Small Molecules and Biologics Toxicology Consultant Support Services

Certara Usa, Inc., Saint Louis MO

Investigators

Abstract

The NINDS Subject Matter Expert Consultant for Toxicology provides technical guidance provide technical guidance to the following programs: • Toxicology consulting support to the NIH Blueprint Neurotherapeutics Network [BPN] drug discovery and development programs. • Toxicology consulting support to the Help End Addiction Longterm [HEAL] drug discovery and development programs. • 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. 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.