NIH DRUG DEVELOPMENT CONSULTING SERVICES

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In 2010, the NIH Blueprint for Neuroscience Research, representing sixteen NIH Institutes and Centers, announced a Grand Challenge for Neurotherapeutics to address the paucity of effective drugs for disorders of the nervous system. To meet this Grand Challenge, the NIH Blueprint is pioneering a new model for drug development¿a network that integrates industry drug development expertise with the innovative disease biology that is the strength of NIH-funded research. The Blueprint Neurotherapeutics Network will operate as a ¿virtual pharma¿ (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). Neuroscience researchers (principal investigators) with a compelling therapeutic rationale and starting materials for a drug development project will be matched with senior-level, industry-seasoned consultants who will design and direct the drug development plan. The principal investigators will conduct the bioactivity assays and biological work, and Contracted Research Organizations (CROs), which will be identified and funded by NIH through separate contracts, will implement all other drug development activities. The principal investigator, consultants, NIH staff, and CRO staff engaged in a project will constitute a Lead Development Team (LDT).