Michael O. Skidmore, MS Ology Bioservices, Inc

Michael Skidmore, MS, is a biologics and ATMP quality and technical services consultant with over 30 years' experience and has held leadership positions as VP QA/QC at Resilience, SotioBiotech, and Blue Water Bio releasing clinical trial materials including CAR-T and gene therapies in US and EU. As a consultant at Inovio Pharmaceuticals he created the Product Quality Control Plan for VGX3100 a combination gene therapy/  DNA based therapeutic and at Adaptimmune he led tech transfer and start-up of their US Manufacturing site for TECELRA^® . While at Merck as an Assoc Director, he led the MSAT CoE for Single Use Systems, Filters, and devices for MMD and was the Process Design Lead for converting the Dengvaxia and YF-VAX fill finish at Sanofi from stainless steel technologies to SUS. He is a former FDA Microbiologist/ Investigator and currently is on the PDA ATMP Advisory Board. He received his BA and MS from UC San Diego, School of Medicine in Biochemistry and Molecular Pathology.

Abstract:

The ATMP Advisory Board which is one of four advisory boards to the PDA Board of Directors, is actively engaged in developing and publishing guidance documents for the gene and cell therapy industry. Three publications focused on ATMPs are either in press or in final external review covering 1) control strategies for critical  starting materials such as vectors and plasmids, 2) for raw materials, as well as 3) Production and Engineering Control Strategy Considerations on Facilities and using Isolators. The AB is jointly publishing a standard with ANSI on Apheresis Collection for Cell and Gene Therapy Products in addition to the ANSI/PDA Standard on Cryopreservation of ATMPs published in 2022. A strategic goal of the AB is to promote undergraduate and adult education in preparing or ‘re-skilling’ to enter the ATMP industry by actively reaching out to young professionals as well as those seeking a career transition. In addition to speaking, writing and review opportunities for members, the ATMP AB is relaunching it’s online Interest Group on Linked-In as a forum with monthly online meetings providing an opportunity to learn about themes discussed at conferences either by Health Authorities or PDA Speakers as well as offering a community to ask questions from a broad range of participants in the industry.