Workshop on “Developmental Immunotoxicity Testing of Pharmaceuticals”

The Immunotoxicology Technical Committee (ITC) organized a workshop on Developmental Immunotoxicity Testing of Pharmaceuticals, held on May 3rd-4th 2010 in Washington, DC.  This goal of this workshop was to communicate the state of the science for developmental immunotoxicity testing of pharmaceuticals.  The workshop discussions considered gaps in science and methods and needs for future research.  Please click here to download the workshop program.

Speaker Presentations

Considerations for Biopharmaceuticals in DIT Testing:  Placental Transfer Considerations
Dr. Pauline Martin, Centocor

Developmental Immunotoxicology with Rituximab
Dr. Anu Vaidyanathan, Genentech

Case Study: Developmental Effects of an Immunomodulatory Biologic
Dr. Suezanne Parker, Biogen Idec

One FDA Reviewer’s Perspective on the Agency’s View of the Need for DIT Testing
Dr. Whitney Helms, US Food and Drug Administration

Regulatory Perspective
Dr. Beatriz Silva Lima, Lisbon University, European Medicines Agency Safety Working Party

The Drivers and Principles for DIT Studies:  Treating Mothers with Immunomodulatory Drugs and Assessing Impact on Children
Dr. Lauren Black, Charles River Laboratories