MRIGlobal, an independent, nonprofit CRO based in Kansas City, Mo., has been awarded a $54 million, 10-year program from the National Institute of Neurological Disorders and Stroke to provide support for the development and manufacturing of drug candidates for ultimate use in human clinical trials.
The project entails process development and preparation of active pharmaceutical ingredients (API); pre-formulation and formulation studies; analytical method development and validation; stability studies; drug product manufacturing, packaging, labeling; and storage and distribution of the drug products for clinical trials.
"Neurological disorders and stroke impact hundreds of millions of people worldwide," said Thomas M. Sack, Ph.D., president and CEO of MRIGlobal. "We are honored to support NIH in securing drugs that could literally transform the lives of so many impacted by stroke and a multitude of neurological diseases such as Alzheimer disease, autism, Parkinson's disease, epilepsy, muscular dystrophy, muscular sclerosis and migraines."
Roger K. Harris, Ph.D., associate vice president, Global Health Security, said, "While MRIGlobal has worked with the NIH since 1969, this is our first program with the National Institute of Neurological Disorders and Stroke and it opens a new era of collaboration working closely with organizations like University of Kansas, University of Kansas Medical Center and Kansas City University of Medicine and Biosciences to help bring new treatment and hope to those afflicted with neurological disorders and stroke."
This project is funded in whole or in part with Federal funds from the National Institute of Neurological Disorders and Stroke, NIH, Department of Health and Human Services.