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NIH to Fund Studies that Adapt Adult Biomarkers to Children

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The National Institutes of Health announced Thursday that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will support studies that propose adapting adult biomarkers to children. This would include the application and validation of biomarkers developed in adults to pediatric diagnosis, prognosis, and estimation of disease progression, toxicity and response to therapy.

The NIH has three grant programs to support the program:

Standard NIH due dates apply for letters of intent and application due dates.

According to the announcement, most candidate biomarkers have been studied in adults. The identification and adaptation of those biomarkers for conditions that are similar in children “is an efficient, expedient and economical way to advance knowledge in the use of biomarkers in pediatrics”.

Moreover, the NIH believes that translating biomarkers from adults to children can provide new insights in disease, response to treatment and toxic effects.

The majority of candidate biomarkers that are associated with a specific mechanism relevant to disease progression or toxicity, or are affected by drug treatment, have been studied in adult medicine. Advances in -omics technology provide a plethora of analytical tools to discover and analyze mechanism- and disease-specific biomarkers for drug development. Translation of innovative systems approaches such as genomics, proteomics and metabolomics into a developmental framework has not been exploited to understand mechanisms of drug efficacy and toxicity in pediatrics. New technologies such as nanotechnology or functional imaging may need to be adapted for pediatric use before related biomarkers can be used in pediatric subpopulations.

There is a paucity of pharmacodynamic studies in children that can be compared to similar measurements in adults. Most pediatric studies only provide pharmacokinetic data preventing the determination of pharmacokinetics-pharmacodynamics correlations and the target concentration that produces the desired effect. Some adult pharmacodynamic biomarkers may need to be adapted for pediatric use. Measurement devices may need to be specifically designed for children instead of as miniature versions of adult devices.

The proposed FOA will foster collaboration between pediatric and adult medicine investigators in related disciplines.

Proposed research may use animal models in support of pediatric studies, stored clinical samples or new clinical testing. Each FOA does not specify the type of biomarker. However, the proposed research should address issues of clinical significance in pediatric therapeutics.

FOA: PAR-11-322: Biomarkers: Bridging Pediatric and Adult Therapeutics (R01)
FOA: PAR-11-323: Biomarkers: Bridging Pediatric and Adult Therapeutics (R03)
FOA: PAR-11-324: Biomarkers: Bridging Pediatric and Adult Therapeutics (R21)

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