We were excited to be included in The Wall Street Journal earlier this week discussing the value of the Critical Path Institute’s new simulation tool for improving clinical trial design for mild and moderate Alzheimer’s disease.
The Alzheimer’s disease simulator can help eliminate the guesswork of the duration, dose and number of patients to treat in clinical trials to determine the efficacy of a new therapeutic in slowing the progression of the disease. The simulator is unique in that it leverages past trials of Alzheimer’s treatments and findings from the National Institutes of Health neuroimaging study of Alzheimer’s patients and academic papers to map out different scenarios for designing trials for new therapies.
As announced earlier this year, the simulator received favorable regulatory designations from the U.S. Food and Drug Administration as well as the European Medicines Agency. These regulatory milestones represent the first example of enabling model based drug development, a vision outlined in the original FDA Critical Path Initiative (2004).
C-Path has received many requests for access to the tool by both large and start up companies. We look forward to the tool to seeing the simulator’s role expand in accelerating the development of treatments for Alzheimer’s disease.
In the meanwhile, please continue to check back on our site, as we are currently in the process of developing new simulators for tuberculosis and Parkinson’s disease.
To read the full article in The Wall Street Journal, please visit: http://online.wsj.com/news/articles/SB10001424052702303914304579192033377938714#printMode.
Key words: simulator, Alzheimer’s disease, National Institutes of Health, simulation tool.