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Milestone 4.H

Institute an expedited review track for applications focused on drug discovery, preclinical, and clinical drug development for Alzheimer’s disease to mitigate erosion of patent life and to allow a viable commercialization strategy for NIH supported molecules.

Ensure that review panels for translational research applications are staffed with adequate cross-disciplinary expertise to evaluate all aspects of drug discovery and development for a variety of therapeutic targets and therapeutic modalities.

Encourage industry utilization of NIH funding to increase the number of therapeutic agents and therapeutic mechanisms tested in phase II proof of mechanism trials.

Success Criteria

Establish an NIH working group to develop an expedited review track for translational AD and ADRD research applications (from target identification/validation drug discovery through Phase III clinical trials).

Time Required

2016 to 2017

Research Implementation Area

Translational Tools, Infrastructure and Capabilities

Activities, Funding Initiatives, and Resources

NIH RFA-TR-15-002: CTSA Network - Trial Innovation Centers (TICs) (U24)
NIH RFA-TR-15-002: CTSA Network - Trial Innovation Centers (TICs) (U24)
NIH PAR-18-513: Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (…

Relevant Recommendation(s)

2012 AD Summit Recommendations: 3H