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Kevin Bosse PhD, RAC-US, CABP(H),
Director of Regulatory Affairs
Nationwide Children’s Hospital
USA
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Kevin Bosse, PhD, RAC-US, CABP(H) is director of Regulatory Affairs at Nationwide Children’s Hospital. As a RAC-certified regulatory professional, he advises the development and regulatory strategy of novel biologics, drugs, and devices developed at Nationwide Children’s, as well as with external groups and researchers at The Ohio State University. Dr. Bosse is a member of the North American Legal and Regulatory Affairs Committee and is the Early State Professionals Committee Co-Chair and is for the International Society of Cell and Gene Therapy (ISCT). He oversees a team who’s portfolio consists of numerous successful investigator-initiated first-in-human clinical programs, having received fast-track, breakthrough, orphan, rare pediatric disease, and humanitarian use device designations for multiple programs. Dr. Bosse has lead the successful filing accepted Drug Master Files to FDA for AAV gene therapy and plasmid production, and has hosted numerous successful early FDA meetings, such as INTERACT, PreIND, Pre-Submission and Type C.