Agenda

DAY ONE - Thursday 30th July 2009

Day One | Day Two

8.30 Registration & Coffee

9.00 Opening Remarks from the Chair

9.10 OPENING ADDRESS
Pharmacogenomics: One Size Does Not Fit All

A diagnostic test that can increase the clinical utility of a given therapeutic drug or procedure, while at the same time reducing the risks and costs associated with developing and marketing is a real synergy. This session will examine pharmacogenomics: the concept of combining a therapeutic intervention with a relevant diagnostic test. The presentation will cover:

> Examples highlighting the use of combining a diagnostic test with a treatment decision
> The first "official" pharmacogenomic application to be used routinely: The genetic testing that takes place before Herceptin
> AmpliChip CYP450 Test: The first microarray-based test for detection of genetic variations that can influence drug efficacy and minimise adverse drug reactions
> The impact of pharmacogenomics in the form of K-Ras testing on patients with colorectal cancer
> Pharmacogenomics: Making personalised medicine a reality in helping physicians improve patient outcomes

Dr George Koumantakis, Scientific & Regulatory Affairs Manager, Roche Diagnostics Australia

9.50 The Pharmacogenomics Policy Context: Global and National Outlook

Melanie Kelly, Director, Deloitte

10.30 Morning Tea

11.00 Nanotechnology & Biomarkers: Implications for Pharmacogenomics Personalised Therapies

• Early disease detection and survival
• Stratification of similar diseases - personalised therapy
• Detection of disease re-occurrence
• Improving drug trials and drug development through the use of biomarkers
• Biomarkers to monitor the effectiveness of therapies
• Applications of nanotechnology in biomarker research and development

Prof Matt Trau, Director - Centre for Nanotechnology & Biomaterials, Australian Institute for Bioengineering & Nanotechnology (AIBN)

11.40 How Close Are We to the $1000 Genome?

• Progress in genome analysis technologies
• What the new sequencing tools can deliver
• Data handling and analysis challenges
• How can this information be utilised?

Sue Forrest, Director/CEO, Australian Genome Research Facility

12.20 Lunch

GenesFX Health will provide an exclusive preview and live demonstrations of their new practical website.
This website uniquely enables the user to:

• Search by drug to see if there is a recommended pharmacogenomic test
• Search by tests for drugs using a particular enzyme
• Allows health professionals to search for alternative drugs
• Learn about GenesFX Health's new multigene gene test (DNAdose)

Join Associate Professor Leslie Sheffield to preview the website

1.20 Implementation of Australia's New Regulatory Framework for In Vitro Diagnostic Tests

• Why a new framework?
• What is proposed?
• How will pharmacogenomic tests be regulated?
• Issues in regulation

Shelley Tang, Director - IVD Framework Development Taskforce, Therapeutic Goods Administration

2.00 Role & Uses for Biomarkers in Pharma

• Role of biomarkers in drug development
• Preclinical and clinical utilisation of biomarkers

Phil Kearney, Director - Licensing & External Research, Merck Sharp & Dohme

2.40 Afternoon Tea

3.10 Health Technology Assessment & the Future Relationship Between Pathology & Pharmacogenomics

• Frameworks for evaluating genetic/genomic DNA tests
• The genetic (single gene) to genomic (multi gene) evolution in pathology
• Traditional model for DNA testing in pathology versus emerging point-of-care testing and direct-to-consumer DNA testing

Ron Trent, Professor of Molecular Genetics - Central Clinical School, University of Sydney & Head, Department of Molecular & Clinical Genetics, Royal Prince Alfred Hospital

3.50 ICT Infrastructure: The Storage & Sharing of Information

• Defining the collective meaning of information
• Supporting storage, discovery and distribution
• Enabling information sharing, privacy and access control
• The case for common infrastructure and tooling

Andy Bond, Chief Clinical Architect, National E-Health Transition Authority

4.30 Closing Remarks from the Chair

DAY TWO - Friday 31st July 2009

Day One | Day Two

8.30 Morning Coffee

9.00 Opening Remarks from the Chair

9.10 The Future for Clinical Physicians & Pharmacogenomics

• Public subsidy of medicines which rely on pharmacogenomic testing
• Cost-effectiveness of delivering personalised medicines
• Genetic testing in the real-world

Prof Robyn Ward, POW Clinical School, University of NSW & Director of Area Cancer Services, SESIAHS

9.50 BioGrid: Linkage Between Clinical Data, Drugs & Genomics

• Framework for collecting and collating data of interest in a privacy protected manner
• Individuals' pathways linked electronically: Clinical data, pathology, drugs, tissue samples, genomics
• A multi-SNP predictor of drug response in epilepsy
• Pharmacogenomic studies in oncology

Dr Marienne Hibbert, Project Director, BioGrid Australia

10.30 Morning Tea

11.00 Interpretation of Tests & Recommendations

• What specific genetic tests should be conducted?
• How do we interpret the tests?
• What patient specific information is required?
• What recommendations should be made based on the tests?
• Working towards developing a national standard

Dr Andrew Somogyi, Faculty Associate Dean - Pharmacology, University of Adelaide

11.40 Prediction of Individual Genetic Risk to Disease from Genome-Wide Data: Prospects & Limitations

• Genome-wide association studies: Success and other stories
• Statistical methods for individual genetic risk prediction
• Limits of individual risk prediction from genetic data

Prof Peter M. Visscher, Queensland Statistical Genetics, Queensland Institute of Medical Research

12.20 Lunch

1.20 Improved Treatment of Disease through Pharmacogenomics: Building the Evidence Base

• Pharmacogenetic phenomena as complex phenotypes
• Translational opportunities: Sorting the wheat from the chaff
• Pharmacogenetics in the era of personal genomes

Assoc Prof Martin A Kennedy, Gene Structure & Function Laboratory & Carney Centre for Pharmacogenomics, Department of Pathology, University of Otago

2.00 Using Pharmacogenomics to Prevent Adverse Drug Reactions

• Steps necessary for the translation of discovery of a genomic test into the clinic
• Factors favouring clinical uptake of a pharmacogenetic test and hurdles with respect to implementation of such tests for adverse drug reaction prevention
• Examples of drugs where there may be potential clinical application of pharmacogenomics to prevent adverse drug reaction
• The broad application of HLA-B*5701 screening to prevent abacavir hypersensitivity reaction as a success story and model in clinical pharmacogenetics

Elizabeth Phillips, MD, FRCPC, Professor & Director Centre for Clinical Pharmacology & Infectious Diseases, Murdoch University

2.40 Afternoon Tea

3.10 Practical Pharmacogenomics - Ethical & Scientific Issues

• New technologies - Deeper sequencing, gene profiling, -omics, cloning, gene medicines, gene doping
• Use and misuse from pharmacogenomic research, and development towards clinical practice
• Protection of information, really informed consent
• Recommended guidelines and regulation

Prof John Rasko, Director, Cell & Molecular Therapies - Sydney Cancer Centre, Royal Prince Alfred Hospital & Head - Gene & Stem Cell Therapy Program, Centenary Institute

3.50 Patent Protection & Enforcement

• Opportunities to protect key areas of innovation
• Obtaining sound patent protection
• Potential hurdles in protecting pharmacogenomic innovation
• Enforcement and commercialisation issues

Dr Trevor Davies, Partner, Allens Arthur Robinson

4.30 Closing Remarks from the Chair

4.40 End of Conference

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