Nicole Hsu joined Elicio Therapeutics as Head of Regulatory Affairs in August 2020. She leads the regulatory strategy for Elicio’s growing portfolio of products and brings a wealth of experience across therapeutic modalities, including adoptive cell therapy and biologics.
Most recently, at Aadi Bioscience, Nicole led the rolling NDA filing for ABI-009 for perivascular epithelioid-cell tumors (PEComa) – a program with Fast Track, Orphan, and Breakthrough designations. Before this, she served as the global and US regulatory lead at Atara Biotherapeutics on a T cell product, Tab-cel, with Breakthrough, PRIME, ATMP, and Orphan designations. Earlier, Nicole worked at Amgen as the US regulatory lead and FDA contact for two marketed products and two early-stage INDs. She holds a Masters in Regulatory Science from the University of Southern California, and a pharmacy degree from the University of Toronto.
Nicole’s spare time is largely spent entertaining her three young children and hearing their professional critiques of the gourmet meals she serves them. She also tinkers on the ukulele and dabbles in paints, charcoal, and pastels.