ImmunoSafety Technical Committee – HESI Sept 2019 HESI/FDA Workshop

In collaboration with the U.S. Food and Drug Administration, the HESI Immuno safety Technical Committee (ITC), co-sponsored an interdisciplinary workshop to discuss the pre-clinical and translational safety assessment of engineered T-cell therapies.  The workshop covered a wide range of topics that included the design, activity, and safety of these therapies; that framed an expanded discussion on the current global regulatory perspectives and considerations.  An abbreviated list of discussion items are included below:

1. How current nonclinical immune safety evaluation is carried out for engineered T cell therapies
2. Understanding both the usefulness and limitations to in vivo and in vitro methodologies currently employed
3. What clinical data is demonstrating, and how it can be used to design more informative nonclinical studies
4. Global regulatory considerations.

Leveraging the key findings from the workshop, a contemporary review was published in the Journal of Regulatory Toxicology and Pharmacology that offers new perspectives on the rapidly evolving field of engineered cell therapies while capturing emerging issues as they pertain to the non-clinical safety assessment of this modality.

In this video clip, Dr. Herve Lebrec provides a brief description of the manuscript and the primary objective of this ITC initiative.  This is an open access publication and can be accessed here