Situation:
Small virtual biotech company was completing a four-year, global Phase 3 study in diabetes. The study was conducted through a series of outsourced providers and this, along with several internal management transitions, led to limited internal clinical and regulatory expertise, as well as minimal understanding of the overall strengths and limitations of the NDA package.
Solutions:
- Prepared an NDA Gap Analysis by reviewing clinical, preclinical, and manufacturing status of the development program. Analyzed historical regulatory interactions and reviewed newer regulatory guidance established since start of the study.
- Identified key issues to be resolved prior to study conclusion by thoroughly reviewing the Phase 3 study conduct. Worked closely with team and external vendors to drive timely correction of critical outstanding issues.
- Reviewed key vendor contracts, billing, and invoices and identified >$1 MM of out of scope activities.
- Partnered with client to review clinical data and determine feasibility of filing NDA or the need for additional studies.
Value:
NDA Gap Analysis was instrumental in rescuing a study that suffered from inconsistent oversight. The study results were not sufficient for NDA filing. However, the client was able to raise $7.5 MM based upon the study results to support additional clinical studies.