• DOI:10.13523/j.cb.20140116
• Corpus ID: 86756443

Policy Issues for the Development and Use of Biomarkers in Health

@article{Ritchie2013PolicyIF,
  title={Policy Issues for the Development and Use of Biomarkers in Health},
  author={Rachael J. Ritchie and Marie-Ange Baucher},
  journal={China Biotechnology},
  year={2013},
  volume={34},
  pages={101-126}
}

• R. J. Ritchie, Marie-Ange Baucher
• Published 15 October 2013
• Economics
• China Biotechnology

The OECD is a unique forum where governments work together to address the economic, social and environmental challenges of globalisation. The OECD is also at the forefront of efforts to understand and to help governments respond to new developments and concerns, such as corporate governance, the information economy and the challenges of an ageing population. The Organisation provides a setting where governments can compare policy experiences, seek answers to common problems, identify good practice and work to coordinate domestic and international policies. The Directorate for Science, Technology and Industry leads the OECD's work on knowledge-based sources of economic and social growth and, more specifically, on the translation of science, technology and knowledge into innovation. Application of biomarkers in the field of human health is improving our understanding of disease, and will provide new knowledge of disease mechanisms and processes providing a means for improved health management through the earlier diagnosis of disease and the delivery of more efficacious and safer therapies. This report examines the current economic, regulatory, and health care context in which biomarkers are being developed and identifies the barriers which may slow or block the uptake and diffusion of biomarker-based technologies in the clinical setting. The report presents several policy options which could foster biomarker research, discovery, development, commercialisation and uptake in clinics. A number of scientific, economic, regulatory and governance challenges need to be addressed if biomarker applications are to be incorporated into clinical practice. The report draws on discussions that took place at a workshop entitled, " Policy Issues for the Development and Use of Biomarkers in Health " , held in Hinxton, United Kingdom in 2008 (under the auspices of the OECD Working Party on Biotechnology), as well as analytical work before and after: We are very grateful to all the consultants and experts who graciously contributed their time and knowledge to this project. We also would like to thank the delegates of the OECD Working Party on Biotechnology and the Task Force on Biomedicine and Health Innovation for their contributions and guidance. Contents Executive summary 5 Chapter 1. Biomarkers: An overview of the opportunities and challenges 7 Introduction 7 Reaping the benefits of biomarkers 7 The genomics revolution 8 Application of biomarkers in evidence-based, personalised medicine 9 Towards a new health care paradigm: opportunities and challenges 12 Chapter 2. Managing biomarker knowledge: generation and sharing 15 A new wave of networking infrastructures 15 …