U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. FDA-HESI Public Workshop: Preclinical and Translational Safety Assessment of CD3 Bispecifics - 10/01/2018
  1. News & Events for Human Drugs

Public | In Person

Event Title
FDA-HESI Public Workshop: Preclinical and Translational Safety Assessment of CD3 Bispecifics
October 1 - 2, 2018

October 1 - 2, 2018

Co-sponsored by the:
U.S. Food & Drug Administration (FDA) and
the Health and Environmental Sciences Institute (HESI)

Twitter: #OncCD3biSpec

Date: Oct 1-2, 2018

Time: 8:00 am to 5:00 pm

Location:FDA White Oak Campus, Building 31, Room 1503A - Great Room, 10903 New Hampshire Avenue, Silver Spring, MD 20993.  FDA Campus Information, (e.g., local airports, directions, and local hotels)
For in-person or webcast participation in this public workshop, please register at the following link: http://hesiglobal.org/event/fda-cder-hesi-workshop-on-preclinical-and-translational-safety-assessment-of-cd3-bispecific/ 

FDA and HESI intend to leverage their combined strengths for the joint development of a workshop that convenes subject matter experts involved in the preclinical and translational development of CD3 bispecific therapies.
Workshop Objectives:
The goal of this workshop is to discuss the preclinical and translational safety assessment of CD3 bispecific therapies. The workshop will focus on eight topics, followed by an in-depth discussion:

  • CD3 bispecifics and their effect on T-cell biology,
  • Target (tumor antigen) expression and liability assessment,
  • Relevance of molecular design and bioactivity to toxicity assessment and potential,
  • In-vivo pharmacology and toxicology,
  • In-vitro assays to assess cytokine release,
  • First-In-Humans (FIH) dose selection,
  • Clinical Experience
  • Translation of nonclinical findings to the clinic.

Webcast Information:
FDA will provide a free-of-charge, live webcast of this workshop which will be accessible at this link: https://collaboration.fda.gov/fdahesi2018.
This workshop will not be recorded; therefore, an archived webcast will be unavailable after the meeting.

Meeting Information: 


Health and Environmental Sciences Institute (HESI)


Back to Top