Chief Consultant & Advisor

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Michael Mendicino

Chief Consultant & Advisor

Michael established Hybrid Concepts International (HCI) as a consultancy and advisory firm in the fields of cell therapy, ex vivo modified cell therapies (gene or non-gene modified), in vivo gene therapy, regenerative medicine, tissue engineering, and cell-based drug discovery.

Michael previously worked at four biotech companies, all within the aforementioned fields, covering areas such as CMC and strategic regulatory affairs, R&D, commercial, manufacturing process development, product & technology due diligence activities, and regulatory and competitive intelligence.

During his FDA appointment, Michael worked in the Office of the Commissioner (OC) with the regulatory science & innovation team, where he was involved with IP protection and emerging technology policy.  He also worked in FDA's Center of Biologics Evaluation & Research (CBER), Office of Cellular, Tissue & Gene Therapies (OCTGT), now Office of Tissues and Advanced Therapies (OTAT), where he performed submission and pre-submission review for innovative biologic products, devices and combination products.  Michael also worked in the Office of Combination Products in OC, and in the Center for Veterinary Medicine's Animal Biotechnology Interdisciplinary Group.

Recent notable efforts include world’s first IND trend projects (partially published in Cell Stem Cell and Nature Biotechnology), and lead author on recent book chapter on regulatory and IP considerations for stem cells and regenerative medicine in the book Stem Cells in Regenerative Medicine: Science, Regulation and Business Strategies.  Michael also recently received a semi-finalist ranking for the Kauffman Fellowship (venture/investment).

Michael is a representative for the Alliance for Regenerative Medicine (ARM) and the International Society for Cellular Therapy (ISCT).

At ARM, Michael significantly contributes to both the Regulatory Committee and Science & Technology (S&T) Committee (co-Chair of the S&T Committee), as well as the Cell Therapy and the Gene- and Gene-modified Cell Therapy Sections.

Also, Michael is an ARM representative on the ARM-ISCT joint steering committee.

At ISCT, both the North American Legal and Regulatory Affairs (NA LRA) Committee, and the Commercialization Committee and Process and Product Development (PPD) Subcommittees.

Michael is also currently a Board Member and Co-Founder for the Standards Coordinating Body (SCB) for Gene, Cell & Other Regenerative Therapies, and Cell-based Drug Discovery non-profit corporation.  Previously, during his SCB leadership appointment, Michael had been a key leader developing and implementing SCB strategy, organizational structure, work plan, stakeholder outreach, and FDA interactions.  For example, Michael was a key player in the establishment of the SCB 501c3 non-profit corporation, its launch, its Sector organization, and its establishment as a Public-Private Partnership via Memorandum of Understanding (MOU) with the National Institute of Standards & Technology (NIST).  Since then, SCB has had successes such as partnering with the Nexight Group on an FDA contract for developing standards in regenerative medicine and advanced therapies.

 

Connect: linkedin.com/michaelmendicinophd