An agenda for "3D Cell Culture Models for Drug PK, Safety, and Efficacy Assessment" is provided below for the convenience of event attendees.
The conference is scheduled for Friday, Aug. 14, 2020. It is an online event. Information about how to access conference sessions will be emailed to all registrants as the conference approaches.
Presentation Slides:
Conference Agenda:
Download a printer-friendly agenda here.
| Time | Activity |
|---|---|
| Noon – 12:05 p.m. | Welcome and Logistics Hongbing Wang, PhD (Professor, UMSOP) Shiew-Mei Huang, PhD, FCP (FDA) |
| Session One: 3D Models in Drug Safety and Risk Assessment Session Chair: Ed Chow (FDA) | |
| 12:05 – 12:15 p.m. | Overview of 3D Cellular Model Research at FDA Suzy Fitzpatrick, PhD Senior Advisor for Toxicology Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration |
| 12:15 – 12:25 p.m. | Organ-on-Chips Application in Drug PK and Efficacy Evaluation Lorna Ewart, PhD EVP European Scientific Liaison Emulate |
| 12:25 – 12:35 p.m. | Considerations About 3D Culture Models for Nonclinical Safety Evaluation Ronald Wange, PhD, and Paul Brown, PhD Associate Directors for Pharmacology and Toxicology Center for Drug Evaluation and Research U.S. Food and Drug Administration |
| 12:35 – 12:40 p.m. | Break |
| Session Two: 3D In Vitro Liver Models for DILI Session Chair: Qi Liu (FDA) | |
| 12:40 – 12:50 p.m. | Liver-on-Chip Model for Toxicity and PK Alexandre Ribeiro, PhD Staff Fellow Division of Applied Regulatory Science Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food and Drug Administration |
| 12:50 – 1 p.m. | HepaRG 3D Spheroids in Comparison to 2D Models Steve Ferguson, PhD Chemist Molecular Toxicology and Genomics Group National Institute of Environmental Health Sciences |
| 1 – 1:10 p.m. | Predicting DILI Risk Using Hepatic Spheroid Co-Culture Models Will Proctor, PhD Director, Predictive Toxicology Genentech |
| 1:10 – 1:15 p.m. | Break |
| 1:15 – 2:10 p.m. | Panel Discussion I Chair: Shiew-Mei Huang (FDA) Panelists: Speakers and Moderators for Sessions One and Two, and Jerry Lee and Shannon Mumenthaler |
| 2:10 – 2:15 p.m. | Break |
| Session Three: Multi-Organ 3D Models Intestine, Liver, and Beyond Session Chair: Grace Guo (Rutgers) | |
| 2:15 – 2:25 p.m. | Novel In Vitro Hepatic and Enteric Technologies for Drug Metabolism, DDI, and Safety Evaluation Albert Li, PhD, MBA President and Chief Executive Officer In Vitro ADMET Laboratories, Inc. |
| 2:25 – 2:35 p.m. | Intestinal Oganoids: An Excellent Ex Vivo Model for Mucosal Regeneration and Defense Jian-Ying Wang, MD, PhD Joseph and Corinne Schwartz Professor in General Surgery University of Maryland School of Medicine |
| 2:35 – 2:45 p.m. | Use of Vascularized Human Kidney Proximal Tubule Microphysiological System and PBPK Modeling to Predict Renal Clearance in Subjects with Variable Kidney Function Nina Isoherranen, PhD Professor and Milo Gibaldi Endowed Chair in Pharmaceutics Department of Pharmaceutics University of Washington School of Pharmacy |
| 2:45 – 2:50 p.m. | Break |
| Session Four: 3D Spheroids/Organoids for Disease Modeling Session Chair: William Hedrich (BMS) | |
| 2:50 – 3 p.m. | Kidney Organoids for Disease Modeling and HTS Benjamin Freedman, PhD Assistant Professor of Medicine and Nephrology Institute for Stem Cell & Regenerative Medicine University of Washington |
| 3 – 3:10 p.m. | Neuronal Multi-organ-on-Chip Models for Disease Modeling and Risk Assessment James Hickman, PhD Professor of Nanoscience Technology, Chemistry, Biomolecular Science, Physics, and Electrical Engineering Head, Hybrid Systems Laboratory University of Central Florida |
| 3:10 – 3:15 p.m. | Break |
| 3:15 – 3:55 p.m. | Panel Discussion II Chair: Hongbing Wang (UMSOP) Panelists: Speakers and Moderators for Session Three and Four, and Scott Heyward |
| 3:55 – 4 p.m. | Summary Hongbing Wang, PhD Professor and Program Chair, Experimental and Translational Therapeutics Department of Pharmaceutical Sciences University of Maryland School of Pharmacy Shiew-Mei Huang, PhD, FCP Deputy Director, Office of Clinical Pharmacology Center for Drug Evaluation and Research U.S. Food and Drug Administration |