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 Ohio Department of Ed Cte 36 2011-2025

Ohio Cte 36 2011-2025 Form

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hi and thank you for the opportunity to speak today i'm kim schultz a gene therapy reviewer in the offices of tissues and advanced therapies i'm going to be giving you some insight into the regulatory considerations for car t cells but before i get into those details i wanted to introduce you to our office the office of tissues and therapies ota is an office in the center for biologics and is composed of five divisions today you'll be hearing from representatives from the division of cellular and gene therapies and then you'll get pre-clinical and clinical advice from two of our colleagues in the division of clinical evaluation and pharmacology toxicology our office has purview over a wide range of products from gene therapies to stem cells based therapies and blood and plasma derived project products i'll be focusing on gene therapies as that's the products that i review which in and of themselves is a diverse field including vectored an

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