Unlocking Next-Generation Therapies – Speaker Biographies
Learn more about panelists and keynote speakers from Friends of Cancer Research’s public meeting Unlocking Next-Generation Therapies. Click here to view the agenda.
SESSION 1 – MODERNIZING EARLY PHASE CLINICAL DEVELOPMENT APPROACHES
Lola Fashoyin-Aje, MD, MPH
Consultant
Clinical-Regulatory Strategy Consulting
Lola A. Fashoyin-Aje, M.D., M.P.H., is a board-certified internist and medical oncologist and clinical regulatory strategy advisor with over a decade of experience providing clinical development and regulatory strategy advice to drug manufacturers at the U.S. Food and Drug Administration (FDA) and as a consultant. She 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 & Research with a primary focus on solid tumor oncology product development, 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. Most recently, Dr. Fashoyin-Aje served as Senior Vice President, Head of Regulatory Oncology, Cell &; Gene in a global contract research organization, leading a team of regulatory strategy consultants specialized in these key areas of innovation and growth. 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.
Steven Fleischer, DVM
Acting Director, Office of Pharmacology/Toxicology
Center for Biologics Evaluation and Research (CBER)
FDA
Steven Fleischer is the Acting Director of the Office of Pharmacology/Toxicology in the Office of Therapeutic Products at the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER). He is a veterinarian with over 20 years of pre-market regulatory experience working at the FDA. He has served in a variety of capacities in the Agency including as a Pharmacology/Toxicology reviewer of cell, tissue, and gene therapy products in CBER, and recently as Director of the Division of Companion Animal Drugs (DCAD) in the FDA Center for Veterinary Medicine. He earned his Doctorate in Veterinary Medicine from the Cornell University College of Veterinary Medicine.
Vijay Kumar
Acting Director of the Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER)
FDA
Dr. Vijay Kumar is a board-certified nephrologist and regulatory leader at the FDA. He currently serves as Acting Director of the Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research (CBER). Dr. Kumar joined the FDA in 2020 as a medical officer. During his tenure, he managed direct reviews of cutting-edge cell and gene therapies, tissue-engineered products, and combination products to treat multitude of clinical conditions ranging from rare disease to advanced organ failure. He is recognized within the agency as a key scientific and regulatory thought leader on expediting development of rare disease therapeutics. He has represented FDA at several patient focused drug development (PFDD) meetings, patient listening sessions (PLS) and as an invited speaker, panelist, moderator at national and international scientific meetings on rare diseases and advanced bio-therapeutics.
M Travis Quigley
Chief Development Officer
Kelonia Therapeutics
Travis Quigley is a seasoned leader in clinical development with more than 25 years of experience advancing innovative therapeutic programs. In his current role, he oversees the clinical development and technical development teams, providing strategic direction to ensure operational excellence, cross-functional alignment, and efficient execution across the development lifecycle.
Previously, Travis has held senior leadership roles across the biotechnology and pharmaceutical sectors, including positions at K36 Therapeutics, Arcellx (anitocel), bluebird bio (idecel), Foundation Medicine, and Infinity Pharmaceuticals. His experience spans early-stage development through late-phase clinical trials, with a strong focus on oncology and cell-based therapies.
Travis brings a patient-centered approach to drug development and is recognized for building and leading high-performing teams that deliver meaningful clinical impact.
Rosanna Ricafort, MD
SVP, Head of Cell Therapy Medical
Bristol Myers Squibb
Rosanna Ricafort, MD, is Senior Vice President and Head of Cell Therapy Medical at Bristol Myers Squibb. She leads the Cell Therapy Medical organization and partners across R&D and the enterprise to advance the development and lifecycle management of innovative therapies, with a focus on delivering meaningful outcomes for patients.
Dr. Ricafort brings more than 20 years of experience in clinical research and drug development across academia and industry. Since joining BMS in 2015, she has held roles of increasing responsibility in oncology and cell therapy development, supporting programs across solid tumors and hematologic malignancies, including Sprycel, Empliciti, Yervoy, Opdivo, Reblozyl, iberdomide, mezigdomide, golcadomide, Breyanzi, Abecma, arlo-cel (GPRC5D CAR T) and zola-cel (CD19 NEX-T). Most recently, she served as Global Program Lead (GPL) Franchise Lead for Hematology and Cell Therapy, where she built and led global teams across early- and late-stage assets and helped deliver major milestones, including the successful BLAs for Breyanzi and Abecma and multiple global indication expansions.
Dr. Ricafort is a pediatric hematologist/oncologist and stem cell transplant physician by training. She established and directed the Pediatric Blood and Marrow Transplantation Program at Montefiore Medical Center in New York, where she held a faculty appointment for more than 10 years. She earned her MD from the Icahn School of Medicine at Mount Sinai and completed fellowship training in Pediatric Hematology and Oncology at Memorial Sloan Kettering Cancer Center.
Nirali N. Shah, MD, MHSc
Senior Investigator, Center for Cancer Research
National Cancer Institute
Dr. Shah is a physician scientist who serves as the Head of the Hematologic Malignancies Section of the Pediatric Oncology Branch. Her research focuses on the development of targeted immunotherapy approaches to treat high-risk blood cancers, such as leukemia and lymphoma, in children, adolescents, and young adults. She is also interested in the prevention and treatment of relapsed disease after allogeneic hematopoietic stem cell transplantation. Her clinical trials focus on exploring and improving chimeric antigen receptor (CAR) T-cell based therapies and other antibody-based therapies to target surface proteins found on leukemia cells to improve outcomes for patients with blood cancers that do not respond to chemotherapy. Her research aims to reduce the toxicities and late effects of these therapies.
Chris White
Friends Advisory Advocate
Chris White is a stage 4 ultra-rare cancer survivor, published author of Killing Cancer with TILs, speaker, podcaster, consultant, and advocate for advanced cell and gene therapies.
Diagnosed in 2018, he pursued a TIL therapy clinical trial after exhausting standard treatment options and was the final patient dosed and to receive his cell infusion from the Phase 2, Cohort 4 clinical trial on January 15, 2020.
He achieved a complete metabolic response within one year and remains with no evidence of disease to this day. His participation contributed to the first FDA accelerated approval of an autologous cell therapy for a Solid Tumor Cancer, lifileucel (AMTAGVI).
In 2023, he founded Mucosal Melanoma Survivor, LLC and travels frequently to speak on various stages and panels along with hosting the podcast TIL Talks.
Chris’s platform allows him to share his experience and those of others while also serving in advisory, advocacy, and leadership roles with multiple organizations including the National Cancer Institute, Friends of Cancer Research, and the Melanoma Action Coalition to advance awareness and access to emerging therapies.
SESSION 2 – OPERATIONALIZING RISK-BASED CMC FLEXIBILITY ACROSS THE PRODUCT LIFECYCLE
John Connolly, PhD
Chief Scientific Officer
Parker Institute for Cancer Immunotherapy
John Connolly, PhD, is the chief scientific officer (CSO) at the Parker Institute for Cancer Immunotherapy (PICI), where he designs and executes PICI’s overall research strategy in close collaboration with the institute’s leadership team, center directors and scientific steering committee.
As a human immunologist, his research interests focus on immune monitoring and immunometabolism. Dr. Connolly previously served as CSO of Tessa Therapeutics, a clinical stage cell therapy company focused on solid tumor immunotherapy, and one of PICI’s strategic partners. He is an associate professor at National University of Singapore and an adjunct associate professor of Immunology at Baylor University, where he served on the Board of Governors for the Institute of Biomedical Sciences.
He is also a senior principal investigator and director for translational immunology at the Institute of Molecular and Cellular Biology (IMCB) A*Star. Additionally, Dr. Connolly serves as director for the IMPACT Program, a multi-disciplinary national initiative focused building cell therapy manufacturing, clinical and regulatory capability for Singapore.
Dr. Connolly received his PhD in Immunology from Dartmouth Medical School and studied human dendritic cell biology under Dr. Michael Fanger. During this time he was involved in the development of immunotherapeutic preclinical models and clinical trials for glioblastoma multiforme (GBM). He moved to the Baylor Institute for Immunology Research, a fully translational research institute dedicated to rationally designed vaccines against cancer and infectious disease. Dr. Connolly served as the director of Research Initiatives for the Baylor Research Institute, leading a large integrated translational research resource and multi-institutional programs that involved a number of international sites. During his tenure at Baylor, he was the central core facility director of the NIAID Centers for Translational Research on Human Immunology and Biodefense, an NIH-funded consortium of basic, translational research and clinical trials focused on vaccine design. Dr. Connolly is the past president of the Board of Directors of The American Cancer Society in N. Texas and founding director of the Singapore Immunology Network’s Immunomonitoring Platform.
Ben Beneski
Senior Vice President, Chief Technical Officer
Allogene Therapeutics
Ben Beneski is the Senior Vice President and Chief Technical Officer of Allogene. With a career spanning more than two decades in biologics manufacturing and technical operations, Ben brings a wealth of experience and strategic vision to Allogene. He joined Allogene in 2019 as Executive Director and Plant Manager, where he played a pivotal role in the design, construction, and successful startup of Cell Forge 1, the company’s cutting-edge manufacturing facility. During his time at Allogene, Ben has advanced through a series of increasingly senior roles, including Vice President of Manufacturing and Vice President of Product Development and Manufacturing where he led the development of next-generation platforms, effectively managed internal and external manufacturing networks, and drove key initiatives to support IND submissions and ensure commercial readiness. Prior to joining Allogene, Ben held senior manufacturing roles at various biotechnology companies, including Vir Biotechnology and Amgen. He holds a Master’s in Business Administration from Northeastern University and a Bachelor’s Degree in Chemical Engineering from Stevens Institute of Technology.
Marc Better, PhD
Principal Consultant, Pharmefex
Core Team Lead, Cell One Partners
Dr. Better is a biotechnology professional with more than 30 years’ experience in cell therapy and biologics CMC. Most recently, Dr. Better has advised companies developing cell and gene therapy products as a consultant with Pharmefex and Cell One Partners. Previously he served as Senior Vice President, Product Sciences at Kite, a Gilead Company, where he led process and analytical development, process characterization and process validation activities leading to the successful US licensure of Yescarta, a first in class anti-CD19 CAR T cell therapy. Prior to joining Kite, Dr. Better was Executive Director, Process Science at Boehringer Ingelheim, Executive Director, Process Development at Amgen and in key leadership roles at both Abgenix and XOMA. Dr. Better received a Ph.D. in Biochemistry from Brandeis University and holds a B.S in Microbiology from Michigan State University.
Magdi Elsallab
Director of Process Development, Director of Cellular Therapeutics and Transplantation Laboratory
Massachusetts General Hospital, Harvard Medical School
Dr. Magdi Elsallab is a leader in cellular immunotherapy process development at Massachusetts General Hospital. His work focuses on advancing the manufacturing and translation of gene and cell therapies. He has led innovative research in CAR T-cell therapy, including rapid manufacturing approaches and technologies to streamline clinical translation. Dr. Elsallab’s research integrates engineering, biology, and regulatory science to address key challenges in the development and delivery of complex cellular therapeutics. He has published widely in high-impact journals and is actively involved in shaping regulatory and manufacturing frameworks for next-generation immunotherapies.
Arvind Natarajan
Senior Vice President, Technical Development
Iovance Biotherapeutics
Arvind Natarajan, PhD, MBA, is Senior Vice President of Technical Development at Iovance Biotherapeutics. He has 25+ years of Chemistry-Manufacturing-Controls (CMC) experience in cell and gene therapies, biologics, and vaccines. Over the course of his career, Dr. Natarajan has worked on bringing four novel products to the market: AmtagviTM, the first autologous T cell therapy for solid tumor indications (melanoma), Kymriah®, the first Chimeric Antigen Receptor T cell (CAR-T) therapy for acute lymphocytic leukemia and diffuse large B cell lymphoma, Keytruda®, the first anti-PD1 biologic approved for multiple solid tumor indications, and Zostavax®, the first approved vaccine for shingles and post-herpetic neuralgia.
Dr. Natarajan is an elected Fellow at the American Institute for Medical and Biological Engineering (AIMBE). He has earned an MBA from Wharton, a PhD in Chemical Engineering from University of Minnesota, an MS in Microbial Engineering from University of Minnesota, and a MSc in Biology and BE in Electronics and Electrical Engineering from Birla Institute of Technology and Science (BITS) Pilani in India.
Alexandra Beumer Sassi, PhD, RAC
Executive Director of Chemistry, Manufacturing, and Controls (CMC) Regulatory
AstraZeneca
Alexandra Beumer Sassi, PharmD, PhD, RAC is an accomplished leader with over 25 years of experience in the biopharmaceutical and consulting industries. She currently serves as Executive Director of Chemistry, Manufacturing, and Controls (CMC) Regulatory at AstraZeneca, where she oversees the biologics, cell, and gene therapy portfolio for oncology. In this role, Dr. Beumer Sassi provides strategic leadership, technical expertise, and regulatory guidance, managing a global team of more than 60 professionals across four countries.
Before joining AstraZeneca, Dr. Beumer Sassi was the Global Head of CMC & Quality at Voisin Consulting Life Sciences (VCLS). During her tenure, she was a trusted advisor to biotech and pharmaceutical companies, she led cross-functional initiatives to help clients achieve key investor milestones and advance portfolios from pre-clinical development to marketing authorization. Her expertise centers on the development of biologics, cell, and gene therapies, with a focus on ensuring product quality, efficacy, safety, and compliance.
Dr. Beumer Sassi held multiple positions with growing responsibilities at GlaxoSmithKline working on monoclonal antibodies, formulation development, characterization and tech transfer.
Dr. Beumer Sassi’s robust scientific foundation is supported by a PhD and post-doctoral training in Pharmaceutical Sciences, complemented by extensive industry and consulting experience. She has played a pivotal role in the development and commercialization of over 50 innovative products, successfully guiding them through clinical milestones and regulatory approvals.
She earned her PhD in Pharmaceutical Sciences from the University of Pittsburgh. She also holds a Pharmacy degree from the University of São Paulo, Brazil, and completed post-doctoral research at the Magee-Womens Research Institute in Pittsburgh. Dr. Beumer Sassi has authored numerous peer-reviewed publications and book chapters and has been a frequent speaker, organizer, and chair at national and international conferences.
Kimberly Schultz, PhD
Director of Division 2, Office of Gene Therapy
Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER)
FDA
Dr. Kimberly Schultz is the Director of Division 2 (DGT2) of the Office of Gene Therapy (OGT) in Office of Therapeutic Products (OTP) in FDA’s Center for Biologics Evaluation and Research (CBER). She oversees the product review for pre-IND, IND, and BLA submissions for gene therapy products. In addition to contributing to stakeholder outreach and regulatory guidance documents, Dr. Schultz serves on working groups related to Advanced Manufacturing initiatives within CBER and across the FDA. Dr. Schultz originally joined the FDA in 2015 as a Commissioner’s Fellow to conduct a cross-study analysis of CAR T cell manufacturing. Prior to joining the FDA, she received her PhD from the University of Wisconsin (2008) and conducted postdoctoral studies at Johns Hopkins Bloomberg School of Public Health specializing in virology and immunology.
FIRESIDE CHAT: PREDICTABILITY IN DRUG DEVELOPMENT IN AN EVOLVING POLICY ENVIRONMENT
Christopher R. Heery, M.D.
Chief Medical Officer
Arcellx, Inc.
Rare Cancer Research Foundation, Board Chair
Chordoma Foundation, Board member
Kincell Bio, Scientific Advisory Board
Chris has years of experience as a leader in the translational and clinical development of immunotherapies. As Chief Medical Officer at Arcellx, he has championed the development of new treatments, including taking anito cel (BCMA CAR T from phase 1 through BLA filing). He has previously served as Chief Medical Officer of Precision BioSciences and Bavarian Nordic. Before joining Bavarian Nordic, he was the Head of the Clinical Trials Group in the Tumor Immunology and Biology Lab at the National Cancer Institute. Following his residency at the University of Illinois Chicago, Chris was an Oncology Clinical Fellow at the National Institutes of Health. He graduated from the Brody School of Medicine at East Carolina University in 2006 with his M.D.. In addition to serving on the Board of Directors at RCRF, he also serves on the Board of Directors and Medical Advisory Board at the Chordoma Foundation.
David Kaufman, M.D., Ph.D.
Partner
Third Rock Ventures
David Kaufman joined TRV as a venture partner in 2020 and was promoted to partner in 2022. He was previously Chief Medical Officer and Head of Translational Development at the Bill and Melinda Gates Medical Research Institute. He helped establish the Gates MRI as a “nonprofit biotech,” developing novel drugs and vaccines for tuberculosis, malaria, enteric diseases, neonatal health, and other global health challenges. Previously, he led Translational Oncology at Merck Research Laboratories, where he oversaw immuno-oncology translational medicine, novel biomarker development and global translational research partnering. He joined Merck through the Merck Drug Development and Leadership Program, and worked across vaccines, infectious diseases and clinical oncology. Prior to joining Merck, he was a physician in the Division of Infectious Diseases and the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and an Instructor in Medicine at Harvard Medical School. He is a Director of Abata Therapeutics and Hookipa Pharma and a Director ex officio of the Society for the Immunotherapy of Cancer and Action Wellness.
Julie Tierney, JD
Principal
Leavitt Partners
Julie Tierney is a Principal at Leavitt Partners, where she advises clients on FDA regulatory strategy and policy development. Prior to joining Leavitt Partners, she spent almost two decades at FDA, where she served in senior leadership roles, including FDA Chief of Staff and, most recently, Deputy Director of FDA’s Center for Biologics Evaluation and Research, leading policy and legislative engagements related to cell and gene therapies, vaccines, and blood products and cross-cutting rare disease efforts, including launching the FDA Rare Disease Innovation Hub.
Julie negotiated FDA-related provisions in the 21st Century Cures Act, including the regenerative medicine advanced therapy designation program, on the Senate HELP Committee and played a key role in its implementation at FDA. She began her FDA career as Associate Chief Counsel for Drugs and previously practiced food and drug law in private firms. Julie holds a J.D. from Georgetown University Law Center and a B.A. in Biology and History from Johns Hopkins University.
SESSION 3 – STRENGTHENING THE FUTURE OF CELL-BASED GENE THERAPY DEVELOPMENT
Lizzy Lawrence
FDA Reporter
STAT
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. She won a 2025 Polk award for her coverage of turmoil at the FDA under the Trump administration. In 2024, she was part of a team that won the Polk and other awards for an investigation into UnitedHealth. Earlier in her career, she wrote about Silicon Valley workplaces for tech news site Protocol.
George Eastwood
Executive Director
Emily Whitehead Foundation
Board Member, Alliance for Regenerative Medicine
George Eastwood is the Executive Director of the Emily Whitehead Foundation, established after Emily Whitehead became the first pediatric CAR-T cell therapy patient. He leads efforts to expand access to advanced therapies, shape policy, and support patients and families, building on the foundation’s mission to fund less-toxic cancer treatments. George brings deep experience in cell and gene therapy, having helped advance CAR-T innovations at HemaCare in collaboration with companies like Kite and Novartis. He has also held leadership roles at Kytopen and co-founded Excellos, a company spun out of the San Diego Blood Bank. In addition, he serves on the Board of Directors for the Alliance for Regenerative Medicine, working to advance global access to next-generation therapies.
Grace Graham
Deputy Commissioner for Policy, Legislation, and International Affairs
FDA
Grace Graham is the Deputy Commissioner for Policy, Legislation, and International Affairs. In this role, she leads the Office of Policy, Legislation, and International Affairs (OPLIA), which serves as the FDA’s focal point for engagement with the U.S. Congress, the Administration, global counterparts and partners, and state, local, territorial, and tribal policymakers.
Immediately before coming to the FDA, Grace served as Chief Health Counsel for the Energy and Commerce Committee (E&C) in the U.S. House of Representatives, where she worked on the 2022 User Fee Reauthorization and other health care matters under the scope of the committee. Prior to that, Mrs. Graham served as Health Policy Director for the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP), working on User Fee Legislation, 21st Century Cures laws, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, and other health care legislation.
Grace has a Master of Public Policy and Health Policy, as well as a Bachelor of Science in Biomedical Engineering from the University of Virginia.
Priti Hegde
Global Head of Research
Kite, a Gilead Company
Priti Hegde has led the research organization at Kite and is responsible for the development of next generation cell and gene therapies for hematologic malignancies, solid tumors and autoimmune diseases. She has over 25 years of experience in pharmaceutical R&D with the last 15 years focused on cancer immunotherapy.
Timothy Hunt
Chief Executive Officer
Alliance for Regenerative Medicine
Tim joined ARM as CEO in 2022, bringing more than 20 years of experience in the biotechnology industry and a strong focus on building company culture and advancing strategic initiatives. He currently leads ARM and its global staff of nearly 30 employees while serving as an external advocate for its membership and the broader cell and gene therapy sector. Prior to this role, he was Chief Culture and Corporate Affairs Officer at Xilio Therapeutics and Chief Corporate Affairs Officer at Editas Medicine, and also held executive public affairs roles at Cubist Pharmaceuticals and Biogen. Tim has served on advisory groups and boards across the industry, including the Duke-Margolis Center for Health Policy, Life Science Cares, and the American Society of Gene and Cell Therapy. He holds a B.A. from Boston College and a J.D. from The Catholic University of America and lives in Boston with his wife and children.
Carl June, MD
Richard W. Vague Professor in Immunotherapy, Perelman School of Medicine at the University of Pennsylvania
Director, Parker Institute for Cancer Immunotherapy at the University of Pennsylvania
Carl June is a physician-scientist and the Richard W. Vague Professor in Immunotherapy at the Perelman School of Medicine at the University of Pennsylvania in the Department of Pathology and Laboratory Medicine. He is the director of the Center for Cellular Immunotherapies at the Perelman School of Medicine, and the Director of the Parker Institute for Cancer Immunotherapy at the University of Pennsylvania. Kymriah (CTL019), the CAR T cell developed in the June laboratory, was the first cell and gene therapy to be approved by the US Food and Drug Administration.