Groundbreaking Rare Disease Drug Approval Propelled By Expert Regulatory Strategy And Program Management

SpringWorks Therapeutics, a biopharmaceutical company dedicated to advancing precision medicine, acquired a promising asset from Pfizer to initiate a pivotal clinical study targeting desmoid tumors. Building on Pfizer’s prior development efforts and compelling results from an investigator-initiated trial that positioned the program at the End of Phase 2 (EOP2), SpringWorks needed to refine their regulatory strategy for late-stage development. Their goals included defining a clear pathway to approval and successfully submitting a New Drug Application (NDA).

To achieve this, Halloran Consulting Group provided strategic guidance, fostering team alignment and collaboration through a unified vision. By leveraging Halloran’s expertise, SpringWorks established a robust development roadmap, ensuring the seamless progression of this life-changing therapy toward regulatory approval. Discover more details about this collaboration in our in-depth case study, created in partnership with the SpringWorks team.