Case Study

Compound Review

Due Diligence Review

The client was looking to in-license an analgesic which had a wide non-clinical pharmacology data package and an investigator sponsored pilot study. The client requested a due diligence review and a high-level costing schedule for development to be able to make a go/no go decision on in-licensing. 

Using Fulcrum's proven analgesia and regulatory expertise, we provided an opinion on the analgesic’s approvability following a focused review of the data available, and a high level development costing from synthesis of drug substance to Phase IIa Proof of Concept. Key success and go/no go decision points plus any key issues were identified.

Fulcrum's report enabled the client to make the decision with a realistic idea of the costs, time and likely developmental and regulatory hurdles. The programme was in-licensed and the review was used as the foundation for the generation of a development plan.

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