Arwa El Hagrasy, PhD Alnylam Pharmaceuticals

Arwa El Hagrasy is Associate Director, Regulatory Affairs (CMC) at Alnylam Pharmaceuticals since 2021. She is currently regulatory CMC strategy lead for lifecycle management of Alnylam’s first oligonucleotide lipid nanoparticle product, Onpattro®. Prior to Alnylam, Arwa worked at FDA as quality assessment lead for ~7.5 years and has reviewed a wide variety of drug product applications submitted to the Agency, including those implementing emerging technologies and advanced pharmaceutical manufacturing. Arwa has over 8 years of prior experience in industry and academia, with focus on the implementation of process analytical technology tools and continuous manufacturing in the pharmaceutical industry. Arwa received her B.S in Pharmacy, Cairo University, Egypt, Ph.D. in Pharmaceutical Sciences from Duquesne University in Pittsburgh, and did a post-doctoral fellowship in the Chemical Engineering Department at Purdue University, IN.