Recently established regulatory guidelines make testing for pediatric indications a necessary step in oncology research and development
Charles River Laboratories International, Inc. (NYSE:CRL) today announced the ability to conduct preclinical cancer research using ITCC-P4’s well-characterized collection of 400 annotated pediatric cancer models. As a global partner, Charles River is offering clients access to this collection. These are critical models for research, as the U.S. Food and Drug Administration’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. Additionally, the EU regulation of the European Medicines Agency (EMA) is being adapted to mirror the FDA’s regulations.
“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.”
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.
“Charles River worked on 84 percent of the FDA-approved cancer therapies over the last five years, and has delivered 16 oncology candidates to our partners,” added Julia Schüler, DVM, PhD, Research Director and Therapeutic Area Lead, Oncology at Charles River. “We are uniquely positioned to help researchers navigate through these new guidelines and progress their studies.”
Charles River offers a comprehensive portfolio of oncology drug discovery and development services, from model selection to safety assessment and support for biologic therapies. With a global infrastructure and deep scientific bench, Charles River is positioned to support programs from basic science to IND submission.
