April 15, 2016 Page 1 of 7 NIH DRUG DISCOVERY AND DEVELOPMENT CONSULTING SERVICES STATEMENT OF WORK BACKGROUND The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), conducting research into the causes, treatment, and prevention of neurological disorders and stroke. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services are provided without cost to the PI through NIH contracts. STATEMENT OF OBJECTIVE The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in the following specific disciplines to provide leadership and technical guidance on drug discovery and development projects in the BPN and possibly other NIH drug discovery and development projects and programs: • Bioactivity Assay • Drug Metabolism and Pharmacokinetics SCOPE OF WORK Each consulting contract will be specific to one or more areas of expertise as outlined in this Statement of Work, and will reflect the NIH time commitment needs for the specific areas of expertise. April 15, 2016 Page 2 of 7 Consultants hired under this requirement will not only make significant contributions to promising drug discovery and development projects that have been selected through a rigorous peer-review process, they will also help shape an innovative, high-profile program that may serve as a model for future NIH drug discovery efforts. Contract consultants will be expected to provide feedback and guidance on programs and projects to th...