Wednesday, March 23, 2016–
Thursday, March 24, 2016
College Park Marriott Hotel & Conference Center
3501 University Blvd.
East Hyattsville, Maryland 20783
How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials?
Clinical trials in humans exposed to new drugs being developed provide data for the regulatory decisions on approval/non-approval but also provide the best information to guide optimal use postmarketing by prescribers in treating patients. Speeding and optimizing new drug development during the investigational new drug (IND) period represents the greatest opportunity to shorten time and reduce costs from discovery to approval. There is urgent need to update and revise thinking to consider investigational treatment of patients with pre-existing liver diseases such as chronic viral infection with hepatitis C or B, alcoholic and non-alcoholic steatohepatitis, and other liver disorders. It is also important to recognize hepatocyte adaptation, and to reconsider if controlled rechallenge can be done safely in the carefully controlled environment of clinical trials. This conference will seek comments and proposals from industry, investigators, and regulators on these and other controversial issues that need to be faced, considered, debated, and if possible resolved toward reaching consensus.
Organizers: John Senior, Paul Watkins, Mark Avigan, John-Michael Sauer, Arie Regev, and Lana Pauls
The program is co-sponsored by the Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER), and the Critical Path Institute (C-Path). The program is endorsed by the National Institutes of Health (NIH) Drug-induced Liver Injury Network (DILIN), the American Association for the Study of Liver Diseases (AASLD), the Hamner-UNC Institute for Drug Safety Sciences, and the Pharmaceutical Research and Manufacturers of America (PhRMA).