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) provides direct support for clinical research and clinical research networks that focus on particular diseases or public health issues. One of the goals of NICHD is to conduct research to better understand the effects and effectiveness of pharmaceuticals on maternal and child health. This initiative will ensure that NICHD is able to access quickly and efficiently experts with the ability to support studies relating to pediatric drug and device development.

Work Details
The NICHD is seeking small businesses capable of designing, conducting, and overseeing the clinical, scientific, and technical aspects of pediatric drug development, including pre-clinical studies, formulations development, and Phase 1-3 pediatric clinical trials. The purpose of this initiative will be to recompete a Pediatric Trials Network (PTN) with experts knowledgeable in pediatric drug development, who through their knowledge and experience, can design, conduct and manage pre-clinical and pediatric clinical trial activities in various pediatric therapeutics areas. The network will support NICHD pediatric drug development activities, primarily focusing on trials that can achieve the objectives of the Best Pharmaceuticals for Children Act (BPCA), which was reauthorized in 2022 to improve labeling information for drugs used to treat children. Over the life of the contract, NICHD anticipates the need to initiate activities in approximately five (5) to ten (10) therapeutic areas with multiple therapeutic approaches for each therapeutic area. These activities will require multiple scientific and clinical investigators with expertise in various disease areas such as Infectious diseases, Treatment of neonatal diseases, Acute Care, Obesity related pharmacology, Lactation related pharmacology, and Training in clinical pharmacology.

Period of Performance
NICHD expects to award an Indefinite Delivery Indefinite Quantity (IDIQ) contract in 2024 with an ordering period of eight (8) years.