Moving From Clinical Development To BLA Through Strategic Planning

The transition from research to development is fraught with challenges that can significantly impact a product's success. Facing numerous obstacles, a small immuno-oncology-focused biotechnology company reached out to Halloran Consulting Group (Halloran) for assistance in their maiden Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA). The company had recently experienced the departure of its Development Program Manager, a series of changes in their Vice Presidents of Regulatory Affairs, and a lack of team members with BLA expertise.

Compounded by these personnel gaps, the company struggled with misalignment, inadequate planning, insufficient executive support, unclear requirements and expectations, resource constraints, and a technology choice that hindered its internal objectives.

See how Halloran was able to step in to address these infrastructure challenges, which were impeding their progress toward meeting their submission goals, and aid the company in successfully filing its BLA submission.