Antibody-based Drug Development, from R&D to Commercialization

Date: August 27, 2022 @ 10:00 am – @ 1:00 pm
Location: Suite 280, 1633 Old Bayshore Hwy, Burlingame, CA 94010

Antibody-based drugs have revolutionized the treatment of many previously untreatable diseases, including solid tumors, hematological malignancies, and autoimmune diseases. Due to the complex nature of antibody-based drugs, there are unique development challenges associated with the Chemistry, Manufacturing, and Controls(CMC) of biologics. CABS and Aton will cohost a seminar titled -Antibody-based Drug Development, from R&D to Commercialization on August 27th, 2022 at 10:00 am – 1:00 pm (PT). Join us and learn about the CMC development process from Investigational New Drug (IND) to Biologics License Application (BLA/market approval) from industry-leading experts.

Agenda

10:00 to 10:05 AM Welcome Remarks from CABS. Yan Wang

10:05 to 10:35 AM CMC Considerations during Drug Development and Commercialization. Wei Huang

10:35 to 11:05 AM From IND to BLA, CMC Considerations from FDA’s Perspective. Sandy Yan

11:05 to 11:35 AM From DNA to IND & Beyond: Considerations for Biopharmas to Outsource CMC to CDMOs. M. Tim Tian

11:35 to 12:05 PM Enable A Novel Therapeutic Antibody Clinical Trial in 12 months. Fan Chen

12:05 to 1:00 PM Panel Discussion and Networking Lunch.

This event will be available in-person and via Zoom. Please confirm in-person in “Notes” during registration