Phase III Biologic, Sickle Cell Disease (SCD)

Phase III Biologic Commercialization Project Team

The problem was the need for a specialized and coordinated team to support the commercialization of a Phase III monoclonal antibody for a biopharmaceutical company. The product, which had received Orphan Drug and Rare Pediatric Disease designations, required comprehensive expertise to ensure its successful transition from development to market readiness.

This challenge was faced by a biopharmaceutical company committed to delivering life-changing treatments for underserved patient communities, starting with sickle cell disease (SCD). As they approached the commercialization of their Phase III product, they needed a team that could handle the complexities of BLA approval and prepare for the commercial launch of this critical molecule.

We provided a solution by deploying a team of 20 specialized consultants over a span of three years. Our experts in Technical Writing, Pharmacovigilance, Quality Assurance, GMP Quality Control, Product Development, Biologics CMC Analytical Development, and Biologics Manufacturing/Technical Operations played a pivotal role in the project. Their combined efforts were instrumental in gearing up for BLA and subsequent approval and ultimately ensuring the successful completion of the trial and the product's readiness for market launch.