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New technologies allow accurate modification of DNA, transformation of skin or hair cells into stem cells, and printing of 3D structures made of cells. Each of these novel technologies, alone or in combination, allows deliberate modification of living tissue and can potentially be used to improve human health and treat disease.

These new, disruptive technologies present novel risks and challenge existing regulatory systems. This project will therefore investigate the laws, regulations and guidelines which apply to these technologies; how this regulatory framework influences their development, and the options for improving governance of biodmodifying technologies in the future.

The project will focus on three case-study technologies:

  1. Gene editing, which allows scientists to make changes to the structure and function of DNA in living tissues and cells,
  2. Induced pluripotent stem cell (iPSC) technology that can convert any ordinary skin or hair cell into a potent stem cell, and
  3. 3D printing of biological material, which aims to create novel structures for bodily repair and renewal.

Each of the three are ‘gateway’ technologies; being relatively easy to use, having a wide range of clinical applications, and attracting significant commercial engagement. Furthermore, each technology interacts with the others: gene-edited iPSC lines are already being developed as research tools and 3D printing is being designed to create bio-structures from differentiated iPSC.

The project will focus on the development of biomodifying technologies in the UK, ultimately aiming to provide an evidence base to inform the development of appropriate, flexible and responsive governance models for converging biodmodifying technologies. This will be attempted through analysis of existing regulations, statutes, guidelines, scientific and ‘grey’ literature, as well as qualitative interviews with key stakeholders in the field. 

The BIOGOV project team is led by Professor Jane Kaye (HeLEX), and includes Professor Alex Faulkner (University of Sussex), Dr Phoebe Li (University of Sussex), Professor Andrew Webster (University of York), Miranda Mourby and Dr Michael Morrison (HeLEX).

Read article in ImpactBiomodifying technologies and experimental space: Organisational and regulatory implications for the translation and valuation of health research

The project is funded by the Leverhulme Trust through grant number RPG-2017-330.