Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases

Our issue brief summarizes challenges impeding the development of therapies for NASH and cholestatic liver disease and recommends goals for basic research and clinical study. Academicians and biopharmaceutical developers can adopt these goals to expedite the availability of novel therapies. The following challenges and recommendations synthesize the discussion of a broad coalition of liver disease experts convened by the Duke-Margolis Center for Health Policy and the U.S. Food and Drug Administration (FDA).