Ravi Dugyala

• Led nonclinical team supporting research and development of early and late clinical stage portfolios (small molecules including viral assembly and PD-L1 inhibitors, siRNA oligos and small molecules to destabilize viral RNAs, and combination therapies) to treat Chronic Hepatitis B Virus and COVID-19. • Completed five IND-enabling preclinical packages and two Phase 2a/2b programs in the United States, Europe, and Asia. • Represented Arbutus for nonclinical safety issues with IB/IND/CTA submissions and clinical trials. • Planned, designed, and conducted sub-chronic and chronic toxicology studies, completing reports on time. • Developed and presented toxicology strategy and results to senior management. • Spearheaded a team of study monitors to select contract research organizations and SMEs for non-GLP and GLP toxicology/DMPK studies. • Served as a member of the senior leadership team, independently planning and implementing company objectives.

• Served as project team representative for multiple projects in neuro-endocrine (oncology) and cardiovascular/metabolic therapeutic areas. • Provided preclinical strategy for FIH and Phase 2-3 clinical trials, and authored HA documents for IND/CTA and NDA/MAA submissions. • Developed drug labels/RMPs and interacted with regulatory authorities for life-cycle management of marketed drugs. • Served as strategy team and target toxicologist for the multidisciplinary chemical biology therapeutic area. • Provided nonclinical safety input to due diligence teams and management. • Served as member of Novartis team contributing to successful Incyte collaboration on JAK/cMET inhibitors in 2009. • Performed duties as study director/monitor for GLP/non-GLP toxicity/mechanistic studies supporting small and large molecule development. • Presented toxicity study data to disease area teams and senior management. • Taught drug development course at Toxicology Program, Rutgers University, Piscataway, New Jersey.

• Acted as the project team representative for preclinical toxicology projects, ensuring effective communication and collaboration. • Designed and monitored chronic toxicology studies at Contract Research Organizations, enhancing study integrity and compliance. • Assisted in the preparation of regulatory documents, contributing to successful submissions and approvals.

• Led the design and execution of GLP nonclinical reproductive and developmental toxicity studies, ensuring compliance with regulatory standards. • Conducted data analysis and interpretation, contributing to successful clinical trial applications and drug marketing submissions. • Developed and implemented new SOPs and protocols, enhancing laboratory efficiency and training personnel in technical procedures.

• Planned and executed studies to identify gene expression markers for hepatotoxicity in early drug development. • Managed in vitro laboratory experiments with rat and human hepatocytes, ensuring high-quality results. • Collaborated with contract research organizations for in vivo studies, enhancing toxicogenomics research capabilities. • Developed a comprehensive gene expression database and predictive models, significantly advancing hepatotoxicant analysis.

• Provided on-site research support at the FDA's Center for Devices and Radiological Health for a joint FDA-EPA project. • Investigated the expression of Heat-Shock Protein 70 and 90 in somitic dysmorphogenesis during hyperthermia in rat embryos. • Developed new Standard Operating Procedures (SOPs) for Molecular Pathology GLP/non-GLP studies, enhancing product development services. • Contributed to advancing scientific understanding of developmental toxicity mechanisms, impacting regulatory policies.

• Planned and coordinated research projects to assess the immunotoxicity mechanisms of fumonisin B1. • Investigated the effects of fumonisin B1 on immune, neuro, hepatic, and renal systems in murine models. • Established an Immunotoxicology/Molecular Biology lab, enhancing research capabilities in the Department of Physiology and Pharmacology. • Trained undergraduate and graduate students, fostering the next generation of scientists in toxicology research.

Involved in a NIH research project on mRNA expression and cDNA sequencing of retinoic acid receptors and their alteration with natural retinoids in 8 - 15 day old hamster fetuses. Investigated the effects of aflatoxin B1 and T2 toxin on various cytokines produced by T lymphocytes (IL-2, IL-3 and IFN-gamma) and peritoneal macrophages (IL-1 alpha, IL6 and TNF alpha) at mRNA and protein level. Studied the myelotoxic effects of low and repeated doses of aflatoxin B1 and T2 toxin in vivo and in vitro in mice granulocyte-macrophage progenitor cells.