Sunday, June 11, 2023
Program subject to change.
09:00 - 12:30 | Morning Short Course | N001
Physiologically-based Pharmacokinetic (PBPK) Models: Basic Concepts to Advanced Applications
Chairs: Kunal Taskar, GSK, Stevanage, United Kingdom and Pradeep Sharma, AstraZeneca, Cambridge, United Kingdom
Background: This workshop will cover some basics as well as advanced applications of PBPK modeling. The first speaker will introduce the concepts and general principles of PBPK modeling and touch upon the various applications of PBPK modeling. The second session will focus on the PBPK applications and considerations in discovery and human dose predictions in healthy as well as patient population. The third session will introduce the applications and recent case studies of applications of PBPK modeling for large molecules as well as other novel modalities.
Introduction and Applications of PBPK Modeling
Neil Parrott, F. Hoffman La Roche, Ltd., Basel, Switzerland
Human Dose Predictions Using PBPK Modeling in HV
Claire Jackson, GSK, Stevenage, United Kingdom
Considerations of Human Dose Predictions in Specific and Patient Populations Using PBPK
Gareth Lewis, GSK, Stevenage, United Kingdom
PBPK of Monoclonal Antibodies and Novel Modalities
Armin Sepp, Certara, Sheffield, United Kindgom
12:30 - 13:30 | Short Course Attendee Lunch | V020
13:30 - 17:00 | Afternoon Short Course | N001
New Modalities, Beyond Rule of Five
Chairs: Simone Schadt, F. Hoffman La Roche, Ltd., Basel, Switzerland and Donglu Zhang, Genentech, South San Francisco, California, USA
Background: New modality molecules e.g. MCPs, PROTACs, ASOs usually show limited oral absorption, high clearance, and low exposures, but have potential to modulate difficult-to-druggabletargets. Their physicochemical properties include high molecular weight (MW), high polar surface area (PSA), high number of rotatable bonds that are beyond the Lipinski’s rule-of-5 (bRo5) space. Their large MW and flexible structures have prevented effective optimization of in vitro and in vivo pharmacokinetics profiles without affecting their cell potency and selectivity. Fundamental questions one can ask 1) How can we deliver these molecules to the targets, 2) will these molecules show uptake in tissues and what are the tissue distribution patterns, 3) are they metabolically stable in vivo, 4) are they retained in tissues or tumors, 5) can we develop a practical dosing regimen in patients?
Why bRo5 Compounds Have Poor PK and What Can be Done About It?
Donglu Zhang, Genentech, South San Francisco, USA
PROTAC Targeted Protein Degraders
Caroline Rynn, F. Hoffmann La Roche Ltd, Basel, Switzerland
DMPK and modeling and DDI Considerations for Oligonucleotides
Farzaneh Salem, GSK, Sheffield, United Kingdom
17:45 - 18:00 | Opening Welcome | Weston Auditorium
Welcome Remarks
ISSX/DMDG 2023 Meeting Chairs
18:00 - 19:00 | Opening Keynote Lecture | Weston Auditorium
Pharmacogenomics: From Discovery to Implementation
Professor Sir Munir Pirmohamed, University of Liverpool
19:00 - 21:00 | Opening Welcome Reception with Exhibitors | Cricket Hall Sports Village
All attendees are invited to meet with fellow attendees, speakers, and our sponsoring and exhibiting partners who will be on-hand to share information about their latest products and services.