Biological Therapeutics Product Development Subject Matter Expert Consulting Services

Investigators

Abstract

The NINDS has a need for biological therapeutics development subject matter expert (SME) consultants to 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 will cover all areas of cell and gene therapies, including chemistry, manufacturing, and controls, pharmacokinetics/pharmacodynamics, toxicology, medical writing, bioassay development, regulatory affairs, quality assurance/quality control, and biostatistics.