Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products

Author:

Stewart Mark D.,Kalos Michael,Coutinho Vicki,Better Marc,Jazayeri Jonathan,Yohrling Jennifer,Jadlowsky Julie,Fuchs Miriam,Gidwani Shalini,Goessl Carsten,Hanley Patrick J.,Healy Jane,Liu Wen,McKelvey Brittany A.,Pearce Laura,Pilon-Thomas Shari,Andrews Hillary S.,Veldman Monica,Vong Judy,Weinbach Susan P.,Allen Jeff D.

Publisher

Elsevier BV

Reference25 articles.

1. Next generations of CAR-T cells - new therapeutic opportunities in hematology?;Tomasik;Front Immunol,2022

2. H.R.2617 - 117th Congress (2021-2022): Consolidated Appropriations Act, 2023. (2022). Retrieved from https://www.congress.gov/bill/117th-congress/house-bill/2617. Accessed May 14, 2023.

3. FDA. Considerations for the development of chimeric antigen receptor (CAR) T cell products; draft guidance for industry. Retrieved from http://www.regulations.gov. Accessed May 14, 2023.

4. FDA. Human gene therapy products incorporating human genome editing; draft guidance for industry. Retrieved from http://www.regulations.gov. Accessed May 14, 2023.

5. FDA. Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial; guidance for industry. Retrieved from https://www.fda.gov/media/106369/download. (2022). Accessed May 14, 2023.

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