Situation:
A small biotech company licensed a compound approved in Japan. The compound had previously been subject of clinical and pre-clinical development in the United States and Europe over a period of nearly 10 years. The client's internal resources were stretched and they lacked the experience of managing a confirmatory Phase 3 trial while building a regulatory strategy for registration.
Solutions:
- Halloran worked with the company to augment clinical operations resources while building a comprehensive regulatory plan – mapping the existing Japanese NDA and existing data to an eCTD.
- A number of significant issues were identified that would have caused failure in either partnering or submission of the filing.
- Halloran compiled an NDA timeline with resource requirements and estimated costs.
- Timeline supported budget and growth plans for the upcoming year while providing structure for ongoing development operations.
Value:
Since the IPO market had closed, the data package and timeline were used as the basis for a big pharma partnership deal worth $500MM and a parallel syndicate equity financing of $12MM.