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

Investigators

Abstract

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 will provide 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 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.