Bio: Dr. Wang is the current Vice President of Nonclinical Drug Safety at InnoCare Pharma Tech Co. Ltd. He has more than 25 years working experiences in nonclinical drug safety assessment. Before he joined the InnoCare Pharma, he worked for Novartis Pharma, Johnson&Johnson PRD and GSK. He led nonclinical safety assessment for two marketed products (Orelabrutinib and Dorazgliatin) and >30 compounds entered to different phases of clinical development. Dr. Wang received his B.S. degree from Beijing Medical College (current Peking University, College of Pharmacy), M.S. from Institute of Materia Medica, CAMS/PUMC, and his Ph.D. from University of Illinois of Chicago.

Dr. Wang has been a board-certified toxicologist (DABT) in US since 2001. He is the current Council member of Biological Product Toxicology and Safety Evaluation and TCM/Natural Product Safety Evaluation Sections of Chinese Society of Toxicology. He served as Council member and Treasure of American Association of Chinese in Toxicology (AACT), Special Interest Group of US Society of Toxicology. Dr. Wang was the 2006-2007 President of Sino-American Pharmaceutical Professionals Association (SAPA), 2015-2017 SAPA China President, 2019-2021 Chair of Board of Directors, and the current Board member of SAPA.

Abstract: Report writing is almost the last, but most important, step for successfully conducting a toxicology study. How to interpretate study data, summarize the findings and draw conclusion for a toxicity study is critical for compound development, which is one of the major responsibilities of Study Director. Report writing is not simply repeating what have been listed in the data tables. An experienced Study Director should be able to link all the findings/data from in-life, TK analysis, clinical pathology and histopathology exams and determine an adverse vs. non-adverse for each finding per discussion with contribution scientists/PIs. Study Director should keep close communication with the sponsor to understand the mechanism of action for the compound and the findings of the same class compound, if possible. This presentation will discuss the “ideal format” of a toxicology study report and key points for writing a study report from a sponsor point of view.