Day Two

2nd May, 2013

8.00 Registration & networking

9.00 Chair’s opening remarks

Ted Burczynski, Executive Director, Head of Integrated Clinical Biomarker Technologies, Bristol-Myers Squibb

Innovation in Clinical Trials Incorporating Pharmacogenomics

9.10 Successfully capturing data from large scale genomic profiling to enable qualification and translation into the clinic

• Setting out the goals: Working to transform the way we acquire, process, and interpret data from living systems

• Computational and data-centric techniques to enable translation

• What does the future hold?

Eric Schadt, Chair, Department of Genetics and Genomic Sciences, Mount Sinai School of Medicine

9.50 Best practise in bioinformatics strategy setting for PGx studies

• Current bioinformatics infrastructure: Examining advantages and areas for improvement

• Hardware and software selection: What criteria should industry be using?

• Aligning bioinformatics strategy with lifecycle objectives and regulatory guidance

Dongliang Ge, Director of Bioinformatics, Gilead Sciences

10.20 Creating a roadmap for discovery of clinically relevant genetic biomarkers

• The search for clinically relevant biomarkers: Why is this still a challenge?

• Working with partners to identify useful biomarkers, versus in house discovery efforts

• Novel techniques for oncology biomarker discovery

Ted Burczynski, Executive Director, Head of Integrated Clinical Biomarker Technologies, Bristol-Myers Squibb

10.50 Morning refreshments

11.20 Using preclinical models to guide predictive biomarker selection in the clinic

• Current effective preclinical models and overcoming challenges of gathering genomic data for preclinical activities

• How to translate models into clinical research and early development

• How can industry further improve preclinical operations incorporating PGx

David Dornan, Associate Director, Gilead Sciences

11.50 Enabling disease stratification through strong predictive biomarker development: What challenges still remain?

• Best practice in harnessing data analysis and novel genomic technologies to support biomarker ID and validation

• Developing PD and target engagement biomarkers, as well as predictive biomarkers

• Novel techniques for molecular characterization of disease sub-types and disease progression

Daniel Chin, Senior Principal Scientist, Roche

12.20 Interactive Mastermind Sessions

1.00 Networking lunch

Establishing Best Practise in Data Capture and Sharing for PGx Success

2.00 Making better decisions about when to conduct pharmacogenetic studies

• Using statistical genetics to support drug discovery and development projects

• Genotype-stratified clinical trial designs

• Considerations for making more informed decisions on when to conduct pharmacogenetic studies

Liling Warren, Senior Scientific Investigator, GlaxoSmithKline

2.30 Data-sharing and bioinformatic platforms to encourage efficiency and progress in the PGx field

• TranSMART and what this means for the future of data sharing amongst PGx stakeholders

• The latest bioinformatics and computational platforms: How can industry successfully build these into pipelines?

• Accelerating clinical and translational research through specialist software: What can we expect from the future of bioinformatics?

Brian Athey, Professor and Chair, Department of Computational Medicine and Bioinformatics, University of Michigan

3.00 Afternoon refreshments

3.30 Exploring the landscape of technical capability and partnerships for phase-appropriate biomarker and PGx development

• In house versus outsourcing approaches to biomarker development

• The role of centralized assay services in PGx

• Considerations around quality and compliance

Anita Pascarella-Hallett, Director, Clinical Diagnostics Services, Eli Lilly

4.00 Addressing the issue of rare variants and harnessing to capture more drug response information

• Identifying and validating rare variants to predict response

• Research into the effects of multiple genetic variants on drug response