| 8:00 - 10:30 |
Session 1 Moderators: Drs. Chalasani & Lewis |
| 8:00 – 8:20 |
1. Opening remarks – Dr. Chalasani & Lewis |
| 8:25 – 8:45 |
2. DILI Overview – Dr. Chalasani (IU) |
| 8:50 – 9:10 |
3. DILI- Perspectives of a Hepatic Event Adjudicator – Dr. James Lewis
(George Town) |
| 9:15 – 9:35 Virtual Speaker |
4. Liver Safety – A regulator’s perspective – Dr. Paul Hayashi (FDA) |
| Virtual Speaker 9:40 – 10:00 |
5. Pharma Perspective: Hepatic Safety in Clinical Drug Development -
Dr. Arie Regev (Lilly) |
| Virtual Speaker 10:05 – 10:25 |
6. Overview of Pharmacovigilance and Benefit – Dr. Frank Rockhold
(Duke) |
| 10:25 – 10:45 |
Break 1 |
| 10:45 – 12:45 |
Session 2 Moderators: Drs. Vuppalanchi & Sexton |
| Virtual Speaker 10:45 – 11:00 |
7. Nonclinical Hepatotoxicity Assessment: An Overview – Dr. Armando
Irizarry (Lilly) |
| Virtual Speaker 11:05 – 11:20 |
8. Advancing Drug Safety with Liver-Chip S1- Dr. Lorna Ewart (Emulate) |
| Virtual Speaker 11:25 – 11:40 |
9. DILI-Sym – Dr. Paul Watkins (UNC) |
| 11: 45 – 12:00 |
10. Patient-Derived Liver Organoids: Hepatotoxicity Risk and Mechanism
Elucidation - Dr. Johnny Sexton (Michigan) |
| Virtual Speaker 12:05 – 12:20 |
11. The Pathology of DILI – David Kleiner (National Cancer Institute) |
| 12:25 – 12:45 |
12. Special lecture: Evaluation of cardiac safety in drug development –
Dr. Dick Kovacs (IU) |
| 12:45 – 13:45 |
Lunch |
| 13:45 – 15:25 |
Session 3 Moderators: Drs. Ghabril & Cointa |
| 13:45 – 14:00 |
13. DILI in CLD. Causality adjudication. Dr. Raj Vuppalanchi (IU) |
| 14:05 – 14:20 |
14. Herbal and Dietary Supplement-DILI – Dr. Dina Halegoua (Jefferson) |
| 14:25 – 14:40 |
15. DILI from Gene Therapy - Dr. Marwan Ghabril (IU) |
| 14:45 – 15:00 |
16.Challenges in Diagnosis and Casuality Assessment in
Immunotherapy Hepatotoxicity – Dr. Lily Dara (USC) |
| 15:05 – 15:25 |
17. Disentangling AIH and DIALH – Dr. Craig Lammert (IU) |
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