Bio: Yun Zhang (YZ) is a full-time Drug Safety Team Lead (DSTL) at Pfizer since 2017. Dr. Zhang is an experienced drug developer, as a Project Toxicologist, with over 20+ years of comprehensive experience in non-clinical drug development across diverse modalities and therapeutic areas in the biopharmaceutical industry (CRO and large pharmaceutical companies).  He started his toxicology career with the CRO in 2002 as the SD/Toxicologist on a variety of GLP toxicology studies designed to evaluate non-clinical safety of drug candidates (small molecules, biologics, vaccines, gene therapy, and siRNA). After he switched to large pharmaceutical companies in 2004 (Merck, GSK China, and Pfizer) as part of the drug development team, he has been involved in the entire process of the drug discovery and development and gained broad working experience/knowledge of the drug discovery/development process and knowledge of regulatory processes and guidelines. He has served as the Safety Assessment (SA) Representative on multiple early and late drug development project teams with demonstrated capability of integrating information across drug development disciplines and influencing program/project directions. As the SA Rep, he is responsible for non-clinical safety program strategy, designing/planning non-clinical safety studies, toxicity risk management, preparation of toxicology regulatory submissions and addressing potential regulatory issues, and participating for review/evaluation of potential licensing candidates.  In addition, he has been actively involved in the SAPA, AACT, and RDPAC activities. 

Abstract: Non-clinical safety assessment plays an important role in the entire process of drug discovery and development to support basic research to select the best candidates entering the clinic and to provide non-clinical safety / toxicology expertise and the regulatory documentation needed for the development and registration of new drugs.  This presentation will focus on non-clinical safety assessment strategic plan to support the FIH and beyond, followed by case analysis for different modalities/indications. The non-clinical safety assessment strategy is a strategic plan to guide us on why, what, and when non-clinical studies should be conducted to support the clinical development plan and registration. The presentation will highlight key points to consider for planning the toxicology programs of varying modalities (eg, small and large molecules, dermal drugs, nucleic acid drugs, gene therapies, vaccines, ProDeg/PROTAC, and ADCs). It’s important to understand key decision-making factors to stop or continue the development of drug candidates based on the benefit/risk for the intended patient population. Case studies will demonstrate the advantages of making the courageous decision to stop compounds early for the right reasons.