The discovery of cutting-edge cell and gene therapy modalities often stems from innovative academic centers, who may then seek to partner with a biotech organization to engage in formal product development and to advance these promising drug candidates to patients. In this instance, a client developing a CAR-T cell therapy licensed from an academic institution hired DHC to provide full support in developing a pre-IND and subsequent IND-enabling nonclinical strategy based predominantly on in vitro and in vivo studies conducted at the academic center. In addition, and as is typical in these scenarios, the nonclinical studies were performed using drug product generated with an earlier production process that was being developed for GMP-readiness in parallel to the aforementioned regulatory activities. This engagement combined 4 of DHC’s core capabilities, namely nonclinical development, regulatory affairs, process development, and analytical development.
By working with Dark Horse, the client submitted a well-crafted pre-IND package, which enabled actionable Agency feedback and a clear roadmap to IND submission. Subsequently, DHC and the client worked in collaboration to craft a robust and detailed nonclinical narrative for the IND, which resulted in its clearance with no hold comments or information requests from the Agency.
