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The Joint Pharmacokinetics UK 2005 and Rosenön Meeting Welcome to the joint Pharmacokinetics UK 2005 and Rosenön Meeting Wednesday 23rd – Friday 25th November, 2005 De Vere Grand Hotel King’s Road Brighton BN1 2FW Programme and Abstract Book Published with the support of John Wiley & Sons Ltd, publishers of the journal BIOPHARMACEUTICS AND DRUG DISPOSITION rd Wednesday 23 November 12.30 Arrival, Coffee & Buffet Welcome & Session 1: Pharmacogenetics on PK/PD 13:50 Welcome (Steve Toon & Amin Rostami) 14:00 Introduction to the First Session: Geoff Tucker and Margareta Hammarlund-Udenaes 14:05 Geoff Tucker Pharmacogenetics on PKPD – expectations and reality 14:35 Duncan McHale Applications of Pharmacogenomics to the drug discovery and development pipeline 15:05 Leif Bertilsson Interethnic differences in drug disposition 15.30 Coffee break Viewing Posters & Exhibitions 16:00 Munir Pirmohamed Pharmacogenetics of adverse drug reactions Simulations as a tool to assess the propagation of genetic polymorphisms in drug Gemma Dickinson 16:20 metabolising enzymes into PK and PD outcomes 16:40 Marja-Liisa Dahl Pharmacogenetics in PK and PD of warfarin 17:30 Break 18:30 Poster Session – Free Bar 20:30 Dinner th Thursday 24 November Session 2: Microdosing in Drug Development 09:00 Introduction to Second Session: Anders Grahnen and Steve Toon 09:10 Colin Garner Human PK studies on microdoses of drugs - scientific and regulatory perspectives Seeing through the MIST: abundance versus percentage commentary on metabolites 09:50 Dennis Smith safety testing 10:30 Coffee break Viewing Posters & Exhibitions 11:00 Mats Bergstrom PET imaging as a biomarker in discovery medicine – pros and cons 11:40 Nenad Sarapa Microdosing in clinical drug development: recommendations and debatable issues 12:30 Lunch Session 3: Advances in PK/PD Modelling 14:00 Introduction to Third Session: Peter Milligan and Mats Karlsson 14:10 Rune Overgaard Stochastic Differential Equations in PKPD Modelling Adrian Dunne & 14:50 Modelling binary data with inter-subject variability Valda Murphy 15:30 Coffee break Viewing Posters & Exhibitions Comparison using simulated data and blinded analysis of approximate and exact 15:45 Pascal Girard likelihood parametric estimation methods for population PK model 16:25 Andrew Hooker New diagnostics for the FO/FOCE methods in NONMEM 17:00 Break 20:00 PKUK Banquet th Friday 25 November Open Session 08:45 Introduction to Open Session: Alison Thomson and Siv Jonsson 08:50 Monica Edholm Current (and future) role of modeling and PK/PD analysis in regulatory assessments 09:20 Esther Schmid Innovation in the Pharmaceutical Industry – Myths versus Reality Increasing the Strategic Value of Kinetic and Dynamic Data Through Unified Modeling, 09:50 Simon Davis Higher Productivity, and Regulatory Compliance 10:15 Coffee break Viewing Posters & Exhibitions Plasma protein binding: prediction of albumin levels in the adult population and ligand 10:30 Mark Baker displacement Prediction of time-dependent CYP3A4 drug-drug interactions - impact of enzyme 10:50 Aleksandra Galetin degradation and intestinal inhibition 11:10 Shuying Yang Evaluation of Methods for PK Modeling with Data below Quantification Limit 11:30 Radojka Savic Evaluation of a nonparametric estimation method in NONMEM VI Optimal design for first in human studies to investigate the pharmacokinetic/ 11:50 Ivelina Gueorguieva pharmacodynamic behaviour of TGF-beta RI kinase inhibitor Lorea Bueno Mechanistic PK/PD modelling for signal transduction modulators. Application to TGF-b RI 12:10 Burgos antagonists 12:30 Final conclusions and Closing remarks, Buffet Lunch The PKUK Organising Committee wishes to express their thanks to Mr Ben Meakin, Mrs Dolores Wellens, and the Swedish Academy of Pharmaceutical Sciences for their role in the administration of advertising, registration, and organising this year’s meeting. Poster Session Titles (Wednesday 23rd, 18.30) Please note that for the Poster Session (not coffee breaks), the presenters should be by their respective posters to answer questions. The application of structural identifiability analysis to the design of pharmacokinetic experiments, S. Y. A Cheung, L. Aarons, I. Gueorguieva, N. D. Evans, K. R. Godfrey and M. J. Chappell. The influence of experimental methods on the estimation of kinact and KI values of a time-dependent inhibitor. L. M. Van, J. Hargreaves, K. R. Yeo, G. T. Tucker, and A. Rostami-Hodjegan. A retrospective PBPK approach to assess Lung metabolism for SR, E. Manolis, P. Delrat, and T. Shepard. Comparative Pharmacokinetics of Five Drugs Administered to Humans at a Therapeutic and Microdose, G. Lappin and R. C. Garner. CYP450 Reductase Knockout Mice – A Useful Tool in Understanding Drug Disposition? A. O’Hara, G. Hughes, H. Meigh, C. Tyman, and K. Watson. Estimation of dosing strategies for cefuroxime by minimisation of a risk function, A. Viberg, O. Cars, M. O. Karlsson, and S. Jönsson. Prediction of Xenobiotic Clearance in Humans: In vitro – in vivo extrapolation (IVIVE) vs allometric scaling (AS). M. R. Shiran, N. J. Proctor, E. M. Howgate, K. R. Yeo, G. T. Tucker, and A. Rostami-Hodjegan. Enterohepatic recirculation of norfloxacin – a whole body physiologically based pharmacokinetic model, C. L. Rodrigues, I. Gueorguieva, M. Channel, and D. A. Berk. Cure Rate Models in Depression Trials, G. Santen, R. Gomeni, M. Danhof, and O. Della Pasqua. A Critical Evaluation of Experimental Designs used in studies of Mechanism-Based Enzyme Inhibition (MBI) with Implications for In Vitro-In Vivo Extrapolation (IVIVE). F. Ghanbari, K. R. Yeo, M. S. Lennard, G. T. Tucker, and A. Rostami-Hodjegan. A Single Dose Study to Investigate the Effect of the CCR5 Antagonist maraviroc on the QTc Interval in Healthy Subjects, J. Davis, F. Hackman, D. Sudworth, and G. Weissgerber. Identification of hOCT2 substrates and prediction of renal clearance in vivo using stably transfected cell lines, N. Attkins, I. Gardner, and K. Duffy. Genetic Algorithms and Their Applications in PK/PD Data Analysis. M. Jamei, J. Yang, K. R. Yeo, G. T. Tucker, and A. Rostami-Hodjegan. Inter-Individual Variability in the Catalytic Activity of CYP3A4 per unit of Enzyme (kcat). Y. Lei, Z. E. Wilson, K. H. Crewe, G. T. Tucker, and A. Rostami-Hodjegan. The Quantification of Residual Blood in Excised Tissue A. M. Quigley and M. B. Baker Inter- and intra-individual variability in gastro-intestinal physiology has significant effects on the prediction of the fraction of dose absorbed (fa). M. Jamei, J. Yang, A. Rostami-Hodjegan, and G. T. Tucker. Building Physiologically-Based Pharmacokinetic Models in NONMEM using the PRIOR functionality. G. Langdon, I. Gueorguieva, L. Aarons, and M. Karlsson. Dynamic Systems as Intractable Systems of Differential Equations: Design of Experiments. J. Cornebise and B. Boulanger. Prediction of biliary clearance using Caco-2- a future screening assay? M. Baker, L. King, H. Hailu, T. Parton, S. Bartlett, and S. Carter. Presentation Abstracts Session 1: Pharmacogenetics on PK/PD Wednesday 23rd November (PM) Pharmacogenetics: Expectations and Reality Geoffrey Tucker Academic Unit of Clinical Pharmacology University of Sheffield Genomic medicine has generated high expectations with regard to the advent of ‘personalised medicine’. This has been fuelled by the pace of technological advances in genotyping, enthusiasts extrapolating beyond small proof of principle and retrospective studies, and a few apparent success stories. However, drug response is a complex function of genetic, environmental and behavioural factors. Given that genetic factors need to be put into perspective, the challenge is to assemble large, prospective, multidisciplinary projects to assess the real clinical value of predictive genetic testing in drug therapy. This presentation will focus on: current evidence for the significance of genetic variation response; factors that enhance the cost- effectiveness of pharmacogenetic testing; criteria for the conduct of prospective studies to develop genetic tests of drug response; and potential constraints on implementing the ‘promise of precise prescriptions’. Tucker, GT: Pharmacogenetics – expectations and reality. Br Med J 329: 4-6, 2004. Applications Of Pharmacogenomics To The Drug Discovery And Development Pipeline Duncan McHale Pfizer Limited Following the success of the late 80s and early 90s the last few years has seen rising failure rates, a marked reduction in the number of drug approvals and a sharp rise in the cost of drug development. This combined with patent expiries and external pricing pressures has led to a critical need to improve the overall survival rate of compounds and reduce the time and resources spent on compounds which will not survive. Pharmacogenomics is the application of genomic technologies to the drug discovery and development process. There is considerable expectation around this emerging science but the demonstrable value to date has been limited. Whilst the drive to develop more personalised or precise medicines is often discussed near term value to the drug portfolio is also required. Pharmacogenomics is one of the tools which can be used to help in industry’s endeavour to overcome the current challenges. Examples of where Pfizer has used pharmacogenomics to aid target choice and early decision making creating near term value will be presented. Interethnic differences in drug disposition Leif Bertilsson Professor, Clinical Pharmacology at Karolinska Institutet Karolinska University Hospital At a given dose of such drugs as antidepressants and neuroleptics, the therapeutic
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