Case Study

Assessing The Safety Of Novel Therapeutics For Pediatric Indications

Source: Altasciences
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A biotechnology company developing a novel therapeutic for pediatric patients was mandated by the FDA to conduct a complex, chronic safety study in 8- to 9-month-old juvenile nonhuman primates (NHPs) to meet regulatory requirements and advance their molecule into clinical development. With pharmaceuticals undergoing a technological revolution, advanced therapy medicinal products (ATMPs)—including gene and cell therapies—are rapidly expanding the possibilities for treating rare and inherited diseases.

These groundbreaking therapies hold significant promise for pediatric patients but pose unique challenges in nonclinical testing. Such studies often require innovative, non-conventional approaches to address the distinct physiological, developmental, and regulatory considerations of this vulnerable population. Altasciences specializes in designing and executing tailored studies that navigate these complexities, enabling the safe and effective development of novel therapies for pediatric and rare disease indications.

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