Science and TechnologyWritten evidence submitted by the Health Protection Agency

Q1. What are the difficulties of funding the commercialisation of research, and how can they be overcome?

1. The Government needs to take the issue of commercialisation of research and translating research into products seriously and this commitment needs to be underpinned by an effective mechanism of financial support.

2. The programmes supported by the Public Sector Research Exploitation fund (PSRE) such as “Interact” were very successful and ideally need to be repeated or for a similar fund to be established. BIS oversee the PSRE, but this is not currently providing any funding. The NHS has realised the importance of exploiting its IP by the formation of the NHS Innovation Hubs; these too suffer the same problems of being funded on short term monies with few options for support for the ongoing commercialisation of products.

3. Academic technology transfer partnerships need government support to draw innovations through the translational pipeline and expedite the delivery of benefits from these technologies. Follow-on funding to pick up the next stage beyond seed funds need to be more readily available. BBSRC have a specialised fund for this type of follow-on activity, but application is restricted to only those who were funded at the preliminary stages by BBSRC.

4. There are funding sources such the Technology Strategy Board (TSB) which do support translation of research into products at Technology readiness Levels 4–6. However there is no support from TSB, for commercialisation of products beyond Proof of Concept (PoC), moreover, the TSB funding terms & conditions allow for only 50% of Full Economic Costs (FEC) to be recovered. Additional funding sources to provide support for PoC studies clearly need to be made available.

5. There is a complete lack of funding streams specifically designed to provide core support for commercialisation of research ideas that have progressed through PoC.

6. Research institutes need to be able to better engage with companies and promising academic groups without the need to cover FEC’s.

7. UK non-human primate (NHP) capabilities are government supported and are key to retaining a lead in this important area of animal models of infectious disease for pre-clinical evaluation of new vaccines and therapeutics.

8. Costs surrounding protection of intellectual property (IP), particularly the exemplification of patents is very difficult to cover and needs government support to retain IP within the UK.

Q2. Are there specific science and engineering sectors where it is particularly difficult to commercialise research? Are there common difficulties and common solutions across sectors?

9. The pipeline to production of biological medicines inevitably involves transfer of manufacturing processes from laboratory via process development to pilot scale. These developmental production activities are expensive and not easily funded, but are a critical stage in the successful commercialisation of UK research. Little thought is given to manufacture by academic and other researchers and this stage then becomes essential for subsequent scale-up, cGMP manufacture, assay development and successful clinical trial.

10. Research funds administered by the National Institute for Health Research (NIHR) is primarily targeted at clinical research and administers a fund of approximately £1Bn. However, funding which supports clinical trials is too late stage in many instances, since it is the pre-clinical/translational research area which desperately needs this funding support, which is not covered by the NIHR funding rules.

11. In order to obtain regulatory approval, it is essential that the correct pre-clinical studies are performed. Our financial inflexibility from research councils and other grant providers currently precludes this as this area of translational research is not covered by any of them.

12. The MRC and Wellcome Trust have both issued statement of support to provide funding to bridge the Valley of Death (VoD), and we welcome that commitment. Both the MRC and Wellcome Trust have significant funds to support this translational research activity, but much of this work is pulled through from academia to the Public Sector; however, Public Sector organisations are not eligible to receive funding from these awarding bodies (or from other Research Councils).

13. The VoD inevitably requires cGMP manufacture for production of any biological medicine products; this activity is inherently expensive, as is the process development needed prior to manufacture. Support is needed to underpin the QBD (Quality by Design) ethos to ensure that advice is given (and received) at an early stage in the development process to help ensure that products can be successfully manufactured. Sites such as HPA Porton Down have significant expertise in doing this, but would like to see funding to support these activities at an earlier stage to avoid the problems that occur when many “bench level” interventions reach the process development or pilot scales. Early, correct advice is critical in the process of bridging the VoD.

Q3. What, if any, examples are there of UK-based research having to be transferred outside the UK for commercialisation? Why did this occur?

14. The majority of research which has been commercialised as a result of research undertaken at HPA Porton Down has been done overseas. This is mainly because of the cost recovery models used by UK-based bodies which provide funds to move commercialisation opportunities forwards; these typically do not cover FEC and for public-sector bodies, supporting the shortfall is becoming increasingly difficult.

15. A specific example is the commercialisation of the botulinum neurotoxin-based therapeutic product family. These were spun out by HPA Porton Down as a new company (Syntaxin), where the funding base came initially from Allergan (USA) and the product manufacture was performed by Diosynth (now Fujifilm Diosynth) also US based.

16. We need to ensure the funding base allows the value of our innovations stays within the UK.

Q4. What evidence is there that Government and Technology Strategy Board initiatives to date have improved the commercialisation of research?

17. The Technology Innovation Centre (TIC) initiative/mechanism could be very useful but they need to be more numerous and flexibly arranged. Of particular note is the need for greater flexibility around formation of the TIC’s as these appear to be driven by BIS and Government Departmental politics rather than need and commercial return. There are a number of examples where there are institutes operating effectively as TIC’s but do not fall into the identified areas of support; infectious disease research & translation is one such subject area. Some of the research capabilities and activities within the HPA would fit very well into the TIC model. If badged as a TIC, this would open up the sites for collaborative projects through the TSB scheme as well as offering UK plc the capabilities that we possess in translational research and bridging the VoD.

Q5. What impact will the Government’s innovation, research and growth strategies have on bridging the valley of death?

18. One of the key aspects in bridging the valley of death needs to be the development and evaluation of targets for the NHS and public sector bodies. Currently the commercialisation of research is not rewarded; this situation needs to change and a positive culture which encourages and rewards the commercialisation of research should be adopted.

19. There is clear need to use a different method of evaluating the impact of research which is performed. Academic departments look only at the impact factor of peer-reviewed journal publications, whereas for work performed in the VoD the impacts are different and the metrics should be to reflect these differences.

20. One way in which impact could be determined is by the use of health economic modelling. These models can be used to determine the effect of introducing a particular intervention on the QALY (Quality Adjusted Life Years) of the UK population. This would be an effective measure of not only the impact, but also of the potential value of such interventions.

Q6. Should the UK seek to encourage more private equity investment (including venture capital and angel investment) into science and engineering sectors and if so, how can this be achieved?

21. Yes the UK should be encouraging more private equity investment because it is currently insufficient to support the number of high-quality opportunities in the UK but we are agnostic as to how this is achieved.

Q7. What other types of investment or support should the Government develop?

22. Sources of funding that would facilitate government and academic institutions to offer support to SMEs on a sub-FEC basis would be welcomed and are seen by us as essential.

February 2012

Prepared 11th March 2013