Causes: Health, Medical Research

Mission: The Critical Path Institute is a catalyst in the development of new approaches to advance medical innovation and regulatory science. We achieve this by leading teams that share data, knowledge and expertise resulting in sound, consensus based science.

Results: Qualified seven pre-clinical kidney safety biomarkers with the FDA, EMA, and PMDAQualified hippocampal volume as a prognostic biomarker for selecting patients to enroll in Alzheimer's disease (AD) clinical trialsReceived regulatory endorsement from FDA and EMA for an AD disease progression model and simulation platform for use in simulating and designing AD clinical trialsDeveloped data standards for AD, Parkinson's disease, polycystic kidney disease, tuberculosis, and multiple sclerosisMany other biomarkers and clinical outcome assessments in various stages of progress.

Target demographics: improve the process for developing drugs and other medical products

Direct beneficiaries per year: 1000s of leading scientists around the world in industry and academia

Geographic areas served: healthcare research

Programs: worldwide consortia to develop and get regulatory endorsement on drug development tools such as biomarkers, clinical outcome assessments, disease progression models, and data standards