When the board of a publicly-traded biotech company faced a critical juncture with their struggling Phase II pharmaceutical program, they turned to our team for leadership. Stepping in as interim management, we quickly assessed the challenges and formulated a clear path forward.
Within just six months, we transformed the trajectory of the program. Our team designed a revised clinical trial protocol, breathing new life into the study with a more strategic and feasible approach. We identified and thoroughly vetted new clinical sites and investigators, ensuring the trial would have the expertise and resources needed for success.
Recognizing the importance of a strong regulatory foundation, we compiled and submitted fresh preclinical data to the FDA, securing approval for extended dosing—a critical step in advancing the program. Meanwhile, we partnered with vendors to guarantee that the new drug product was meticulously manufactured, tested, packaged, and delivered to the clinical sites on schedule.
By addressing the program’s operational and strategic needs head-on, we provided the company with a revitalized path forward, ensuring their Phase II pharmaceutical was set up for the best chance of success.
