New Collaborations to Promote Medical Products Innovation
This thematic area of flagship activity integrates several key areas to improve our nation’s approach to innovative new strategies to prevent, diagnose, and treat disease and health conditions. As a composite of several specific initiatives taking place at several HHS agencies, new models of collaboration on innovation pathways for creating new, more effective interventions. Among the various components of this plan are new capabilities addressing unmet public health needs. These include FDA’s Innovation Pathway – End Stage Renal Disease Challenge that will introduce new decision tools to help FDA assess and characterize benefits and risks to patients. In a new collaboration model, FDA will use tools and other approaches to foster collaboration with innovators to share ideas about new device concepts. During 2012, this project will complete its collaboration phase with innovators, and in early 2013, FDA will publicly share lessons learned from the process.
Another component of this flagship is an innovative joint FDA-NIH initiative on new pediatric formulations of medical products. This collaboration is designed to address the lack of commercially-available, age-appropriate oral forms of medications for pediatric patients for several critical diseases. The project will use an open-source approach to sharing non-confidential information included in applications to FDA from researchers, regulators, and sponsoring industry through a new platform that promotes networking and collaboration. This project aims to use prototypical drug products and employ computational methods to characterize their molecular structure through standardized testing to produce an open-source, publicly available approach to pediatric oral formulations by 2014.
Collaboration and partnerships opportunities will be key elements underpinning a major new effort underway at NIH to strengthen our nation’s medical product pipeline. The National Center for Advancing Translational Sciences is reshaping research capabilities and infrastructure to catalyze a generation of innovative methods and technologies to enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.
More information about each of these components of this flagship initiative can be found in the participation and collaboration section of this plan. Collectively, these initiatives will demonstrate new approaches to bringing scientific knowledge together in collaborations that use technology capabilities to foster new ideas and approaches to problem solving. The yield of this Open Government effort will bring innovations in areas of high public health need in 2013 and 2014.