health practitioners. Currently, the Clinic focuses on representing immigrants in matters involving access to health-supporting public benefits. Professor Makhlouf was named a 2020 Atlantic Fellow for Health Equity to support the Clinic’s work.
Professor Makhlouf received her undergraduate degree magna cum laude from Brown University and her law degree from Yale Law School. After law school, she served as a public interest fellow at the Political Asylum/Immigration Representation Project in Boston and at Asylum Access in Quito, Ecuador; as an associate attorney at Ropes & Gray LLP in Boston; and as the Medical-Legal Partnership Staff Attorney at the Central West Justice Center in Worcester, Massachusetts. She joined the faculty of Penn State Dickinson Law in 2015.
-
Versiti Blood Research Institute
Senior Investigator
Program Co-Leader
Dr. Mast is a Senior Investigator and Leader of the Thrombosis and Hemostasis Program at the Versiti Blood Research Institute in Milwaukee Wisconsin where he holds the Walter A. Schroeder Endowed Chair for Blood Research. Dr. Mast received a BS in biochemistry at the University of Illinois and MD and PhD degrees from Duke University. He performed residency training in Laboratory Medicine at Washington University in St. Louis. He has directed a research laboratory that focuses on the biology of tissue factor pathway inhibitor for over 25 years.
-
Chief Medical Officer
Head of Strategy
Chadi Nabhan, MD, MBA, is an award-winning hematologist and a medical oncologist who is the host and creator of the Healthcare Unfiltered Podcast – going on its 6th year, this weekly podcast is an honest, raw, timely podcast tackling all topics in healthcare. No edits and no filters; that is “Healthcare Unfiltered.” Combining his background in clinical care, artificial intelligence, cancer research, precision medicine, genomics, clinical trials, real-world data, controversies in medicine, and health care advocacy, Dr. Nabhan brings a unique and powerful perspective to all current medical events.
Dr. Nabhan has over 300 peer-reviewed original articles, abstracts or book chapters, and serves on the editorial board of JAMA-Oncology. Dr. Nabhan has authored two books; the first was released in 2023 “Toxic Exposure: The True Story Behind the Monsanto Trials and the Search for Justice; the second was released in September 2024 and titled “The Cancer Journey: Understanding Diagnosis, Treatment, Recovery, and Prevention” His third book on AI and cancer care is due in 2026 and his 4th book (and first fiction book) is also due later in 2026. Dr. Nabhan maintains active medical licenses to practice in the states of IL, IN, WI, FL, and CA. He is sought-after speaker, moderator, and facilitator.
-
University of Pennsylvania School of Medicine
Physician Leader, Leukemia Clinical Research Unit
Associate Professor of Clinical Medicine (Hematology-Oncology)
Catherine Lai, MD, MPH, is an Associate Professor and the Physician Leader of the Leukemia Clinical Research Unit at the University of Pennsylvania. Dr. Lai specializes in detecting, monitoring, and treating acute leukemia and myeloid malignancies in adults. Dr. Lai’s research focuses on integrating health outcomes into clinical trials with novel therapeutics, with a focus on measuring physiologic age and interventions to improve early mortality and overall survival, minimize treatment toxicity and maximize tolerability to therapy.
Most recently, Dr. Lai served as the Director of Leukemia at MedStar Georgetown University Hospital’s Lombardi Comprehensive Cancer Center in Washington, DC. She completed her Hematology/Oncology fellowship at the National Cancer Institute of the National Institutes of Health. Dr. Lai received her master’s in Public Health in Epidemiology from George Washington University.