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A EUROPEAN TECHNOLOGY PLATFORM |
Working
Group 2 “Technology Transfer and Exchange” - Report
Brussels,
1 December 2005
Final, 19 December 2005
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Intervet / Paul Van Aarle (Chair) GALV / Ian Maudlin (Vice-chair) CEVA
/ Jerôme
Thevenon CVO DK / Preben Willeberg Hipra / Enric Espuña Ingenasa Madrid / Carmen Vela INRA / Thierry Gauthier Merial / Caroline Schumacher OIE / Christianne Bruschke Pfizer / Jeremy Salt Tridelta / Kieren Walshe (for Dr Barrett) University of Nova, Lisboa / Manuel J.T. Carrondo Vakzine Projekt Management / Albrecht Läufer |
IFAH-Europe / Jim
Scudamore (minutes) IFAH-Europe / M. Chaton-Schaffner IFAH-Europe / D. O’Brien IFAH-Europe
/ H. Marion Observer EC / B. Arbelot EC / I. Minguez-Tudela EC / Ph. Steinmetz Apologies Lohmann Animal Health / Dietmar Flock Merial / Michel Bublot SVANOVA / Malik Merza VLA / Trevor Drew |
Agenda
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Welcome |
D. O’Brien |
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Presentation agenda points out of Concept SRA |
J.
Scudamore |
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Presentation disease prioritization |
P. van
Aarle |
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Wrap up discussion and prepare short presentation per sub-group |
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Formulation / edit agenda points for SRA |
J.
Scudamore |
Minutes
1. Mr Declan O’Brien, Chair of the
European Technology Platform for Global Animal Health (ETPGAH), updated the
group on the progress to date. The chairs of the 3 working groups had met to
prepare the agenda for the meetings and to discuss the layout and content of
the Strategic Research Agenda (SRA). The Executive Board of the Platform
discussed a range of issues including the work of the 3 groups during a recent
teleconference. Mr O’Brien was pleased to announce that the vision document for
the platform had been finalised. IFAH-Europe had arranged for 4000 copies to be
printed. He asked representatives at
the meeting to distribute the vision document as widely as possible. Good
progress was being made. Mr O’Brien thanked Professor Scudamore for his work in
producing the initial drafts of the Strategic Research Agenda.
2. Professor Scudamore summarised the current position with the
development of the SRA. An initial rough draft had been prepared for use at the
working group meetings. It was anticipated that this would be subject to
considerable revision following the meetings. The initial draft was based on
the outcome of the first series of working group meetings which had
concentrated on research needs and rationale for the research requirements.
Consequently there was little in the initial SRA detailing specific research
requirements. It was important to identify specific areas for research during
the current meeting of the working group. In addition methods to overcome the
barriers to the development and delivery of new and improved tools to control
diseases of major importance were needed.
3. Professor Scudamore outlined the proposed format for the SRA
document and re-emphasised the importance of including specific research
requirements. It was also important to develop an action plan for the
implementation of the SRA. Potential sources of funding would need to be identified
especially as the EU Framework 7 funding was only one of a number of potential
sources.
4. Paul van Aarle set the scene with a presentation on disease
prioritisation. A copy of the presentation is on the ETPGAH website at www.ifah.be/europe/euplatform/platform.htm.
He based his analysis on the
OIE disease list although other diseases may be of significance to the EU. The
analysis was quantitative rather than qualitative and accepted that different
stakeholders would have different priorities. There had to be a balance between
what is available and what is needed. Paul van Aarle suggested a simple scoring
system of 0 to 5 for a number of set
criteria for each disease on the list. These criteria included: societal
relevance to the EU, food safety, direct economic impact, trade consequences,
risk of introduction, zoonotic properties and impact on developing countries
5. From this analysis a group of 10 top diseases were
identified. These are listed in his presentation. There was an extensive
discussion of the list especially as diseases such as BSE and Scrapie were
missing. BSE was a good example of a disease where there was high societal
interest and where the current control measures were extremely expensive.
Public perception and political importance had to be included in the list of
criteria. Limiting the work of the platform to only ten diseases also posed a
potential problem especially as there would be different priorities in
different geographical areas of the EU. A more developed methodology was needed
to address priorities. It was also pointed out that in the developing countries
the delivery of products to the users was very difficult due to the decline in
the efficiency of the veterinary services. The work of the platform was not
necessarily to find the ideal vaccine or test but to identify the most
effective in the relevant circumstances.
6. A gap analysis was presented which sought to answer a range of questions about the present situation and
future needs. Questions included: what do we have? do we need a vaccine or a
test? are there vaccines and tests available? do we have the knowledge
necessary to control the disease? A separate table was produced relating each of the top 10 diseases to the perceived
requirements.
8. Following the presentation on prioritisation by Paul van
Aarle, two sub groups considered a number of issues in more detail. Each sub
group prepared a report which was presented for discussion by the whole working
group
9. Sub-Group 1 chaired by Ian
Maudlin
considered disease prioritisation in more detail by reviewing the top 30
disease list and revising individual scores. More disease candidates were
identified and prioritized. The report of the sub-group is at annex 1
10.
The report from sub-group
1 raised many questions concerning the practicality of prioritising diseases
and the criteria which should be used. Questions related to the correctness and
relevance of the criteria adopted, the scoring method, the way to reflect the
views of governments, inclusion of the risks or potential risks to Europe,
inclusion of society’s perception as a criteria and why the disease was a priority.
It was difficult to define which were the priorities but if all the relevant
factors could be considered it would be possible to prepare a priority list
from which the priorities for the Strategic Research Agenda could be prepared.
11. Sub- Group 2 chaired by Carolin Schumacher was asked to define if research is
still needed for the listed diseases and if so in what direction and in what
areas. The sub-group also considered the technology currently available and
that which was needed.
12. The sub-group considered the initial list of disease
priorities and the most effective way in which to identify the gaps and
research requirements. A table was developed with the main diseases across the
horizontal axis and the research requirements down the vertical axis. In doing
this it was possible to develop a matrix which clearly indicated the gaps and
needs for each of the diseases under consideration. In the time available it
was only possible to produce an outline and much more intensive input is
required to complete and validate the chart for the diseases listed.
13. The research areas which the sub-group identified included:
mapping, disease prioritisation, sourcing strategy, response capacity, new
product needs, evaluation of existing products, knowledge of the disease,
research into control methods, technology transfer. Each of the diseases was
considered against the specific headings. A summary of the headings produced by
the sub-group is shown at annex 2
14. In the general discussion the problems of transfer of
scientific findings into policy and legislation was raised especially with the
need for peer review and advice to the policy makers. The fundamental question
was the way in which the SRA could incorporate all these requirements.
Technology
Transfer
15. A gap existed between the research scientist and the
development process. Europe had many of the best scientists but this was not
reflected in the number of successful
patent applications. Part of the problem was that scientists did not
develop their ideas to the proof of concept stage with the result that the
industry was often not able to develop the idea. It was important for the
scientists to develop their ideas to proof of concept stage by ensuring
stability of a compound, reproducibility of test results, purity of the
material, scalability and finally safety and efficacy. This should be a minimum
requirement before a product or idea could be exploited by the industry.
16. The industry is always on the look out for a market but has to
be convinced that the development of an idea is worth funding. The development
of products which have not reached the proof of concept stage (POC) is not an
attractive proposition for the industry. It is good practice to develop to the
POC stage at which time the industry steps in to develop a potential end
product. Research institutes are not interested in this part of the process for
a number of reasons not least the cost of the process.
17. The identification of innovative ideas is crucial to
technology transfer as is the exploitation of ideas through the development of
new products to a stage where they are authorised and manufactured. This is
becoming increasingly important as the research funders expect to see concrete
developments and products delivered to the market. If the issue of proof of
concept is overcome the successful transfer of technology can be achieved in a
number of ways. Possible models include;-
18. A further area involving technology transfer concerns product
already available but which are not used in the developing countries either due
to lack of knowledge or lack of funds to purchase and apply the product. This
relates also to the global perspective of the platform especially in terms of
EU cooperation and EU aid to developing countries. Capacity building in the
developing world is also a major issue. EU research funding into disease
control measures would help capacity building in the developing countries and
would improve access by the EU research workers to the diseases which may not
be present in Europe at the present time. Financing of the joint projects by
the EU would be an important way of capacity building in the developing
countries. The Global Alliance for Livestock Vaccines (GALV) will obtain
funding to transfer available products from the shelf to the market by funding
products which are commercially unviable at present.
Intellectual
Property rights
19. The problems related to intellectual property rights (IPR) had been identified
at the first meeting of the working group. Whilst these were major problems the
solution to many of these was outside the remit of the working group. No
specific research needs were identified but it was clear this was an important
area where improvements were needed in order to enable the development of
innovative tools to control disease. IPR should be seen as a hurdle as it is an
essential prerequisite to the development and use of innovative ideas. Four
specific actions were identified:
Education of scientists and researchers on the importance of patents and
developing the idea to the proof of concept stage
Funding to permit the filing of patents as part of the overall research
funding for a project. In the US funding is provided to patent nearly all
ideas.
Provision of advice or funding to enable advice to be obtained from
patent attorneys, marketing experts and technical experts in order to correctly
file for a patent.
Advice on the use of licensing and sub-licensing once the patent was
obtained.
20.
The situation varied from
research establishment to establishment. Some research institutes were geared
up to patent ideas but in many cases the universities were not. The problem was
that universities in general did not patent their discoveries nor did they
develop their ideas to the proof of concept stage. From an industry perspective
the development work involved a great deal of investment and was not practical
in many circumstances which meant that potential innovations were lost.
21. Professor Scudamore summarised the provisional conclusions of
the working group. It was apparent that a disease prioritisation methodology
was needed but could be complicated to develop especially with the wide range
of criteria which had to be considered. A start had been made by the group but
would need to be continued as part of the SRA. The prioritised list so far used
had been incorporated in the matrix table which was beginning to identify the
diseases, the gaps in the research and the research requirements. This matrix
could be developed for the priority diseases but would need more work to
finalise and complete.
22. Other areas for consideration for the SRA which had emerged
during the discussion included:
23. A number of barriers to the efficient transfer of technology
had been identified. Various steps could be taken to improve technology
transfer and it was important for these to be included in the SRA. The
conclusions of the working group would be incorporated into the SRA which would
be redrafted to take account of the discussion of the three working groups. The
revised SRA would identify prioritisation and research needs for the diseases as
the main component but would then expand on the enabling research, regulatory
issues and enabling environment to facilitate the delivery and development of
new products.
Work Plan
24. The following work plan was agreed by the
working group:
Aim to place presentation by Paul van Aarle on the web site within 2
weeks
Circulate the notes of this meeting to all participants for their
comment/agreement within 2-3 weeks
Produce a revised Strategic Research Agenda incorporating the working
group discussion and conclusions for discussion by the chairman of the 3
working groups meeting on 20 December 2005.
A revised Strategic Research Agenda to be circulated to all working group members
for comment and revision in early January 2006.
Further revised version
of the SRA to be sent to all stakeholders for comment and discussion at a
stakeholder meeting on 15 February.
Annex
1
Group 1
December
1st, 2005
Disease
Prioritisation
List from WG 1 is
mapping list.
Paul van Arle list is
a priority list - headings for priority
on top of list. Societal relevance –
does it cover BSE? Yes, but high score
on this issue alone does not make it a priority.
Some diseases, such
as BSE, have a high public profile and necessitate research regardless of
objective scores in grid system.
Two lists compared on
board – top 15 of both lists.
Bovine Tuberculosis/
Para Tuberculosis
Classical Swine
Fever/ Bovine Viral Diarrhoea
FMD
Influenza
Parasitic Diseases/
Neglected Parasitic Diseases
Rabies
Food-borne Diseases
(Salmonella, Campylobacter, others)
TSE
West Nile Fever
Bluetongue
Brucellosis
Clamidia
Cryptosporidiosis
Emerging Diseases
Leptospirosis
Neglected Zoonoses
Q Fever
Rift Valley Fever
Zoonoses from non
human primate
Most
important discussion points:
Annex 2 Group 2 Chair Carolin
Schumacher
Research
areas
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1 |
Mapping |
Map Research, Technologies,
Patents etc |
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Identify existing products worldwide – identify
gaps |
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2 |
Disease Prioritization |
Develop a risk-based disease prioritization model
for Europe |
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3 |
Sourcing strategy development |
Develop a risk-based souring strategy for
required product from within and outside the EU |
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4 |
Response capacity |
Develop contingency plans |
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5 |
New product needs |
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6 |
Evaluation of existing products |
Evaluation of products (EU and worldwide) to
match minimum requirement for purity, safety, efficacy (individual/herd
level) |
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Test against new requirement in field (DIVA on
herd level, new species, new application) |
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7 |
Knowledge of the Diseases |
Surveillance and epidemiology |
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Pathologies |
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Immunology on individual level () |
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Identification of relevant antigens for
diagnostics |
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Efficacy of sanitary control |
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8 |
Research into control methods |
Efficacy of sanitary control |
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Efficacy of produts in diseases control on herd
level (prevent disease, transmission, shedding, infection) |
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Analysis of disease and control
(pharmaco-economics) economics |
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Capacity building of Veterinary services /
improving access to control/tools/field competencies in endemic and
non-endemic countries |
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9 |
Technology Transfer (TT) |
Foster passage from research to application by protection of intellectual property
(IP) through patenting |
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Move research to Proof of Concept as enabler to
TT (purity, reproducibility, scalability, safety, efficacy) |
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Foster understanding of what is required to what
is critical to move to application (training/communication/collaboration) |
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Foster TT from industry in EU to industry in
developing countries (i.e. for exotic diseases) (INCO-DG Research + DG
AID/Development) |
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Review mechanisms (incl. Timing) for
transformation of research findings into disease control policies and
legislation |
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