The risk of cytokine storm triggered by biotherapeutic modalities remains a significant safety concern in the clinic. Many organizations have developed customized assay systems to assess the potential risk for cytokine release, with the primary goal to determine the level of caution that should be taken in a clinical setting. Currently there are no clear guidelines with regards to assay conditions and experimental design, data interpretation and the overall predictive value using current in vitro methodologies is not well-understood. The ILSI HESI Immunotoxicology Technical Committee sponsored a one-day workshop focused on cytokine storm risk assessments. The objective of this workshop is to bring together academic, industry and regulatory agency scientists to discuss current technologies, practices and scientific challenges.
When: October 22, 2013 (full day)
Where: Magnolia Ballroom, Sheraton Silver Spring Hotel, Silver Spring, Maryland
Cytokine assessment from a FDA pharmacology/toxicology reviewer’s perspective
Dr. Whitney Helms, US FDA
For more information, please contact Dr. Raegan O'Lone (firstname.lastname@example.org).