Project & Program Management

A investor client with a target identified for potential investment required DHC support to engage and convene top-tier Clinical Key Opinion Leaders (KOLs) to evaluate a therapeutic candidate’s clinical data package in order to inform a determination regarding the asset’s current status and path to licensure relative to client’s investment thesis and risk appetite.

Development of novel, potentially groundbreaking manufacturing equipment and consumables for cell therapies is a complicated dance. It is a delicate balance of conflicting development and commercial priorities against customer requirements and the need to get to market quickly. In this case a client came to DHC concerned with the progress of their internal development program and worried about the maturity of their integrated bioreactor system for the manufacture of CAR-T and next generation cell therapies.

Experienced regulatory writers at DHC can provide a range of support from full authorship of regulatory submissions to gap analysis and editing of existing documents. A simple regulatory writing request can occasionally uncover unexpected gaps. In this example, as part of meeting package development and remediation of another consultancy’s work, Dark Horse experts identified a path to accomplish the client’s goals in a way that met the crucial initial timeline constraints and set them up for clarity in how to achieve their ultimate regulatory goals.

An emergent situation calls for simultaneous problem-solving on multiple fronts.
This client approached DHC for interim leadership support as they faced a critical clinical supply shortage—driven by manufacturing and comparability challenges—for their clinical stage lipid nanoparticle (LNP)-based drug product.

Our clients may experience a variety of situations that lead to a leadership gap within their organizations. Senior staff at Dark Horse possess years of leadership experience and can help fill the gap and keep operations moving forward. With senior staff available for nearly any technical or strategic need (and the ability for each of them to call upon 40+ technical SMEs for additional support), this has become a common request for DHC.

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.