Situation:
A small, emerging biologics company was starting their first Phase 2/3 program with limited resources and systems in place. The company had just been acquired by an EU-based quasi-government conglomerate.
Solutions:
- A gap analysis identified clinical and quality systems that were inadequate to support the planned clinical objectives and timeline.
- The investigational product manufacturing and distribution process for an ultra-orphan indication was misaligned to site location and enrollment goals, putting successful trial completion at risk.
- The quality system was entirely GMP focused and did not incorporate clinical or regulatory activities, potentially leading to audit findings. Halloran developed and optimized key clinical SOPs.
- Business continuity was at serious risk due to lack of process and product development documentation and reliance on single individuals performing un-integrated functional activities. Halloran supplemented the clinical team during the study start- up period.
Value:
The company management team was able to develop an action plan to prepare the organization for the dual transitions of acquisition and clinical development.