FDA/CDER-HESI Workshop on Preclinical and Translational Safety Assessment of CD3 Bispecifics
Silver Spring, Maryland, USA
October 1, 2018 – October 2, 2018
US Food and Drug Administration
With the emergence of CD3 bispecifics as a novel weapon in the fight against cancer, there is a growing need to share information and learnings about these compounds that range from strategies for target expression profiling to nonclinical safety assessment to clinical experience. This workshop is designed to engage with a multi-stakeholder group of experts that will present and discuss their case examples with the objectives of learning from each other through robust engagement and discussion to enable the best outcomes for patients.
Goal: The goal of this workshop is to discuss the preclinical and translational safety assessment of CD3 bispecific therapies, focusing on 8 topics as described based on agenda below. To allow for in-depth discussions, the presentations in each session will consist primarily of short (~10-20 min) cases studies.
Agenda: Please find a draft agenda here
Accommodations: Click here to find a list of nearby hotels. Please note that participants are responsible for their own transportation to and from the US FDA site.
Requirements: To gain access the building, you must bring an acceptable and valid government issued identification (ID).
Registration: In-person registration is closed, please use the webinar link below to access the workshop remotely
Webinar: Click here to access the webinar.