28 January 2002 – 30 January 2002
Victorian College of Pharmacy, Monash University and Royal Children’s Hospital
Last updated 23rd January 2002
Parkville campus is approximately 25mins from the airport, and a AUD$40-45 cab fare (including tolls). A taxi is the most efficient way to get here, so try and “cab pool” if you can. Airport bus is approximately $20, but will take you into the city, where you will then have to negotiate the public transport and catch either the number 18, 19 or 20 tram from Elizabeth St up Royal Pde to VCP. (<$5) Ask a tram driver to let you off at “Pharmacy College”. This will probably take 60mins or more. Once you arrive at the Victorian College of Pharmacy, proceed past the main entrance, and Cossar Hall to the Lecture theatre block. The registration desk will be on the ground floor of the lecture theatre block. Further information about the venue, and location of the computer lab and lecture theatre will be provided with your conference materials.
Please see the Accommodation Details — make your own arrangments
PAWS – Population Analysis WorkShop
Monday January 28th
Lecture Theatre Chair: Noel Cranswick
09:30 Introduction to clinical trial simulation (Steve Duffull))
What can it do?
10:00 Simulation Plan (Nick Holford)
10:30 Morning tea
10:45 Small group discussions on objectives and design of simlastatin survival (2S) study and simulation experiment
11:30 CTS Models and Examples (Nick Holford)
12:15 Pharmacoeconomic Models and Examples (Stephen Lim)
Afternoon Parallel Sessions
Advanced Group (in computer lab) Chair: Steve Duffull
14:00 Small group discussions on simulating the 2S trial
Does Simlastatin save lives?
How many lives does Simlastatin save?
15:00 Afternoon tea
15:15 Software demonstrations
NONMEM (Paul Williams)
Trial Simulator (Nick Holford)
PEC Program (Steven Lim)
16:45 Plenary session on Clinical Trial Simulation
Basic Group (in lecture theatre) Chair: Craig Rayner
14:00 Introduction to Population Modelling (Bruce Charles)
15:00 Afternoon tea
15:15 Introduction to Population Modelling (Bruce Charles)
17:30 End of Day 1
Tuesday January 29th
Morning Parallel Sessions
Advanced Group (lecture theatre) Chair: Noel Cranswick
09:00 Advanced CTS issues
Confirming Trial Objectives (Nick Holford)
True P value (randomization test)
10:00 Morning tea
10:30 Learning Trial Objectives (Steve Duffull)
Bias & Precision
Credible Intervals (Bootstrap)
Covariate Distributions (Diane Mould)
Basic Group (computer lab) Chair: Craig Rayner
08:30 How to use NONMEM (Bruce Charles)
10:00 Morning tea
12:00 All participants. Lunch and Seminar at Royal Children’s Hospital
12:30 “Pharmacokinetics Made Interesting by Noel Cranswick”
Seminar Room 2 , 4th Floor of Front Building (Entry from Flemington Rd and proceed to 4th floor via silver lift)
A map will be provided with the conference materials. The Royal Children’s Hospital is a lovely 15 to 20 minute walk from VCP.
Leave VCP @ 12.00, leave RCH @ 13.30.
Lecture Theatre Chair: Bruce Charles
14:00 Optimal vs Simulation Design Methods (Steve Duffull)
15:30 Afternoon tea
15:50 AGM/Report of last meeting, and future course for PAWS/PAGANZ Chair: NH
16:15 Hot topics Chair: Nick Holford
Panel (SD, BC, SL, PW, DM, NC) discussion of topics in population analysis
e.g. what covariates predict the rate of ethanol consumption following PAWS?
17:00 End of Session
19:00 PAGANZ Dinner
Presentations on the Population approach. Come share your experiences in this area, and present either a paper or poster presentations.
Contact Craig Rayner (craig.r[email protected] ) or Noel Cranswick ([email protected]) for further details.
Wednesday January 30th
State of the Art Lectures Chair: Nick Holford
09:30 Bruce Charles
Population modelling in “infancy” – Opportunities and applications in the intensive care of very premature babies
10:30 Morning tea
10:50 Paul Williams
Model Appropriateness and Population Pharmacokinetic Model Development
11:50 Diane Mould
Using Clinical Trial Simulation for Antineoplastic Drugs
12:50 Lunch and Poster Presentations
14:00 Conference close
14:15 Optional WinNonMix session in computer lab (Noel Cranswick)
Biographical Sketches of Participating Faculty
Dr Charles holds an appointment as Reader in the School of Pharmacy, The University of Queensland, and is Director of the Australian Centre for Paediatric Pharmacokinetics, Mater Children’s Hospital, Brisbane (1999-on). He graduated BPharm with First Class Honours (1971), and PhD (1976) from the University of Queensland, then pursued postdoctoral studies in biopharmaceutics and pharmacokinetics at the College of Pharmacy, University of Iowa under a Harkness Fellowship of the Commonwealth Fund of New York (1975-1977). From 1978-1988 he was Senior Scientist in the Department of Clinical Pharmacology, Princess Alexandra Hospital, then followed a move to the School of Pharmacy at The University of Queensland (1988-on). Dr Charles has 100 publications in many areas of pharmacokinetics, but more recently in paediatric pharmacokinetics and pharmacodynamics, especially in very premature babies. Current efforts are focused on determination of the absolute bioavailability of a number of drugs used in neonatal intensive care – This work has required extensive use of population modelling approaches. He has supervised numerous BPharm (Honours), MPharm and PhD students many of whom now hold positions in hospitals, academia and the pharmaceutical industry. For several years he has been a member of the Editorial Board of the Journal of Chromatography B – Biomedical Sciences and Applications. Professional memberships include the Pharmaceutical Society of Australia, Australian Society for Medical Research, Perinatal Society of Australia and New Zealand, Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, International Association of Therapeutic Drug Monitoring and Clinical Toxicology, Australasian Pharmaceutical Science Association, Drug Information Association.
Dr Duffull obtained his undergraduate pharmacy qualifications in New Zealand in 1985. He then worked predominantly in the Department of Clinical Pharmacology at Christchurch Hospital. During this time he completed a Masters Degree in Clinical Pharmacy at the University of Otago (NZ) in 1993 and a PhD in Clinical Pharmacokinetics from the University of Otago in 1997. Dr Duffull then spent two years in the School of Pharmacy at the University of Manchester (UK) as a post-doctoral research fellow, during which time he developed an interest in optimal design and clinical trial simulation. Recently he has taken up a position in the School of Pharmacy, University of Queensland (Australia) as a Lecturer. His main research interest involves pharmacometrics particularly study design and population analyses using Bayesian approaches.
Dr Holford obtained his medical qualifications (MB. ChB., MRCP) in the United Kingdom He worked at UC San Francisco from 1975-1983 initially as a Fellow in Clinical Pharmacology and subsequently as a Faculty member. During this period he developed an interest in the quantitative aspects of clinical pharmacology and developed software for pharmacokinetic-dynamic analysis. His computer program MKMODEL has been published and used worldwide since 1985. In 1983 he moved to Auckland, New Zealand to take up an appointment in the Department of Pharmacology and Clinical Pharmacology, University of Auckland. Until 1989 he had a part time appointment as a Specialist in Internal Medicine at Auckland Hospital. During this period he was elected a Fellow of the Royal Australasian College of Physicians. In 1990 he had a 9 month sabbatical leave at Hoffmann-La Roche, Basel, Switzerland where he was involved in developing a population approach to clinical pharmacology in the drug development process. More recently he has been involved in the development of a multimedia teaching program on the clinical pharmacologicalaspects of drug development (RIDO). A major commitment has been made to the development of a clinical trials simulation and analysis system and Dr Holford is a member of the Scientific Advisory Board for Pharsight Inc. Dr Holford was on sabbatical in 1998 and worked on a variety of projects related to disease progress modelling and clinical trial simulation. He is currently involved in describing the effects of anti-Parkinsonian agents on the progression of Parkinsons’s disease. In 1995 he was invited to be a founding member of the Center for Drug Development Science Scientific Advisory Board. The CDDS is based at Georgetown University, Washington DC and is concerned with promoting research and teaching on the scientific basis of drug development. Dr Holford is currently an Associate Professor at the University of Auckland. He is co-editor of The In Vivo Study of Drug Action and the recently published 4th edition of Avery’s Drug Treatment. He has been consulting editor for Clinical Pharmacokinetics since 1995. He has developed tools for helping to use NONMEM “Wings for NONMEM” which are freely available for downloading.
Stephen Lim holds an appointment in the Department of Epidemiology & Preventive Medicine, Monash University as a Lecturer teaching postgraduate and undergraduate courses in epidemiology, health policy and decision analysis. He graduated BA BSc with First Class Honours (1997) from Monash University. After working with the Baker Medical Research Institute, he studied Health Economics and is currently in the final year of a PhD. Current efforts are focused on the Assessing Cost Effectiveness (ACE) – Heart Disease project – a large collaborative project with the Department of Human Services, Victoria. ACE – Heart Disease aims to analyse the costs and impact of existing and potential new interventions in coronary heart disease, in order to provide governments and health service providers in Australia with evidence-based information on the relative cost-effectiveness of the major interventions. This work involves extensive use of decision analytic techniques (Markov modelling and Monte-carlo simulation) using programs such as DATA (TreeAge Software).
Dr. Mould graduated from Stevens Institute of Technology in 1984 with a BS in Chemical Engineering and Chemical Biology. She then attended the Ohio State University, where was awarded an AFPE Fellowship and an Academic Challenge Fellowship, and obtained a PhD in Pharmaceutics and Pharmaceutical Chemistry in 1989. After graduation, she worked with Dr. Tom Ludden at The University of Texas at San Antonio to learn the population approach to pharmacokinetic modeling. She is a member of several scientific societies including Rho Chi, Sigma Xi, Phi Kappa Phi, AAPS and ASCPT. She has published 13 articles and 2 book chapters on pharmacokinetics and pharmacokinetic/dynamic modeling. Her research interests include XAFS analysis, QSAR + AI for molecular modeling, and population PK and PK/PD analysis. She is recently moved from SmithKline-Beecham Pharmaceuticals where she was an assistant director in the department of Drug Metabolism and Pharmacokinetics to a position as Associate Professor of Pharmacology at the Center for Drug Development Science, Georgetown University, Washington DC, USA.
Paul Williams, Pharm. D., M. S. is Professor of Pharmacy Practice at the University of the Pacific and is a partner in Trials by Design, LLC. He received his M.S. in pharmaceutical sciences from the University of North Carolina in 1981, completed a residency at North Carolina Memorial Hospital in 1980 and received his Pharm. D. from the University of the Pacific in 1974. He established the Therapeutic Drug Monitoring Service at the University of Alabama Hospital (1980-1982) and was a member of the Therapeutic Drug Monitoring Team at St. Joseph’s Medical Center. He teaches a graduate level class in Pharmacokinetic and Pharmacodynamic Experimental Design and is the instructor of record for the Therapeucitcs I course at the University of the Pacific. Dr. Williams has been an instructor at the NONMEM introductory workshop sponsored by the University of California at San Francisco and has served on the panel of experts at the FDA Population PK Guidance meeting. His scholarly interests include the application of simulation technology to experimental design, the application of resampling methods to population pharmacokinetic models, and novel methods for population pharmacokinetic model validation.