scientific operations

Kevin Holsapple

With more than eighteen years of experience in nonclinical research and development, Kevin specializes in the oversight, coordination, and management of outsourced toxicology studies. As a Study Monitor, he collaborates closely with project toxicologists from study conception through final reporting, ensuring the successful execution of nonclinical programs that support regulatory submissions.

Drawing on extensive experience gained at a Contract Research Organization (CRO), Kevin has coordinated a broad range of studies, from dose-range finding through chronic toxicology evaluations, across multiple animal models and routes of administration. He has managed complex, multi-site study programs, including studies conducted in North America, Europe, and Asia.

Kevin's expertise includes protocol review, toxicology report coordination, preparation and review of tabulated summaries, expedited reporting timelines, SEND dataset management, and regulatory document development. He routinely coordinates cross-functional review activities, conducts site monitoring visits to assess study conduct and compliance, and performs detailed data and report reviews, including interpretation of study methods and results.

In addition, Kevin provides SEND guidance and training, supports process development initiatives, and contributes to the preparation, quality review, and coordination of regulatory submissions, including INDs and international regulatory filings. His strong project management skills and technical expertise help ensure high-quality study execution and regulatory readiness across nonclinical development programs.