EuroMEEting - Genetic Alliance UK

THEME 1 | THEME 2
17
This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
Improving Drug Development – Stratification and Drug Rescue
Adrian Towse, Director, Office of Health Economics, UK
Drug Diagnostic Combinations – Incentives for Stratification
Speaker invited
Aligning Drug Diagnostic Development – Impact on Value
Speaker invited
11:00-12:30 Session 0106
QUALIFY, VALIDATE, APPLY – ASSURING ASSAY QUALITY THROUGH THE
BIOMARKER LIFECYCLE
Session Chair:
Glen Hughes, Associate Director, DECS Translational Sciences, AstraZeneca,
UK
Successful application of our newly acquired insight into the aetiological
pathways at play in complex disease is largely predicated on the quantitative
assay of a variety of novel biomarkers. Such biomarkers require qualification
for this purpose and the qualification cycle needs extend throughout the drug
lifecycle.
Moving from Biomarker to ‘Fit for Purpose’ Assay
Caroline Dive, Clinical and Experimental Pharmacology Group Leader, Paterson
Institute for Cancer Research, UK
The Development of Robust Validated Assays
Henrik Winther, Director R&D, DAKO, Denmark
Assay Deployment from Early Development to Proof of Concept
Speaker invited
14:00-15:30 Session 0107
CLINICAL UTILITY AND IMPLEMENTATION - THE GATEKEEPER FOR
SUCCESSFUL PERSONALISED MEDICINE
Session Chair:
Munir Pirmohamed, NHS Chair of Pharmacogenetics, The University of
Liverpool, UK
Despite the technical sophistication of modern biomarker analyses, the
rationale for personalised medicine depends entirely on the ability of predictive
information to change care pathways. As such assessment of clinical utility
remains the primary filter for recognising the value of personalised healthcare
projects and should inform consideration of biomarker applications even in the
earliest stages of drug development.
Barriers to Uptake for Personalised Medicine: Understanding the value of
stratifications in practice
Munir Pirmohamed, NHS Chair of Pharmacogenetics, The University of
Liverpool, UK
Session under development
16:00-17:30 Session 0108
PERSONALISED MEDICINES FOR THE REAL WORLD
Session Chair:
Ron Zimmern, Chairman, PHG Foundation, UK
impact it has on medical practice in a global setting prepare us for the changes
engagement with predictive data at the individual level will bring.
Personalised Medicine: An introduction to real-world perspectives and needs
Ron Zimmern, Chairman, PHG Foundation, UK
Session under development
Theme 2 | Securing Approvals in a Changing
Environment
Henrik Kim Nielsen, Corporate Vice President, Novo Nordisk A/S, Denmark
Tomas Salmonson, Vice Chairman, CHMP, Director Scientific and Regulatory
Strategies, MPA, Sweden
This theme will address the changes in the European regulatory environment,
discuss the appropriateness of the current level of regulations and suggest
some of the strategies the pharmaceutical industry can take to secure
competitive approvals. Special aspects of approvals will be addressed in
separate sessions: Benefit/risk assessment from a regulatory point of view,
advanced therapies, and a review of the recent new approaches to maintaining
the approvals (variations). Finally, two sessions will deal with how the
regulatory environment is able to meet the needs of the patient both in terms
of strategies for making the product available to all patients and how the
information need of the patient is met.
Tuesday, 29 March 2011
09:00-10:30 Session 0201
THE FUTURE OF THE EU REGULATORY LANDSCAPE
Session Chair:
Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence,
Pfizer AB, Sweden
The regulatory environment is highly dynamic with new challenges appearing
constantly, which demands that the regulatory framework is able to adapt to
changes within reasonable time. The impact on the European regulatory system
will be discussed in a panel session by representatives from the Commission,
EMA, a NCA and industry. Examples of topics that may be discussed are, the
proportionality of the framework, the many aspects of the globalisation of
pharmaceutical operations, what consequences might be expected long-term
from the switch to DG SANCO, the appropriateness of the framework for medicinal
product + companion diagnostic, etc.
Noel Wathion, Head of Patient Health Protection, European Medicines Agency, EU
Susan Forda, Vice President, International Regulatory Affairs, Eli Lilly, UK
Rolf Bass, Professor of Pharmacology and Toxicology, University Berlin - Charité,
Germany
Tomas Salmonson, Director Scientific and Regulatory Strategy, Vice-chair CHMP,
Medical Products Agency (MPA), Sweden
European Commission speaker invited
The emergence of scientific information as to methodologies for patient
stratification is just the beginning of the changes that Personalised Medicine
will bring to medical practice. Real-world examples of stratification and the