A researcher at a leading Research I University had developed a promising drug delivery system for treating glioblastoma but needed expert guidance to move the innovation forward. Our team stepped in to design the preclinical and clinical studies and refine the clinical study protocol, laying a strong foundation for regulatory success.
We prepared a comprehensive Pre-IND meeting package and led discussions with the FDA on behalf of the researcher, securing crucial clarity on the path ahead. This strategic collaboration resulted in continued grant funding, allowing the project to progress into animal testing and one step closer to a potential breakthrough in glioblastoma care.
