Conference on 3rd Annual Biomarkers

3rd Annual Biomarkers Conference
An essential addition from discovery to approval in clinical development

23rd - 24th March 2010, BSG Conference Centre, London, UK

Background Info

Key Speakers
• Mike Lau, Principal Clinical Development Scientist, GSK Oncology
• James Weatherall, Global Lead, Biomedical Informatics, AstraZeneca
• David W. Moskowitz, Chairman, CEO & Chief Medical Officer, GenoMed
• Fabio Magrini, Director, Inflammation and Autoimmunity, MedImmune
• Hassan Rahmoune, Head of Translational Medicine & Discovery Biomarkers, University of Cambridge/Psynova
• Patrick Sluss, Director, Special Chemistry Core Laboratories, Massachusetts General Hospital, Associate Professor, Harvard Medical School
• Christian Rohlff, CEO, Oxford BioTherapeutics
• Richard Kennedy, Vice President of Translational Research and Development, Almac group
• Stéphane Lucchini, Business Manager, Biovays
• Patricia Hurley,Head of Project Management & Head of Biomarkers Division, ERA Consulting UK
• Peter Duncan, Director of Business Development, Clinical Diagnostics, Definiens
• Huw Davies, Director Business Development, Pronota
• Eddie Blair, Director, Integrated Medicines
• Niro Ramachandran, R&D Manager, Life Technologies
Pharmaceutical and biotech companies are looking for new ways to increase the efficiency of drug discovery process while minimising costs and time for approvals. Biomarkers are fast becoming an essential part of clinical development from discovery to approval. According to industry research, the global biomarker market is estimated to be $20.5 billion by 2014, growing at a CAGR of 19.7 %.

Additionally, the use of proteomics in biomarker testing and identification has boosted the services for biomarkers. A large number of companies now have commercialised biomarker tests employing a variety of technologies. However, there are several barriers and challenges that must be overcome behind these technologies.

Visiongain is proud to present its 3rd Annual Biomarker Conference, which will be held in London UK on 23-24 March 2010.This conference will enable you to identify and overcome challenges on how to incorporate biomarkers into your discovery programs as well as highlighting new technologies and strategies to improved prevention and care approaches.

Conference Main Themes:

• Use of academic laboratories in clinical development to foster collaborative research
• Biomarkers in Translational Medicine
• Integration of a companion diagnostic strategy into oncology drug development
• How biomarkers, personalized medicines, and pharmaceutical will interact and create value for patients?
• Mass Spectrometry in Biomarker Discovery
• New results in functional genomics
• Anti-inflammatory efficacy of drug substances using biomarkers of inflammation
• Biomarker assay development and validation in cancer
• Role of biomarkers in the development of personalized medicine
• Biomarkers in a clinical perspective
• Development in protein array technologies for biomarker discovery

Who should attend?

VPs, Directors, Heads and Managers of:-
• Biomarker Development Programmes
• Clinical Pharmacology
• Clinical Research
• Drug Discovery and Development
• Alliance Management
• Safety Assessment
• Assay Development
• Proteomics/ Genomics Programmes
• Regulatory Affairs
• Translational Medicine
• Oncology
• CNS
• Inflammation and Immunology
• Biological Sciences
• Marketing
• Product
• Diagnostics
• Bioanalysis
• Pharmacokinetics & Drug Metabolism
• Genomics Business Development
• Strategic Alliances
• Cellular & Molecular Dev
• Clinical Discovery Technologies
• Pharmacogenomics & Human Genetics
• Discovery Research
• Bioengineering

Day 1

Day One, Tuesday 23rd March 2010, London, UK
09:00 Registration and refreshments

09:30 Chair’s opening remarks

09:40 Use of academic laboratories in clinical development to foster collaborative research
• Use of biomarkers in oncology clinical development
• Outsourcing to commercial laboratories
• Collaborations with academic laboratories for biomarker research
• Collaborative approaches/agreement types / mutual benefits
• Maintaining quality while reducing overhead
• Case study/example

Mike Lau
Principal Clinical Development Scientist
GSK Oncology

10:20 Biomarkers in translational medicine
• Introduction
• Bio-sampling
• Lessons learned “Biomarkers discovery and clinical protocols’’
• Case study - functional studies and study design
• Summary

Hassan Rahmoune
Head of Translational Medicine & Discovery Biomarkers
University of Cambridge / Psynova

11:00 Morning refreshment & networking session

11:20 Presentation to be announced

Christian Rohlff
CEO
Oxford BioTherapeutics

12:00 Protein array technologies for biomarker discovery
• How to design a biomarker discovery study.
• Technology requirements for discovering biomarkers
• Types of protein arrays and their use in biomarker discovery
• Development and use of ProtoArrays

Niro Ramachandran
R&D Manager
Life Technologies

12:40 Lunch

13:40 Panel discussion: Analysing key requirements for delivery of high-quality biomarker assays
Panellists will be analysing how biomarker measurements support key decisions throughout the drug development process. Focus will be on practices biomarker laboratories are adopting to deliver high quality data.

14:20 Combining open platform and targeted approaches for protein biomarker discovery and development
• Analytical requirements for plasma protein biomarker discovery
• Study design and technology considerations for discovery and verification stages
• Bridging the gap between discovery and clinical implementation
• Case study: discovery and validation of novel plasma protein biomarkers for the diagnosis and management of heart failure

Huw Davies
Director, Business Development
Pronota

15:00 Afternoon refreshments & networking session

15:20 How biomarkers and pharmaceuticals interact as personalised medicines to create value for patients?
• Diagnostic value as leverage in companion diagnostic relationships
• Relative value of predictive and prognostic markers
• The role of stakeholder perceptions in the value proposition
• The cash value and market for companion pharmaceuticals and diagnostics

Eddie Blair
Director
Integrated Medicines

16:00 Integrating your biomarker into drug development: The importance of the EMEA/FDA qualification procedures
• Use of biomarkers from the pre-clinical and clinical drug development process; Case studies
• The importance of seeking agency input on the validity of your biomarker
• New biomarker qualification procedures in Europe and the US
• Why does going through the qualification procedure make sense?

Patricia Hurley
Head of Project Management & Head of Biomarkers Division
ERA Consulting UK

16:40 Chair’s closing remarks

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day Two, Wednesday 23rd March 2010, London, UK
09:00 Registration and refreshments

09:30 Chair’s opening remarks

09:40 New results in functional genomics
• Overview of the current and emerging tools involved in genomic studies
• Integrated functional genomic analysis
• Genomics-derived drug pipeline
• Experimental case scenarios

David W. Moskowitz
Chairman, CEO & Chief Medical Officer
GenoMed

10:20 Biomarker assay development and validation in cancer
• Types of biomarkers used in cancer and available technologies
• Potential sources of tissue from patients
• The use of FFPE archived tissue for biomarker discovery and delivery
• Examples of prognostic and predictive test development for personalised cancer management
• Issues around test validation

Richard Kennedy
Vice President of Translational Research and Development
Almac group

11:00 Morning refreshment & networking session

11:20 Anti-inflammatory efficacy of drug substances using biomarkers of inflammation
• Use of biomarkers of inflammation as indicators of drug efficacy
• Methods for assessing the efficacy of drug substances using biomarkers of inflammation
• Application and examples

Fabio Magrini
Director, Inflammation and Autoimmunity
MedImmune

12:00 The application of biomedical informatics to biomarker development in the clinical setting
• Background to Biomedical Informatics in clinical drug development
• Modeling and Simulation for personalised Healthcare
• Integrating modelling and simulation into a clinical program
• Support for biomarker discovery, development and validation via data mining
• Case studies for both efficacy and safety

James Weatherall
Global Lead, Biomedical Informatics
AstraZeneca

12:40 Lunch

13:40 Analysing the role of biomarkers in a clinical perspective

Patrick Sluss
Director, Special Chemistry Core Laboratories, Massachusetts General Hospital
Associate Professor, Harvard Medical School

14:20 Biomarkers imaging and their use in clinical trials
• Biomarker role in clinical trials and why are they important
• Identifying implications for imaging biomarkers
• Regulatory issues to integrate the use of investigational imaging biomarkers into multicenter clinical trials
• Case scenarios

Peter Duncan
Director Business Development, Clinical Diagnostic
Definiens

15:00 Afternoon refreshments & networking session

15:20 Panel Discussion: - Predictive Dx tests for clinical use
Panellists will be discussing how to select the right drug for the right patient from a diagnostic industry perspective. Focus will be on the challenges and opportunities involved in the co-development of Dx and Rx versus development of Dx-post-approval of Rx.

16:00 Strengthening your pipeline: collaborative partnerships
• Promises and challenges of biomarkers
• Commercial opportunities for biomarkers
• Role of partners in biomarker assay development
• Harnessing human capital: expertise & experience
• Maximising drug success: innovating forward

Stéphane Lucchini
Business Manager
Biovays

16:40 The importance of contract service providers in development of biomarkers
• Biomarker analysis and contract research services
• Biomarker assay validation
• Regulatory considerations

16:50 Chair’s closing remarks

17:00 End of conference

Related Reports:

Biomarkers- Advanced Technologies and Global Market
The 2010-2015 Outlook for Cardiac Biomarkers in Greater China
The 2010-2015 Outlook for Cardiac Biomarkers in India
The 2010-2015 Outlook for Cardiac Biomarkers in the United States
Companion Biomarkers in Drug Development
Expanding Applications of Personalized Medicine: Use of biomarkers in prognostic, predictive and pharmacogenetic tests in a targeted approach