Biomodifying technologies and experimental space: organisational and regulatory implications for the translation and valuation of health research.
Three key developments form the focus for this project: the arrival of ‘gene-editing’ whose goal is to understand and remove disease-related mutations, the creation of induced pluripotent stem cells that can be controlled to create different types of tissue for cell therapy, and the emergence of 3D printing of biological material which aims to create novel structures for bodily repair and renewal.
These developments can all be described as ‘biomodifying technologies’, they modify living biological tissue in novel and increasingly patient-orientated and customised ways. Biomodifying Technologies challenge the suitability of traditional manufacturing, governance and reimbursement pathways designed for small molecule pharmaceuticals or medical devices.
Each of these fields have potentially far-reaching effects as ‘gateway technologies’ with wide-ranging applications, significant commercial engagement and high levels of transferability. In this context, the project’s overarching aims are:
To understand and anticipate emerging developments in these three fields and to build an informed and constructively critical social science of biomodifying technologies.
To provide insight to stakeholders on likely translational pathways and organisational healthcare models for the selected technologies.
To assess the societal and health implications of biomodifying technologies and the processes of valuation at work across different stakeholder groups.
The BioMod project team is led by Dr Michael Morrison (HeLEX) and includes Professor Jane Kaye (HeLEX), Professor Alex Faulkner (University of Sussex), Dr Phoebe Li (University of Sussex) and Professor Andrew Webster (University of York).
A series of short, policy orientated articles about the BioModifying Technologies project can be found here.
The MHRA Patient Forum Report on Biomodifying Technologies is now available.
Martin, P., M Morrison, Turkmendag I and Nerlich B, 'Genome editing: the dynamics of continuity, convergence, and change in the engineering of life' (2020) 39 New Genetics and Society 219
M Morrison, 'Making bio-objects mobile: behind the scenes of a translational stem cell banking consortium' (2020) BioSocieties
"The promises and challenges of biomodifying technologies for the UK" written by Michael Morrison for Open Access Government, July 2019 edition, pages 216-217