Pave an Expressway to Phase I –Strategies That Accelerate Your Early Phase Programs

What does it take to make an API into a drugproduct? Learn advanced solid state studies and formulation development technologies that can accelerate early phase drug development.

Register Free: Pave an Expressway to Phase I –Strategies That Accelerate Your Early Phase Programs

Event Overview:

The success of any new drug development starts in its early phase. The probability of success of a molecule increases dramatically after it passes first-in-human (FIH) and proof-of-concept (POC) studies. Building a comprehensive understanding of the molecule is crucial to successful early phase development. API salt form and formulation selections are also key factors to successful phase I studies. Effective CMC strategies can significantly enhance the speed of early phase development and ultimately the chance for success in late-stage development.

Solid state studies not only provide a fundamental understanding of a molecule but also serve as a platform that leverages the knowledge from API development and manufacturing, which can further enhance the speed of early-phase development. With more than 70% of new chemical entities being poorly soluble, having a comprehensive bioavailability enhancement toolbox and strategies is critical to success in the early phase. This webinar will present our experience in using the integrated API and drug product platform and formulation technologies to accelerate early-phase development to phase I and beyond.

Key Learning Objectives:

• Key considerations in early stage drug development
• The role of salt form and polymorph screening in early stage development
• Formulation strategies to accelerate the path to phase I with a better chance of success.

Speakers:

Xiaoyang Wang
Executive Director, Head of Solid
State Development
WuXi STA

Dr. Xiaoyang Wang joined WuXi STA in 2018 and established Solid State Development (SSD) team. As part of STA integrated CMC platform, the team focuses on solid form screening, solid state characterization, powder characterization, and material science. It provides solutions to drug substance and drug product development in preclinical, clinical, and commercial stages. He has more than 10 years of experience in form selection, solid state characterization, crystallization, drug development, and organic chemistry. Before joining WuXi STA, Dr. Wang was a solid state expert in Novartis. He has multiple patents in various areas and published more than 10 papers in peer-reviewed scientific journals.

Dr. Wang worked as a postdoctoral researcher in chemical biology at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He received his Ph.D. in Organic Chemistry from the University of Cincinnati, Master’s and Bachelor’s degrees in Environmental Engineering from the Nanjing University of Science and Technology.

Santipharp Panmai, Ph.D
Vice President, Head of
Formulation Development
WuXi STA

Dr. Santipharp Panmai is the Vice President and the head of formulation development at WuXi STA, a subsidiary of WuXi AppTec since 2017. He leads formulation teams in Shanghai and Wuxi, China, responsible for formulation development and clinical trial materials of new chemical entities from global clients (US, Europe, and Asia).Before joining WuXi STA, he worked at MSD in the US (PA/NJ) for 18 years in the Pharmaceutical Sciences group. He has extensive experience in formulation development and material characterization.

Dr. Panmai obtained his B.S. in Chemical Engineering from the University of California at Berkeley and his Ph.D. in Chemical Engineering from Princeton University.

Register Free: Pave an Expressway to Phase I –Strategies That Accelerate Your Early Phase Programs