Drug Development Program Management

A biotech company specializing in immuno-oncology engaged ProPharma to assist with its first New Drug Application (NDA) and Marketing Authorization Application (MAA) filings. A seasoned consultant was provided to support the initiative, working closely with the development team to devise a comprehensive, cross-functional filing plan, involving stakeholders from various departments and external partners. Key activities included developing timeline reports for the product and portfolio, updating the target product profile, and identifying and addressing gaps in the filing plan. As the filing deadline approached, the manager instituted weekly reviews and maintained an Issues, Decisions, and Risk Log to ensure alignment and timely submission. Coordination with executives was crucial to streamline approvals, which were identified as frequent bottlenecks. This structured project management approach facilitated the on-time submission of the NDA, minimizing confusion and stress, and providing vendors with clear timelines. The meticulous planning and execution were instrumental in the successful and timely filing of the company's first NDA.