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Understanding the US FDA Guidance on Nonclinical Evaluation of Immunotoxic Potential in Pharmaceuticals: Implications and Insights


Hosted by: The SOT Biotechnology and Immunotoxicology Specialty Sections


  • David McMillan, PhD, DABT, Toxicologist, US FDA Division of Pharmacology/Toxicology for Infectious Diseases


  • Mary Ellen Cosenza, PhD, DABT, RAC, ERT, Fellow ATS, President MEC Regulatory & Toxicology Consulting LLC
  • Florence Burleson, PhD, Executive Vice President, Burleson Research Technologies
  • Wendy Freebern, PhD, Senior Director, Immunotoxicology Global Leader, J&J Innovative Medicine

The pharmaceutical industry is constantly evolving, driven by advances in scientific knowledge and regulatory expectations. A pivotal aspect of drug development is the assessment of potential immunotoxic effects caused by pharmaceutical compounds. To provide clarity and consistency in this area, the US Food and Drug Administration (US FDA) released the “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals” guidance document. This webinar aims to provide the rationale behind the document, elucidate the key elements of this guidance, and engage in a panel discussion about its anticipated impact on drug development strategies. The webinar speaker will focus on the rationale for the document and highlight the scope, objective and key considerations. The following panel discussion will focus on key areas including: 1) Practical implications of the new guidance; 2) Influence on study designs, nonclinical testing strategies, overall drug development process; and 3) Challenges and opportunities for the new guidance. The webinar will then close with a Q&A session with audience members.

Webinar Recording

Webinar Slides

Wednesday, January 17, 2024

Advancements Within the Field of Predictive Immunotoxicity In Vitro Models for Chemical Safety


Hosted by: The In Vitro and Alternative Methods and Immunotoxicology Specialty Sections

George Papadopoulos, Investigative Toxicologist, Takeda Pharmaceuticals
Victor Johnson, Director of Operations, Burleson Research Technologies, Inc

Immunotoxicity is emerging as a critical dose limiting toxicity across small molecules and newer modality therapeutics. Accordingly, US FDA reported drug-induced immune system disorders have increased 10-fold since 2002. Immunotoxicities are frequently difficult to predict within preclinical species; thus, development and implementation of advanced In Vitro assays for de-risking immunotoxicity liabilities is warranted. The field of In Vitro immunotoxicity model development is driving more predictive first in human dosing and translatability of immune-mediated adverse events within the clinic. In this webinar, three experts will present their current research surrounding In Vitro immune model development and applications for drug development. Learnings from this webinar can be utilized for implementation of In Vitro tiered screening and advancement of immune model development across research sectors.


Webinar Recording

Webinar Slides

Tuesday, June 13, 2023