Phase III Biologic, Sickle Cell Disease (SCD)
Phase III Biologic Commercialization Project Team
Our client, a biopharmaceutical company dedicated to the discovery, development, and delivery of life-changing treatments that provide hope to underserved patient communities, starting with sickle cell disease (SCD), was in the process of commercializing their Phase III Monoclonal antibody. This product received Orphan Drug and Rare Pediatric Disease designations. We were an instrumental partner to our client and successfully deployed a team of experts who played a pivotal role in gearing up for BLA approval and the commercial launch of this molecule. Our team consisted of 20 consultants who specialized in Technical Writing, Pharmacovigilance, Quality Assurance, GMP Quality Control, Product Development, Biologics CMC Analytical Development, and Biologics Manufacturing/Technical Operations. This project spanned 3 years and culminated in the successful completion of the trial.