Adeyemi Afuwape

Associate Director, Regulatory Affairs CMC

PharmaLex UK

Yemi possess 12+ years’ industrial experience as an immunological expert in in vitro medical devices, biologics with a strong focus on cell and gene therapies. He has CMC expertise in the product development and regulation of a variety of gene modified and cell therapy products (TcR modified, CAR immune and Treg cells plus induced pluripotent (IPSC), hematopoietic (HSC) and mesenchymal (MSC) stem cells). He has prepared and authored module 3 sections for IND/IMPD, briefing packages for Scientific Advice with the EMA and EU national competent authorities (PEI, MHRA), INTERACT, pre-IND and Type C meetings with the US FDA and RS consultation with the PMDA in Japan. He also has 8+ years’ postdoctoral experience in pre-clinical in vivo disease models of rheumatoid arthritis, inflammatory conditions and asthma. Yemi holds both an MPhil from the University of Sheffield and a PhD from University College London.

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