I found this presentation by none other than Matthew Klinker a few months before CRL last year on potency asays for a research network. It‘s interesting in that it emphasises the FDA is prepared to be flexible with potency assays and the exact MoA does not need to be mapped out. See slides 12 and 13 for their prefered approach to developing an assay.
https://www.casss.org/docs/default-source/bioassays/2023-speaker-presentations/klinker-matthew-fda-2023.pdf?sfvrsn=bc110e90_6
Also, slide 2 is the structure of the Office of Therapeutic Products: there are 3 CMC offices that sit alongside the Office of Clinical Evaluation. Klinker is head of branch 2 within the CMC Office of Cellular Therapy and Human Tissue (from the FDA website). This gives credence to the way the potency assay is seen more as a CMC rather than clinical efficacy issue.
banter and General Discussion, page-8573
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