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Dr Vijaykumar Kale, BVSc, MVSc, PhD, DABT, ERT

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  • Working as a Project Toxicologist at Amgen, South San Francisco since Jan 2020. Prior to Amgen worked as a Study Director at Battelle Memorial Institute, Ohio for 4.5 years, and as a toxicologist and Vet Clinical Pathologist at Zydus Research Center, India for 6 years. 
  •  Graduated with PhD from Penn State University, MVSc from S.D. Agricultural University, India and B.V.Sc. & A.H. from Bombay Veterinary College.    
  • Over 11 years of industrial (pharmaceutical and Contract Research Organization) experience as a Study Director and Project Toxicologist in drug safety evaluation, particularly nonclinical toxicology studies of small molecules and biologics in various rodent and non-rodent animal models.
  • Successfully led short-term toxicology team for conducting IND-enabling toxicity studies of novel therapeutic drug candidates developed for wide spectrum of indications such as inflammation, diabetes, obesity, and hematological disorders.
  • Acted as Laboratory Director of Clinical Pathology laboratory which contributed to nonclinical drug safety evaluation of eight drugs registered with drug regulatory authority of India (Drug Controller General of India)
  • Experienced in conducting non-GLP and GLP toxicology studies as a Study Director per regulatory guidelines such as ICH, OECD, EMA, US-FDA (US-Food and Drug Administration) and DCGI.
Member Since 2011