News Release

I-ACT for Children established to catalyze pediatric therapeutics clinical research & education

New non-profit institute to work with public and private stakeholders to enable research and education on innovative treatments to enhance healthcare for children.

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(Tucson, AZ) [Regionally: Baltimore, MD], 4/10/2017. Critical Path Institute (C-Path) has established a new 501(c)3 non-profit, the Institute for Advanced Clinical Trials for Children (I-ACT for Children), to support and advance research and education on innovative pediatric treatments.

I-ACT for Children serves as a neutral forum for public-private collaboration in addressing common challenges in pediatric trials to help demystify the studies. It will also assist in optimizing study designs, protocols, best practices, training and engagement of patients and parents.

"Children of all ages deserve innovative medical therapies that are developed with the same level of urgency and commitment afforded adults," said Ed Connor MD, MBE, FAAP, Chairman and President of I-ACT for Children. "This new institute will work with others to improve the efficiency, feasibility, timeliness and impact of clinical trials of innovative drugs and devices in children."

For many drugs and devices used in children, insufficient data exist to support safe and effective use in this population. Statutes and regulations in the US and EU require and incentivize certain pediatric studies and I-ACT for Children will work with public and private stakeholders to help ensure that this work has maximal impact on child health.

"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," said Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research at the US Food and Drug Administration.

I-ACT for Children was developed through the work of the Pediatric Trials Consortium, a C-Path initiative that included clinicians, academicians, regulators, patient advocates, parents, professional societies, international experts, representatives from the biopharmaceutical industry and disease-focused pediatric networks.

Biopharmaceutical companies, often the sponsors for new drug and device development, have recognized the need for a new approach to clinical trials in children with a focus on solutions as the demand for innovative health solutions for children increases.

"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," shared Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson. "We look forward to engaging with I-ACT for Children as it brings caregivers, patients, clinicians, investigators, regulators, sponsors and other stakeholders together to address unmet medical needs in children."

C-Path has a ten-year history of establishing consortia of public and private collaborators to address key issues in therapeutics development and it has been instrumental in the establishment of I-ACT for Children. C-Path will continue to partner with the new institute as it launches its work in 2017.


About the Institute for Advanced Clinical Trials for Children

The Institute for Advanced Clinical Trials for Children is a new independent, nonprofit organization that works with public and private stakeholders to improve the planning and completion of pediatric clinical trials. It facilitates advanced research and education directed at improving the timeliness, quality and medical impact of clinical trials of innovative therapeutics on child health. The Institute was established by Critical Path Institute with advice and guidance from its Pediatric Trials Consortium that includes more than 30 diverse organizations, including patients/parents, government agencies, professional organizations, academia, the biopharmaceutical industry and international experts. I-ACT for Children is headquartered in Rockville, MD. For more information, visit

About Critical Path Institute

Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the US Food and Drug Administration (FDA). C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established 12 global, public-private partnerships that currently include over 1,450 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona. For more information, visit

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