Introduction to the ongoing FP-7 Regenerative Medicine in Europe project.
Presented at the Innovative health technologies: health systems in transition Workshop, Internet Interdisciplinary Institute, Barcelona, November 27th 2009.
1. Measuring Innovation – a brief introduction to the REMEDiE project Michael Morrison Innovative Health Technologies: health systems in transition Barcelona 26-7 November 2009
10. EUROPEAN RM COMPANY UNIVERSE 4# No Cancer, Parkinson's’ 10+ Small UK Oxford Biomedica No Cancer vaccines 10+ Medium France Transgene No Cancer 10+ Small Germany Mologen AG No Cancer 10+ Small Italy MolMed Main program is therapeutic vaccine for diabetes Chronic pain 10+ Small Sweden Diamyd Medical AB No Rheumatoid Arthritis <5 Small Netherlands Arthrogen BV Five non-RM products, mainly wound dressings Vascular disease and cancer 10+ Small- medium UK Ark Therapeutics No Protein deficiency 5-10 Small Netherlands Amsterdam Molecular Therapeutics PRODUCTS ON MARKET DISEASE FOCUS AGE (years) SIZE LOCATION NAME
This talk is intended as a brief introduction to the REMEDiE project, the lead partner of which is the Science and Technology Studies Unit at the University of York (UK). My main aim here is not to dwell on the findings of the project itself (which remain a work in progress) but to discuss some specific problems we faced in trying to operationalise our part of the research. My details can be found here: http://www.york.ac.uk/depts/soci/about/s_morr.htm And on academic.edu
REMEDiE stands for Regenerative Medicine in Europe. The projects sub-heading is “Emerging needs and challenges in a global context”. The Project is funded under the European Union’s 7 th Framework Programme, under the Socio-economic Sciences and Humanities (SSH) funding stream. More details of the project can be found at http://www.york.ac.uk/res/remedie/ In this presentation I will focus on my own work on work package 1 of the project, being carried out by SATSU and the York Management School
The aim of our work package is essentially to investigate and trace the patterns of capital investment in the commercial regenerative medicine industry in Europe, with a view to assessing Europe’s competitive position in relation to other significant zones of RM development such as North America, China and India. However, as emphasised by the current financial crisis, the allocation of capital has not been subject to stringent governance and it is not possible to account for how much money has been invested in this industry nor where it has been spent.
This leaves us with a problem: if we cannot trace investment directly, what can we measure to give some idea of the economic development (or lack thereof) of commercial regenerative medicine in Europe? We have chosen two possible solutions An detailed examination of the RM companies actually operating within Europe and Looking at patents as an index of innovative activity (innovation here referring specifically to the commercialisation of novel inventions) Our rationale being that if we cannot trace investment itself, then we can at least attempt to measure the outcomes of (successful) investments
This slide displays some basic descriptives of the ‘universe’ of European RM companies. A recent report from a separate EPSRC project entitled REMEDI (although not affiliated with the REMEDiE project) complied by a team led by Dr Paul Martin at the University of Nottingham provides a comprehensive overview of commercial cell therapies currently in development. This report has been very helpful in providing an independent data set against which to compare our own findings and also as a platform for us to build on in developing our investigation. The report can be downloaded from http://www.nottingham.ac.uk/iss/research/Current-Research-Projects/Staff_projects/regenmed/reports_publications.htm
I want to use this slide to illustrate the kinds of data we can get from a detailed breakdown of RM companies by technology platform. The left hand graph describes two trends in the European cell therapy industry: First, it is clear that European RM firms have invested heavily in an autologous model of cell therapy –where therapies employ cells derived from a patient’s own tissue, rather than an allogeneic approach – where cells are collected from a small pool of donors and treated to (hopefully) be transplantable into a larger patient pool of tissue-typed recipients. This is in marked contrast to the US where commercial cell therapy firms have favoured allogeneic approaches. The different approaches have important consequences for the business models of firms involved as allogeneic products can be patented and sold much more like conventional drug therapies, whereas there is little scope for intellectual property rights in either autologous use of a patient's own cells or the surgical procedure of transplantation, meaning firms pursuing autologous technologies must seek revenue from proprietary processes of cell culturing and/or medical devices associated with the procedure. The second pertinent observation is that while the number of stem cell therapies being developed is significant, non-stem cell based therapies still form a dominant part of the European cell therapy sector. This, and the very limited investment in induced pluripotent stem cells, illustrate that the most recent (and most hyped) scientific developments do not rapidly come to dominate the commercial sector but rather emerge alongside, and often in competition with older paradigms of regenerative medicine.
The company universe data also has an additional function of acting as a case study selection ‘matrix’ for ongoing work in the REMEDiE project.
This slide gives an example of how the company data can be used as a matrix to give an idea of the shape of a particular regenerative medicine sub sector (in this case gene therapy) and to identify a ‘typical’ company in that sector. The industry is not concentrated in any one European state but is made up primarily of small companies, most of which are ten or more years old and only one of which has been founded in the past five years. The most common disease focus for the gene therapies being delivered is cancer of various forms. While an early focus of gene therapy, following a ‘magic bullet’ characterisation of the treatment, was ‘single-gene’ disorders such as cystic fibrosis and muscular dystrophy, the majority of gene therapy clinical trials have been in cancer, not least because it has been easier to get regulatory approval for this indication then for most others (Martin and Morrison, 2006). On this evidence the European gene therapy companies are taking a similar approach to their counterparts in other parts of the world.
The company universe data is a useful starting point but has a number of limitations, not least that it is hard to ascertain if the data set is complete and it is difficult to track changes over time. Our second proposal is to employ patent data as a means of charting the development of commercial regenerative medicine.
There is considerable existing literature on the use of patent analysis as a means of measuring and tracking biotechnological innovation
What kind of data can patents give us? This slide shows a (modified) section of the front page of a European patent. Distinctions can be made between granted patents (distinguished by the B1 code at the end of the patent identification number) and patent applications, and patents can be classified by International Patent Classification (IPC) codes and keywords in the title and abstract (abstract not shown). It is possible to combine particular sets of keywords (e.g. ‘human OR primate’ and ‘stem cell’) with IPC codes (such as C12N 5/08 for products containing human cells) to produce search parameters which will match our project definition of regenerative medicine and allow us to search patent databases for relevant patents.
This slide shows a US patent front page (also altered). Collected patents can be broken down by a number of factors including granted patents vs. applications and the date of granting or application, organisations holding the patent (assignee), nationality of patent holders and or assignee institutions, patent office (e.g. European patent Office, United States Patent and Trademark Office) etc. This slide also illustrates how keywords can be found in an abstract (in this case ‘gene therapy’).
Analysis of a collected set of regenerative medicine patents should be able to produce the kinds of trend and pattern described on this slide.
This final slide raises some additional considerations not directly addressed in the REMEDiE project but that arose as a result of ideas formed in response to the Public Life of Data project, with which the University of York is also involved. (See a separate presentation from Dr Darren Reed). The main points I wanted to raise were that, by recognising the secondary, pre-processed nature of much of the data we have had to rely on to create the company universe – whether from company websites, third party surveys, commercial reports etc –we must also be aware that when we ‘release’ our own data, through publication, reports to the European commission etc it takes on a similar life of its own – that is we cannot predict exactly who will be using it or for what ends and nor can we ignore the fact that in our own analysis we too are selecting indices of measurement and actively shaping the discourses of what regenerative medicine ‘is’ (and is not) and how it should be handled. This adds an additional layer of reflexivity to the project.
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