Santhosh Bommegowda BVSc, PhD, DABT, RAC

• Board-Certified Toxicologist and Regulatory Affairs certified professional with over twenty years of hands-on experience in discovery and regulatory safety assessment of Small Molecules, Biologics, ADC, ASO, siRNA, and Cell and Gene Therapy modalities for diverse therapeutic indications. • Designed, conducted, interpreted and reported exploratory and Good Laboratory Practice (GLP)-compliant safety assessment studies for new molecules and reformulated compounds to support IND as well as NDA/BLA applications. • Evaluated numerous safety assessment programs to provide critical assessment of nonclinical toxicity including identification of toxicity; evaluation of clinical significance of adverse animal findings; evaluation of quality and completeness of safety studies; and gap analysis based on ICH, FDA, EMA, WHO, GLP and ISO guidelines. • Prepared nonclinical sections of regulatory documents including dossier/executive summary and common technical document (CTD) for IND and NDA/BLAs. Interacted with US, Europe and Japan regulatory/health authorities on nonclinical aspects of study design, data interpretation, and addressing nonclinical safety concerns. * Provided support to Clinical groups in preparation of nonclinical sections and review of DSUR and IB updates. * Provided support to the CMC group in the development of SDS; and impurities assessment of drug substance and drug products. * Prepared (nonclinical section) and reviewed the CCDS.