Regenerative medicine - Science and Technology Committee Contents


APPENDIX 3: CALL FOR EVIDENCE


26 July 2012

The House of Lords Science and Technology Committee, chaired by Lord Krebs, is conducting an inquiry into regenerative medicine. The Committee will be looking, in particular, at whether the UK is in a position to facilitate the translation of knowledge from world-leading research to treatments and to benefit from the commercial opportunities that they present. It also seeks to explore how realistic some of the reported claims of regenerative treatments and therapies are, both in the UK and internationally.

Scope

The term "regenerative medicine" is used to refer to any methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function. This includes cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as the more traditional therapies of pharmaceuticals, biologics and devices. Examples of such treatments are the transplantation of a new trachea grown using the patient's own stem cells and the use of a hormone (Erythropoietin) to promote red blood cell production. The inquiry will also extend to cell therapies that have applications in other areas of medicine, for example, the use of cell therapies to control immune responses to conditions such as paediatric steroid resistant GvHD,[334] or the use of stem cells for drug screening.

The UK is a world leader in many areas within the field of regenerative medicine, particularly the platform technology cell therapies. Foresight's Technology and Innovation Futures report states that regenerative medicine could be a driver of growth for the pharmaceutical sector if regulatory, financial and translational research challenges can be overcome.[335] Regenerative medicine has the potential not only to lead to significant improvements in the treatment of chronic diseases (such as diabetes and certain kinds of blindness) but also to generate economic benefits for the companies that develop therapies and related infrastructure (such as manufacturing equipment). The deadline for written evidence submissions is Thursday, 20 September 2012.

Questions:

The Committee invites submissions on the following points, with practical examples where possible (please only answer the questions of relevance to you):

THE RESEARCH BASE

(1)  How does the UK rank internationally in the scientific field of regenerative medicine?

(2)  Where does the UK have strengths and weaknesses in the field?

(3)  Who are the major funders of research in the field of regenerative medicine? What funding is available to support this research?

APPLICATION OF THE SCIENCE

(4)  Is the science being translated into applications? What are the current applications of the science of regenerative medicine for the treatment of disease in the UK and internationally? Which treatments are available on the NHS or through private healthcare?

(5)  What potential does regenerative medicine hold to treat disease in the next 5-10 years? What is the reality versus the headlines about what the science will deliver?

BARRIERS TO TRANSLATION

(6)  Are the actions outlined in the Government's Strategy for UK Life Sciences, their report: Taking Stock of Regenerative Medicine in the UK, and the Research Council and Technology Strategy Board's Strategy for UK Regenerative Medicine sufficient to encourage the safe development of regenerative medicine treatments and to overcome the significant regulatory barriers and challenges to innovation in this inter-disciplinary field? If not, what more action is required? In particular:

(a)  What difficulties are encountered when conducting clinical trials and how could these be overcome?

(b)  What other difficulties are encountered conducting translational research within the NHS and how could these be overcome?

(c)  What barriers are encountered when seeking approval for the use of such treatments on the NHS or through private healthcare?

BARRIERS TO COMMERCIALISATION

(7)  What is the current, and potential future, commercial value of the sector to the UK economy? What is its value to society?

(8)  Where there is market failure, are Government providing sufficient incentives in the current commercial environment to attract investment in companies working in this high risk area? If not what more should Government do?

(a)  What role does patenting play in the commercial development of regenerative treatments?

(b)  What business models are most appropriate to support the development of regenerative treatments?

(c)  What are the barriers to securing finance to develop such treatments?

(d)  Are the pricing structures for the use of such treatments on the NHS appropriate to support their development?

(e)  What infrastructure barriers exist within the NHS, or externally, that prevent the scaling-up or commercial development of such treatments?

INTERNATIONAL COMPARISONS

(9)  What could the UK learn from its competitors about supporting the development and commercialisation of regenerative medicines?

(10)  How do regulations that govern the development of regenerative medicines in other countries and at an EU level impact on the development of regenerative medicines in the UK?

(11)  Is there sufficient harmonisation between the standards and regulations that govern the development of regenerative medicines in different countries?

(12)  What risks do UK citizens face when travelling to other countries for regenerative treatments? How do the safeguards in place to protect their interests in the UK compare to those overseas?


334   Graft versus Host Disease, a common disease amongst transplant or tissue graft patients where the hosts immune system attacks the transplanted cells. Back

335   See: http://www.bis.gov.uk/assets/bispartners/foresight/docs/general-publications/10-1252-technology-and-innovation-futures. Back


 
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