The selection of drug substance regulatory starting materials (RSMs) and justification of their designation in the pharmaceutical supply chain has become an industry-wide focus as a measure of mitigating regulatory risks, as well as preventing unexpected rises in cost when transitioning from clinical to commercial supply chains.
In this webinar, the speakers will discuss expectations of regulators on the selection of RSM and the justification of their designation in the pharmaceutical supply chain. In addition, the scope of presentation of RSMs required in regulatory filings and how to prepare for “push backs” in the event of a major objection to the sponsor’s RSM designation will be examined.
The speakers will also summarize several case studies where pharmaceutical/biotech CMC teams worked with outsourcing partners to design and execute strategies, enabling successful risk mitigation on RSM “push backs” for global filing.
Valdas Jurkauskas, PhD, VP of CMC, Akebia Therapeutics
Dr. Valdas Jurkauskas specializes in creating CMC (chemistry, manufacturing and controls) strategies and global manufacturing networks that successfully transition pharmaceutical companies from development stage into commercialization. He earned his Doctoral Degree in Organic Chemistry at the Massachusetts Institute of Technology (MIT), USA and his Bachelor of Science degree in Chemistry at the University of Toronto, Canada. Dr. Jurkauskas is based in Cambridge, Massachusetts, USA.Message Presenter
Ke Chen, PhD, VP, Process Research & Development, WuXi STA, a WuXi AppTec Company
Dr. Ke Chen is Vice President of Process Research & Development (PRD) at WuXi STA. Prior to joining STA, Dr. Ke Chen worked for 9 years at Bristol-Myers Squibb, accumulating experience and expertise in process research and development, process validation, vendor relationship management, CMC and regulatory affairs. At BMS, Dr. Chen led her team to quickly advance several drug candidates into clinical trials, two of which have been commercialized. She received multiple prestigious awards/titles such as the “American Chemical Society Young Investigator” and “Bristol-Myers Squibb Chemistry Leadership Award”.
Dr. Ke Chen received postdoctoral fellowship training at Scripps Research Institute. Prior to that, she received her PhD degree in Organic Chemistry from the University of Rochester and BS degree in Chemistry from Beijing University. Dr. Chen is a co-inventor/co-author of numerous internationally issued patents/patent applications and her research work has been published in over 20 peer-reviewed scientific journals, including two articles in the journal Nature.Message Presenter
Who Should Attend?
- Head of new drug development
- Head of Pharmaceutical R&D
- Head of Process R&D
- Head of CMC
- Process R&D Scientist
- Drug Development Scientist
What You Will Learn
- Understand how RSM designation can mitigate regulatory risks and prevent unexpected cost rises
- Learn the expectations of regulators on the scopeof presentation of RSMs required in filings
- Learn from real world case studies on how to design and execute RSM strategies for potential RSM “push backs”
WuXi STA, a WuXi AppTec Company
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing and technology platform company serving the life sciences industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions with integrated CMC (Chemical, Manufacturing, and Control) services for both drug substances and drug products, ranging from preclinical to commercial uses.
For more information, please visit: http://www.STApharma.com