Ziheng (Harry) Wang serves as Senior Director in DP Early Phase
Development Department at WuXi STA. He has more than 10-year experience in the fields of oral drug product development with the focus on oral peptide formulation development and lipid-based drug delivery system. He successfully led the development and commercialization of different drug products including one peptide with enhanced oral bioavailability. Before joining WuXi STA Pharmaceutical Co., Ltd., he served as director for oral formulation development at Qilu Pharmaceutical in China and formulation scientist at Thermo Fisher Scientific, Perrigo, and Catalent in the US and Canada. During the employment, he successfully developed several oral drug products that have been received
FDA approval and added value to the product pipeline and business portfolio.
 
Ziheng (Harry) Wang graduated from the University of Toronto with a Ph.D. Degree in chemical engineering in 2015.

Presentation Title: An Integrated CMC Approach to Expedite Early Phase Drug Product Development

Abstract: Pharmaceutical innovation continues to be prolific, with more and more new drug candidates entering clinical trials. Speed to the clinic and conducting efficacy studies are critical and can influence the success of new molecules during early-phase drug product development. CMC activities often pose bottlenecks to IND filing if they aren’t part of a larger strategy. Implementing an integrated CMC strategy can mitigate these challenges, streamline development timelines, and enhance success rates at the early stage.

In this presentation, we will explore WuXi STA's comprehensive "end-to-end" integrated CMC platform, showcasing a range of specialized drug substance techniques, as well as diverse formulation approaches for oral and parenteral delivery systems across both small molecules and new modalities. Additionally, we will present case studies demonstrating how our integrated CMC platform has accelerated the progression of molecules from preclinical development through clinical stages and into commercial production.

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