Diligence & Business Strategy

Modeling capabilities allowed this client to receive a highly-informed current and future-state estimate of potential market size ranges for a reagent company under consideration for acquisition.

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.

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.

Requests for a roadmap to IND are common queries at DHC. This case study combines the experiences of a range of client projects to extrapolate the elements of a typical roadmap. In this type of engagement, DHC’s cross-functional expertise provides clients with an integrated understanding of the major activities, timelines, costs and value inflection points on the path to IND. Project deliverables are valuable both for internal planning and for fundraising activities.

DHC was asked by an investor client to support due diligence on two cutting-edge CGT assets that the investor was considering combining in order to spin out a new cell therapy company. DHC reviewed quality, CMC, and regulatory information relating to both assets, performed onsite evaluations of each, evaluated manufacturing contract terms, and reviewed the new entity’s planned timelines, budgets, and milestones.

DHC was engaged to provide strategic guidance in building a “hotel”-style manufacturing facility, which requires the ability to provide flexible GMP clean room suites for direct use by a wide range of early-stage manufacturing clients.

In this example, an international tools and tech company requested a market analysis of the gene-editing and advanced therapies space as well as a facility buildout plan to manufacture a critical component for gene therapy applications.

Due to our extensive expertise in CGT, Dark Horse is uniquely positioned to identify attractive investment opportunities. Here, we performed a detailed landscape scan for a client interested in investing in the space. 

Diligence in CGT requires not only the necessary research, but also an integrated in-depth analysis and interpretation of the findings based on a deep understanding of the technical field.

Due diligence support for this VC client involved a rapid evaluation of CMC Phase III readiness for a cell therapy asset (complete with an element of Quality Systems).