The combination of drug reprofiling and clin. trial offshoring offer dramatic improvement in the cost, speed, and risk of clin. development of drug products.We will provide a case study of our FDA-sanctioned Phase 2 clin. trial being conducted in the US and India of our reprofiled drug product for cancer cachexia.Cancer cachexia is a catastrophic wasting disorder associated with advanced cancer for which there is no FDA approved therapy.We will highlight the unique synergistic advantages of reprofiling and offshoring and the steps necessary to realize such advantages.In addition, we will review recent changes in the DCGI (Indian FDA-regulatory equivalent), Indian clin. research infrastructure, and the acceptance of Indian data by the FDA that is driving the explosive growth of clin. research in India.