Launched on May 19, 2015, INC is a global collaboration formed to forge a predictable regulatory path for advancing the safety and effectiveness of therapies for neonates across the world.
More than 96% of neonates receive at least one off-label medication while in the neonatal intensive care unit (NICU). Off-label medications are a normal part of patient care, however their use results in more adverse drug reactions in NICU patients. For medications to be used on-label, or to be indicated, for a specific patient population, they must first be rigorously studied in that population. Unfortunately, designing drug trials in neonates is extremely difficult. There is a persistent unmet need for safe and effective products specifically catering to and studied in neonatal populations.
C-Path launched the International Neonatal Consortium (INC) in order to address this unmet need. This global public-private partnership is designed to create a predictable regulatory pathway for evaluating the safety and efficacy of therapies for neonates. INC unites stakeholders from hospitals, research institutions, drug developers, patient advocacy groups, regulatory agencies, and other organizations around the world to generate consensus and develop tools that accelerate medical innovation for neonates.
Through open collaboration in a noncompetitive format, teams share data, knowledge, and expertise, in order to advance medical innovation and regulatory science for this underserved population.
INC and its partners have developed guidelines to inform the design of rigorous and efficient clinical trials for potential treatments of neonatal seizures. Neonatal seizures are the most common neurological emergency in neonates, occurring in about 3 in 1,000 term live births, and are associated with significant mortality and neurodevelopmental disability. Trials for this condition are exceedingly difficult and face many challenges, including different diagnostic criteria in different countries, relative rarity in occurrence and the self-limiting nature of many neonatal seizures, which can make them difficult to capture in the setting of a controlled study.
As a result of INC’s work, consensus recommendations were developed and published to address vital aspects of neonatal seizure clinical trials, including considerations for alternative designs, inclusion and exclusion criteria, safety monitoring, appropriate outcome measures, analytical plans and more.
Looking for more about INC, like FAQs, information about annual meetings, and general resources? Click here.
Interested in reviewing resources developed by the Institute for Advanced Clinical Trials for Children (I-ACT)? Click here.
With the support of FDA’s Office of Medical Policy, INC has initiated an ambitious real-world data integration effort, which will greatly accelerate drug development in neonates. Building on C-Path’s expertise in data integration, analysis, model-informed drug development (MIDD), and regulatory submissions, this effort has already integrated more than 300,000 patient-level data points (Electronic Health Records, registries, clinical trials) and is currently focused on:
Data integration activities from additional sources are ongoing. The Real-World Data and Analytics Program (RW-DAP) is scalable. The MIDD process is disease agnostic. Upcoming use cases will address industry needs by leveraging RW-DAP to establish historical controls for a range of neonatal diseases. The existing data are already capable of supporting other neonatal disease areas.
INC’s work in other focus areas include:
Jonathan Davis
Professor of Pediatrics, Tufts University
Deb Discenza
Founder and CEO, PreemieWorld
Jennifer Degl
Speaking for Moms and Babies, Inc
Wakako Eklund
Advance Neonatal Solutions. L.L.C.
Carole Kenner
Chief Executive Officer, Council of International Neonatal Nurses, Inc. (COINN)
Thomas Miller
VP and Global Head, Pediatrics, Bayer
Mark Turner
Senior Lecturer in Neonatology, University of Liverpool
Kanwaljit Singh, MD, MPH,MBA
Executive Director, INC
Christine Barry, MPH,
Senior Project Manager, INC
Olivia Muszynski,
Project Coordinator II, Pediatrics
Frank Walker
Data Manager IV
Klaus Romero, MD, MS, FCP,
Chief Executive Officer, Chief Science Officer, Executive Director of Clinical Pharmacology
Collin Hovinga, PharmD, MS,
FCCP,
Vice President, Rare/Orphan and Pediatric Disease Programs
Rick Liwski,
Chief Technology Officer and Data Collaboration Center Director
Lewis Barbieri, JD,
Director of Contracts
Jagdeep Podichetty, PhD,
Director, Predictive Analysis
Ramona Walls, PhD,
Executive Director, Data Science
Nicole Vasilevsky, PhD,
Associate Director of Data Science
Bob Stafford, MA,
Data Management Team Lead, DCC
Keith Scollick,
Platform Development Lead
Will Roddy,
Data Engineer Team Lead, DCC
Ian Braun,
Data Engineer
