Zahra Shahrokh

ZDev Consulting a

With 30 years of experience in biotechnology product development, Zahra has a track record in global regulatory approvals of several biologics, having authored 9 BLAs and several dozens of INDs. As Chief Development Officer at STC Biologics, Zahra established CMC development capability and provides Development, Quality, and Regulatory strategy to advance client’s biotherapeutics programs. As a CMC Consultant, she provides technical and strategic CMC guidance throughout the development life cycle. She was SVP of Development at Aurabiosciences, responsible for regulatory, nonclinical and CMC development of protein nanoparticle delivery systems. She led Pharmaceutical and Analytical Development at Shire for 10 years and was Head of CMC & PD Operations. She had technical and leadership roles at Genentech's Pharmaceutical R&D department for 10 years, where she drove pharmaceutical development of several classes of biologics and small molecules.

Zahra has a PhD in Biophysics from UC Berkeley, BA in Chemistry and in Physics from University of Pennsylvania, and post-doctoral fellowship at UCSF. She has received an NIH grant as Assistant Biophysicist at UCSF, and holds several pharmaceutical patents and over 60 papers & invited presentations. She is on the organizing committee of WCBP and CMC Strategy Forum, addressing issues at the interface of analytical and regulatory sciences. She is a lecturer at the University of Kansas biannual Graduate Biotechnology Course.

Zahra has a PhD in Biophysics from UC, Berkeley, dual BA in Chemistry and Physics from University of Pennsylvania, Philadelphia, and holds several patents and over 60 papers & invited presentations. She is an active Organizing Committee member for WCBP.


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