In an exciting step forward to support research and development of innovative new medicines and devices for pediatric patients, the Critical Path Institute (C-Path) announced the launch of a new nonprofit to address challenges in bringing new therapies to children in need.
Called the Institute for Advanced Clinical Trials for Children (I-ACT for Children), this new organization will seek to foster public-private collaboration in finding solutions to barriers to pediatric medicines development as well as improving the pediatric clinical trials process. Specifically, it will work to optimize pediatric study designs, protocols, best practices, training and engagement of patients and parents to advance clinical trials to improve children’s health.
PhRMA has been working with C-Path and our member companies since 2014, to address challenges in pediatric medicines development, including collaborating on the establishment of the Pediatric Trials Consortium (PTC), which is committed to ensuring timely and efficient evaluation of innovative therapies for pediatric patients. The PTC convened stakeholders from the patient, academic, medical, government and biopharmaceutical communities to produce its 2016 Advisory Report, which ultimately led to the formation of the I-ACT for Children.
In the I-ACT launch announcement, Johnson & Johnson’s Chief Medical Officer Joanne Waldstreicher, MD noted, "dedicated, science-driven expertise is critical to developing safe, effective and properly formulated therapies for children. I-ACT for Children will play a pivotal role as an independent, child-centered catalyst that will help us all accelerate the availability of scientific data needed to inform the safe and effective use of medicines and devices for children globally."
Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration added, “The launch of I-ACT for Children is an important milestone in the global effort to collect reliable data and accelerate treatment development for our pediatric patients. We look forward to engaging with stakeholders as we work toward the common goal of improving children's health."
America’s biopharmaceutical companies are committed to bringing new medicines to patients in need, including those that are often most vulnerable – children – and we are proud to support this new initiative.