The biopharmaceutical industry is rapidly growing, with about half of the growth in emerging markets. The goal of a biopharmaceutical company is to build a sustainable, cost-efficient supply chain while meeting global regulatory requirements. In particular, launching innovative drug products in China presents a unique set of challenges.
In this webinar, we will discuss the differences and commonalities among major global agencies, including US FDA, EMA, and China NMPA. Building upon that, we will discuss approaches to build a robust data package that satisfies expectations from global health authorities for clinical and commercial regulatory filings. We will share real-world case studies of how WuXi STA supported clients with their China filing strategies and expedited development and commercialization in China.
Melody Mak-Jurkauskas, Ph.D., is the Senior Director of Regulatory Affairs, responsible for all regulatory aspects of CMC. Her group provides STA’s clients with the preparation of regulatory filings, assistance during interactions with health authorities, and the development of robust global regulatory strategies to ensure uninterrupted clinical studies and successful marketing applications. Dr. Mak-Jurkauskas joined STA in 2019 with over a decade of expertise in analytical development, and drug substance and product manufacturing. Dr. Mak-Jurkauskas earned her Ph.D. degree in Physical Chemistry at Brandeis University under the guidance of Professor Judith Herzfeld and her Bachelor of Science in Chemistry at the University of Toronto.
Cliff Yin, Ph.D., is the Executive Director and Head of Formulation R&D and Clinical Supply at WuXi STA, a WuXi AppTec Company. Dr. Yin is experienced in managing CMC projects. In the past 15 years, he has led projects ranging from API and drug product R&D and supply chain management to clinical trials. Presently, Dr. Yin manages more than 100 projects, from early-stage drug product development to commercialization, every year. Before joining WuXi STA, Dr. Yin was the chief scientist, principal of clinical supply, and director of clinical projects of Novartis. He led the establishment of Novartis API R&D center and formulation department. Dr. Yin received his Ph.D. degree in 2002 and continued with a post-doctoral fellowship at Auburn University.
Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.