Sterling Chung

Sterling Chung has over 18 years of experience in Regulatory Affairs, having worked for Abbott Laboratories from 2003-2008, Takeda from 2008-2010, Astellas Pharma from 2010-2012, Gilead Sciences from 2012-2014, Seattle Genetics from 2014-2018, Immatics Biotechnologies from 2018-2019, Molecular Templates from 2019-2020, and Neoleukin Therapeutics from 2020-2022. At Abbott Laboratories, Sterling was a Senior Regulatory Affairs Associate, where they supported post-approval changes and common technical document (CTD) conversion for hypertension drug in Europe over 18-month period. At Takeda, Sterling was a Senior Associate, Regulatory Affairs, where they led a 3-member regulatory team through phase 2-3 of erythropoiesis-stimulating agent (ESA) compound in hematology and prepared IND submission in oncology over 6-month period. At Astellas Pharma, Sterling was a Manager, where they attained approval of oncology NDA submission in August 2012 by developing CMC (Module 3) sections, reviewing clinical oncology NDA sections, assisting in label and patient insert creation, and responding to FDA inquiries. At Gilead Sciences, Sterling was a Manager, where they established processes, mapped content, and managed Japanese communication which led to approval of company’s 1st Japanese NDA (JNDA) for Chronic Hepatitis C (CHC) in Mar. 2015. At Seattle Genetics, Sterling was an Associate Director and Senior Manager, where they directed life cycle of company’s only mature oncology biotech product, submitted 2 supplemental biologics license applications (sBLAs) for frontline advanced Hodgkin’s lymphoma (HL) and Cutaneous T-Cell lymphoma (CTCL), facilitated 3 in-person meetings with FDA for indications of HL, CTCL, and Diffuse large B-cell lymphoma (DLBCL), attained approval for 6 orphan drug designation (ODD) applications, and managed submissions in US, Canada, and EU. At Immatics Biotechnologies, Sterling was a Director, where they formalized strategies for 4 cell and gene therapy products and companion diagnostic devices by outlining regulatory requirement timelines and increasing efficiencies. At Molecular Templates, Sterling was an Executive Director, Head of Regulatory Affairs, where they formed regulatory group and implemented company-wide document management system for version control, historical data, and collaboration, and coordinated responses on registrational trial design and current clinical and CMC development plans with 15 health agencies including FDA, Health Canada, and EMA. At Neoleukin Therapeutics, Sterling was a Vice President and Senior Director, Head of Regulatory Affairs, where they established Regulatory Affairs and Medical Writing groups, processes, and documentation system, and led the company’s first submissions for Australia (Oct. 2020), USA (Dec. 2020) and Canada (May 2021). Sterling is currently working as the Vice President of Regulatory Affairs at Aurion Biotech.

Sterling Chung completed their Bachelor of Arts and Science degree at the University of Michigan in 2003, majoring in Biology and Political Science. In 2006, they completed a Regulatory and Quality Assurance Certificate at Purdue University.