Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network (PTN)   3

Background
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to solicit proposals to establish an Indefinite-delivery, Indefinite-quantity (IDIQ) contract to support clinical activities for the Best Pharmaceuticals for Children Act Program (BPCA).

The Pediatric Trials Network (PTN) serves as the clinical trials infrastructure for this program. The goal is to conduct regulatory rigorous pediatric clinical trials that lead to drug label updates and provide new information on medication disposition and response in children.

Work Details
The successful offeror shall provide personnel, facilities, and services to establish, conduct, and support pediatric clinical trials. Key tasks include:
- Expert consultation in pediatric clinical trial designs;
- Clinical site management;
- Monitoring for opportunistic and standard of care trials;
- Pediatric clinical pharmacology expertise;
- Method development;
- Product formulation consultation;
- Drug distribution;
- Pediatric device validation.

The contractor will also gather epidemiology data on drugs used in routine care and utilize novel research designs such as electronic health record extraction. NICHD anticipates initiating activities in therapeutic areas including rheumatologic diseases, infectious disease, acute care, neonatal therapeutics, lactation-related therapeutics, obesity-related pharmacology, biodefense, and standard of care pharmacology research.

Period of Performance
The anticipated period of performance is eight (8) years, beginning May 1, 2025.

Place of Performance
The work will be performed at various locations as determined by individual task orders.