James Harris

James Harris serves as a key procurement lead within the Office of the Assistant Secretary for Preparedness and Response, supporting the Department of Health and Human Services’ mission to secure and deploy medical countermeasures against public health emergencies. He manages strategic acquisitions for biodefense-related products and research, focusing on the rapid development, manufacturing, and scaling of vaccines, therapeutics, and diagnostics. His work directly enables the agency’s ability to respond to pandemics, bioterrorism, and emerging infectious threats through timely, mission-critical contract actions aligned with federal biodefense priorities. Harris maintains consistent contracting relationships with specialized biopharmaceutical and biotechnology firms, including Cidara Therapeutics, Aquestive Therapeutics, Rafa Laboratories, and Osivax. These partnerships center on advanced product development, formulation science, and clinical-stage manufacturing capabilities. His procurement approach emphasizes technical readiness and scalability, favoring vendors with established GMP compliance, regulatory experience with FDA pathways, and demonstrated capacity to deliver under public health emergency conditions. The relationships are characterized by long-term, performance-based contracting frameworks designed to ensure continuity of supply and adaptive response capabilities. Harris’s procurement portfolio reflects a strong preference for full and open competition, with 100% of awards issued under no set-aside categories. This indicates a strategic focus on securing the most technically capable and scalable solutions rather than socioeconomic preferences, aligning with the urgency and scale of national biodefense requirements. While small business participation is not formally prioritized through set-asides, vendors of all sizes are evaluated strictly on technical merit, manufacturing capacity, and regulatory compliance. His primary procurement focus lies in NAICS 325414 (Biological Product Manufacturing) and 541714 (Research and Development in Biotechnology), reflecting deep expertise in procuring novel biologics, antiviral therapeutics, and advanced drug delivery systems. He routinely engages with contractors developing mRNA platforms, lyophilized formulations, and immunotherapies, demonstrating specialized knowledge in biopharmaceutical development lifecycles and regulatory compliance frameworks essential to public health emergency response.