Danielle (Dani) joined Nuventra in October 2019 with 20+ years of experience in nonclinical DMPK (GLP and non-GLP) and clinical PK (Phase 1 and Phase 2) in both large pharma and CRO environments across a range of therapeutic areas. She has extensive experience in NCA-based PK/TK analyses and reporting in a regulated environment, providing PK data and interpretation for small molecule compounds, biologics, monoclonal antibodies, antibody‑drug conjugates, etc., including assessments of anti‑drug antibody (ADA) effects on PK. She is a reliable resource for protocol preparation/review, selection of appropriate PK/PD sample collection time points, and ensuring compliance with applicable regulations. Dani’s experience extends into providing PK data in a regulatory submission-ready format (eCTD and CDISC SEND), as well as summarizing results across multiple PK studies for inclusion in regulatory submissions. She has a proven history of high-quality PK data/reports compliant with FDA and/or OECD regulations, and continues to focus on complete customer satisfaction.