Accelerating Regulatory Submission for Pediatric Gene Therapy

This case study presents the strategies employed by a biotech company in collaboration with Fortrea to expedite regulatory submission for a Phase I/II clinical trial of a gene therapy aimed at rare diseases in infants. The biotech faced delays in finalizing core documents, which pushed its regulatory submission timeline back by three months. To address this challenge, Fortrea implemented a tailored problem-solving approach that included preparing documents in parallel, prioritizing the review of informed consent forms, and facilitating transparent communication through regular progress meetings. As a result, the regulatory submission timeline was successfully reduced from four weeks to just 4.5 business days. Key milestones achieved included rapid approvals for the master informed consent form and the country-specific informed consent forms, demonstrating how strategic collaboration can effectively meet urgent deadlines in high-stakes clinical trial environments.