Mohammad El Kalay, Ph.D.

Entrepreneurial Technical Operations senior executive with over 30 years of professional leadership and expertise that spans start-up to late-stage Cell & Gene Therapy companies. Extensive experience building Technical Operations teams that have successfully completed CMC requirements supporting Phase I through Phase III to early product commercialization. Experience interacting with and filing numerous regulatory packages with FDA as well international regulatory agencies. Extensive experience selecting and managing CDMO, including overseeing Tech Transfer of manufacturing process and analytical assays to USA and internationally based CDMOs. Contributed in development of two approved products: AIS’ stem cell purification device, CELLector and, Osiris’ GvHD mesenchymal stem cell product, Prochymal. Mohammad holds a BSc. in Chemical Engineering, and MSc and PhD in Biomedical Engineering from Strathclyde University, Glasgow, Scotland, UK.