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Regulatory guidelines make testing for pediatric indications a necessary step in oncology R&D.
October 16, 2023
By: Anthony Vecchione
Charles River Laboratories International, Inc. reported that it has the ability to conduct preclinical cancer research using ITCC-P4’s well-characterized collection of 400 annotated pediatric cancer models, and is offering clients access to this collection. These are critical models for research, as the U.S. FDA Research to Accelerate Cures and Equity (RACE) for Children Act, requires all oncology drugs to be tested for pediatric indications ahead of approval. In addition, the EU regulation of the European Medicines Agency (EMA) is being adapted to mirror the FDA’s regulations. The ITCC-P4 repertoire offers access to models that are relevant to pediatric cancer, allowing researchers to appropriately investigate targets of interest, and ultimately increasing translation to preclinical trials. Pediatric tumors have different genomic drivers and phenotypes than adult tumors, requiring unique preclinical models. The ITCC-P4 collection is supported by an accompanying dataset consisting of molecular phenotyping and pharmacological characterization backed-up by expertise from internationally recognized pediatricians. By offering this collection, Charles River is combining decades of oncology research experience with a powerful tool that will better guide critical investigative decisions. “Globally, 400,000 children and adolescents develop cancer each year, and approximately one in four cannot be cured with currently available therapies,” said Aidan Synnott, corporate vice president, global discovery services at Charles River. “The ITCC-P4 collection is comprehensive, relevant, and well-characterized, meaning we can better assess the safety and efficacy of new oncology treatments specifically for children. This will ultimately lead to new treatment options for a critically important patient population.”
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