For new modality therapeutics (cell and gene therapy), what would be your recommendations on ECs submission for early-phase (Phase 1/2) programs with low level of prior knowledge?
"I think in general, one could always overthink ECs. Nonetheless, in earlier phases with little prior knowledge, effort is needed to set up ECs. It is the key question for the company whether at this stage ECs will provide a good ROI. I do not think this is a critical question in earlier phases and would focus on fit for purpose method to support proof of concept."
Learn more from Dr. Lars Geurink by viewing his presentation "Analytical Procedure Control Strategy (ACPS)" during the Expert Forum: Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development
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