WEBINAR ON BIOTECHNOLOGY Terms and Definitions

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1 WEBINAR ON BIOTECHNOLOGY Terms and Definitions 14 JUNE :30 11:00 CEST repeated 15:00 16:30 CEST

2 Background ISO Council task force on biotechnology met in April 2009 Requested to make recommendations regarding ISO work in the domain of terminology, measurement and characterization for biotechnology/bioscience Specified priority areas: industry/environment Examined current ISO committee activities related to biotechnology

3 Agreed definitions Biotechnology The application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services (OECD) Industry/Environment Applications of life sciences to traditional manufacturing and chemical synthesis; using micro-organisms (bacteria, fungi) and enzymes (specialty proteins) to improve manufacturing processes, make new biobased fuels, industrial raw materials, intermediates and consumer goods.

4 Task force findings Current ISO committees are only peripherally related to biotechnology Need to focus on: Terms and definitions Measurement and characterization: Techniques of analysis (Horizontal) Note: Many of these issues are generic to biotechnology/bioscience and not specific to the industry/environment applications

5 What are we talking about? Terms and definitions as key factors for science, industry and politics Well defined terms are basic for discussion and decision making in science, industry and politics Best example: the term biotechnology itself: ISO COUNCIL task force on biotechnology had to agree on a definition of biotechnology before starting discussions Terms like biotechnology, life sciences, have huge influence on developments in science, industry and political decision making

6 Many terms dominating recent topics seem well defined but are they? Example synthetic biology Cutting edge science with large potential for industrial applications and possible need for political regulation The European Group on Ethics in Science and New Technologies to the European Commission: Ethics of synthetic biology, 2009 ( s/opinion25_en.pdf) cites eight different definitions and concludes:

7 Example synthetic biology (continued) It therefore appears that a general consensus on a standard classification of synthetic biology does not exist. The definitions so far provided depend on the scientific approach taken or the applications carried out by biologists. The situation has not changed since Potential for ISO, as internationally agreed definition is urgently needed Otherwise this important topic will be discussed further using the term synthetic biology by stakeholders and interested parties - but meaning different things

8 Consistent and internationally agreed definitions? A chance for review and discussion in the context of ISO Terms which might be discussed a few examples from biotechnology Synthetic biology Systems biology Metabolomics Biomimetics Terms which might be discussed a few examples from biomedicine Personalized medicine Molecular medicine Translational medicine

9 Inputs required from participants Information on related activities by other organizations Consideration of which areas within biotechnology use terms and definitions which are not sufficiently defined or use definitions which are too heterogeneous to be acceptable on an international level Identification of gaps and needs (where does ISO have a role to play?) Suggestion of priority areas for reviewing / discussing terms and definitions Refinement and prioritization Agreement on agenda and invitees for follow up workshop

10 Some Input from participants at the first Webinar (9:30 CEST session) Focus on more basic definitions (i.e. specifity, specific activity, certain units) instead of more general definitions Identification of priority items considering a global picture of the various domains covered by biotechnology and the standardization initiatives addressing specific fields

11 Some Input from participants at the first Webinar (9:30 CEST session) Focus on add-on value where can ISO really be helpful? A solid and recognized infrastructure supporting international standards development (and maintenance), where other organizations i.e. scientific committees may have difficulties? A contribution to support harmonization (where relevant) of work undertaken by organizations focused on specific domains? A contribution to promote the use of standards by all the concerned stakeholder groups A contribution to support involvement and use by stakeholders in developing countries? Attention on avoiding redundancies/duplication of efforts with ongoing acitivities

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