From promise to proof: the evidence agenda for in vivo CAR-T 

Dr Green trained at UCB and UCSF where she developed and employed preclinical models of cancer to study tumor development and potential therapeutic approaches. She then spent over a decade developing T cell-based immunotherapies for oncology, and more recently autoimmune diseases. Her expertise in cell therapy drug development span autologous CAR- and TCR-engineered T cells, epigenetic and genetic enhancements of T cell function, allogeneic approaches, iPSC-derived products, NK cell engineering, and in vivo CAR T cell engineering. Focused on cutting-edge innovations at small to mid-size biotech companies, she guided multiple novel therapeutics through preclinical and CMC development to clinical testing.

Currently she consults companies in the Cell and Gene Therapy space while working on launching a new startup biotech that aims to cure severe allergies with in vivo CAR technology.

Ashley Koegel, MD, is an Executive Director and the Global Program Lead for in vivo Cell Therapy at Bristol Myers Squibb (BMS), overseeing comprehensive development strategies to advance transformative cell therapies, enhance accessibility and improve scalability for patients. In this role, she is responsible for end-to-end asset development strategy, integrating clinical, translational, regulatory, CMC, and commercial considerations.

Ashley brings more than a decade of experience in cell therapy development and has most recently pioneered the application of CAR T and related modalities in non-oncology indications at BMS. Prior to her current role, she served as Executive Director, Early Clinical Development, Hematology & Cell Therapy, where she led a team of physicians developing CAR T studies across nine distinct non-oncology indications. Her leadership was instrumental in shaping BMS’s Immune Reset strategy, particularly in rheumatology and neuro-inflammatory diseases, and in guiding multiple first-in-human next-generation cell therapy programs from IND through proof-of-concept.

Ashley received her MD from Stanford University School of Medicine and a BS in Biochemistry from the University of California, Los Angeles. She completed her residency in Pediatrics at Boston Children’s Hospital/Harvard Medical School and her fellowship in Hematology and Oncology at the University of California, San Francisco (UCSF). Ashley brings a deeply patient-centered perspective to drug development and is committed to advancing transformative cell therapies that can break down barriers, address more diseases, and ultimately benefit more patients.

Dr Luis Pelloso, MD, PhD, serves as Vice President and Medical Director within Medical and Scientific Services, Pharmacovigilance, at PPD, part of Thermo Fisher Scientific’s Clinical Research Group (CRG). He currently leads the global Oncology Medical Monitoring Cell and Gene Therapy team, overseeing multidisciplinary physician and medical monitoring operations across the Americas, EMEA, and APAC regions. With more than 14 years of leadership experience in haematology, oncology, and advanced therapies within the CRO and pharmaceutical industry, Dr Pelloso has directed global medical monitoring strategy for over 55 Phase I–III clinical trials spanning hematologic malignancies, solid tumours, rare diseases, and cell and gene therapies.

Recognized for his strategic leadership and therapeutic expertise, Dr Pelloso has served as an oversight therapeutic lead for Haematology, Oncology, and Cell & Gene Therapy programs, providing scientific and safety guidance across the pharmaceutical product lifecycle. His contributions include medical monitoring oversight, pharmacovigilance strategy, safety signal assessment, protocol and endpoint consultation, and cross-functional risk mitigation initiatives supporting sponsors, investigators, and global development teams. In recognition of his impact and leadership, he received the PPD CEO Leadership Award in 2016.