What are biomodifying technologies?

Developments in biomedical innovation today can be seen in areas such as robotics, digital systems or new imaging techniques – and increasingly in areas marked by highly sophisticated forms of medical biology and biotechnology that involve altering ‘natural’ biological processes.

 

Three key developments form the focus for this project:

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  1. the arrival of ‘gene-editing’ whose goal is to understand and remove disease-related mutations,

  2. the creation of induced pluripotent stem cells (iPSC) that can be controlled to create different types of tissue for cell therapy,

  3. 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’, that is, those that modify living biological tissue in novel and increasingly patient-orientated and customised ways.

 

The three technologies stand alone, but can also interact with each other – for example gene-edited iPSC lines are already being developed as research tools and 3D printing is being designed to create bio-structures from differentiated iPSC.

Why are biomodifying technologies important?

Biomodifying technologies are important in a scientific and medical sense but also because of their potential to reshape the landscape of biomedical innovation in the 21st century.

 

These are ‘gateway’ technologies with wide-ranging applications, significant commercial engagement and high levels of transferability, which open up far-reaching possibilities.

 

At the same time, these technologies, alone and in combination also challenge existing pathways for developing new therapeutic products and services in a number of ways:

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  1. There are questions about the applicability of existing standards for safety, quality control, and traceability of biological materials, raising questions about how to manage the particular risks and uncertainties in applying novel biotechnologies to human patients

  2. There is not a single clear development trajectory for biomodifying technologies, but multiple, interlinked innovation pathways. This raises the likelihood that findings in one domain, for example, standards for iPSC quality for disease modelling, could influence development in other such as quality control of iPSC for cell therapy.

  3. The development of lines of research using these technologies is likely to involve local ‘tinkering’ with the performance and capabilities of these technologies, and sharing of adapted components or protocols (e.g. software for 3D printing, gene-edited cell lines)

  4. Are existing Health Technology Assessment calculations of utility, cost/benefit analyses and so on adequate to capture the value of novel applications of biomodifying technologies? Are they compatible with increasingly patient-centred research and new standards for expedited or compassionate access to untested therapies, and are these even appropriate routes to consider?

What do we want to know?

The project’s overarching aims are:

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  1. To understand and anticipate emerging developments in biomodifying technologies in the UK.

  2. To provide insight to stakeholders on likely translational pathways and organisational healthcare models for the selected technologies.

  3. To assess the societal and health implications of biomodifying technologies and the processes of valuation at work across different stakeholder groups.

  4. To build an informed and constructively critical social science of contemporary biomedical innovation.

Who is this research for?

The findings from this work are intended to be useful for a range of groups including:

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  • professionals working in the healthcare field,

  • patients and patient organisations,

  • academic scientists,

  • researchers and business leaders working in the biotechnology industry,

  • policymakers,

  • regulators and lawyers,

  • member of the general public

What are the intended benefits?

  • Help healthcare professionals, hospital managers, biotechnology and pharmaceutical firms, and regulators to  identify emerging clinical applications of these new technologies that are likely to be relevant to their work in the mid-to near term future.

  • Incorporate the needs and perspectives of patients and charities on the value of different biomodifying technologies and the ways in which they might be made available as new medical products and services.

  • Provide guidance on the legal and ethical requirements and responsibilities of service providers operating or planning to operate in this space

  • Help to shape viable business models for new products and services based on these technologies.

  • Produce an evidence-base on the social, regulatory and organisational implications of current research trajectories and how biomodifying technologies might be translated to the clinic.

How is this research funded?

This research is funded by the UK Economic and Social Research Council through grant number ES/P002943/1