Application of External Control Arms in Oncology Drug Development – Speaker Biographies
Learn more about panelists and keynote speakers from Friends of Cancer Research’s public meeting Application of External Control Arms in Oncology Drug Development. Click here to view the agenda.
SESSION 1 – METHODOLOGICAL AND DATA INSIGHTS FROM THE ECA PILOT PROJECT
Elizabeth Garrett-Mayer, PhD, FASCO, FSCT
Vice President, Center for Research and Analytics
American Society of Clinical Oncology
Dr. Garrett-Mayer’s department (CENTRA) leads the American Society of Clinical Oncology’s research efforts, including the TAPUR Study (a pragmatic basket trial of FDA approved targeted agents in patients with advanced cancer), the CDK Study (a PCORI-funded clinical trial comparing two dosing strategies for CDK4/6 inhibitors), and programs aimed at dose optimization, improving access to clinical trials, and oncology workforce issues. Prior to joining ASCO, she served on the faculty at Johns Hopkins in the Department of Oncology and then joined the faculty of the Medical University of South Carolina (MUSC) where she established the Biostatistics Shared Resource at the Hollings Cancer Center (HCC).
She earned her PhD in Biostatistics from Johns Hopkins Bloomberg School of Public Health. Her publication record includes more than 350 peer-reviewed publications, primarily in clinical trial design methods and clinical cancer research. She serves on the board of The Society for Clinical Trials, has been a member of numerous NIH committees, NCI task forces and steering groups, Data Safety Monitoring Boards for NIH-supported clinical trials, and serves on the editorial board of three peer-reviewed journals. She has served as course director for both the ASCO-AACR Methods in Clinical Cancer Workshop and the Society for Immunotherapy of Cancer’s Clinical Immuno-Oncology Network Workshop.
Ruthie Davi, PhD
Senior Vice President, Statistics and Regulatory Science Innovation
Medidata, a Dassault Systèmes company
Ruthie Davi is Senior Vice President, Statistics and Regulatory Science Innovation at Medidata, and has a background in pharmaceutical clinical trials with more than 20 years working at the FDA, most recently as a Deputy Division Director in the Office of Biostatistics in CDER. At Medidata Ruthie is part of a team using data science to create analytical tools to improve the efficiency and rigor of clinical trials. Ruthie’s recent work is focused on creation and analysis of synthetic or external controls, and she has numerous publications on this topic. Ruthie holds a Ph.D. in Biostatistics from George Washington University.
Janet Espirito, PharmD
Senior Medical Director
Ontada
Janet Espirito is a Senior Medical Director at Ontada, an oncology technology and insights company that provides real-world data and research to help accelerate innovation in cancer care. She has over 20 years of experience in oncology, providing leadership across the areas of real-world evidence, clinical trials, treatment pathways, value-based care and quality initiatives, and electronic health record technology. She has held several roles within The US Oncology Network and McKesson, where she has built and led clinical, physician, and research teams. Her prior academic experiences include working at The University of Texas, M.D. Cancer Center where she held various clinical, research, and teaching responsibilities. She has authored many real-world data publications in peer-reviewed journals. She received her Doctorate of Pharmacy from the University of Washington and completed her oncology residency at The University of Texas, M.D. Anderson Cancer Center.
Brad Karalius, MPH, BS
Associate Director of RWE
AstraZeneca
Over the past 20+ years, Brad Karalius has conducted research spanning epidemiology, pharmacology, immunology, and microbiology across academia, biotech, consulting, and the pharmaceutical industry.
Most recently, he has supported GI, GU, GYN, and pan-tumor oncology programs at AstraZeneca (AZ) as an RWE-focused epidemiologist. In this role, he leverages diverse real-world data (RWD) sources—including claims, EHRs, registries, and multimodal datasets—to generate actionable evidence that informs registrational trial design, accelerates pre-commercial clinical development, and supports responses to regulatory post-marketing commitments (PMCs).
Previously, Karalius spent over a decade at the Harvard T.H. Chan School of Public Health, conducting epidemiologic research across three HIV/AIDS observational study protocols. He contributed to the development and execution of study protocols and co-authored 20+ peer-reviewed manuscripts, drawing on rigorous epidemiologic design, statistical analysis, and programming—both through direct contribution and through managerial oversight.
He regularly mentors junior colleagues and partners closely with clinicians and study teams to translate research questions into robust, decision-ready analyses. His applied methodological experience includes longitudinal modeling, machine learning, and causal inference approaches such as inverse probability weighting, target trial emulation, and the creation of external control arms using observational/RWD data, as well as group-based trajectory modeling, ROC analysis, and related techniques.
Cassadie Moravek
Senior Director, Strategic Collaborations and Patient Advocacy
Pancreatic Cancer Action Network (PanCAN)
Cassadie Moravek is the Senior Director of Strategic Collaborations and Patient Advocacy at the Pancreatic Cancer Action Network (PanCAN). In her current role with PanCAN, Cassadie leads key strategic collaborations for the organization with other patient advocacy organizations, professional societies, institutions, and industry and serves as a patient advocate on several national boards and committees. Her patient advocacy work began when she joined PanCAN’s Patient Services team 15 years ago, where she communicated with pancreatic cancer patients and their families, providing pancreatic cancer education and resources. In recent roles with PanCAN, she led program management for the organization’s phase 2/3 platform clinical trial for metastatic pancreatic cancer and key patient research initiatives, including the organization’s clinical trial database and clinical trial matching service, biomarker testing initiative, and patient registry.
Cassadie has served as a patient advocate for the National Cancer Institute and American Society of Clinical Oncology (ASCO). She has also participated in working groups focused on overcoming barriers to clinical trial participation, including the American Cancer Society Cancer Action Network’s clinical trial matching summit and the ASCO and Friends of Cancer Research Broadening Clinical Trial Eligibility Criteria project. She currently serves as the patient advocate on the National Comprehensive Cancer Network (NCCN) Guidelines Panels for Pancreatic and Ampullary Adenocarcinoma, NCCN Pancreatic Cancer Patient Guidelines, and Society of Nuclear Medicine and Molecular Imaging’s Patient Advisory Board.
Cassadie is passionate about improving patient care, access to clinical trials, and increasing the number of effective therapies available for patients with pancreatic cancer.
Jennifer R. Rider, ScD, MPH
Vice President, Real World Evidence Services
ConcertAI
Jennifer R. Rider, ScD, MPH is a cancer epidemiologist with more than 20 years of experience in using observational research methods to investigate questions related to the full spectrum of cancer – from etiologic factors and natural history through treatment-related safety and effectiveness. In her current role as Vice President, RWES, Client Services at ConcertAI, Dr. Rider leads the team responsible for the design and implementation of custom data solutions and research services for life science customers. In her prior role, Dr. Rider was head of the Oncology Center of Excellence and Senior Director, Science at Aetion, where she served as the scientific strategy lead for the company’s largest pre-competitive collaboration focused on oncology trial emulation, conducted real world evidence regulatory feasibility assessments, and oversaw multiple regulatory-facing descriptive and comparative studies. Dr. Rider previously oversaw product management and provided subject matter expertise for ConcertAI’s genitourinary cancer-related RWD products, bespoke cohorts, and ECAs. Prior to first joining ConcertAI in 2020, she was an Assistant Professor in the Department of Epidemiology at the Boston University School of Public Health and the Harvard T.H. Chan School of Public Health/Harvard Medical School, where she maintained an independent research program focused on prostate cancer that resulted in more than 90 peer-reviewed publications. Dr. Rider received her Masters in Public Health from the University of Massachusetts-Amherst, and completed a ScD in epidemiology and a postdoctoral fellowship at the Harvard T.H. Chan School of Public Health.
C.K. Wang
Chief Medical Officer and GM Oncology
(COTA) Verana Health
C.K. Wang is a hematologist/ oncologist by training. He is the General Manager of Oncology and Chief Medical Officer at Verana Health where he oversees the oncology business line and serves as the clinical lead for the company.
C.K. joined Verana Health through a merger with COTA where he served as the Chief Medical Officer for over six years prior to the merger. Prior to COTA, C.K. served in numerous leadership roles within IBM Watson Health’s Oncology and Genomics. Previous to IBM Watson Health, C.K. spent 12+ years in clinical practice where he focused on establishing oncology practices and cancer programs.
C.K. holds a B.A. in Biology from Washington University in St. Louis and received his medical degree from the University of Texas Medical School in San Antonio. He completed his internal medicine residency at the University Hospitals of Cleveland/ Case Western Reserve University and his hematology and oncology fellowship at the University of Texas Southwestern Medical Center.
SESSION 2 – TRANSLATING EVIDENCE TO PRACTICE: INTEGRATING ECAS INTO ONCOLOGY DRUG DEVELOPMENT
Ashita S. Batavia, MD MS
Global Head of Study Innovation
J&J Innovative Medicine
Ashita S. Batavia, MD MS is the Global Head of Study Innovation at J&J Innovative Medicine and serves on the steering committee of CancerX. Dr. Batavia is the Principal Investigator for FDA U01 grant to develop novel statistical approaches to address measurement bias in real-world data. Previously, she worked at McKinsey & Co. advising Fortune 50 executives on harnessing advanced analytics to drive strategic business outcomes. Alongside their industry expertise, Dr. Batavia is a Clinical Assistant Professor at Weill Cornell Medicine and has practiced medicine for over fifteen years. She has a Masters in Epidemiology and was previously an NIH-funded clinical investigator. She has received numerous research awards and has authored multiple peer-reviewed publications. Dr. Batavia is passionate about using data. AI and technology to improve the health of patients
Pete Ansell, PhD
Director and Research Fellow, Precision Medicine Oncology
AbbVie
Pete Ansell, Ph.D., is a seasoned scientific leader with over two decades of expertise in oncology research, precision medicine, and companion diagnostic development. Currently serving as Scientific Director and Research Fellow at AbbVie, he spearheads precision medicine strategies across the solid tumor portfolio, contributing to successful FDA approvals and key industry collaborations. His career spans progressive scientific roles at AbbVie, where he has led biomarker strategies for diverse therapeutic modalities, including small molecule inhibitors, therapeutic antibodies, and antibody-drug conjugates, across multiple solid and hematological malignancies.
Dr. Ansell has a proven track record in establishing real-world data collaborations to advance biomarker discovery, optimize clinical trial success, and inform health economics and commercialization strategies. He is recognized for integrating AI/ML-driven datasets, designing strategic research initiatives with global key opinion leaders, and navigating complex regulatory frameworks.
Holding a Ph.D. in Biochemistry from the University of Missouri and a postdoctoral fellowship from Harvard Medical School/Massachusetts General Hospital, Dr. Ansell’s scientific foundation encompasses cancer genetics, signal transduction, and advanced biomarker platforms. His contributions are evidenced by numerous patents, over 49 peer-reviewed publications, and leadership in developing strategic IT infrastructure to enhance research efficiency.
Jaclyn L. F. Bosco, PhD, MPH, FISPE
Vice President and General Manager
Global Head, Epidemiology and Scientific Strategy
Real World Evidence
IQVIA
Jaclyn Bosco, PhD, MPH, FISPE, is a doctoraltrained epidemiologist with more than 20 years of experience in realworld evidence (RWE) research. She is responsible for driving RWE generation for regulators, clinicians, patients, and payers. She is a global leader of epidemiologists (over 100 worldwide), RWE medical writers, and scientific feasibility experts. Her team designs, implements, and interprets studies using realworld approaches and realworld data—including primary data from clinicians or directtopatient sources, persongenerated health data, and secondary data—to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the postapproval phase. She has considerable expertise in applying realworld methods and approaches to the innovative delivery of studies that generate realworld evidence. Dr. Bosco serves on the RWE Alliance Board of Directors, the Biologics & Biosimilars Collective Intelligence Consortium Steering Committee, and the DIA RWE Conference Planning Committee. She collaborates on RWE workstreams with DukeMargolis and is an active member of DIA and a fellow of ISPE, where she teaches courses on RWE for regulatory decisionmaking and pharmacoepidemiologic methods for biologics and biosimilars, respectively. She holds an adjunct faculty appointment at Boston University in the Department of Epidemiology.
Dr. Marie Bradley
Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER)
FDA
Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee, and a portfolio of RWE demonstration projects. She also evaluates complex real-world evidence related study protocols submitted to FDA. Recently, she has been helping to drive Agency level RWE initiatives in the Office of the Commissioner and is co-chair of FDA-RWE-ACCELERATE. Dr Bradley is an established advocate, speaker, and panelist across national and international platforms on RWE related topics and participates extensively in external engagement. She is a pharmacoepidemiologist and a pharmacist with over 16 years of experience working in regulatory, government, and academic sectors in US and the UK, including 11 years at the FDA. Dr. Bradley has a PhD in Pharmacoepidemiology and a Masters in Pharmacy degree from Queen’s University Belfast as well as an MSc.PH degree from London School of Hygiene and Tropical Medicine.
Neal J. Meropol, MD
Senior Advisor
Flatiron Health
Incoming principal investigator, ASCO TAPUR study
Neal J. Meropol, MD is a medical oncologist, clinical investigator, outcomes researcher and health tech executive with a career spanning academia and industry. He currently provides advisory services to academic programs, non-profits, health tech and life sciences companies.
Most recently, Dr. Meropol served as vice president of Research Oncology at Flatiron Health. In this role, he oversaw the clinical teams supporting retrospective and prospective real-world evidence generation, providing strategic leadership in building and leveraging Flatiron’s technology and services platforms to close the gap between research and care. Dr. Meropol continues his participation in the Friends of Cancer Research external control arms project as a senior advisor to Flatiron.
Dr. Meropol’s research contributions span drug development and health services research, including evaluation of new agents, diagnostics, predictors of response and outcome, development of tools to overcome barriers to clinical trial participation, and assessment of the economic impact of care. Dr. Meropol was recently appointed as the new principal investigator of the American Society of Clinical Oncology (ASCO) Targeted Agent & Profiling Utilization Registry (TAPUR) Study. Previous roles include chair of NCI Clinical Trials and Translational Research Advisory Committee (CTAC), and co-chair of the NCI Streamlining Clinical Trials Working Group. Dr. Meropol completed a four-year term as an elected member of the ASCO Board of Directors. He also served as a member of the National Academies of Science, Engineering and Medicine National Cancer Policy Forum. He has authored more than 300 publications related to cancer prevention, treatment, decision making, and health economics.
Jane Perlmutter
Patient Advocate
Jane Perlmutter is a long-term survivor of multiple cancers and an active advocate. Her advocacy is largely rooted in her own experiences and those of others with similar diagnoses. However, it is also informed by her formal training in cognitive psychology and experimental methods (Ph.D.), computer and information science (MS) and business (MBA), as well as her career experiences which included many years in academia, not-for-profit R&D, corporate senior management, and independent consulting.
During her early advocacy Jane was a peer counselor and grant reviewer. She has been involved in many research projects from early translational research to use of real-world data. Currently much of her advocacy focuses on clinical trials, ensuring that the patient voice is considered in the selection of research questions and that trial protocols are sensitive to patient issues. She is especially interested in innovative trial designs that can speed new treatments to patients who need them.
Jane has also been involved in health advocacy beyond cancer and works with many government and not-for profit groups. Because she especially passionate about developing the next generation of advocates and fostering collaboration between advocates and researchers, she has developed and delivered training for many advocacy groups and been a long-term faculty member of the ASCO/AACR Methods in Clinical Research Workshop as well as SITC’s SCION workshop. In 2023 Jane was honored with AACR’s 2023 Distinguished Public Service Award for Exceptional Leadership in Cancer Advocacy, ASCO’s 2023 Patient Advocate Award and the 2025 Susan G. Komen Research Advocacy Award.
SESSION 3 – POLICY PERSPECTIVES AND REGULATORY PRIORITIES FOR ECAS
Clay Alspach, JD
Principal, Leavitt Partners
Executive Director and Co-Founder, Alliance for mRNA Medicines
Executive Director, ACRO
Clay Alspach is a principal at the health policy firm Leavitt Partners. He co-founded and serves as Executive Director of the Alliance for mRNA Medicines (AMM), a global organization advancing RNA-based therapeutics, including personalized cancer treatments, rare disease therapies, vaccines, and gene editing technologies.
Clay also serves as Executive Director of the Association of Clinical Research Organizations (ACRO), representing leading clinical research and technology companies that support the development of innovative drugs, biologics, and medical devices worldwide.
Previously, Clay served as Chief Health Counsel to Chairman Fred Upton of the U.S. House Energy and Commerce Committee, where he led major bipartisan health care legislation, including the Food and Drug Administration Safety and Innovation Act (FDASIA), MACRA, Drug Quality and Security Act (DQSA), Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), and 21st Century Cures Act.
He holds a B.A., cum laude, from the University of Richmond and a J.D. from the University of Texas at Austin.
Amy Comstock Rick
Associate Director for Rare Disease Strategy, Center for Drug Evaluation and Research (CDER)
FDA
Amy Comstock Rick, J.D., is CDER’s Associate Director for Rare Disease Strategy and the Director of Strategic Coalitions for FDA’s Rare Disease Innovation Hub (the Hub). She serves in a cross-cutting role across FDA’s Center for Drug Evaluations and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to facilitate implementation of the Hub. She also works closely with both centers to develop and carry out a rare disease strategic agenda. Ms. Rick, with support from staff in CBER’s and CDER’s rare disease programs, is the Hub’s primary point of engagement for parties external to FDA.
Most recently, Ms. Rick served as Principal Consultant at Leavitt Partners, focusing on health policy matters, with a primary focus on rare disease and medical product development. Before Leavitt Partners, she served as President and Chief Executive Officer of the Food and Drug Law Institute (FDLI), a non-profit organization dedicated to providing an innovative, open, balanced exchange of ideas and viewpoints across the field of food and drug law.
Before joining FDLI, Ms. Rick was Chief Executive Officer of the Parkinson’s Action Network. Ms. Rick also served as President of the Coalition for the Advancement of Medical Research and on the Boards of Directors for Research America, the National Health Council, and the American Brain Coalition.
Ms. Rick had previous federal service as a career attorney at the U.S. Department of Education in 1988, focusing primarily on the field of government ethics. She was the Senate-confirmed Director of the U.S. Office of Government Ethics from 2000 to 2003 and Associate Counsel to the President in the White House Counsel’s Office from 1998 to 2000. She received a bachelor of arts degree from Bard College and a juris doctor degree from the University of Michigan.
Joe Franklin
Chief Legal and Policy Officer
Biotechnology Innovation Organization (BIO)
Joe Franklin, JD, PhD, is the Chief Legal and Policy Officer at the Biotechnology Innovation Organization (BIO). In this role, he leads BIO’s legal function and oversees key policy priorities including access and reimbursement, intellectual property, national security, and international affairs.
Joe joined BIO in 2026 from Covington & Burling LLP, where he played an active role in the firm’s life sciences and artificial intelligence practices, advising clients in the biopharma and tech industries on complex FDA regulatory matters, clinical research, and the deployment of artificial intelligence. Previously, Joe was Chief Counsel for Regulatory and Strategic Affairs at Verily, Alphabet’s precision health company.
Over nearly a decade as an attorney and policy lead at FDA, Joe held several senior leadership positions and advised on a range of issues. Joe spent multiple periods in FDA’s Office of the Chief Counsel, where he advised agency staff and leadership on biologics and biosimilars, emergency use authorizations, user fees, drug compounding, and controlled substances, among other areas. Joe advised FDA on the reauthorization of the Prescription Drug User Fee Act (PDUFA VI) and Biosimilar User Fee Act (BsUFA II) and development of the commitment letters for these programs. During the COVID-19 pandemic, Joe worked within the HHS General Counsel’s Immediate Office to advise HHS leadership on vaccine regulation and support the White House’s pandemic response efforts. As policy director to the FDA Principal Deputy Commissioner, Joe helped lead FDA’s technology and data modernization strategy and oversee a broad portfolio of regulatory and scientific programs. In FDA’s Center for Drug Evaluation and Research, he built and led the biosimilars policy staff in the Office of New Drugs. Joe also served as FDA’s Deputy Chief of Staff in 2015.
Mark Lee, MD, PhD
CEO and Co-Founder
N-Power Medicine
Mark is the CEO and Co-founder of N-Power Medicine. He was most recently Senior Vice President and Global Head for Personalized Healthcare, Product Development at Genentech/Roche, where he spearheaded the transformation of drug development and care delivery through data-at-scale and technology.
Prior to joining Genentech, Mark was a member of the founding leadership team and Head of Clinical Development and Medical Affairs at GRAIL, where his team built one of the largest clinical research programs in genomic medicine aimed at early cancer detection.
Some of his previous roles include Lead for Oncology Clinical Sciences at Google[x] Life Sciences, Chief Medical Officer at Boreal Genomics, and Vice President of Oncology Development at Genomic Health, where he led the successful development and validation of the Oncotype DX Colon and Prostate Cancer Assays.
Mark received a PhD in Biological Chemistry and Molecular Pharmacology from Harvard and an MD from Stanford University, where he completed his residency and medical oncology fellowship training.
Donna Rivera, PharmD., MSc., FISPE
Executive Vice President of Clinical Evidence Modernization
Canal Row Advisors
Donna Rivera, PharmD., MSc., FISPE is the Executive Vice President of Clinical Evidence Modernization at Canal Row Advisors with expertise in scientifically rigorous strategies for use of real-world data (RWD), real-world evidence (RWE), innovative trial design, and artificial intelligence (AI) from experience across government, industry, and academia.
At the FDA, Dr. Rivera was Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence (OCE) and Founding Director of the Oncology Real-World Evidence Program, leading collaborative review across CDER, CBER, and CDRH to advance the appropriate use of RWE in oncology product development to facilitate patient-centered regulatory decision-making. She directed initiatives to modernize evidence generation through regulatory review of all oncology submissions containing RWE, regulatory science research portfolio management, regulatory policy development, and leadership of international partnerships and educational programs. Dr. Rivera contributed to the development of multiple FDA guidances related to RWD and RWE, clinical studies, pragmatic clinical trials, and artificial intelligence (AI). She also formed the FDA Oncology AI Program, leading the Oncology AI Council to guide the use of AI applications in regulatory review, research, and policy.
As a pharmacist and pharmacoepidemiologist, she has deep expertise in clinical RWD and leveraging pragmatic clinical trials to strengthen patient-centric evidence generation. In her prior role at the National Cancer Institute, Dr. Rivera led a strategic RWD initiative to facilitate SEER registry data linkages through collaborative public-private partnerships, as well as other data science strategy efforts. She has previous experience in clinical trial design from Stiefel, a GlaxoSmithKline company. Dr. Rivera is a Fellow of the International Society for Pharmacoepidemiology and serves as an Affiliate Associate Professor at the University of Maryland School of Pharmacy.