Bio: Dr. Wei Wang is currently Director, Toxicology Project Lead at Eli Lilly and Company. She is a board-certified toxicologist with expertise in the areas of endocrinology, physiology, reproductive and developmental toxicology. Dr Wang received her Ph.D. in physiology and toxicology from University of Illinois, Urbana Champaign, and started her career in toxicology as a SD in CRO focusing on reproductive and developmental toxicology testing of broad range of therapeutic candidates. Dr Wang joined Eli Lilly in 2017 and acted as toxicology project leader and in charge of non-clinical safety assessment of clinical candidates throughout the entire development cycle. Wei also serves as a committee member to approve study design and supported several programs through Ph2/3, NDA/BLA submission/approval across different geographies. Wei is actively involved in ACT and SOT and serve in RDPAC nonclinical working group.   

Abstract: Novel peptide drugs continue to gain interest as effective modalities against previously undruggable targets. As with any other technology, development and safety assessment of peptides presents with various complex challenges. Additionally, there is a lack of specific regulatory guidance for peptide development, with the industry relying mainly on associating existing small molecule [ICH M3(R2)] and biologic [ICH S6(R1)] guidance. Based on a recent EFPIA sponsored industry survey on nonclinical safety assessment, this presentation will focus on the learning from the survey in regard to guidance followed, nonclinical safety assessment strategy adapted, and the requirements and/or value of assessment on genotoxicity, metabolite, safety pharmacology and alternative approaches been explored. This session will also include cases that weight of evidence approach to advocate 3Rs principle and streamline nonclinical safety testing of peptide therapeutics.