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OECD Expert Workshop on Policy Issues for the Development and Use of Biomarkers in Health 발표자료
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자료발간일
2008-10-06
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출처
OECD
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#바이오마커#Biomarkers#OECD#Health
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1.Evaluation_and_Regulation_of_Biomarkers.pdf
나머지파일.zip
출처 : OECD
OECD Expert Workshop on Policy Issues for the Development
and Use of Biomarkers in Health 발표자료
6 OCTPBER 2008
SESSION 1: INTRODUCTION
This session introduced what biomarkers are and why they are so important for patient care improvement. The discussion sed on what makes research on biomarkers today substantially different from the past; what this departure means in terms of scientific and clinical opportunities; and what policy issues it raises for governments.
Introduction to Biomarkers Policy Challenges and Workshop sessions: OECD Secretariat
Evaluation and Regulation of Biomarkers ? A Public Health Perspective : Ron ZIMMERN, Executive Director, PHG Foundation, United Kingdom
SESSION 2: EVIDENCE BASE AND KNOWLEDGE SHARING AROUND BIOMARKERS DATA
This session described why biomarker knowledge integration and sharing is necessary and what are some of the main difficulties associated with doing so. It identified different approaches for improving integration and sharing of data (for examples industry incentives to stimulate data sharing, systems or databases that provide access to knowledge for the public, computer storage). It raised the question of whether governments should be involved in promoting the sharing, access and/or use of biomarker data and if so how. It presented thoughts on how to generate useful and relevant data that will allow an evidence-base decision making that is fundamental to biomarker evaluation.
Perspectives based on the analytical papers - The Vision of Industry: David POLVERARI, Technical Director, Atragene, France
Creating an Evidence-base: Peter FURNESS, Vice President, RCPath, United Kingdom
Panel questions and discussion with the audience
David POLVERARI, Technical Director, Atragene, France
Noboru YUMOTO, Vice-President, AIST board of trustees, Japan
Peter FURNESS, Vice President, RCPath, United Kingdom
SESSION 3: THE CLINICAL EVALUATION OF BIOMARKERS
This session did elucidate why a crucial challenge for biomarker development is the evaluation of biomarkers for clinical use. It addressed the central questions of clinical evaluation: what are the different levels of validation; how should government treat the discovery of new biomarkers, new therapeutic targets and medical tests and; are there efficient systems of validation in place already? The objective was to give governments a clearer sense of how to approach the discovery of new biomarkers, therapeutic targets and medical tests at a national and international level.
Perspectives based on the analytical paper: Ralph COATES, Associate Director for Science, Centers for Disease Control and Prevention, CDC Atlanta, United States
Panel questions and discussion with the audience
Anne MARQUET, Exploratory Medicine Science and Operations Manager, Merck Serono International
Chris PRICE, Visiting Professor in Clinical Biochemistry at the University of Oxford, United Kingdom
Ralph COATES, Associate Director for Science, Centers for Disease Control and Prevention, CDC Atlanta, United States
7 OCTOBER 2008
SESSION 4: REGULATION AND POLICY
This session sed on some of the regulatory policy issues that arise from the accelerated development of biomarkers. There appears to be consensus that some form of regulatory control over and above what is presently available is likely to be needed, but the extent to which this should be carried out within a statutory framework (and the form of any extra-statutory controls) is a matter of debate and controversy. The pros and cons of statutory regulation was discussed as well as options for extra-statutory mechanisms of control. The risk stratification of biomarkers within the regulatory framework has also been much discussed, but exactly what we mean by 'risk' in this context and how the concept of 'safety' is to be conceptualised are policy issues that need further exploration. Governments should to give this subject higher priority in their deliberations on health and innovation policy.
Perspectives based on the Analytical paper: Ron ZIMMERN, Executive Director, PHG Foundation, United Kingdom
Panel questions and discussion with the audience
Susanne LUDGATE, Medical Director of MHRA, United Kingdom
Ron ZIMMERN, Executive Director, PHG foundation, United Kingdom
SESSION 5: INNOVATION AND COMMERCIAL PERSPECTIVES
This session discussed how industry is reacting and contributing to biomarker development. How are firms using biomarkers in drug and medical tests development? Are there different industry approaches? What are company hopes and what are the challenges they face? The session also asked what actions by governments could influence biomarker development and use by industry.
Perspectives based on the analytical paper: Arsia AMIR-ASLANI, Managing Director, Araxes Associates, France
Panel questions and discussion with the audience
Arsia AMIR-ASLANI, Managing Director, Araxes Associates, France
Laszlo TAKACS, General Director, Biosystem International, France
Chris CHAMBERLAIN, Biomarker Expert (Inflammation), Pharma Development, Roche Products, United Kingdom
SESSION 6: WHAT NEXT?
In this session participants reviewed the policy recommendations made in earlier sessions about what governments can do to facilitate the development of biomarkers for research, industrial use (medical testing and drug development), and for health care sector uptake. The OECD Secretariat outlined some possible options for future work and ask participants for their opinions and recommendations.
Presentations of options for future work: OECD Secretariat
첨부
1. Evaluation and Regulation of BiomarkersA Public Health Perspective
Dr Ron Zimmern MA, FRCP, FFPHMExecutive Director, PHG Foundation
Dr Ron Zimmern MA, FRCP, FFPHMExecutive Director, PHG Foundation
2. Data Integration and Decision-Making For Biomarkers Discovery, Validation and Evaluation
D. POLVERARI, CTO
3. Evaluating biomarkers : Creating an evidence base
Professor Peter Furness Vice Preident The Royal College of Pathologists
4. A CDC Perspective on Clinical Evaluation of Biomarkers
Ralph J. Coates, PhD
National Office of Public Health Genomics, NCCDPHP
Coordinating Center for Health Promotion
Centers for Disease Control and Prevention (CDC)
Coordinating Center for Health Promotion
Centers for Disease Control and Prevention (CDC)
5. CLINICAL EVALUATION OF BIOMARKERS
Christopher P PriceClinical Biochemistry,University of Oxford,Oxford, UK
6. The Regulation of BiomarkersSome Policy Perspectives
Dr Ron Zimmern MA, FRCP, FFPHMExecutive Director, PHG Foundation
7. Industry strategies and biomarker business models
Arsia AMIR-ASLANI, PhD
...................(계속)
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