Dr. Sebastian is a Veterinarian and a Board certified toxicologist, and currently working as Senior Director, Head of Toxicology & Non-Clinical, Development Consulting & Scientific Affairs at Cencora Pharmalex. Dr. Sebastian has over 18 years of industrial experience that include drug discovery, non-clinical development, toxicology, Good Laboratory Practices (GLP) and medical writing. In his past assignment he gained hands-on experience in design, conduct, review, analysis, interpretation, and reporting of in vitro and in vivo (rodent and non-rodent) toxicology and pharmacology experiments. He established number of in vitro and in vivo safety pharmacology models and contributed significantly in establishing an integrated safety pharmacology facility. He has extensive knowledge of OECD principles of GLP, its implementation and application in a regulatory environment for the safety evaluation of pharmaceuticals. He functioned as Study Director for toxicology and safety pharmacology studies and also as Study Monitor for outsourcing key investigational new drug (IND) application enabling studies. He strategized and developed non-clinical development strategy for the preclinical development of new chemical entities (oncology/inflammation) and number of differentiated products in support of USFDA 505b2 application and Article 8(3) hybrid pathway applications. Dr. Sebastian provided strategic and tactical leadership on toxicology issues affecting drug development and commercialisation to wide range of global clients. He has extensively worked on toxicological risk assessment including permitted daily exposure (PDE) and occupational exposure limit (OEL) derivation; environmental risk assessment (ERA); evaluation of extractables and leachables; qualification of organic and inorganic impurities, excipients; and setting limits for genotoxic/carcinogenic compounds. His complete Curriculum Vitae are available upon request.