PHARMACEUTICS FORMULATION/CHEMISTRY MANUFACTURING AND CONTROLS CONSULTING SERVICES FOR SMALL MOLECULES AND/OR BIOLOGICS

Investigators

Abstract

Subject Matter Expert (SME) for Drug Metabolism Pharmacokinetics (DMPK) to support the Blueprint Neurotherapeutics Network for Small Molecule (BPN-Small Molecule) and NIH Blueprint Neurotherapeutics program (BPN) The NIH Blueprint for Neuroscience Research, is a collaborative framework that includes the NIH Office of the Director and 12 NIH Institutes and Centers that support research on the nervous system, 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 subject matter experts 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 can be provided without cost to the PI through NIH contracts. “This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to understand the basis of pain and enhance clinical pain management.” The Subject Matter Expert Consultant for Pharmaceutics / Formulation / Chemistry Manufacturing Control [CMC] provides technical guidance to the following programs: • Pharmaceutics / Formulation / CMC consulting to support the NIH Blueprint Neurotherapeutics [BPN] program. • Pharmaceutics / Formulation / CMC consulting to support the NIH Help End Addiction Longterm [HEAL] program. • Pharmaceutics / Formulation / CMC consulting to support the NIH Biologics program. • Other NIH neuroscience-focused drug discovery and development programs. 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. The HEAL program supports preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate promising small molecule and biologic hits/leads towards clinical trials. The HEAL program provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The Pharmaceutics / Formulation/ CMC consultants support the mission of The National Institute of Neurological Disorders and Stroke (NINDS) to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people.