C-Path was created in 2005 under the auspices of the Critical Path Initiative to catalyze advances in medical innovation and regulatory science by leading teams of stakeholders from academia, industry, government, and advocacy organizations and promoting the sharing of data, knowledge and expertise in order to produce sound, consensus-based science. C-Path's successes include the creation of cooperative consortia, the qualification of new drug development tools (DDTs), the endorsement of fit-for-purpose disease progression models and clinical trial simulation tools, the generation of new data standards and databases, and the creation of educational initiatives that advance regulatory science. With renewed funding C-Path will be able to continue developing Critical Path Public-Private Partnerships and advancing innovative, collaborative projects in research, education, and outreach for fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety.
In March of 2004 FDA launched its Critical Path Initiative to bridge the widening gap between scientific discovery and the availability of innovative medical products to patients. The Critical Path Institute (C-Path) was created in 2005 as a public-private partnership with FDA under the auspices of the Critical Path Initiative with a mission to be a catalyst in the development of new approaches to advance medical innovation and regulatory science. This mission is realized by leading teams of stakeholders from academia, industry, government, and patient and disease advocacy organizations that share data, knowledge and expertise resulting in sound, consensus-based science. Developing solutions to unmet needs in regulatory science also requires elements of data science, quantitative analytics, and knowledge of appropriate regulatory contexts. C-Path has established core competencies in these areas that allow it to make meaningful impact on unmet drug development needs. C-Path's core competencies can function independently to further their respective fields (e.g., refine data management practices, develop new analytic and modeling techniques, or train future regulatory scientists) and collaboratively with experts and stakeholders in therapeutic areas to meet specific needs such as qualified biomarkers and clinical outcome assessments. During the previous grant period, C- Path expanded its ability to carry out its mission through the broadening and deployment of its core competencies into specific consortia-related efforts as well as broader, cross-cutting activities. C-Path's successes include the creation of new consortia, qualification of new drug development tools (DDTs), endorsement of fit-for-purpose disease progression models and clinical trial simulation tools, generation of new data standards and databases, and educational initiatives that advance regulatory science. These accomplishments can decrease the time, resources, and number of patients needed to develop and approve medical products and thus de-risk and expedite the medical product development process. Altogether, these efforts support the FDA in its mission to promote public health and ensure the safety, efficacy, and efficiency of medical product development.
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