Michael Mendicino

Michael founded Hybrid Concepts International (HCI) as a consultancy and advisory firm and is President/Owner, and Chief Consultant & Advisor. HCI is a niche firm in exponentially growing fields of cell therapy, gene and gene-modified cell therapies, other regenerative medicines, tissue engineering, and cell-based drug discovery that has successfully served over 125 clients since establishment. Michael manages over nearly 20 experts under the HCI umbrella. Michael previously worked at numerous biotech companies, and/or consulted, all within the aforementioned fields, covering areas such as CMC, strategic regulatory affairs, regulatory meetings & submissions, R & D, commercial, and product & technology due diligence activities. His experience ranges from early preclinical to post-regulatory approval, working with private and public companies, contract manufacturers, and investors, in the aforementioned areas, as well as multi-disciplinary early-stage start-up/stealth support (e.g., EVP, Dept. Head, C-level advisory roles). During his prior FDA appointment, Michael worked primarily in what is now the Office of Tissues & Advanced Therapies (OTAT), where he performed regulatory submission review, and special projects, and provided guidance to sponsors for OTAT-regulated products, and devices, including combination products. Michael is a representative on multiple Alliance for Regenerative Medicine (ARM) Committees (current Co-Chair of CMC Regulatory Task Force), and International Society for Cellular Therapy (ISCT) committees. Also, Michael is a Co-founder and on the Board of Directors for the Standards Coordinating Body (SCB). Michael has published FDA-related articles in Nature Biotechnology and Cell Stem Cell, and recently led authoring of landmark regulatory review publications and book chapters.