Kumar Sripathirathan, Ph.D.

Kumar Sripathirathan, Ph.D.

Kumar Sripathirathan, Ph.D.

Senior Regulatory Consultant

Kumar has over 25 years of domestic and international experience in Toxicology and Pharmacology studies. He has extensive experience working with candidate drugs (small molecules, biologics) in multiple pathologies such as in cancer, infectious disease, CNS, CV, ocular indications. He has proven leadership in drug discovery and development, CRO outsourcing and in managing development programs. He serves as consultant for startup and mid-stage pharma and nutraceuticals.

Kumar is well versed in application of in silico/in vitro/ in vivo studies in translational studies and use of novel in vitro/animal models for efficacy. Has a good handle on the use of bio-analytical techniques (LC, LC-MS/MS, ICP, GC-MS) for evaluating PK/TK. He has worked on risk mitigation and de-risking strategies for drugs and in support of selection of therapeutic targets. He has contributed to the IND package for Phase I/II studies (US), and in application of current FDA guidelines for drug development and in practices relevant for the development cycle.

Work experience

As a toxicologist, he has worked with industry, academia, and non-profit institutions, including projects for Environmental Protection Agency and World Health Organization. He has worked with the Global Project Development Teams on drug discovery and development activity on a novel drug discovery platform of small molecule inhibitors for Alzheimer's disease with CoMentis-Astellas (Japan) by providing leadership skills and cross-cultural experience. With a master's degree in Clinical Research, he was involved in clinical research study of stroke patients using novel imaging biomarkers for prediction of dementia. Has designed and implemented non-clinical safety strategies for drug discovery and development, both exploratory and GLP-compliant, providing analysis and interpretation of results and approval of final study reports for submission.

Education

Kumar holds a PhD in Pharmacology-Toxicology from the University of Madras, India, and a MS in Clinical Research in Rush University, Chicago.

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