NINDS Biotechnology Products and Biologics Regulatory Affairs Consulting Services STATEMENT OF WORK FINAL REVISED DOCUMENT 04/11/2016 BACKGROUND 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. NINDS intramural labs are headed by federal employees who work for the Institute, primarily located in Bethesda, MD. For more information on the NINDS Intramural program visit the website http://dir1.ninds.nih.gov/ninds/Home.aspx For extramural research, NINDS awards grants and cooperative agreements to outside academic institutions, small business concerns and other organizations all over the U.S. and world to fund promising basic, translational, and clinical research projects. Specifically, the NINDS Office of Translational Research (OTR) is committed to facilitate the translation of basic discoveries into the development of new therapeutic interventions through early nonclinical development and early clinical investigation. For more information about the Office of Translational Research visit the website http://www.ninds.nih.gov/funding/areas/translational_research/index.htm Projects that are funded through a cooperative agreement award mechanism are led by the principal investigators (PI) team with NINDS program staff participation in guiding the project plan. The PI’s team performs all of the experiments while NINDS role is to establish performance milestones for each project to facilitate go/no-go decision making and then monitor research progress and achievement of project milestones. STATEMENT OF OBJECTIVE The NINDS is seeking senior-level, industry-experienced discovery and development Biologics Regulatory Affairs consultants with expertise in biotechnology products and biologics to assist NINDS program staff to vet and advance only the most promising therapeutic biologics through the discovery and development pipeline. Both individual subject matter experts and multidisciplinary teams from consulting firms are encouraged to apply. The NIH anticipates awarding multiple consulting awards in reference to this requirement. Approximately two, and a maximum of three, awards are anticipated. A. SCOPE OF WORK General Requirements Each consultant is expected to provide technical guidance and advice on advancing discovery and development projects through early nonclinical development and submission of an Investigational New Drug (IND) package, and in some cases, design of early clinical protocol and launch of a first in human clinical trial. Consulting services will be for NINDS biologics-focused projects or any other NIH program with similar needs as outlined in the scope of this statement of work. Consulting adv...