The specific consultant SME technical areas required are outlined below. 1. Biologics Chemistry, Manufacturing and Controls (CMC) viral vector therapeutics SMEs Subject matter experts in manufacturing of viral therapeutics platforms, including but not limited to modalities such adeno-associated viruses (AAVs), and/or lentiviruses, and other therapeutic viral vector platforms are required. Biologics CMC consultants will be expected to provide senior-level chemistry, manufacturing and controls expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email. The role of the CMC SME consultant may include, but is not limited to, the following responsibilities and tasks: a) Consultants will provide the type of input that will allow the NINDS to design and implement new programs to address external research needs and objectives b) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage CMC to facilitate preclinical evaluation and safety testing, IND submission, and clinical studies c) Provide strategy and feedback on AAV and/or other viral vector biologics process development and manufacturing plans proposed by the team d) Facilitate Team discussions via telephone and email regarding assigned CMC efforts e) Provide strategic guidance for the continued development and improvement of the URGenT program f) Serve as the CMC expert in order to identify potential product manufacturing challenges and suggest strategies to address these challenges g) Provide feedback on therapeutic viral vector processes proposed by the team h) Review and comment on the adequacy of biologic manufacturing including scale-up, analytical method development, and process development (upstream and downstream processing) approaches proposed by PIs and CMOs