WP 7: IMPACT: Dissemination, Exploitation and Knowledge Transfer activities
The key stakeholders in regenerative medicine (RM) are:healthcare providers, and indeed patients, who require the ‘best’ treatments that are safe, reliable and cost effective, supported by evidence and approved by regulators. regulators who require accepted standards and traceable data that demonstrate the safety and effectiveness of novel products and treatments. medical products companies, often small spin-out companies, who need advanced techniques to support the development of novel products, means of monitoring the cell/tissue culture process to improve quality and efficiency of processes (particularly to support commercial scale-up of production), means of quality assuring their products and standards/protocols for gaining regulatory approval for new products. scientists and clinicians who need accurate measurement techniques to further the understanding of cellular processes, and underpin the discovery and implementation of innovative new therapies.
Each nation will develop forums for industrial and academic input into the project (such as the MET working groups established by NPL and LGC) that will provide advice to the project and review/evaluate the outputs. National trade associations and knowledge/professional networks will be targeted for knowledge transfer to ensure wide dissemination of findings through their meetings and newsletters. These bodies will contribute to pan-European Knowledge Transfer partnerships and a European Advisory Board, including national trade associations, is planned. This is particularly important since the nascent regenerative medicine industry is mainly based in small academic spin-outs which have limited resources but would benefit significantly from access to collective expertise in this European NMI consortium. The exchange of experience and knowledge between different institutes and organizations across Europe will encourage innovation. A number of European institutes have expressed an interest in the project and would wish to collaborate, including TKK (Finland) in WP 2, 4, and 7, and UNI-TO (Italy) in WP 5, 6 and 7. NPL will develop a website for communicating with stakeholders and partners.
The regulation of medical products is a key driver for the development of metrology for regenerative medicine. Legislation, such as the in-vitro diagnostic medical devices directive 98/79/EC and the regulations of the US Food and Drug Administration (FDA), requires more and more substances and techniques to be covered by metrology. The absence of a well structured regulatory and metrology environment, arising from poor understanding of the novel technologies and inadequate measurement methodologies, is hindering the market for RM therapies. Strong links will be built with regulatory agencies to ensure that advances in metrology become embedded in regulations, helping companies gain swifter and less expensive clinical approval for their products.
Development of international standards in conjunction with ISO and national standards bodies, critical to the success of emerging RM treatments, will be assisted through representation by project partners at ISO. Key committees include:
ISO/TC 150 Implants for surgery, which sets standards for active and non-active medical devices which are implanted in the body either permanently or temporarily for therapeutic or diagnostic purposes. These implants are dedicated to replace, repair or stimulate defective or worn-out or damaged parts of the body. ISO/TC 194 Biological evaluation of medical devices, which covers biocompatibility and the clinical investigation of medical devices and develops standards for the “approach of and tests for evaluation of medical devices that come into contact with the human body” ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems, which addresses laboratory medicine through a focus on quality management, reference systems, in vitro diagnostic products, and antimicrobial susceptibility testing.
The research within the project is extremely relevant to national (e.g. BS, DIN) and international (e.g. ISO, CEN) standards committees and will be reported to these bodies to support the development of new measurement standards and specifications for tissue engineered medical products. Global collaboration through VAMAS (Versailles Project on Advanced Materials and Standards, – Technical Working Area 30 prenormative standards research for tissue engineering) will enable Europe to access metrological research from Asia and America. Views on the need to develop standards will be sought from stakeholders in RM to ensure that standards are relevant.
Dissemination to the scientific and academic community will take place through scientific papers and conferences. The partners will build on strong links with medical research organizations , academics and healthcare companies to encourage exchange of ideas and results, to build a vibrant European level community in RM. A website will be developed to act as a focal communication point for the wider community of academics, industrialists, regulators and therapy providers. New uses of the web for communicating with stakeholders will be explored, for example the use of Second Life.
It is anticipated that the development of new measurement technologies and the knowledge gained in processing and characterising cell based products and novel materials may result in new intellectual property (IP). Procedures for identifying and protecting such IP will be agreed by the project steering committee and included in the consortium agreement. IP opportunities will be reviewed by the project steering committee. Exploitable IP may result from.
Improvements to measurement instruments – partnerships will be developed with appropriate instrumentation companies depending on the opportunity New processes for sorting/culturing stem cells – opportunities for collaborative research with medical research organisations will be pursued Reference materials and artefacts for calibrating instruments and verifying measurement methodologies are critical – JCTLM (International Joint Committee for Traceability in Laboratory Medicine) recommended expansion of the range of “reference measurement procedures and reference materials of a higher order” - a plan for certifying and distributing such materials developed in the project will be established
Access to better standards, guidance and facilities and facilities is needed by many organizations and the project, through improved understanding of partners capabilities, will encourage better access to state of the art facilities across Europe (e.g. metrological CARS) for calibration and research and development activities so that benefits of the research can be more widely exploited.
Cellular imaging and analysis methods have applications spanning applications such as diagnostics, cell based sensing and toxicology assessments (where alternatives to animal testing would be both commercially and politically beneficial to the implementation of the REACH directive).
For more information: Dr. Paul Tomlins
