As ADCs as a modality see continued clinical progress, drug developers are becoming more creative with their drug design and new analytical technologies are improving the resolution so that you can understand the characteristics of your drug. However, key regulatory questions are arising and agency expectations regarding what needs to be characterized and to what degree, what quality attributes are critical, and what variation is allowed in control processes are at the forefront of mind.
The 2nd ADC Analytical Development Summit is your only and definitive event dedicated to giving you full coverage of the core analytical challenges facing ADC developers including drug-linker, drug substance, drug formulation and drug product to enable you to understand your drug in more depth and confidently enter conversations with regulators to achieve regulatory approval.
With an increased focus on ADC comparability, connect with 100+ likeminded experts from leading companies including Merck and Co., GlaxoSmithKline, Mersana Therapeutics and more to take a deep dive into the issues surrounding the analytical field such as the complexity of the ADC, bioassays and regulatory requirements, to name a few.
Covering analytical development, CMC, quality control and process development, this is a conversation you won't want to miss to foster collaboration, address shared challenges, and set a framework for future regulatory clarity.
Speakers: Hongmei (May) Li, Associate Director, RemeGen Biosciences, Jessica Webb, Scientist, Analytical Sciences, AstraZeneca, Julie Beaudet, CMC Staff Scientist, Regeneron Pharmaceuticals Inc, Manoj Pal, Senior Principal Scientist, Ambrx, May Zhu, Director Analytical Development - External Interface Management, Takeda Pharmaceutical Co. Ltd., Melvin Flores, Director - Quality Control Analytical and Microbiology, Sutro Biopharma, Mingyan Cao, Associate Director, GlaxoSmithKline Plc, Peiling Su, Scientist Analytical Chemistry, Seagen, Sarah Owen, Senior Scientist, Seagen, Shawn Novick, Principal Consultant, BioPhia Consulting, Shiyue Zhou, Senior Scientist, Abbvie, Shuwen Sun, Principal Scientist, Merck and Co, Simon Letarte, Director, Gilead Sciences, Thomas Gardinier, Head of Materials Analysis, Elucida Oncology Inc., Vimal Patel, Vice President and Head of CMC and Supply Chain, Orum Therapeutics, Yuan Gao, Head of Analytical Development, ADC Therapeutics
Schedule:
9:00 am - 3:00 pm