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.

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
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
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
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