Case Study

In-licensed assets have complexity at the start-usually sitting on a shelf in one company’s library for months to years. It can take a new team months to gather the right documentation and knowledge to lift the asset off the ground on a path to its next destination. Sometimes little to no access to the experts who have the know-how (manufacturing, site relationships, patient and market insights) stall progress even further.  The growth of biotechnology pipelines often rely on these business deals, and leadership often set aggressive goals for the licensee.  

Phase 2 asset deal signed, EOP2 meeting complete. The NDA target date was established and a team of about 8 R&D experts assembled to plan and execute the program. For the next 2 years this small but mighty team pulled off what seemed impossible.  Accelerating trial enrollment, re-establishing world wide supply chains for drug substance and drug product and compiling and submitting the NDA  ahead of plan. The drug application was approved and a new therapy offered to patients who needed it.  

Simple? No.  Well-planned and led? Yes.  How? With the right team, right skills and clear direction.  Support every step of the way to remove obstacles and keep the goals (patients, quality, work with urgency) in focus.  That’s what we did for this program and that’s what we can do for yours.