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Janice Lansita
Ph.D., D.A.B.T. ·
Kennett Square, Pennsylvania
Toxicology
Specialized expertise in the nonclinical evaluation of biologics, including pharmacologically relevant species selection, immunogenicity, immune-mediated toxicity (e.g., complement, anti-drug antibody, autoimmunity, cytokine-release), and immunotoxicology study design
Pharmacology/Toxicology Reviewer at USFDA
Expertise in the integrated interpretation of nonclinical safety data, and providing recommendations to the FDA review team and management to inform clinical trials and patient safety
Experience in the design and monitoring of non-GLP and GLP toxicology studies, including the review, analysis, and interpretation of data to inform preclinical and clinical development
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