Production and quality analysis of clinical drug for a novel CNS protein kinase inhibitor therapeutic candidate

The Northwestern University (NU) site for this STTR MPI application under the leadership of the NU principal investigator (NU-PI), Dr. Daniel Martin Watterson, will work with NeuroKine Therapeutics (NKT), LLC, to attain the overall goals of the project. This includes working with the contract manufacturer on the preparation, validation, storage and distribution of the drug substance and the production and validation the drug product.. The NU site will conduct the following work related to the overall goals of the project: • NU will monitor protocols as well as draft and final reports from contract research organizations. • NU will monitor test results for drug stability. • NU will monitor analytical methods and supervise report approval and raw data file archiving. • NU will assist with regulatory filings.