Nonclinical Immunotoxicity Assessment: State of the Science and Future Directions (CE7)

CE Course Chair(s)

• David McMillan, PhD, DABT

  Toxicologist
  Division of Pharmacology/Toxicology for Infectious Diseases
  US FDA
  Silver Spring, Maryland, United States

• Gary Burleson, PhD

  President and CEO
  Burleson Research Technologies, Inc.
  Morrisville, North Carolina, United States

CE Course Speaker(s)

• Gautham Rao, PhD, DABT

  Distinguished Scientist-Toxicologist
  Genentech, Inc.

• Kristina Howard, DVM, PhD

  Research Veterinary Medical Officer
  Division of Applied Regulatory Science, OCP, OTS, CDER
  US FDA
  Silver Spring, Maryland, United States

• Carmen Booker, PhD

  Deputy Division Director
  CDER/OND
  US FDA
  Silver Spring, Maryland, United States

• Jamie DeWitt, PhD, DABT

  Professor
  Environmental & Molecular Toxicology
  Oregon State University
  Corvallis, Oregon, United States

Educational Co-Support Provided by: Burleson Research Technologies and American College of Toxicology

The last several years have witnessed several advancements within the field of immunotoxicology. These include, but are not limited to, a greater understanding of the mechanisms underlying various immune-mediated diseases including cancer, new therapeutic options to treat inflammatory and autoimmune diseases, and the development of new immunotoxicity assays (including in vitro alternatives for the evaluation of dermal sensitization). This past year also saw the publication of the revised FDA guidance, “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals”, which covers several aspects of immunotoxicology that have arisen since the publication of ICH S8, “Immunotoxicity Studies for Human Pharmaceuticals”. This session will provide an overview of the new guidance and address three areas that are key to this guidance and of increasing interest within the immunotoxicology community – dermal sensitization, immunostimulation/immunomodulation, and developmental immunotoxicity.

Presentations:

• 1:00 PM – 1:30 PM CT

  Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals: A Regulatory Perspective
  

  CE Course Speaker: David McMillan, PhD, DABT – US FDA
• 1:30 PM – 2:00 PM CT

  Strategies and Tools for Assessing Immunosuppression
  

  CE Course Speaker: Gautham K. Rao, PhD, DABT – Genentech, Inc.
• 2:00 PM – 2:30 PM CT

  Immunomodulation and Immunostimulation: Risk Identification and Assessment
  

  CE Course Speaker: Kristina Howard, DVM, PhD – US FDA
• 2:30 PM – 3:00 PM CT

  Break
• 3:00 PM – 3:30 PM CT

  Assessing Dermal Sensitization in a Topical Pharmaceutical
  

  CE Course Speaker: Carmen Booker, PhD – US FDA
• 3:30 PM – 4:00 PM CT

  Tools for Assessing Developmental Immunotoxicological Impacts
  

  CE Course Speaker: Jamie DeWitt, PhD, DABT – Oregon State University
• 4:00 PM – 4:30 PM CT

  Panel Discussion