CE 6: Immunotherapies and Collaborative Approaches to Immunosafety Assessment

Immunotherapies constitute a rapidly growing class of pharmaceuticals which have significant potential benefit for numerous indications. The nonclinical development of immunotherapeutics requires a variety of scientific experts, including immunologists, pathologists, toxicologists, and regulatory personnel working together to ensure these products are safe and effective. Such assessments require a thorough understanding of the immune system as well as the often complex pharmacology and toxicology of each product, and assessing potential effects (intended or unintended) often requires specialized nonclinical safety testing and endpoints. In this session, five scientific experts (discovery and NAMs immunologists, pathologists, toxicologists, and regulatory personnel) with unique roles will provide their complementary perspectives for a comprehensive immunotherapy risk assessment and highlight the challenges faced throughout the nonclinical safety assessment of immunotherapies. Practical suggestions on the contextualization and communication of immunosafety endpoints will be provided. An interactive round table session that incorporates concepts from the speakers will be included in the 2nd half of the session. The interactive session will center around an immunosafety (case study) scenario that will include a round table discussion with opportunities for an interactive question and answer component, as well as, time for additional Q&A and discussion. This session is hosted in collaboration with the HESI Immunosafety Technical Committee (HESI-ITC).

CE Course Chair: Tracey L. Papenfuss, DVM, MS, PhD, DACVP – Papenfuss Consulting Inc.
CE Course Chair: David McMillan, PhD, DABT – US FDA
CE Course Speaker: Nikki B. Marshall, PhD – GSK
CE Course Speaker: Daniel Weinstock, DVM, PhD, DACVP – D Weinstock Consulting
CE Course Speaker: Sarah Benjamin, PhD, DABT – Johnson & Johnson