Situation:
A commercial stage antibiotics company needed to expand its pipeline, and was conducting due diligence on a distressed asset. The team needed validation on the quality of data and analysis of resources required to get the product to a marketing submission.
Solutions:
- Participated on the due-diligence team as a co-clinical expert.
- Audited all clinical trial documentation, CRO reports, compliance and contract details.
- Contributed resource estimates for trial rework and future development needs.
- Validated concerns about the development plan and likely scenarios to complete program of study.
Value:
The company passed on the acquisition, and later moved on to acquire a higher quality asset. Likely would have spent more than $15-20MM of unanticipated capital to repeat the proof of concept trials due to quality and compliance issues.