The 2026 FDA Cellular, Tissue, and Gene Therapies Advisory Committee Meeting is a pivotal event organized by the U.S. Food and Drug Administration (FDA). This committee is dedicated to reviewing and evaluating data concerning the safety, effectiveness, and appropriate use of human cells, tissues, gene transfer therapies, and xenotransplantation products intended for transplantation, implantation, infusion, and transfer in the prevention and treatment of a broad spectrum of human diseases, as well as in the reconstruction, repair, or replacement of tissues for various conditions.
The meeting will cover key topics such as the latest advancements in cellular therapies, tissue transplantation, gene transfer therapies, and xenotransplantation. Discussions will focus on evaluating new research findings, assessing clinical trial data, and considering regulatory pathways for emerging therapies. The agenda will also include deliberations on the ethical implications and safety concerns associated with these innovative treatments.
Attendees will have opportunities to engage in networking sessions, participate in panel discussions, and attend presentations by leading experts in the field. The event will feature an expo hall showcasing the latest technologies and products related to cellular, tissue, and gene therapies. Notable speakers will include prominent researchers, clinicians, and regulatory officials who will share their insights and experiences.
This meeting is essential for healthcare professionals, researchers, industry representatives, and policymakers involved in the development, regulation, and application of cellular, tissue, and gene therapies. Participation will provide valuable insights into current trends, regulatory considerations, and future directions in these rapidly evolving fields.
Speakers(18)
Alexis C. Komor, Ph.D.
Assistant Professor at University of California, San Diego
Dr. Komor is an Assistant Professor at UC San Diego, specializing in gene editing.
Amy Shapiro, M.D.
Medical Director and CEO at Indiana Hemophilia & Thrombosis Center
Dr. Shapiro is the Medical Director at the Indiana Hemophilia & Thrombosis Center, specializing in sickle cell disease.
Christopher K. Breuer, M.D.
Director of Tissue Engineering Program and Surgical Research at Nationwide Children’s Hospital
Dr. Breuer leads the Tissue Engineering Program and Surgical Research at Nationwide Children’s Hospital, focusing on pediatric surgery.
Donald B. Kohn, M.D.
Distinguished Professor at University of California, Los Angeles
Dr. Kohn is a Distinguished Professor at UCLA, specializing in gene therapies for blood diseases.
Eric Crombez, M.D.
Chief Medical Officer at Ultragenyx Gene Therapy
Dr. Crombez serves as the Chief Medical Officer at Ultragenyx Gene Therapy, representing industry perspectives.
Gil I. Wolfe, M.D.
Professor and Chairman of Neurology at University at Buffalo/SUNY
Dr. Wolfe is the Professor and Chairman of Neurology at the University at Buffalo, specializing in neurology.
Jasmine Hightower, M.S.W.
Patient Representative
Ms. Hightower serves as a patient representative, providing insights on sickle cell disease.
John F. Tisdale, M.D.
Branch Chief
Dr. Tisdale serves as Branch Chief, focusing on stem cell research.
Joseph Wu, M.D., Ph.D.
Director, Stanford Cardiovascular Institute at Stanford University
Dr. Wu directs the Stanford Cardiovascular Institute, with expertise in cardiology and radiology.
Kathleen O’Sullivan-Fortin, Esq.
Founder at ALD Connect, Inc.
Ms. O’Sullivan-Fortin is the founder of ALD Connect, Inc., serving as the consumer representative.
Lisa Lee, Ph.D.
Associate Vice President for Research and Innovation at Virginia Polytechnic Institute and State University
Dr. Lee is the Associate Vice President at Virginia Tech, focusing on bioethics and epidemiology.
Marshall E. Bloom, M.D.
Chief, Biology of Vector-Borne Viruses Section at National Institutes of Health
Dr. Bloom is the Chief of the Biology of Vector-Borne Viruses Section at the NIH, with expertise in virology and gene therapies.
Melanie Ott, M.D., Ph.D.
Director at Gladstone Institute of Virology and Immunology, University of California, San Francisco
Dr. Ott directs the Gladstone Institute of Virology and Immunology, with expertise in virology and immunology.
Nirali N. Shah, M.D., M.H.Sc.
Head, Hematologic Malignancies Section at National Cancer Institute
Dr. Shah leads the Hematologic Malignancies Section at the National Cancer Institute, focusing on hematology and oncology.
Robert A. Dracker, M.D.
Medical Director at Summerwood Pediatrics and Infusacare Medical Services
Dr. Dracker is the Medical Director at Summerwood Pediatrics, specializing in sickle cell disease.
Sean J. Morrison, Ph.D.
Director at Children’s Medical Center Research Institute, University of Texas Southwestern Medical Center
Dr. Morrison directs the Children’s Medical Center Research Institute, specializing in stem cell biology.
Tabassum (Taby) Ahsan, Ph.D.
Vice-President, Cell Therapy Operations at City of Hope
Dr. Ahsan is the Vice-President of Cell Therapy Operations at City of Hope, specializing in biomedical engineering.
Wendy B. London, Ph.D.
Associate Professor of Pediatrics at Boston Children’s Hospital/Dana-Farber Cancer Institute
Dr. London is an Associate Professor at Boston Children’s Hospital, focusing on biostatistics and clinical trial design in oncology.
Event Details
- Date
- October 31, 2023
- Location
- 🇺🇸 N/A, United States
- N/A
- Audience
- Healthcare professionals, researchers, industry representatives, policymakers