The Initiative for Pediatric Drug and Device Development (iPD3) is a first-in-kind venture uniting leaders in pediatrics and pediatric pharmacology aimed at filling critical unmet needs in advancing the pediatric therapeutics landscape. iPD3 will work with pharmaceutical companies and other clients from inception to regulatory filing, including the conduct of pediatric clinical trials. We will provide services including pediatrics-appropriate preclinical disease modeling and safety/toxicity analyses, clinical trial design informed by the most advanced quantitative methodologies and in line with regulatory agency requirements, access to pediatric patient populations, along with all necessary pediatric, pharmacologic as well as regulatory expertise.