Focus On Biomarkers Research
NINDS Program Description
A biomarker is a defined characteristic that is used as an indicator of normal biological processes, pathogenic processes or responses to a therapeutic intervention. Biomarkers are recognized as essential tools for the development of therapeutics, allowing improved and better informed clinical trial design through indicators of target engagement and those that enable patient stratification. In addition, biomarkers can facilitate the evaluation of therapeutic intervention on disease progression or recurrence. Although biomarker discovery is a very active research area, few biomarkers have been sufficiently validated for use in clinical practice or clinical trials.
Biomarkers Development Process
- Only 13% of new drug approvals in 2017 were in neurology
- Selection biomarkers improve the probability of advancement from Phase II-NDAby 18-21%
- Only 5% of biomarker publications resulted in patented biomarkers in 2011
NINDS Biomarker Funding Opportunities
Biomarker Discovery
PAR-19-315 R61/R33 Research Project – Exploratory/Developmental Grant
Analytical Validation
PAR-21-056 U01 Research Project – Cooperative Agreement
PAR-21-057 U44 SBIR Fast Track – Cooperative Agreement
Clinical Validation
PAR-21-058 U01 Research Project – Cooperative Agreement
PAR-21-059 U44 Fast Track SBIR – Cooperative Agreement
The NINDS Biomarker Program is focused on improving the quality and efficiency of neurotherapeutic clinical research by supporting rigorous biomarker development and validation. In order to achieve this goal, the program: 1) promotes rigorous biomarker identification and validation through milestone-driven funding opportunities, 2) maintains an updated website containing information about existing NINDS and NIH biomarker sample and data repository resources and 3) facilitates the development of future resources focused on bridging the gaps in the biomarker development pipeline.
Proceedings & Outcomes
NINDS Biomarker Q&A Webinar (November 10, 2020)
NIH Workshop: Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain: Marriott Wardman-Park, Washington, DC (November 14-15, 2018)
GUIRR Webinar on Developing Biomarkers for Neurological Disorders and Pain
(October 30, 2018)
Biomarkers to Enable Therapeutics Development in Neurodevelopmental Disorders
(December 7-9, 2017)
Quantitative Systems Pharmacology and Drug Discovery: Filling the Gaps in Current Models of the R&D Process for Neurotherapeutics (July 26-27, 2017)
NIH Workshop Examines Role of Quantitative Systems Pharmacology Approach to CNS Drug Discovery (July 26-27, 2017)
Resources and Tools
Brings together diverse partners around a common mission to develop promising biomarkers in order to help accelerate the delivery of successful new technologies, medicines and therapies for prevention, early detection, diagnosis and treatment of disease.
A searchable catalogue of nearly 500 profiles on research consortia. Includes information on mission, structure, data sharing, partners, ways to connect, and more.
List of all current (active) NINDS supported projects available in the NIH RePORTER database, with associated publications.
List of all current (active) HEAL supported projects available in the NIH RePORTER database, with associated publications.
Provides draft guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs).
Clarifies terminology and uses of biomarkers and endpoints as they pertain to the progression from basic biomedical research to medical product development to clinical care. Developed by FDA and NIH to promote consistent use of biomarker terms and concepts, and thereby advance biomarker science.
