Wednesday, September 14, 2022

Program subject to change.

7:15 am - 8:15 am | Concurrent Industry-Sponsored Symposia with Breakfast

SOLVO Industry-Sponsored Symposium: ICH M12 Draft Guidance on Drug Interaction Studies: Comparisons and Considerations
Joseph Zolnerciks and Zsuzsanna Gáborik, SOLVO Biotechnology, A Charles River Company, Wilmington, Massachusetts, USA and Budapest, Hungary

Inotiv Industry-Sponsored Symposium

8:30 am - 9:30 am | Plenary Lecture 3

Structure-Metabolism-Toxicity Evaluation of Protein Kinase Inhibitors
Klarissa Jackson, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

9:30 am - 10:00 am | Refreshment Break with Posters and Exhibitors

10:00 am - 12:00 pm | Plenary Session

Clinical Importance of Drug Transporters
Chairs: Aiming Yu, University of California Davis, Sacramento, California, USA and Lauren Aleksunes, Rutgers University, Piscataway, New Jersey, USA

Placental Efflux Transporters in Health and Disease
Lauren Aleksunes, Rutgers University, Piscataway, New Jersey, USA

Drug Transporters in Chemotherapy-Induced Peripheral Neuropathy
Tore B. Stage, University of Southern Denmark, Odense, Denmark

Roles of Transporters in Disposition, Tumor Targeting, and Tissue Toxicity of Meta-Iodobenzylguanidine
Joanne Wang, University of Washington, Seattle, Washington, USA

Drug Interactions with MDR Transporters
Arthur Roberts, University of Georgia, Athens, Georgia, USA

12:00 pm - 2:30 pm | Exhibits and Posters

2:30 pm - 4:30 pm | Plenary Session

Drug Discovery from the Trenches
Chairs: Masayo Oishi, Astellas Pharma Inc., Tsukuba, Ibaraki, Japan and Karim Azer, Axcella Therapeutics, Cambridge, Massachusetts, USA

Virtual Clinical Trial Simulation for a KRASG12 Covalent Inhibitor using a Mechanistic Pharmacokinetic Model Combined with Quantitative Systems Pharmacology Approach
Hiroyuki Sayama, Astellas Pharma Inc., Applied Research & Operation, Tsukuba, Ibaraki, Japan

Developing a Robust QSP Model of AAV-based Gene Therapy for Clinical Applications
Nessy Tania, Pfizer, Cambridge, Massachusetts, USA

Model informed Development for mRNA Vaccines
Stephen Greene, Moderna Inc., Cambridge, Massachusetts, USA

M&S for Pompe Enzyme Replacement Treatment Development
John Mondick, Metrum Research Group, Tariffville, Connecticut, USA

4:30 pm - 5:00 pm | Meeting Closing

Closing Remarks

ISSX/MDO 2022 Meeting Co-Chairs, Michael Zientek, Takeda Pharmaceuticals, San Diego, California, USA, and Xiaobo Zhong, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut, Storrs, Connecticut, USA

Scott Obach, ISSX President, Pfizer, Groton, Connecticut

Magnus Ingelman-Sundberg, MDO, Karolinska Institute, Stockholm, Sweden and Xinxin Ding, MDO, R. Ken Coit College of Pharmacy, University of Arizona, Tucson, Arizona, USA