Upcoming Events
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Past Events
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
Speaker:
- David McMillan, PhD, DABT, Toxicologist, US FDA Division of Pharmacology/Toxicology for Infectious Diseases
Panelists:
- 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.
Wednesday, January 17, 2024