P. Kalaiselvan

Background

About P. Kalaiselvan

American board-certified toxicologist (DABT) and Board certified toxicologic pathologist (DIBTP) with 16 years of experience in preclinical toxicology and pathology in pharma companies and CROs. Key expertise in evaluation of pathology data from nonclinical safety studies for human health risk assessment and support for drug discovery, development and regulatory filing (small and large molecules including vaccine). Broad expertise as primary and peer review pathologist in exploratory and regulatory (GLP) type toxicology studies of varying durations (single dose, sub chronic, chronic, reproduction and carcinogenicity studies) involving different routes of administration (oral, dermal, inhalation, intravenous, intramuscular and subcutaneous routes) in laboratory animals. Worked with multidisciplinary team of scientists and collaborated across discovery sciences like biology, DMPK, in vivo pharmacology and mutagenicity. Participated as primary and peer review pathologist for IND enabling studies and authored comprehensive reports. Provided scientific input about adverse effects observed in preclinical toxicology studies and contributed to risk assessment. Part of scientific team in integrated drug discovery programs.