Sheila Brown

Sheila Brown supports the FDA Center for Drug Evaluation and Research in executing critical procurement activities that advance the agency’s mission to ensure the safety, efficacy, and quality of pharmaceutical products. She manages acquisitions for scientific and technical services essential to drug review processes, including analytical testing, regulatory science support, and workforce development. Her portfolio focuses on securing specialized professional services that enhance the Center’s capacity for evidence-based decision-making, leveraging computational modeling, data analytics, and laboratory validation capabilities to inform regulatory outcomes. Sheila maintains a consistent working relationship with THINKTRENDS, LLC, a key contractor providing scientific and technical consulting services aligned with the Center’s evaluation priorities. Her procurement patterns reflect a preference for established vendors with demonstrated expertise in pharmaceutical compliance, laboratory operations, and regulatory strategy. These partnerships are typically structured as task-order or indefinite-delivery/indefinite-quantity contracts, enabling agile responses to evolving scientific and regulatory needs. Her contracting approach prioritizes broad market access, with 72.7% of awards issued under open competition and 27.3% designated as total small business set-asides under FAR 19.5. While she does not routinely utilize specialized socioeconomic programs such as 8(a), HUBZone, or SDVOSB, her consistent use of small business set-asides reflects a deliberate commitment to fostering innovation and diversity among qualified technical service providers. Sheila’s procurement focus centers on NAICS 541380 (Testing Laboratories and Services) and 541990 (Other Professional, Scientific, and Technical Services), reflecting demand for analytical validation, bioequivalence studies, and regulatory consulting. She also procures professional training services under NAICS 611430 to strengthen reviewer competencies in emerging therapeutic modalities. Her work supports technical domains including biopharmaceutical development, generic drug assessment, and data-driven regulatory science, ensuring the FDA maintains rigorous, science-based standards for drug approval.