To address the paucity of effective treatments for disorders of the nervous system, the NIH is establishing the Blueprint Neurotherapeutics Network (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). This program intends to develop drugs successfully through clinical Phase I and facilitate industry partnerships for their full development. The long-term goal of this grand challenge is to produce at least one novel and effective medication for a disorder of the nervous system that is currently poorly treated or untreatable. To address this problem, the NIH Blueprint Neurotherapeutics Network is establishing a ?virtual pharma? network of contract service providers and consultants with extensive industry experience to enable drug development in the NIH neuroscience research community. The Network offers neuroscience researchers access to a full range of industry-style drug development services and expertise, including medicinal chemistry, IND-enabling studies, and Phase 1 clinical trial infrastructure. The goal of the Blueprint is to advance compounds successfully from chemical optimization through Phase 1 clinical testing. The Pharmacology and Toxicology for Neurotherapeutics Program (PTNP) contract award will support all preclinical pharmacology and toxicology testing needed to inform lead optimization and the selection of a clinical candidate, and comprehensive studies needed for an Investigational New Drug (IND) application for the FDA to allow for clinical evaluation of New Chemical Entities. The NIH Blueprint Neurotherapeutics network is an initiative of the NIH Blueprint for Neuroscience Research, a collaborative framework of NIH Institutes, Centers, and Offices that support research on the nervous system (http://neuroscienceblueprint.nih.gov/blueprint_basics/about_blueprint.htm). By pooling resources and expertise, the NIH Blueprint for Neuroscience Research takes advantage of economies of scale, confronts challenges too large for any single Institute or Center, and develops research tools and infrastructure that serve the entire neuroscience community. The Blueprint Neurotherapeutics Network will include the following components: 1. Pharmacology and toxicology facilities (PTNPs). As detailed in this SOW, the PTNP Contractor(s) will provide all preclinical pharmacology and toxicology testing needed to inform lead optimization and the selection of a clinical candidate, and testing required for an Investigational New Drug (IND) application for the FDA to support clinical evaluation of the compound. 2. Contractors for all other aspects of the drug development process, including medicinal chemistry, GMP manufacture, formulation, regulatory consultancy and IND preparation, and Phase 1 clinical trials. 3. Neuroscience researchers (Contributors) with bioactive small molecule compounds and bioactivity assays. The Contributors? compounds will serve as starting points for optimization and development within the Blueprint Neurotherapeutics network. 4. NIH staff. The NIH Contracting Officer (CO) and Contracting Officer Technical Representative (COTR) will oversee the PTNP contract. The COTR will offer suggestions and provide feedback to the Contractor on preclinical development strategies and protocol design, in consultation with the Contributors and NIH-hired consultants (see below). 5. Drug development consultants. The NIH will hire expert consultants to assist the COTR in reviewing proposals, reports, and data produced by the network Contractors and contributors. 6. Information Technology (IT) system. The NIH will establish a database and user-friendly, web-accessible interface for entering, searching, downloading, and visualizing development project data. At the direction of NIH, the PTNP Contractor(s) will be responsible for entering the data that they generate into this database. All network participants will receive training on how to use the IT system and technical support.
