*** Agenda for the European conference ***

Personalized Medicine & Diagnostics Europe

7-8 March 2011

Session 1: Roadmap of personalised medicine

• Setting the scene: personalised medicine is not a new trend but scientific advances have allowed new applications; so that it can be applied in a wide range of therapeutic areas
• Explore how personalised medicine is a trend that has the potential to impact on society as a whole and patients in particular.
• Determine the role, functionalities and place of personalised medicine in the healthcare industry.
• Present and discuss the evolution of the business model: from Blockbuster to Nichebuster?
• Comparing business models to develop personalised medicine: What does an organisational structure look like that can deliver personalised healthcare?
• Discover how to strengthen the drug pipeline with companion diagnostics and how this trends is becoming a necessity.
• Learn how compounds can be “resurrected” and repositioned with personalised medicine applications.
• Examine major trends and learn where to invest your efforts.
• Discuss market trends and hurdles to bring personalised therapeutics to the clinic.

Session 2: Personalised medicine and the value of companion diagnostics

• Hear about what constitute value for a diagnostic and companion diagnostics in particular.

• Supported by case studies, discuss methodologies for assessing the value of companion diagnostics 

• Learn about best ways of characterisation and validation of biomarkers in drug development to satisfy the regulatory authorities.

• Investigate best strategies for the co-development of drugs and diagnostics with external partners.

• How to develop commercialisation models for personalised healthcare and incorporate the right approaches from the start.

• The potential of biomarkers for drug resurrection and repositioning to open new markets.

Session 3: Optimise personalised medicine in the development process

• Find out the best ways to sub-group subjects to focus on the right patient cohort.

• Discover how to use and integrate biomarkers in clinical trials: adaptive trials as an example.

• Learn the best ways of biomarker validation and assay development for patient stratification.
• Identify the key factors for translational science in diagnostics development.

• Learn to use the best strategies to maximise the value of biomarkers and strengthen your development  pipeline.

• Discover the role of non-invasive biomarkers and imaging techniques.

• Learn about IT-related hurdles associated with personalised medicine and solutions to overcome them.

• How to utilise biobanks and partner with health centre networks for testing and building a biobank.
• Learn about the best practice in sample handling, logistics, ethics and regulatory requirements.
• Hear about successful cases in molecular diagnostics and how to move from technologies to treatments.

Session 4: Partnering opportunities in personalised medicine

• Learn how to unite drug development and diagnostics to maximise return on investment through an in-depth discussion of case studies.
• How to harness existing frameworks for partnerships and utilise the available funding from government grants.
• Hear about powerful strategies for aligning business models from pharmaceutical and diagnostics companies to maximise return.
• Learn about the role of SMEs in the development of personalised medicine applications and their models of partnership with other (larger) companies

• How to manage the partnering expectations to ensure shared vision and values.

• Find out about best practices for balancing risks and rewards to ensure long term benefits.

• Get a deep dive and analysis of partnerships that have been consummated.

• Hear about the role of clusters in fostering partnership in personalised medicine, including case studies.

• Discuss real life partnerships and projects between diagnostics and pharma companies on diagnostics and biomarker projects.

Session 5: The challenges of assessing, pricing and reimbursing personalised medicine

• How to assess the value of personalised medicine: the need for a holistic approach taking into account all additional health benefits.

• Understand the national pricing and reimbursement landscapes for personalised medicine and explore ways to overcome the fragmentation of competence and methodologies.
• Focus your efforts on the right areas and find out what the EMA and Health Technology Assessment departments have planned.
• Can the Transparency Directive 89/105/EEC support the improvement of access to personalised medicine?

• Discuss how to overcome the market access hurdles in the European markets.

• Hear the payer and providers perspective and what they expect from the industry.