Steven Gagnon

Steven Gagnon serves as a key procurement lead within the FDA Center for Drug Evaluation and Research, supporting the agency’s mission to ensure the safety, efficacy, and quality of pharmaceutical products through data-driven regulatory science. He manages acquisitions focused on advanced computational modeling, analytical software, and digital infrastructure critical to drug review processes. His portfolio primarily encompasses technology services that enhance the agency’s capacity for evidence-based decision-making, including data analytics platforms, cloud-based research environments, and software solutions for regulatory submission processing. Gagnon’s work directly enables the modernization of FDA’s scientific evaluation capabilities through strategic sourcing of innovative technical services. His primary contractor relationship is with THINKTRENDS, LLC, a vendor frequently engaged to deliver specialized IT services supporting drug evaluation workflows. Gagnon consistently partners with firms capable of delivering secure, scalable computing solutions aligned with federal data integrity standards. His contracting patterns reflect a preference for agile, responsive vendors with demonstrated expertise in regulatory-compliant software development and high-performance data processing environments. These partnerships are typically structured as task-order contracts under indefinite-delivery, indefinite-quantity (IDIQ) mechanisms to ensure flexibility in responding to evolving scientific priorities. Gagnon demonstrates a strong commitment to small business participation, with 66.7% of his acquisitions designated as total small business set-asides under FAR 19.5. His procurement strategy actively prioritizes socioeconomic programs that expand access for small, disadvantaged firms, reinforcing the FDA’s broader goals of inclusive innovation. He routinely structures solicitations to maximize opportunities for small businesses while maintaining rigorous technical and compliance standards. His primary NAICS focus is 541519 (Other Computer Related Services), reflecting his specialization in custom software development, data analysis tools, and scientific computing services. He also procures services under 518210, indicating a reliance on cloud infrastructure and data hosting platforms that support secure, high-volume regulatory data processing. Gagnon’s expertise lies at the intersection of regulatory science and information technology, ensuring that procurement decisions directly enable the FDA’s mission of public health protection through cutting-edge digital capabilities.