Bench to Market Webinar Series: Non-clinical safety assessment of ADCs

Gong Likun, Professor and Principal Investigator (PI) at the Shanghai Institute of Materia Medica（SIMM）, Chinese Academy of Sciences (CAS)；Deputy of Center for Drug Safety Evaluation and Research，Director of Center for Toxicology Research at SIMM. She also serve as a Professor, PI, Director of Center for Drug Safety Evaluation and Research at Zhongshan Institute for Drug Discovery, CAS. As well as  the CDE external review expert in new drug evaluation.

With nearly three decades of experience in drug toxicology, Professor Gong has pioneered an integrated technical platform combining molecular and conventional toxicology approaches. Her research has been continuously supported by key national initiatives during the 11th to 13th Five-Year Plans, establishing a comprehensive new technology system for drug evaluation. Working under international GLP standards, CDSER SIMM has conducted non-clinical evaluations for nearly 200 new drugs that achieved IND approval domestically and internationally, with over 20 approved for market use.

A key aspect of her research explores the interplay between immunity, drug toxicity, and disease progression, leading to the discovery of novel drug targets and immunomodulatory molecules. Additionally, her team has created advanced approaches to address preclinical challenges in evaluating antibody-based therapeutics such as ADCs, including high-throughput screening for on/off-target effects and improved immunogenicity prediction models. These have been utilized in developing site-specific ADC drugs, several of which have been transferred to industry partners.

Prof. Gong has authored over 100 papers in journals including STTT, APSB, and JMC, co-authored 5 monographs, obtained 30+ patents, and achieved 2 technology transfers. She has led 30+ national and regional projects, and contributed to the review of over 10 NMPA non-clinical guidelines and 6 organoid/organ-on-a-chip group standards. Prof. Gong holds multiple leadership roles in academic organizations, serving as Vice President, Council Member, Director, Deputy Director, Secretary, and Committee Member in societies including the Chinese Society of Toxicology, Chinese Pharmacological Society, Chinese Pharmaceutical Association, and Shanghai Society of Toxicology etc. Her honors include the National Science and Technology Progress Award (Second Prize), two First Prizes of the Chinese Pharmaceutical Association Science and Technology Award, the March 8th Red-Banner Pacesetter, and the Pearl Engineer Award.

Title: Non-clinical safety assessment of ADCs