Critical Path Institute launches neonatal consortium
The International Neonatal Consortium (INC) aims to accelerate the development of safe, effective therapies for newborns
The Critical Path Institute (C-Path) has formed its ninth consortium, the International Neonatal Consortium (INC). The launch took place in London at the European Medicines Agency (EMA) during a widely attended workshop focused on the needs of the neonate.
Dr Jordi Llinares Garcia (Interim Head, Human Medicines Research and Development Support Division, EMA) welcomed the collaborative efforts to create novel and improved methods to evaluate treatments that will one day benefit a vulnerable and under-served population.
Dr Janet Woodcock, Director of CDER/FDA, commented: ‘By uniting stakeholders from research institutions, drug developers, regulatory agencies, patient advocacy and other organisations, INC can develop practical tools that can be incorporated into clinical trials for neonates, which will then lead to more successful, efficient trials and provide this population with better treatments.’
INC is the latest in a series of successful developments for C-Path, which includes the celebration of its 10th anniversary and the opening of a new office in London.
‘Individual organisations simply do not have the data, resources or expertise to address the many gaps in regulatory science that exist for the neonatal population,' explained C-Path President and CEO Dr Martha Brumfield. ‘By using our consensus science model to advance regulatory science, this consortium will lead the way in developing a new paradigm to evaluate drugs and devices for much-needed neonatal treatments.’
‘The International Neonatal Consortium embodies the collaborative nature of the Arizona Health Sciences Center, which has major multidisciplinary initiatives in health disparities, population health, paediatrics, translational medicine and many other areas,’ said Dr Joe Garcia, UA’s Senior Vice President for Health Sciences. ‘We welcome the opportunity to partner with C-Path to more rapidly develop better treatments for this vulnerable population.’
INC will concentrate on conditions commonly observed in neonatal intensive care units (NICUs), including neonatal brain, lung and gastrointestinal injury, neonatal sepsis, retinopathy of prematurity and neonatal abstinence syndrome.
