- October 1 - 2, 2018
4:00 AM - 1:00 PM ET
Co-sponsored by the:
U.S. Food & Drug Administration (FDA) and
the Health and Environmental Sciences Institute (HESI)
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.
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.
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.
- Dianne Spillman: email@example.com
Oncology Program, Office of Hematology and Oncology Products
- Dwayne Keels: firstname.lastname@example.org
Office of New Drugs
Health and Environmental Sciences Institute (HESI)
- Dr. Stanley Parish: email@example.com
Scientific Program Manager, HESI