Wednesday, September 13, 2023

Program subject to change.

07:15 am - 08:15 am | Industry-Sponsored Symposia | Grand AB

BioIVT : Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison With Current Guidance

Brian Ogilvie, Vice President, Scientific Consulting, BioIVT

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

Towards Platform PBPK Model for Protein Therapeutics
Dhaval Shah, University at Buffalo, Buffalo, New York, USA

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

9:45 am -10:00 am | Exhibitor Showcase by Pharmalegacy

Swift Solutions to Complex Challenges in DMPK, Pharmacodynamics, and Toxicology
Baomin Xin, Senior Vice President of DMPK and Bioanalytical

10:00 am - 12:00 pm | Concurrent Symposia 7 and 8

Symposium 7: Drug Induced Liver Toxicity | Grand AB
Chair: José Manautou, University of Connecticut, Mansfield, USA and Scott Obach, Pfizer, Groton, Connecticut, USA

Historical Perspective - Mechanisms of Drug Induced Liver Injury
William Proctor, Kymera Therapeutics, Watertown, Massachusetts, USA

Toxicity of Trimethoprim and Sulfamethoxazole
Jennifer Goldman, Children’s Mercy, Kansas City, Missouri, USA

Exploration of Bioactivation of a Branched-chain Ketoacid Dehydrogenase Kinase (BDK) Inhibitor
Matthew Cerny, Pfizer, Inc., Groton, Connecticut, USA

Acetaminophen-Induced Liver Injury and the Microbiome
Young Jeong, Perdue University, West Lafayette, Indiana, USA

Symposium 8: PK Considerations for the Next 50 Years | Marina Ballroom
Chairs: Joseph Balthasar, SUNY Buffalo, Buffalo, New York, USA and Mark Stroh, Intellia, San Francisco, California, USA

Projections for Future Challenges and Opportunities for Pharmacokineticists
Joseph Balthasar, SUNY Buffalo, Buffalo, New York, USA

Lecture Title to Be Confirmed
Aman Singh, Takeda, Cambridge, Massachusetts, USA

An Overview of Selected Topics in the Clinical Pharmacology and Translation of in vivo CRISPR-based Therapies
Mark Stroh, Intellia, Cambridge, Massachusetts, USA

Using Quantitative Systems Pharmacology (QSP) Models to Characterize the PK of Novel Drug Modalities
Jamie Nosbisch, Applied BioMath, Asheville, North Carolina, USA

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

Exhibit Hall Open

12:15-12:45 pm | Exhibitor Showcase by Q2 Solutions

ADME screening, Met ID to Method Validation: BioA Case studies demonstrating Drug Discovery process
Tom Fleischmann, Toby Magers, Nick Ingram, Brian Engel, Prakash Bhosale

12:30 - 2:30 | Poster Presentations P92-P182

2:30 pm - 5:30 pm | Plenary Session | Grand AB

50 Years of CL Prediction
Chairs: Malcolm Rowland, University of Manchester, Manchester, United Kingdom and K. Sandy Pang, University of Toronto, Toronto, Ontario, Canada

The Spectrum of Hepatic Clearance Models, from Old to New
K. Sandy Pang, University of Toronto, Toronto, Ontario, Canada

Issues in Assessing Tissue: Plasma Partition Coefficients (Kp) in PBPK Models
William Jusko, State University of New York at Buffalo, Buffalo, New York, USA

Transporter or Membrane Barriers Effects on Hepatic Clearance (the Extended Clearance Equation) Models and the Need for Scaling for IVIVE
Yuichi Sugiyama, Josai International University, Togane, Japan

Experiences in Industry Predicting Hepatic Clearance: Successes, Disconnects, Failures, and Room for Improvement
Cornelis Marcel Hop, Genentech, South San Francisco, California, USA