In recent years, basic scientists have made breathtaking advances in our understanding of the human body?s biology and chemistry. The human genome has been sequenced, stem cells understood and RNA interference discovered. All of these advances have been celebrated for holding enormous promise for improving human health. But the road from promise to achievement of health impact ? what is called ?translation? in medical research terms ? is long, complex and full of obstacles. For example, it can take 14 years or more before a basic discovery leads to a new treatment. Another decade can pass before that intervention is available to all patients who need it. The National Center for Advancing Translational Sciences (NCATS) was established in 2011 to speed up the translational process and fully realize the potential of these scientific advancements for the healthcare benefit of American public and help eradicate neglected diseases worldwide and to bridge the gap of lack of investment in early development phase for new drugs to treat a variety of human conditions. Through programs in its Division of Pre-Clinical Innovation (DPI), NCATS drives advances in early stages of the translational process, from target validation to first-in-human studies. NCATS DPI aims to move small molecule and biologic drug candidates forward in the drug development pipeline to predetermined milestones, at which point, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. In addition to developing new candidate drugs for rare and neglected diseases, DPI seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial pre-clinical stage of drug development. DPI business model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an IND is filed with the US Food and Drug Administration (FDA). For certain drug development programs, DPI will support its candidate development up to human phase IIB studies if and when determined by NCATS management team as necessary to achieve its mission. DPI drug development programs are originated from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. DPI R&D operational strategy is to combine the capabilities of DPI in-house staff and its partners, who may be the drug originators, identify technical areas best suited for outsourcing, and utilize contract research organizations (CROs) to conduct some or all parts of a given drug development program. Each drug development program operates in a multi-disciplinary, multi-partnership matrix team environment. DPI has formed a partnership with SAIC-Frederick to engage and manage CROs and consultants for certain DPI drug development projects and studies.
