Date: May 5 - 7, 2019
Location: Gaithersburg Marriott Hotel Washingtonian Center
Bioassays 2019 is a premier bioassay symposium that presents a truly unique opportunity for attendees to interact with key industry thought leaders and discuss topics such as current perspectives, strategies and technologies used for bioassays. In addition, attendance by regulatory representatives from the US FDA, Health Canada and various European agencies has been strong each year. Participation by both industry and regulatory leaders encourages active discussion and debate on contemporary issues related to bioassays.
Date: May 5
Time: 1:00pm - 5:00pm
Catalent Speaker: Mike Sadick, Ph.D., Principal Scientist, Catalent Biologics
Title: Beyond Basic mAbs…Bioassays for New Complex Modalities
Abstract: Bioassays are essential components of drug discovery, development and analytical control strategies for biologics. The ability of bioassays to reflect the relevant biologic activities is essential; however, developing such assays is increasingly challenging as newer therapeutics are being engineered with a diversity of mechanism(s) of action. These typically represent complex modalities, such as cell therapies, RNA therapies, DNA vaccines, multi-target/multi-functional antibodies and antibody-drug-conjugates.
This session will focus on bioassays used for release/characterization, and the challenges for novel therapies including a general understanding from industry (industry consensus) of the entire package of bioassays needed to support the full program for the novel therapy. Talks will assess bioassay strategies/approaches/lessons learned, especially for those molecules with unusual/complex mechanisms of action.