Situation:
Small virtual biotech start-up with well-funded stem-cell therapy treatment for vascular repair, but no experience in product development. Research had been ongoing for five years and was supported through government grants. Strong scientific expertise, but limited experience in moving research phase work into early clinical (pre-IND) development. Client was uncertain whether they were ready for IND or not.
Solutions:
- Prepared an IND Gap Analysis by reviewing full preclinical data package, existing regulatory framework, and current competitive landscape.
- Worked with scientific team to streamline research activities to efficiently answer scientific questions and build preclinical IND data package.
- Led ongoing pre-IND discussions with FDA.
- Prepared investment presentation for use in fund-raising.
- Identified and introduced potential investors to client.
- Conducted ongoing participation in investor presentations and discussions.
Value:
IND Gap Analysis concluded that client was ready to proceed with FDA discussions and initiate IND-enabling activities. The Gap Analysis, together with the investor presentation, made up the documents used in fund raising discussions. At present, client is in ongoing discussions with one off-shore pharma company, one US-based biotech company, and multiple VC groups to secure additional funding and/or partnerships.