3rd Meeting of Working Package 3 on Gap Analysis
October 23rd, 2009, Brussels
at the offices of DG RESEARCH
SDME building, Room 8E
List of participants
Members:
Merial / Carolin SCHUMACHER (Chair)
IZSVe / Stefano MARANGON (Vice-Chair)
INGENASA / Jacques DELBECQUE
ILRI / Paulo DUARTE
EMEA / Kristina VIDENOVA (For David MACKAY)
FAO / Stephane DE LA ROCQUE (For Juan
LUBROTH)
Bologna University / Alessandra SCAGLIARINI
Tiho – Hannover / Alexandra MEINDL-BOEHMER
(For Volker MOENNIG)
VLA / Falko STEINBACH
DISCONTOOLS / Declan O’BRIEN
DISCONTOOLS / Morgane DELAVERGNE
Invited:
EC – DG RTD / Isabel MINGUEZ TUDELA
Apologies :
INRA Tours/ EMIDA / Jean De RYCKE
National Veterinary Institute DK / Lars Erik
LARSEN
Boehringer Ingelheim / Randolph SEIDLER
University of Utrecht / Arjan STEGEMAN
IDT Biologica GmbH / Michael SCHLEGEL
Intervet SP / Paul Van AARLE
EMDV / Johanna KOOLEN
AVC / Klaus HELLMANN
Pfizer / Peter JEFFRIES
GALVmed / Johan VANHEMELRIJCK
CEVA / Guillaume AGEDE
CVI – Wageningen / Janet Van Der GOOT
CVI – Wageningen / Aline De KOEIJER
Epizone / Wim H. M. Van der Poel
Pfizer / Theo KANELLOS
VSF / Reginald De DEKEN
Romanian Poultry Producers Asso / Ilie VAN
DISCONTOOLS / Jim SCUDAMORE (Consultant)
Agenda
1. Approval of the Agenda and the minutes of the 2nd WP3 meeting
2. Actions arising
a.
b.
c.
d.
Vaccine availability – Ames, Iowa – update from Carolin Schumacher
Vaccine availability – Europe – update from David Mackay
Diagnostic availability – Spreadsheet provision by Johanna Koolen
Status of Theileria – Reginald De Deken
3. Methodology for Gap Analysis – Results of the testing of models
a.
Example of Classical Swine Fever – Volker Moennig
b. Prioritisation model – results of work on 6 diseases – Morgane Delavergne
c. Gap Analysis model – results of work on 6 diseases– Morgane Delavergne
d. Implications for Gap Analysis criteria & Interpretation model– Morgane Delavergne
4. Discussion on the Experts Groups – Declan O’Brien
a. Current status of the creation of Experts Groups by disease
b. Inclusiveness of range of expertise
c. Comments on the lists of Experts by Expert group
5. Disease database and public website – Morgane Delavergne
a.
Website online
b. Loading data into the Database
6. AOB
a.
b.
Questions on the future steps – Carolin Schumacher
date of next meeting
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Discussion
1.
Approval of the Agenda and the minutes of the 2nd WP3 meeting
Following brief introductions, the agenda and minutes were approved with attention being
drawn to one outstanding action related to the creation and writing of the Terms of
Reference (ToR) for the Expert Groups to formalise the instructions sent out to the experts.
Action: Secretariat to develop ToR
for the Expert Groups.
On discussion Declan O’Brien (DOB) presented a brief overview of the Stakeholder meeting
which was held in Brussels on the 8th July 2009 and the ETPGAH EB and DISCONTOOLS
PMB meetings that were held the day after. He explained that the main point agreed during
these meetings was the review of the ETPGAH Action Plan in 2010.
Action: Secretariat to organise the review of the Action Plan.
Secretariat to keep WP 3 informed of progress.
Isabel Minguez Tudela (IMT) expressed her satisfaction about the various European
initiatives that exist in animal health. However, she stated that the ETPGAH Mirror Groups
need to move towards Eastern European countries to better coordinate the actions in the
EU. She highlighted that DISCONTOOLS and the ETPGAH need to maintain strong
connections with the EMIDA ERA-Net, the Community Animal Health Strategy and other FP
projects focusing on animal health. Carolin Schumacher (CS) remarked on the great
progress made to date as witnessed by the creation of EMIDA, DISCONTOOLS, ICONZ to
mention but a few and thanked IMT for promoting animal health initiatives. CS remarked
that breakthroughs in animal health could enable trade and that this benefit should also be
borne in mind.
2.
Actions arising
a. Vaccine availability – Ames, Iowa – update from CS
CS presented the work she had done in the ETPGAH in 2006 where she highlighted the
need to know what products are available, where, and how to make them available in
Europe. The group agreed that there is a need for a clear sourcing strategy for vaccines in
Europe. CS made reference to the work done by the Australian government (Animal Health
Australia) on vaccine availability in Australia. A document is due to be finalised soon and
could be a good resource for this group. Then, she introduced a book published by the
International Association for biologicals (F. Brown and J. Roth, 2003) reviewing the
availability, safety and efficacy of veterinary vaccines for OIE List A diseases and for
selected emerging animal diseases. These documents provide good examples of what
needs to be done from a European perspective.
CS explained that the list of vaccines provided by the Iowa State University
(http://apps.cfsph.iastate.edu/Vaccines/) is an interesting database, but has been
completed mainly by SMEs only and that information on some products is incomplete.
International companies should consider providing information to have up-to-date data and
a broad overview of what products are available worldwide.
Action: Industry to be requested to provide data to the
Iowa State University Database on vaccines.
(Post meeting note: Iowa State have developed this list as a possible source
to fill gaps complimenting the full USDA list of vaccines)
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On discussion IMT expressed the need for such a database in Europe to be more prepared
in case of unexpected outbreaks and that DISCONTOOLS will be a useful tool by helping to
target scarce resources to fill-in the existing gaps in products for 47 diseases. It was noted
that the US authorities have completed a lot of work on tools available in relation to ASF,
CSF & Nipah and we should link into this information via the relevant Expert Groups.
b. Vaccine availability – Europe – Update from Kristina Videnova (KV)
KV explained that David Mackay (DM) will be meeting the HMA in the coming weeks to seek
agreement on a questionnaire to conduct a survey aiming at better defining which vaccines
are available and where in Europe. The EMEA has prepared the questionnaire and plan to
send it to the European National Agencies at the end of this year. KV stated that developing
such a list may be complex. The EMEA expects to have a consolidated list by mid 2010.
Action: EMEA to conduct a survey through National Agencies
to collect information on registered vaccines in Europe.
EMEA representative to give an update on the
progress at the next WP3 meeting.
On discussion Alessandra Scagliarini (AS) proposed to consult the ETPGAH Mirror Groups
(MGs) after the release of the document in mid-2010, if the WP3 group feels that
information is missing.
Action: Following the publication of the EMEA list, Secretariat to
contact the MGs to liaise with National Agencies if needed.
c. Diagnostic availability – Spreadsheet provision by Johanna Koolen (JK)
Jacques Delbecque (JD) presented the work of JK who could not attend (document
attached). The spreadsheet is a list of the EMVD members’ products (8 companies). It
represents a lot of work and is easy to use. However, information from companies such as
Prionics (now represented by the EMDV) and Public Laboratories is missing and the group
agreed that we need to collect the missing data about diagnostic availability in Europe to
complete the work.
Action: JK to contact Prionics to complete the list with their products
(Done already).
MD to ask DISCONTOOLS Expert Groups to provide
information on the products available in Public Laboratories.
DOB proposed that we place the spreadsheet on the DISCONTOOLS website for input by
the Expert Groups. He stated that we should also involve the FVE and maybe the FAO and
OIE to help completing the diagnostic list.
Action: MD to contact JK to check if the spreadsheet can be placed on the website.
MD to ask the FVE and OIE to contribute to the document concerning smaller
producers and public laboratories.
d. Status of Theileria
Reginald de Deken sent his apologies to the meeting, but provided a draft D&P document
prior to the meeting on Theileria. The group agreed that the D&P document should refer to
strains present in southern Europe.
Action: Propose Theileria for inclusion in the list to WP2 & PMB.
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3.
Methodology for Gap Analysis – Results of the testing of models
a. Example of Classical Swine Fever
Alexandra Meindl-Boehmer (AMB) made a presentation (attached) on the work of Volker
Moennig (VM) and his team at Hannover University on Classical Swine Fever. They filled in
the D&P document, the prioritisation scoring model and the gap analysis scoring sheet. The
main remarks on the D&P and prioritisation model were the geographical focus which could
lead to very different answers, the population referred to, the choice of coefficients,
possibility to score with decimal numbers and that some specific questions such as the
economic impact and the future development of products were very difficult to answer with
only academic expertise available. DOB explained that the focus, when filling in the
documents, should be European with a global perspective, but some diseases may only be
Global – such as Rift Valley Fever. It was noted that this point should be included in the
ToR going to the Expert Groups. Stefano Marangon (SM) and CS stated that the remarks
from VM’s team highlighted the need for a good balance of expertise in the Expert Groups
including economic expertise.
SM stated that difficulties emerge in the gap scoring model when various types of vaccines
are available for one disease as one vaccine may score well on one point but not on
another and vice-versa. WP2 may need to review the prioritisation scoring model with this
feedback in mind. CS added that the group should have a look at the 6 diseases when the
testing phase is complete. The group agreed that five critical gaps per disease should be
identified.
b. Prioritisation Model – results of work on 6 diseases
c. Gap Analysis Model – results of work on 6 diseases
d. Implication for gap analysis criteria & interpretation model
Based on the discussions that had taken place, it was decided to make one presentation
covering agenda points 3b, 3c and 3d and to then discuss the data issues in an overall
context. MD made a presentation covering these points (attached). Input remains
outstanding and a more thorough analysis cannot be undertaken until more data is
received by the secretariat. However the current results and comments on the gap analysis
model allowed the group to focus on critical comments to address. In terms of scores, it
was suggested that we stick with whole numbers. The wildlife reservoir issue needs to be
taken into account and may be a critical gap in our ability to prevent recurrent outbreaks
and may have trade implications. Likewise, commercial versus backyard production issues
need to be considered – again, critical gaps may emerge. The wildlife and backyard issues
need to be documented in the D&P. It was recognised that products under development are
not available and the score should reflect non availability unless the Expert Group are
convinced otherwise. It was recognised that we need to find a solution to the issue of
scoring for diagnostics, vaccines and pharmaceuticals where one or more type of product
may be irrelevant for a certain disease.
Action: Secretariat to address issues encountered
and make propositions to WP3 for improvement.
Secretariat to include solutions agreed on how
to score and give guidance in the ToR.
On discussion the group agreed that industry input would be valuable concerning the
availability of products. CS stated that the testing exercise should be complete for the end
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of this year to allow some modifications and solutions to be included early next year. A
meeting should be organised, if necessary, to discuss the final outcome of this testing
phase.
Action: MD to organise a meeting of WP3, if necessary, to discuss
the results of the test scoring exercise.
Secretariat to stress the importance of feedback from
those that did not yet reply to the testing exercise.
To summarise, the following steps were agreed in relation to the testing:
-
Complete the testing exercise before the end of 2009
Secretariat to prepare a report
Secretariat to prepare a proposal on how to address problems
Meeting or Teleconference of WP3 to reach an agreement
On discussion Alessandra Scagliarini (AS) proposed and the WG agreed to include 2
endemic diseases in the testing for a better representativeness in the diseases range. The
group agreed to include Paratuberculosis and Liver Fluke in the testing exercise.
Action: MD to include ParaTB and Liver Fluke in the testing exercise.
4.
Discussion on the Expert Groups
a. Current status of the creation of Expert Groups by disease
DOB made a presentation (attached) summarising the 12-step process designed to
keep track of the creation of the 47 Expert Groups and the receiving and sending of
documentation. This method is developed in an Excel spreadsheet that will be filled in
regularly by the secretariat. He briefly presented the current status in forming the 47
Expert Groups. 20 groups remain to be created and the secretariat will follow-up now
that the workload is easing with the creation of the 27 groups that are up and running.
In all cases, a leader has been identified.
Action: Secretariat to contact leaders and
complete the establishment of all expert groups.
b. Inclusiveness of range of expertise
c. Comments on the lists of experts by Expert Group
The group covered point 4b and 4c together. It was agreed to provide regular updates to
WP3 to check the progress in completing the Expert Groups as well as the balance in
expertise in each group. In a second step, WP2 will be asked to comment on the balance.
Action: Secretariat to provide regular updates to WP3 on the Expert Groups.
WP2 and WP3 to comment on the balance of expertises in all the groups.
IMT to provide names of experts if needed.
AS proposed to split the disease titled “Ruminant pox virus infections” into “Ruminant pox”
(“capripoxviruses” group led by Eeva Tuppurainen) versus “Zoonotic pox”. AS would be
willing to lead the second group.
Action: WP2 and PMB to be invited to approve the split of
“Ruminant pox viruses” into 2 groups.
5.
Disease database and public website
a. Website online
5
MD presented the main features of the website which is online since mid-September. The
group agreed that it is an easy to use website. MD explained the functioning of the
database and specified that it is empty for the moment, but that people can still check how
it operates.
b. Loading data into the database
MD highlighted the steps related to data uploading in the 12-steps process used by the
secretariat (document attached). She explained that step 7, step 10 and 12 are the
relevant steps for data loading and that the information and scores will be placed on the
website only after approval by the WPs and the PMB.
On discussion the group agreed to place the “Disease & Products analysis” documents on
the website when validated by the Expert Groups and approved by the WPs. Regarding
scores, WP3 agreed not to place them in the database before having considered them in
more details, when an appropriate number of scores are received and only after validation
and approval by the WPs and PMB. The group approved the placing of relevant information
on the database search engine page to indicate the state of development of the database.
Action: MD to upload “D&P” documents after validation by the WPs.
MD to upload scores after more consideration
on how to do so and after approval by the WPs and PMB.
MD to add links to OIE, FAO and the diagnostic industry on the main page.
6.
AOB
a. 4 questions arising from the Chair
- How to manage the data flow from a technical point of view?
The secretariat made reference to the Excel spreadsheet used for keeping track of the
progress made and of the flow of information circulating between the 47 Expert Groups and
the secretariat. KV proposed the use of a useful but complex electronic data management
system (EDMS) used currently by the EMEA to manage data flow.
Action: Secretariat to contact the EMEA re-EDMS software.
- Update on the other DISCONTOOLS WPs?
DOB explained that WP2 will not meet until the testing exercise is completed and that a
workshop on technology evaluation methods entitled “New Technologies: the future?” will
be organised by WP4 on the 8th December 2009 in Brussels. DOB stated that 4 speakers
have agreed to speak to date and that the secretariat hopes to have 6 speakers presenting
their methodologies of technology identification, evaluation and selection. The aim of this
workshop will be to create an overview of the existing methods in various sectors
(Nanotechnology, mobile technology, diagnostics & machinery plus hopefully Human health
and the NZ Ministry of Science) and get an insight into what has been done in the past 5
years and what people believe will happen in the future.
-
Economic reality of developing products where no market exists: how do we address
this? What models exist across the globe?
CS stated that in human health the WHO is an interesting example as they firstly identify
and purify strains that they provide to industry and then place orders. This provides a
guarantee of return on vaccine development. She then presented the strategy in place at
the US Department of Homeland Security where they launch calls to develop products for
their preparedness initiative and may fund an initiative in the order of $10m. In Australia,
the government is looking closely at what products are available globally and what they
6
need to do to make them suitable for use in Australia. CS explained that production
standards and purity issues may sometimes need to be overcome and if impossible they
will start from scratch. Another solution they are implementing is the development of
antigen or vaccine banks and if possible they sign relevant agreements with producers.
In Europe, DG SANCO is currently looking at bank needs, but which diseases to include?
How many doses to stock? CS explained that this strategy only works if a market exists and
that DG SANCO is aware of the problem. Price per dose is a factor as companies will only
respond to tenders if the overall expected revenue makes development financially viable.
Falko Steinbach suggested that this issue should be highlighted in the deliberations of the
Expert Groups and might be considered in the prioritisation model.
-
How do we stay focused and act in a complementary manner to other European
initiatives?
The group agreed that it needs to constantly follow projects such as ICONZ and EMIDA, but
also the work done by DG SANCO and the OIE. CS stated that it is an important point to
address at each WP3 meeting to ensure that we are well aligned with the other initiatives.
b. Meeting date: The group agreed to meet on March 19th 2010 in Brussels (from 10:00
to 16:30) if the testing results are available at this date.
3rd DISCONTOOLS WP3 meeting on 23rd October 2009: Summary of Actions
Action / Decision
Issue
Who
When
ETPGAH
 Review of the AP - keep WP 3 informed
of progress
Secretariat
2010
Expert groups
 Develop ToR for the Expert Groups
Secretariat
Feb 2010

Contact leaders and complete the
establishment of all expert groups
Secretariat
Feb 2010

Provide regular updates to WP3 on the
Expert Groups
Secretariat
Ongoing

Comment on the balance of expertises
in all the groups
WP2 & WP3
Ongoing
Provide names of experts if needed
IMT
If needed
Industry
Mid-2010

Products
availability
 Provide data to the Iowa
University Database on vaccines
State

Conduct a survey through National
Agencies to collect information on
registered vaccines in Europe
EMEA (DM)
Mid-2010

Give an update on the progress at the
next WP3 meeting
EMEA (DM)
Ongoing
Secretariat
If needed
MD
Ongoing
 Following the publication of the EMEA
list, contact the MGs to liaise with
National Agencies if needed
 Ask DISCONTOOLS Expert Groups to
provide information on the products
available in Public Laboratories
 Contact JK to check if the spreadsheet
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can be placed on the website
MD
Dec 2009
MD
Jan 2010
 Ask the FVE and OIE to contribute to the
document concerning smaller producers
and public laboratories
Additional
diseases
 Propose Theileria for inclusion in the list Secretariat
Dec 2009
 Approve the split of “Ruminant pox WP2 & PMB
Dec 2009
 Address issues encountered and make
Secretariat
Dec – May
2010
 Include solutions agreed on how to
Secretariat
Mid-2010
 Organise a meeting of WP3, if
MD
May 2010
Secretariat
Ongoing
MD
Dec 2009
 Upload “D&P” documents after
MD
2010
 Upload scores after more consideration
MD
2010
 Add links to OIE, FAO and the diagnostic
MD
Dec 2009
 Contact the EMEA re-EDMS software
Secretariat
Jan 2010
to WP2 & PMB
viruses” into 2 groups
Testing of models
propositions to WP3 for improvement
score and give guidance in the ToR
necessary, to discuss the results of the
test scoring exercise
 Stress the importance of feedback from
those that did not yet reply to the
testing exercise
 Include ParaTB and Liver Fluke in the
testing exercise
Website database
validation by the WPs
on how to do so and after approval by
the WPs and PMB
industry on the main page
Data Flow
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