Making An Unapprovable Drug Product Approvable

By Parrish Galliher

This is the real story of a drug that was in the middle of Phase 3 trials, showing great promise against a fatal neurological disease, and garnering a lot of interest from the FDA regarding the outcome of the trials.

That interest, though, also led to the agency determining that the commercialization potential of the manufacturing process was severely inefficient and making an unsafe drug product. They asked us to think about how we would completely transform the manufacturing process and turn it into a licensable process.