Aisha Khan, PhD, MBA, Executive Director of Clinical Research and Laboratory Operations and Director of the Clinical Research Cell Manufacturing Program, Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine. Dr. Khan has more than 30 years of experience in regenerative medicine, cell and gene therapy manufacturing, clinical research, quality systems, and regulatory affairs. Her work focuses on the translation of advanced biologic therapies, including mesenchymal stromal cells, Schwann cells, extracellular vesicles, induced pluripotent stem cell-derived products, and tissue-engineered therapeutics, from laboratory development to clinical application.

Dr. Khan has led the development and GMP manufacturing of numerous cell- and EV-based products for Phase I–III clinical trials and has extensive expertise in FDA regulatory strategy, IND preparation, CMC development, quality assurance, and clinical trial operations. She has authored and co-authored multiple peer-reviewed publications, book chapters, and regulatory reviews, including recent work on the impact of U.S. regulatory framework 21 CFR Part 1271 on the advancement of cell-based therapies.

She serves as a scientific collaborator and advisor on academic, industry, and government-funded programs focused on regenerative medicine, tissue engineering, biofabrication, and translational therapeutics. Her current research interests include extracellular vesicle therapeutics, regenerative biomaterials, cell manufacturing technologies, and regulatory pathways that accelerate the safe and effective clinical translation of innovative therapies.