The following support shall be provided for Therapeutic Development Branch: • Continuation of the "Integrated Data Resource for Rare Diseases" working with Advanced Biomedical Computational Science at Leidos Biomedical Research, Inc.; • Assay validation and non-GMP and GMP manufacturing of batches of drug substance and drug product; • Stability studies to support projects with GMP and / or non-GMP products; • Biodistribution / imaging and pharmacokinetic studies; • Consulting services for development of bioanalytical methods; • Regulatory services to support preclinical and / or clinical-stage projects; • Electron microscopy studies; • Gene expression and proteomic data analyses and cell-based screening studies; • Proteomic profiling, cell-based efficacy studies, and clinical trials for canine comparative oncology; • Laboratory animal support.