Conference Description:

The updated ICH Q14 guidance from the FDA revising analytical procedures used for release and stability testing has shown higher product quality expectations from regulatory agencies. As analytical studies become an indispensable requirement to progress the antibody-drug conjugate space forward, so has the need for rigorous analytical methodologies that ensure product quality ahead of regulatory submissions.

The 3rd ADC Analytical Development will provide a technical deep-dive into optimizing physiochemical methods to better quantify DAR and drug distribution, carry out size variant and charge variant analysis, develop bioassays to improve understanding of the potency in a timely fashion, and better utilize impurity assays to measure free-linker drug and overcome species separation, to ensure you are producing a high-quality product within regulatory boundaries.

Join 100+ experts including Daiichi Sankyo, Eli Lilly, ADC Therapeutics, AstraZeneca, and many more to gain an in-depth but holistic overview of all facets of analytical development that ensure you deliver a high-quality, safe and effective ADC that will progress through regulatory checkpoints.

Designed for analytical development, CMC, and quality control experts within the ADC field, this is an exciting opportunity to foster collaboration, address need-to-know analytical challenges shared by the entire community and set a framework for future regulatory clarity that you cannot afford to miss.

Tickets: https://go.evvnt.com/2097379-2?pid=154
Time: 08:00 AM - 03:45 PM

Prices:
Drug Developer - Conference Day Only: USD 2999.00,
Drug Developer - Conference + Workshop Day: USD 4297.00,
Academic - Conference Day Only: USD 2599.00,
Academic - Conference + Workshop Day: USD 3697.00,
Solution Provider - Conference Day Only: USD 3699.00,
Solution Provider + Workshop Day: USD 5097.00

Speakers: Allison Torgesen, Quality Control Director, Bolt Biotherapeutics, Amit Katiyar, Senior Director - Late Stage Biologics, Exelixis, Chen Qiu, Chemistry, Manufacturing and Controls Scientist, Takeda, Chris Chumsae, Director of Biophysical-Chemical Characterization, Bristol Myers Squibb, Chris Woods, Scientist, Analytical Development, Seagen, Chuan Leng, Associate Principal Scientist, Merck and Co, David Lee, Executive Director, Analytical Chemistry, Mersana Therapeutics, Delphine Peric, Bioassay Laboratory Supervisor, Sanofi, Dengyun (Daisy) Sun, Principal Scientist, Merck and Co, Diego Arturo Alonzo Muniz, Scientist, Analytic (Mass Spectrometry), Zymeworks, Halei Zhai, Senior Scientist - Analytical Development, Chemistry, Manufacturing and Controls, Bolt Biotherapeutics, Linda Nelson, Executive Director, Daiichi Sankyo, Lizzy Zhao, Senior Scientist, Regeneron, Madhumati Mukherjee, Senior Scientist, AstraZeneca, Manghong Zhu, Scientist, Mersana Therapeutics, Mark Eggink, Principal Scientist, Byondis, Melvin Flores, Associate Director, Quality Control Analytical, Sutro Biopharma, Mysore Ramprasad, Executive Director, Pharmaceutical and Analytical Development, Ambrx, Nailing Zhang, Lead Biologist, FDA, Qin Yan, Senior Scientist, AstraZeneca, Ray Lin Director, Potency Assay Department, Seagen, Renpeng Liu, Principal Scientist, Pyxis Oncology, Weijun Li, Senior Director Biologics Analytical Development / CMC Team Lead, Exelixis, Yan-Hui Liu Director, Analytical Development, Drug Product and Anti-Oxidant, Strategic External Development, GSK, Yuan Gao, Head of Analytical Development, ADC Therapeutics