Timothy I. Mitchell

Tim Mitchell is Vice President, Quality Assurance at Aktis Oncology. Tim brings over 40 years of process development, manufacturing, and quality compliance experience associated with both clinical drug and commercial manufacturing operations. Prior to joining Aktis, Tim served as Senior Vice President of Global Quality for ProKidney Corporation leading all facets of Quality and Compliance for ProKidney’s Phase III global clinical program for Chronic Kidney Disease (CKD) through cellular therapy technology with the aim of preserving kidney functionality in those patients suffering from Type 2 Diabetes in order to avoid dialysis. Prior to his time at ProKidney, Tim held the position of Vice President, CMC and Clinical Quality at Castle Creek Biosciences, Inc, working on their gene therapeutic Phase III global program for autologous fibroblast technology development, targeting the pediatric genetic disorder causing life threatening epidermolysis bullosa (EB) and localized scleroderma. He also has previous experience in the Radiopharmaceutical theater in the field of oncology targeting late-stage prostate cancer. Tim brings a broad range of expertise regarding biologic product CMC development and licensing from pre-clinical IND development through final product BLA filing and operational transition into commercialization. He also has in-depth experience with quality and technical oversight of fifteen (15) new GMP aseptic manufacturing facilities design and start-up. Tim also brings direct face-to-face interaction success with FDA (CDER, CBER, ORA), European Union (EMEA, MHRA), Japan (PMDA), Health Canada, Australian (TGA), and Chinese (CFDA) regulatory authorities regarding IND, BLA, and NDA submissions, pre-approval inspections (PAI’s), post-approval (commercialization) GMP inspections, follow-up written communications addressing compliance questions to existing operations, along with new facility design and validation presentations to agency representatives prior to construction. Over the span of his career, he has gained a comprehensive degree of experience in Site Management Quality Assurance, Quality Control, Regulatory Affairs, GMP/GLP/GCP Global Compliance, Manufacturing Operations (both clinical and commercial), Pharmaceutical Engineering, and Validation.

Tim holds a Master’s Degree from Purdue University in Biochemistry and Human Genetics. He was awarded his MS degree from his direct work in the development and commercialization of world’s first biosynthetic human insulin (Humulin®) through recombinant DNA technology by Eli Lilly & Co. and Genentech, Inc. during his earlier technical work with Eli Lilly & Company prior to graduation. In his free time, he enjoys traveling to historical locations, spending time with his family, and electrical and mechanical home projects.