For nearly 20 years, Janssen, the pharmaceutical companies of Johnson & Johnson (J&J), have been working to bring hope to the millions of children with serious diseases worldwide. With a science- and evidence-based approach to addressing the unmet needs of treating childhood diseases, J&J often engages and collaborates with external experts, including from academia, regulatory authorities, government and others in industry.
Now, thanks to an initiative born out of J&J’s participation in a consortium led by the Critical Path Institute (C-Path), a powerful effort is underway to optimize and accelerate biomedical innovation to benefit the development of innovative treatments for children in need.
J&J co-led the Pediatric Trials Consortium that helped C-Path shape and support the establishment of the independent, non-profit Institute for Advanced Clinical Trials for Children (I-ACT for Children). I-ACT for Children aims to serve the needs of children by asking the right scientific questions, and providing the right data and evidence necessary for treating pediatric patients with confidence.
In this post, Joanne Waldstreicher, M.D., Chief Medical Officer for Johnson & Johnson, shares her thoughts on I-ACT for Children, and the value it offers not only to Janssen, but more importantly to children worldwide who are waiting for the breakthrough research and the innovative medicines that will bring new hope in their fight against serious disease.
Children comprise nearly one-third of the world’s population today – that’s more than two billion children living around the globe. But many of them can’t benefit from modern medicine’s most promising treatments because the healthcare industry as a whole -- including public and private institutions -- has not overcome some of the hurdles to generating sufficient data in children. As a doctor, healthcare executive, and as a mother, I find that intensely challenging.
That is why we have worked diligently to lead collaborations across industry, government and academia to advance children’s health – collaborations led by Samuel Maldonado, M.D., Head of our Child Health Innovation Leadership Department (CHILD), and Pamela Simpkins, CHILD’s Senior Director.
Johnson & Johnson is a founding member of Institute for Advanced Clinical Trials for Children (I-ACT for Children), an independent, non-profit organization that believes children of all ages deserve to have innovative medical therapies developed in children with the same level of commitment afforded to adults .
I-ACT for Children is a newly formed nonprofit that will work to assure that studies are designed to generate sufficient data to allow safe and effective use of new medications and devices in children. A key factor in making this a reality is to optimize and accelerate biomedical innovation using child-centered clinical trial networks and collaboration with like-minded institutions, trial sponsors and other stakeholders.
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.
Our patients are often best served when we partner with external independent experts, and by fostering these important collaborations, we facilitate innovative solutions that enhance the lives of children worldwide.
I-ACT for Children supports and advances independent research, education and clinical trials related to treatments to enhance pediatric healthcare. I-ACT for Children will operate the first multi-therapeutic, globally collaborative clinical trial network, accelerating access to better prescribing information for pediatric medicines and devices. It will play a pivotal role as an independent, child-centered catalyst that will help accelerate the availability of scientific data needed to ensure that pediatric treatments have sufficient scientific and clinical evidence to support their safe and effective use.
We look forward to engaging with I-ACT for Children as it brings external experts together – caregivers, patients, clinicians, investigators, regulators, sponsors and other stakeholders – to address urgent, unmet medical needs in children.
Posted July 20, 2017
