Critical Path Public Private Partnerships

As part of its Critical Path Initiative, FDA recognizes the need for collaborations established under the terms and conditions of a cooperative agreement, whereby existing resources and expertise can be used to the fullest extent possible. The Critical Path Institute has developed 8 individual consortia – the Coalition Against Major Disease Consortium (CAMD), the Multiple Sclerosis Outcome Assessment Consortium (MSOAC), the Patient Reported Outcomes Consortium (PRO), the Electronic Patient Reported Outcomes Consortium (ePRO), the Coalition for Accelerating Standards and Therapies (CFAST), the Predictive Safety Testing Consortium (PSTC), the Polycystic Kidney Disease Outcome Consortium (PKD), and the Critical Path to TB Drug Regimens Consortium (CPTR). These consortia have been active in developing biomarkers and Clinical Outcome Assessment Tools for Qualification under the FDA’s Drug Development Tool Qualification Program. The goals of this program are to maintain the administrative and scientific infrastructure of these consortia efforts while continuing to support the creation and execution of ongoing and new projects (such as a Neonatal Consortium) under the FDA's Critical Path Initiative.