Project & Program Management

When a client's project's timeline was in jeopardy due to a lack of communication between the vendor and the client, DHC’s project management services were added to support overall project governance.

A pure-play gene therapy client whose product was just being spun out of academia brought DHC in early to provide long-term guidance, conceptualizing and building a dev process that would stand up to the challenges of future trial phases and into commercial production.

This case study follows the experience of a client who is new to CGT (though otherwise practiced in late stage processes) and requires CRL remediation to prepare for BLA resubmission.

Precision is key, especially in a(n international) tech transfer. DHC provided Person in Plant support in managing dose preparation training of clinical sites for this client's flagship product.

This case study exemplifies proactive project management of cross-functional program details; specifically, those that occur at the interface of CMC and clinical operations.

This study highlights a custom piece of manufacturing equipment for a cell therapy client. In addition to engineering oversight, DHC also provided regulatory and PM support.