sharing

Sharing Knowledge,
Driving Innovation

c_trial

Developing models that can be used for medical research and drug development

Projects

Coalition Against Major Diseases

Critical Path to TB Drug Regimens

reported_out

Gathering data reported by patients about therapies in order change their care

data

Maintaining data standards, tools, & methods for conducting research that is important to the public

Projects

Coalition Against Major Diseases

Multiple Sclerosis Outcome Assessments Consortium

Polycystic Kidney Disease Outcomes Consortium

Critical Path to TB Drug Regimen

C-Path relies on three basic tenets in its approach to improving medical product development: “faster, safer, and smarter.” Our programs support the FDA’s Critical Path Initiative and were developed with detailed input from scientists from the FDA, industry, and academia.

Establishing Consortia

From its beginning, the creation of consortia has been fundamental to the work of C-Path. The FDA, after consulting with experts in industry, government, academia, and patient advocacy groups, in 2006 identified the critical work that was needed to ensure that novel therapies could move through development and to patients as quickly as possible, i.e., the 76 projects on the Critical Path Opportunity List. Many of these projects required collaboration, and C-Path has since become the international leader in forming successful collaborations that advance scientific innovation to improve human health.

One of C-Path’s first steps was to reach agreement with the FDA and leading industry scientists on what processes they would use to advance the Critical Path Initiative.

The resulting process is transparent and entrepreneurial, driven by swift, thoughtful decisions, and accountable to timely, predetermined milestones.

The challenge was to create a productive environment among private sector competitors, while balancing their needs with those of the FDA, academic scientists, and public health.

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Complete Project Pipeline

blue U.S. Food & Drug Administration (FDA)

green European Medicines Agency (EMA)

orange Pharmaceutical & Medical Devices Agency Japan (PMDA)

Terms

1Feasibility: During this phase, discussions are in progress to determine if the drug development tool has sufficient priority based on its potential impact on public health and value to both the industry and regulatory agencies to justify launching a project to proceed toward a regulatory qualification submission.

2Scoping: During this phase, the project’s goals, objectives, deliverables, timeline, and budget are being developed.

3Research: During this execution phase the project team is actively engaged in carrying out the research plan.

4Submission: During this phase, a qualification dossier that reports the results of the research project and supports the context of use of the novel drug development tool is being prepared and will be submitted to the agency as indicated by the color code.

5Qualification: During this phase, the regulatory agency is reviewing the submission and will issue an opinion regarding the proposed utility of the novel drug development tool. When qualification decisions are made, links to the regulatory decisions will be provided at this site.