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.


ISSX and DMDG Thank our Sponsors!