Product & Process Development

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.

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.

Combine BLA rejections and late-stage product delays with the rising proof of comparability burden as therapies approach a regulatory hurdle, and an expert comparability review becomes a near-necessity.

Nonsensical, counterintuitive, or otherwise "off" data is likely to signal a problem. A team with remediation experience, like Dark Horse's, can perform a failure analysis to identify and remediate the source(s) of the issue. 

Clinical development of CGT products is increasingly an international endeavor, requiring an integrated global regulatory strategy.

This client requested design and outsourcing of pre/nonclinical efficacy and safety studies to demonstrate comparability of a changing clinical stage manufacturing process.

This client requested assistance in codifying their manufacturing process in preparation for an international technology transfer and global regulatory filings.

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.

DHC’s support for this client's gene-modified cell therapy platform demonstrated comparability of the improved manufacturing process (thus streamlining associated filings with global regulators).