Frameworks for improving policy and regulation of life-sciences innovation

Innogen’s research on life-science innovation, its regulation and governance has led to three systemic frameworks with which to conduct `action research' with decision-makers in government and companies: TARGET, which supports regional R&D policy-making; AGIT, which focuses on improving policy and regulation for life-science innovation; and STRATIS, which allows decision-makers in companies to take a systemic approach to decision making in innovation processes. Users of all three frameworks in both government and companies have testified to the way in which they have led to improved decision-making.

Targeted R&D Policy (TARGET) is designed to support policy-makers in Europe's regions and smaller countries, who face increasing pressure to be selective in their funding of R&D but with little existing effective guidance or resources to help them do this wisely. TARGET is a systematic methodology for mapping a) the strengths and weaknesses of the existing innovation system in a given region/country and sector, and b) the stages of the innovation process that key developments within that sector have reached. TARGET then helps policy-makers identify both the strategic and the tactical decisions that need to be taken to give those innovation processes a realistic chance of successfully coming to fruition.

TARGET was developed and tested by applying it in retrospective case studies of the development of biotechnology in five regions/small countries, which have had varying degrees of success in biotech (Israel, North Carolina, the Øresund `region' of Denmark/Sweden, Scotland and Singapore) and then applied `in real time' in collaboration with policy makers in Galicia (Spain), Lithuania and Slovenia, and in France's Direction générale de la compétitivité (Rosiello, A. et al. 2011a; Rosiello, A., Avnimelech, G. & Teubal, M. 2011b)

Policy-makers who have used TARGET report that they have found it very helpful in determining the best policies to implement according to the local context and capabilities

Adaptive Governance of Innovative Technology (AGIT) is based on extensive longitudinal research on innovation in a number of areas of the life sciences (pharmaceuticals, agro-biotechnology, biofuels, human stem-cell therapies). This research has revealed the crucial role of regulatory decisions taken in early stages of product development that then have unforeseen outcomes (Mittra, J., Tait, J. & Wield, D. 2011; Mittra, J. & Tait, J. 2012; Tait, J. 2007). AGIT helps policy-makers identify the potential enabling and/or constraining roles of their decisions; encourages policy-makers to retain the scope for future modification of policies and regulations as more is learned about the benefits and risks of a technology, product or process; and encourages them to consider new, more critical approaches to stakeholder engagement.

Innogen’s co-director, Joyce Tait, has employed the results of AGIT-type analyses to advise government policy-makers on how to improve regulation so that it is more supportive of beneficial innovation. Tait, as a member of the Emerging Science and Bioethics Advisory Committee (ESBAC) and of the Synthetic Biology Leadership Council (SBLC) has been given leading roles in sub-committees to advise, based on the STRATIS and AGIT approaches, on governance-related aspects of their remits.

Companies using AGIT report that it helps their staff understand the complexities of regulation of new technologies.

Strategic Planning for Advanced Technology Innovation Systems (STRATIS), implemented using Banxia's Decision Explorer software, is a method that allows managers in companies to systematically work through the decisions that will need to be made as they translate innovations towards practical use. It allows them to examine a variety of scenarios (for example, in which demand for the product in question suddenly rises or falls, or regulatory/production difficulties emerge). STRATIS is informed by the results of AGIT research on regulation and its likely medium-term changes (it can be hard even for experienced industry personnel to keep abreast of changing, dauntingly complex regulatory frameworks and practices). STRATIS was developed and tested in action research with early stage companies involved in developing regenerative medicine products based on human embryonic stem-cell lines (Mastroeni, M., Mittra, J. & Tait, J. 2012).

The companies using STRATIS report that it has enabled them to make better-informed decisions on product and process development in light of emerging regulatory systems. Five multinational companies and nine smaller companies are investing staff time and effort in joint research projects with Innogen members.


Rosiello, A. et al. (2011a) TARGET Policy Report: Promoting the Biotechnology Sector.

Rosiello, A., Avnimelech, G. & Teubal, M. (2011b) Towards a Systemic and Evolutionary Framework for Venture Capital Policy. Journal of Evolutionary Economics, 21(1), pp.167-189, DOI: 10.1007/s00191-010-0189-x.

Mittra, J., Tait, J. & Wield, D. (2011) From Maturity to Value-Added Innovation: Lessons from the Pharmaceutical and Agro-Biotechnology Industries, Trends in Biotechnology, 29(3), pp.105-109, 10.1016/j.tibtech.2010.11.004.

Mittra, J. & Tait, J. (2012) Analysing Stratified Medicine Business Models and Value Systems: Innovation-Regulation Interactions. New Biotechnology, 29(6), pp. 709-719, DOI: 10.1016/j.nbt.2012.03.003.

Tait, J. (2007) Systemic Interactions in Life Science Innovation. Technology Analysis and Strategic Management, 19(3), 257-277, May 2007.

Mastroeni, M., Mittra, J. & Tait, J. (2012) Methodology for the Analysis of Life Science Innovation Systems (ALSIS). Innogen Centre Report to Technology Strategy Board. Available via