2025 Annual Meeting – Speaker Biographies
Learn more about panelists and keynote speakers from Friends of Cancer Research 18th Annual Meeting. Click here to view the agenda and access the white paper.
SESSION 1 – SEAMLESS TRIAL DESIGNS FOR RARE CANCER DRUG DEVELOPMENT
Allen S. Melemed, M.D., M.B.A — Moderator
Chief Medical Officer
Chimerix, a Jazz Pharmaceuticals Company
Allen Melemed is the Chief Medical Officer for Chimerix, which was recently acquired by Jazz Pharmaceuticals. Dr. Melemed is a pediatric oncologist that has been involved in oncology drug development for over 25 years; he also has an MBA from the University of Chicago. He started his career at Eli Lilly and Company, where he held multiple leadership positions in oncology, including in development, program leadership, pediatric drug development, and regulatory affairs. While at Lilly, he led over 20 global approvals for ALIMTA, GEMZAR, VERZENIO, CYRAMZA, LARTRUVO, ERBITUX, PORTRAZZA, and RETEVMO. Dr. Melemed has been at Chimerix as the CMO since 2020 and led the TEMBEXA approval for small pox in 2021. Chimerix was originally an infectious disease company, and Dr. Melemed was instrumental in transitioning Chimerix to an oncology company. Chimerix’s lead asset is MODEYSO (dordavaprone), which is being developed to treat rare brain tumors that with an H3 K27M-muation that is predominately seen in children and young adults, and was recently approved by FDA in August 2025.
Harindra R. Abeysinghe, Ph.D.
VP and Head for Oncology, Global Regulatory Affairs
Johnson & Johnson
Harindra Abeysinghe is Vice President and Head of Oncology in Global Regulatory Affairs at Johnson & Johnson. He is responsible for leading regulatory strategy for the oncology portfolio from early development through registration and post-approval. The oncology therapeutic area focuses on best-in-class therapies for Hematology, Prostate, Lung, Colorectal, Bladder and Head and Neck cancers, applying novel and cutting-edge mechanisms of actions for small and large molecules.
Prior to his role in Oncology, Harindra was Vice President and Head of Regulatory Affairs for Vaccines and prior to that, he spent five years in Singapore as Vice President, Asia-Pacific Regulatory Affairs Head, where he successfully built and led a team across the region.
Harindra has over 25 years of pharmaceutical experience in R&D at J&J, which includes Drug Discovery, Development, and Global Regulatory Affairs. Harindra has worked across several Therapeutic Areas, including Oncology, Diagnostics, Neuroscience, Psychiatry, Analgesia, Vaccines, Infectious Disease, Immunology, and Established Products.
Harindra holds a Bachelor of Science degree with honors in Biochemistry and a Bachelor of Arts degree in Classical Music. Harindra also holds a Master of Science and Ph.D. in Molecular Oncology from the University of Rochester, New York. He has authored over 20 journal manuscripts and abstracts, a book chapter in a cell biology textbook and is the co-inventor on a patent for a novel tumor suppressor gene.
Harindra was also a competitive athlete in rowing and swimming and represented his country.
Lola A. Fashoyin-Aje, M.D., M.P.H.
Senior Vice President
Parexel
Lola A. Fashoyin-Aje, M.D., M.P.H., is Senior Vice President, Head of Regulatory Oncology, Cell & Gene where she leads a team of regulatory strategy consultants specialized in these key areas of innovation and growth. Dr. Fashoyin-Aje is a board-certified internist and medical oncologist with over a decade of experience at the U.S. Food and Drug Administration (FDA). She most recently served as the Director of the Office of Clinical Evaluation in the Office of Therapeutic Products at the FDA Center for Biologics Evaluation and Research, providing clinical and scientific oversight for the clinical assessment of cellular, gene, and tissue products across all indications. Prior to that she was Deputy Director in the Division of Oncology 3 in the Office of Oncologic Diseases at the Center for Drug Evaluation and Research, and an Associate Director at the FDA Oncology Center of Excellence, serving as executive lead for several scientific and policy initiatives to accelerate drug development, generate evidence in representative populations, and optimize multiregional clinical development programs. Dr. Fashoyin-Aje completed her undergraduate and graduate training at Columbia University and Yale University, respectively, and received her M.D. degree from the University of Rochester School of Medicine and Dentistry. She completed her training in internal medicine and medical oncology at Johns Hopkins.
Martha Donoghue, MD
Associate Director for Pediatric Oncology and Rare Cancers
FDA Oncology Center of Excellence
Dr. Martha Donoghue is a pediatric oncologist and the Associate Director for Pediatric Oncology and Rare Cancers in the FDA Oncology Center of Excellence. She also serves as the Acting Associate Director for Pediatric Oncology in the FDA Office of Oncologic Diseases. In these roles, she oversees implementation of regulations designed to promote timely investigation of drugs and biological products for pediatric patients with cancer, supports work relating to pediatric oncology and rare cancer drug development across FDA, and works with stakeholders to address challenges and foster development of drugs to treat pediatric and other rare cancers. Areas of special interest include the use of clinical outcomes assessments and innovative designs in clinical trials to optimize drug development. Prior to joining FDA in 2009, Dr. Donoghue completed a fellowship in Pediatric Hematology and Oncology at the Children’s National Medical Center after working for several years as a general pediatrician in private practice. She received her medical degree from Emory University and completed a residency in general pediatrics at the Georgetown University Medical Center.
Misha Mehta, PhD
Friends Advisory Advocate
Misha Mehta is a scientist, nonprofit leader, and relentless research advocate dedicated to transforming the future of pediatric brain cancer. She is the Founder and President of the Neev Kolte & Brave Ronil Foundation and Senior Director of Research at the Pediatric Brain Tumor Foundation. As a convener and industry liaison, Misha drives collaboration to break down data silos, accelerate discoveries, and champion legislation that advances research and speeds families’ access to promising treatments.
Above all, Misha is Neev’s mom. Her son’s courage and legacy guide her mission to accelerate research, expand clinical trial access, and bring hope to families today while building the foundation for tomorrow’s cures.
Christopher Turner, MD, FAAP
Chief Medical Officer
Nuvalent, Inc.
Christopher Turner, M.D. is the CMO for Nuvalent and is an experienced oncology drug developer and executive with 25 years of clinical and pharmaceutical experience in early and late-stage oncology drug development. Nuvalent is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer and is advancing a robust pipeline with parallel lead programs in ROS1-positive and ALK-positive non-small cell lung cancer, a program in HER2 Exon 20 insertion-positive cancers, and multiple discovery-stage research programs.
Prior to joining Nuvalent, Dr. Turner was Vice President of Clinical Development at Blueprint Medicines where he led the clinical development of GAVRETOä (pralsetinib) in RET altered lung and thyroid cancers.
Dr. Turner has also held oncology clinical development leadership positions at Celldex Therapeutics and ARIAD Pharmaceuticals and was involved with the clinical development of the oncology drugs ICLUSIGÒ(ponatinib) and ALUNBRIGÒ (brigatinib). Prior to that, Dr. Turner was Director of the Pediatric Neuro-Oncology Outcomes Clinic at the Dana-Farber Cancer Institute/Children’s Hospital Boston and an Instructor of Pediatrics at Harvard Medical School.
Dr. Turner is board certified in both Pediatrics and Pediatric Hematology and Oncology and is a Fellow of the American Academy of Pediatrics. He received his M.D. from the University of Rochester School of Medicine and Dentistry in Rochester, New York. He completed fellowships in both Pediatric Hematology/Oncology and Pediatric Neuro-Oncology at Duke University Medical Center in Durham, North Carolina.
Ying Yuan, PhD
Chair and Professor
Department of Biostatistics, University of Texas MD Anderson Cancer Center
Ying Yuan is the Bettyann Asche Murray Distinguished Professor and Chair of the Department of Biostatistics at the University of Texas MD Anderson Cancer Center. Dr. Yuan is internationally renowned for his pioneering research in innovative Bayesian adaptive designs, including early-phase trials, seamless trials, biomarker-guided trials, and basket and platform trials. The designs and software developed by Dr. Yuan’s lab (www.trialdesign.org) have been widely adopted by medical research institutes and pharmaceutical companies. Among these, the BOIN design, developed by Dr. Yuan’s team, is a groundbreaking oncology dose-finding method recognized by the FDA as a fit-for-purpose drug development tool. The BOP2 design is also widely used for Phase II trials and toxicity monitoring. Dr. Yuan is a member of the FDA Advisory Committee for Genetic Metabolic Diseases, an elected Fellow of the American Statistical Association, and the lead author of two books: Bayesian Designs for Phase I-II Clinical Trials and Model-Assisted Bayesian Designs for Dose Finding and Optimization, both published by Chapman & Hall/CRC.
SESSION 2 – TRIAL DESIGNS FOR COMBINATION DRUG DEVELOPMENT
Gideon Blumenthal, MD — Moderator
Vice President, Global Clinical Development in Oncology
Merck & Co.
Dr Gideon Blumenthal is a Medical Oncologist who is Vice President, Global Clinical Development in Oncology at Merck & Co. In this role, he oversees the Asset Leads for multiple ADCs and small molecules. The asset teams are charged with overseeing end-to-end clinical development and multi-functional strategy across cancers and across the product lifecycle, from dose-finding and proof of concept to Phase 3 registrational clinical trials and beyond. Prior to this role, Gideon served as VP Oncology Regulatory Affairs Therapeutic Area Head at Merck, overseeing Genitourinary, Gastrointestinal, Head and Neck, and Hematologic Malignancies, leading regulatory strategy for Pembrolizumab as well as Belzutifan, Olaparib, and Lenvatinib.
Prior to joining Merck, Dr Blumenthal spent over a decade at the US FDA. He initially served as Medical Officer, then Clinical Team Leader, followed by Deputy Director Office of Hematology Oncology Products, and most recently as Deputy Center Director of the Oncology Center for Excellence. While at FDA, he oversaw the development programs leading to groundbreaking approvals of novel targeted and immunotherapy treatments for patients with cancer. Dr Blumenthal trained in internal medicine at the University of Maryland School of Medicine, followed by a hematology/ oncology fellowship at the National Cancer Institute. He also served as attending physician in the NCI Thoracic Oncology clinic. He received numerous awards, including the 2018 American Society for Clinical Oncology Public Service Award. He has co-authored over 100 articles in the Oncology and Therapeutic Development peer-reviewed literature and authored numerous book chapters.
Julie M. Bullock, PharmD.
Executive Dir, Early Development Lead, GSK
Dr. Bullock has over two decades of drug development experience and is a recognized leader in clinical pharmacology, clinical development, and regulatory strategy within oncology and hematology. She joined GSK in 2024 as an Early Development Lead, where she supports the multidisciplinary strategy and program leadership for two oncology assets in the pre-IND/IND stages. Prior to GSK, Dr. Bullock served as Senior Vice President and Head of Clinical Pharmacology and Translational Medicine at Certara. She also spent 10 years at the U.S. Food and Drug Administration as a Clinical Pharmacology Reviewer and Team Leader in Oncology.
Gary Doherty MB BChir MA PhD FRCP
Global Clinical Head, AstraZeneca
Gary Doherty is a Medical Oncologist and Global Clinical Head in R&D, Late Development Oncology at AstraZeneca, based in Cambridge, UK. Since joining AstraZeneca in 2022, he has led immunotherapy programs spanning multiple cancer types and disease stages.
Before AstraZeneca, Gary was a Consultant Medical Oncologist at Cambridge University Hospitals, where he led the thoracic and brain tumor clinical research programs and held regional, national, and international leadership roles. He completed his medical degree and PhD at the University of Cambridge, completing his doctoral research at the MRC Laboratory of Molecular Biology. He was a Henry Fellow at Harvard University and is a Fellow of the Royal College of Physicians. Gary is also a Fellow in Medicine and Dean at Robinson College, University of Cambridge.
Elad Sharon, MD, MPH
Clinical & Translational Director, Immunotherapy Toxicity Program
Dana-Farber Cancer Institute
Associate Professor of Medicine
Harvard Medical School
Co-Chair, Alliance Immuno-Oncology Committee
Alliance for Clinical Trials in Oncology
Dr. Elad Sharon, MD, MPH, is a medical oncologist at DanaFarber Cancer Institute, where he serves as the Clinical and Translational Director of the Immunotherapy Toxicity Program. He is also an Associate Professor of Medicine at Harvard Medical School. Dr. Sharon’s work focuses on the development of novel immunotherapies and the management of immune-related adverse events (irAEs), with a particular emphasis on translational research and clinical trial innovation.
From 2011 to 2023, Dr. Sharon was a senior investigator at the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP), where he played a key role in the development of immune checkpoint inhibitors and antibody–drug conjugates. He led national efforts to better understand and manage irAEs, including co-founding the Alliance–NIH irAE Biorepository and serving as co-Principal Investigator of the AIM-NIVO trial, which investigates nivolumab in patients with preexisting autoimmune diseases.
Dr. Sharon is recognized for his expertise in clinical trial design and implementation, particularly in the context of immunotherapy. He continues to lead investigator-initiated and cooperative group trials that bridge laboratory insights with patient care. He received his MD from Baylor College of Medicine, completed internal medicine training at Emory University, earned an MPH from the Harvard T.H. Chan School of Public Health, and completed a Hematology/Oncology fellowship at the NIH.
Carol Vallett, EdD
Friends of Cancer Research Advisory Advocate
Carol has been a cancer advocate since 2008, following a breast cancer diagnosis. She has been a CDMRP reviewer, is a Komen Advocate in Science, and a reviewer for the Cancer Prevention and Research Institute of Texas. She was recently appointed to the Protocol Review and Monitoring Committee at the University of Vermont Cancer Center. Carol also served as an advocate participant on the Friends 2024 Annual Meeting Working Group. She retired after a career in higher education as an administrator, teacher, and researcher.
SESSION 3 – CONTROL ARM SELECTION FOR MULTI-REGIONAL CLINICAL TRIALS
Harpreet Singh, MD — Moderator
Chief Medical Officer
Precision for Medicine
Dr. Harpreet Singh serves as Chief Medical Officer of Precision for Medicine, a global leader in biomarker-driven clinical research and development. Dr. Singh was previously an Oncology Division Director at the U.S. Food and Drug Administration (FDA) and is responsible for medical strategy and oversight at Precision.
She is an experienced leader with a demonstrated track record in building high performing cross functioning teams, developing, and maintaining excellent working relationships with colleagues in academia, industry, and international regulatory bodies. Dr. Singh is scientifically driven, patient centered, with high academic integrity and a commitment to regulatory standards.
Motivated by a desire to accelerate breakthrough treatments in oncology and rare disease, Dr. Singh has a multi-dimensional understanding of drug development along with deep experience as a medical oncologist, having trained at the National Cancer Institute and the University of Southern California Keck School of Medicine. Dr. Singh maintains an active public presence as a thought leader for important issues facing the life sciences industry.
Judd Englert, MD, PhD
VP Global Development, Oncology
Amgen
Judd Englert is the Vice President for Late Development Oncology at Amgen, leading the advancement of novel therapies for genitourinary cancers, hematologic malignancies and supportive care. He is a physician-scientist and medical oncologist by training with over a decade of experience in drug development in both academia and industry spanning all phases of development and numerous therapeutic modalities.
Since joining Amgen in 2023, he has led the advancement of numerous global studies for key oncology programs across the portfolio, including: Blincyto, xaluritamig, Kyprolis and Nplate. Prior to Amgen, he held leadership roles at Cyteir Therapeutics, UPMC Enterprises, and MedImmune/AstraZeneca.
Judd holds a Ph.D. in Cellular and Molecular Pathology and an M.D. from the University of Pittsburgh. He completed his internal medicine training at Brigham & Women’s Hospital and his Medical Oncology and post-doctoral fellowship at Johns Hopkins.
Sumithra J. Mandrekar, Ph.D.
Professor of Biostatistics and Oncology, Mayo Clinic Group Statistician, Alliance for Clinical Trials in Oncology
Dr. Sumithra Mandrekar is a highly respected leader and expert in clinical trial design and conduct. Dr. Mandrekar is Professor of Biostatistics and Oncology at the Mayo Clinic and holds an adjunct faculty appointment as Professor of Biostatistics at the University of Minnesota and the University of Florida, Gainesville. She is the Group Statistician and Program Director for the Statistics and Data Management Center for the Alliance for Clinical Trials in Oncology, a national clinical trials network for the conduct of phase II and III clinical trials in adult cancer. She is widely recognized for significant contributions to the statistical methodology for the design, conduct and analysis of clinical trials, particularly in oncology; for leadership in clinical trials and data management coordination; for leadership on national and international steering committees and advisory panels related to cancer, including the National Cancer Institute Clinical and Translational Advisory Committee (CTAC). She co-chaired the Streamlining Clinical Trials Workgroup as part of CTAC and is currently co-chair of the NCI Streamlining Clinical Trials Implementation Committee. She is a fellow and past president of the Society for Clinical Trials, and on the expert statistical review panel for the New England Journal of Medicine Evidence. Dr. Mandrekar has published over 190 peer reviewed publications that include innovative designs for phase I, II, and III clinical trials as well as advances in alternative endpoints, and improvements in clinical trial conduct and methodology.
Kristin R. McJunkins, M.Ed.
Friends Advisory Advocate
In 2008, at age 38, Kristin was diagnosed with Stage IIIa cutaneous melanoma. Surgical intervention, including lymph node removal, resulted in clear margins, but limited treatment options were available at the time. As clinical trials were reserved for later-stage patients, Kristin received the standard interferon protocol, which offeed less than a 10% chance of preventing recurrence. The landscape of melanoma treatment has advanced significantly in the last 15 years, with numerous therapies now approved by the FDA, thanks to ongoing research and clinical trials. Motivated by her patient perspective, Kristin has contributed as a consumer reviewer on research panels for both the Melanoma Research Foundation (MRF) and the Congressionally Directed Medical Research Program (CDMRP), serving as a full voting member. These opportunities have enabled Kristin to advocate for patient-focused research, ensuring proposals address diagnosis, treatment, and quality of life for those living with melanoma. A cancer diagnosis brings unique challenges, particularly when treatment options are limited. Through advocacy, Kristin aims to give hope and voice to the cancer research community as a national priority.
Ray U. Osarogiagbon, MBBS, FACP
Director of the Multidisciplinary Thoracic Oncology Program and the Thoracic Oncology Research (ThOR) Group
Baptist Cancer Center
Dr. Osarogiagbon is Chief Scientist at the Baptist Memorial Healthcare Corporation, Director of the Multidisciplinary Thoracic Oncology Program and the Thoracic Oncology Research (ThOR) Group at the Baptist Cancer Center, in Memphis, Tennessee. He is a Research Professor at Vanderbilt University, and a member of the Vanderbilt Ingram Cancer Center.
Kathleen Winson
Executive Group Director, Regulatory
Genentech
Kathleen Winson is an Executive Group Director at Genentech and serves as Portfolio Strategy Lead for Oncology Lung and Pan-Tumor Development within Product Development Regulatory (PDR). She brings more than 30 years of clinical research experience across various settings, including industry, hospitals, and academia, spanning oncology, cardiovascular disease, neuroscience, infectious diseases, and immunology. Her background includes leadership roles in Clinical Science, Clinical Operations, and Regulatory Affairs, providing her with a comprehensive, end-to-end view of how evidence is generated, assessed, and translated into filings that support patient access to new therapies.
In her current role, Kathleen guides global regulatory strategy across a molecule’s lifecycle—from early development plans and first-in-human studies to registrational trial design, interactions with health authorities, approvals, and post-marketing lifecycle management. She is responsible for anticipating, interpreting, and translating evolving global regulatory requirements and for embedding innovation to enable efficient, seamless development.
Kathleen is also actively involved in cross-organizational, industry, and academic collaborations that advance innovative drug development approaches and address emerging challenges as the field evolves. Her current work focuses on novel endpoint development, particularly ctDNA, and on optimizing the design and execution of multi-regional trials. Current priorities include improving the applicability of global data to regional patient populations, particularly in terms of how a rapidly changing treatment landscape and control-arm selection impact external validity and regional relevance. She also has a longstanding commitment to strengthening partnerships among academic and cooperative groups and industry sponsors to accelerate evidence generation and address potential evidence gaps that contribute to some of the development hurdles.
Lunch Discussion – Future Policy Perspectives
Anna Abram
Senior Advisor
Akin
Anna brings over two decades of experience shaping U.S. health policy, with extensive knowledge in FDA policy and legislative advocacy. Anna has shaped U.S. health policy at the highest levels of government, she has held senior leadership roles, including deputy commissioner for policy, legislation, and international affairs at the Food and Drug Administration (FDA) and associate director at The White House Domestic Policy Council. Anna brings extensive Capitol Hill experience, she served as health policy director and senior advisor to Sen. Richard Burr (R-NC) and worked at the Senate Health, Education, Labor and Pensions (HELP) Committee.
Anna is recognized for her strategic foresight and ability to build bipartisan coalitions, advancing reforms that cross political divides. Her hands-on approach and seasoned know-how position her clients to achieve tangible results in a complex policy environment. She is a trusted advisor known for her leadership in crafting policy and navigating the policymaking process to achieve results on a range of health care, life science, and public health issues.
Anna’s leadership and influence in health policy have been recognized nationally. She was named one of Washingtonian’s 500 Most Influential People Shaping Policy (2025), listed among The Hill’s Top Lobbyists, Hired Guns (2024), and honored by the National Institute for Lobbying & Ethics as a Top Lobbyist (2022-2023).
Anna holds a B.A. from the University of Pennsylvania, magna cum laude, 2003.
Remy L. Brim, Ph.D
Head of the Health and Life Sciences Practice
BGR
Remy Brim, PhD. is the head of the Health and Life Sciences Practice and a firm Principal at the BGR Group. She helps clients navigate the complex regulatory and political landscapes required to advance the discovery, development, and delivery of innovative products and care to patients and consumers. Prior to joining BGR, Remy served as Senior FDA Policy Advisor on the Senate HELP Committee and as Health Policy advisor for Sen. Elizabeth Warren. Remy came to Washington DC as a Bioethics Postdoctoral Fellow at the National Institutes of Health where she analyzed ethical issues in clinical research, applying frameworks from philosophy, ethics, and law.
Roy S. Herbst, MD, PhD
Deputy Director
Yale Cancer Center
Dr. Herbst is nationally recognized for his leadership and expertise in lung cancer treatment and research. He is best known for his work in developmental therapeutics and the personalized therapy of non-small cell lung cancer, in particular the process of linking genetic abnormalities of cancer cells to novel therapies.
Amy McKee
Senior Vice President and Global Head of Oncology Regulatory Science, Strategy & Excellence
AstraZeneca
Dr. McKee is the Senior Vice President and Global Head of Oncology Regulatory Science, Strategy & Excellence at AstraZeneca and has over 20 years’ experience in drug development, including 11 years at the U.S. Food and Drug Administration. She previously held the role Chief Medical Officer at Parexel International, managing the medical and scientific groups involved in study conduct and consulting. Her expertise in drug development includes clinical trial design for new molecular entities as monotherapy and in combination regimens, line extensions and asset prioritization. She has led and managed complex submissions to FDA and has experience in scientific advice and regulatory submissions to the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency, and rest-of-world agencies. During her time at the FDA, she held several positions, including Deputy Center Director of the Oncology Center of Excellence. Dr. McKee developed and implemented the multi-disciplinary reviews for marketing applications (NDAs & BLAs) within oncology and co-authored inter-center and intra-center Guidances to Industry on drug development. She received her M.D. from Tulane University School of Medicine and her Bachelor of Arts in Russian and East European Studies from Middlebury College. She completed her clinical fellowship training in pediatric hematology/oncology at the National Cancer Institute/Johns Hopkins University. Amy serves on the Board of Directors of Biocryst Pharmaceuticals (NASDAQ: BCRX).