Oncology Case Study

A therapeutic monoclonal antibody for treatment of B-cell chronic lymphocytic leukemia.

Problem.

The FDA had refused to approve the drug for treatment of B-cell chronic lymphocytic leukemia based on limited data presented.

Solution.

Applying our guiding principles to the solving the problem:

Be Creative: The solution required redefining the measures of efficacy. MediVector used qualitative data – patient histories – to better describe the benefits reported by treating physicians.

Be Effective: MediVector MDs re-evaluated all of the study data and were able to prove that the drug had actually worked. An amendment to the NDA was filed in five months. 

Be Entrepreneurial: The rescue of the drug required minimal investment of time and money in lieu of an expensive new clinical trial.

Result.

Six months after submitting amendments, the FDA approved the drug.

Successes in Drug Development

MediVector’s creative, effective, and entrepreneurial approach to drug development reduces the drug development cycle time and yields success.