Biological Therapeutics Product Development Subject Matter Expert

Investigators

Abstract

The NINDS biological therapeutics development subject matter expert (SME) consultants provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs. The support included in this contract covers chemistry, manufacturing, and controls (CMC) for gene therapies. BPN Biologics, part of the NIH Blueprint for Neuroscience Research, aims to advance the development of novel biologics-based drugs for nervous system disorders. The program covers diverse biotherapeutics modalities, including antibodies, proteins, peptides, oligonucleotides, gene and cell therapies, and other emerging modalities. Support is provided for projects from lead optimization to first-in-human clinical trials through participation from multiple NIH Institutes and Centers. In addition to funding, BPN Biologics provides integrated project support to help academic and small company labs bridge critical gaps. Awarded projects receive, including: Assistance from NIH-funded drug development consultants with extensive industry and regulatory experience The option to run industry-standard nonclinical, manufacturing, and early-phase clinical activities through NIH-funded contract research organizations (CROs).