Biosafe Immunotoxicology Session Registration

Biosafe Immunotoxicology session abstract:

BioSafe/ HESI Immunosafety Technical Committee Shared Session will include 3 topics of discussion that have elicited health authority inquiries or input, are hot topics in the Immunosafety community and/or are consistently brought up by BioSafe members as subjects of interest. A robust discussion on the balance of immunopharmacology and immunotoxicology (exaggerated pharmacology?) and the why, when and how of immunopharmacology evaluation in nonclinical studies will lead the Wednesday morning session. Subsequently, a dynamic, audience enriched dialogue will center around a fairly old topic with new twists, cytokine release. The discussion leaders will, together with the audience, interpret the latest immunotoxicology guidance concerning cytokine release within the context of designing cytokine release evaluation strategy for programs in development. Meeting attendees will appreciate how the pharmaceutical industry has progressed with optimal cytokine release evaluation strategies during this decade of learnings. Finally, the session will conclude with the hot topic of Fc receptors and their immunotoxicologic potential when engineered for longer exposure and/or greater efficacy. Industry-wide strategies for nonclinical evaluation, translatability of findings and risk versus benefit assessments will be discussed with a plethora of data and case studies gained from an industry-wide survey.

If ITC members are attending the Immunotox session in person Merck requires the following information: Non Biosafe member can attend the Immuntox tox session.

Registration

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• In-Person
• Virtual

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Please use the space below to indicate any special accommodations (dietary or otherwise).

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The ITC meeting will be held at Sonoma Bio therapeutics ( a few blocks away from Merck)