7:30 - 8:15 a.m. |
Breakfast |
|
8:15 - 11:00 a.m. |
Session 1 Moderators: Drs. Chalasani & Lewis |
8:15 - 8:30 a.m |
Welcome Address - Drs. Chalasani and Lewis |
8:30 - 10:30 a.m |
What's New in 2025 |
8:30 - 9:10 a.m |
● Published (peer reviewed) - 40 min. Impactful DILI publications relevant to hepatic
safety, Dr. Chalasani |
9:10 - 9:50 a.m |
● Unpublished (press releases) - 40 min. Updates from ongoing drug development
programs related to hepatic safety, Dr. Vuppalanchi |
9:50 - 10:10 a.m |
● Regulatory updates - 40 min. Updates from ongoing drug development
programs related to hepatic safety, Dr. Hayashi |
10:10 - 10:30 a.m |
● Industry updates - 20 min. Building hepatic safety dossiers for NDA submission, Dr. Regev |
10:30 - 10:45 a.m |
Q&A |
|
10:45 - 11:00 a.m. |
Break |
|
11:00 a.m. – 13:30 p.m. |
Session 2 - Chair, Dr. Lewis |
11:00 a.m. - 12:00 p.m. |
Case-based Panel Discussion: Drs. Chalasani, Lewis, Regev, Hayashi, Garcia
Audience response system used |
11:00 a.m. - 11:20 a.m. |
● Case 1 - 20 min - led by Dr. Lewis |
11:20 a.m. - 11:40 a.m. |
● Case 2 - 20 min - led by Dr. Ghabril
|
11:40 a.m. - 12:00 p.m. |
● Case 3 - 20 min - led by Dr. Vuppalanchi |
12:00 p.m. - 12:25 p.m. |
ABC of Data Safety Monitoring Board (DSMB) - Dr. Rockhold to review charter,
chair responsibilities, and review of TFLs
|
12:30 p.m. - 12:55 p.m. |
Real-world Evidence for Safety and Efficacy - Dr. Rockhold |
13:00 p.m. - 13:25 p.m. |
HAC: From Charter to Safety Summary - Dr. Lewis to review the inner workings of
the Hepatic Adjudication Committee |
|
13:00 – 14:00 p.m. |
Lunch |
|
13:00- 16:30 p.m |
Virtual Master Class: Drug Induced Liver Injury and Liver
Safety for Clinicians and Clnical Researchers (optional
attendance) |
18:00 p.m. - 19:00 p.m. |
Welcome Reception |
19:00 p.m. - 21:00 p.m. |
Dinner |