Yasameen Qazen
SVP, Regulatory Affairs and Quality Assurance
Yasameen Qazen has over 20 years of global regulatory affairs and quality leadership experience across all stages of biopharmaceutical development. She most recently served as SVP of Regulatory Affairs and Quality at IconOVir Bio and was previously VP of Regulatory Affairs, Quality, and Medical Writing at FortySeven Inc., where she played a key role in its acquisition by Gilead.
She has contributed to the successful development of therapies across multiple modalities and therapeutic areas, including oncolytic viruses, small molecules, and biologics. Yasameen has led numerous IND submissions and major marketing application filings, including the NDA approval of Calquence® (acalabrutinib) for mantle cell lymphoma at Acerta Pharma. Her global regulatory expertise spans interactions with health authorities in the US, EU, and Asia through roles at Genentech, Gilead, Astex, and Acerta.
Yasameen earned her BS in Biochemistry from Rutgers University and PharmD from the University of the Pacific. She completed a post-doctoral fellowship in global drug development with Roche and serves as an Adjunct Professor of Pharmaceutics at the Thomas J. Long School of Pharmacy.