Nuggehally Srinivas (Srini), Ph.D., has 30 years of extensive experience in preclinical and clinical drug development with expertise in clinical pharmacology, ADME, PKPD, regulatory and biopharmaceutics/drug delivery. He has used ADME strategy for clinical candidate nomination during drug discovery-development transition. In the past, Dr. Srinivas worked for Jubilant Life Sciences, Cadilla Healthcare, Eli Lilly’s JV company, Dr. Reddy’s and Bristol-Myers Squibb. His therapeutic area experience includes: metabolic disorders, oncology, neurosciences, cardiovascular, immunology, inflammation, and anti-infective. He has experience with product differentiation strategies and seamless development using a 505(b)(2) approach and has interacted with multiple regulatory agencies including: FDA, HPB/TPD, EMEA, MHRA, MCC, TGA, and DCGI.