The Action Plan Draft for Consideration

1
European Technology Platform for Global Animal
Health (ETPGAH)

• The Action Plan Draft for Consideration
• Steering Council, April 19th, 2007

April 19th, 2007 Jim Scudamore, Consultant to the
ETPGAH
2
ETP Global Animal HealthAction plan

• Introduction
• Developing the action plan
• Structure of the Action Plan
• Chapter 1 Introduction
• Chapter 2 Themes
• Chapter 3 Priority Diseases
• Way Forward

3
ETP Global Animal HealthAction plan

• Introduction
• Developing the action plan
• Overview of the Action Plan
• Chapter 1 Introduction
• Chapter 2 Themes
• Chapter 3 Priority Diseases
• Way Forward

4
European Technology Platform for Global Animal
HealthWhere are we now?
Stakeholders, led by industry, come together
to agree on a common vision for the technology
Stakeholders, define a Strategic Research
Agenda setting the necessary mid- to longterm
objectives
Stakeholders, implement the Strategic
Research Agenda with the mobilisation of
significant human and financial resources
Implementation Plan detailed, roadmap,
quantify, identify funding sources creation of a
financial working group Launch June 2007
Vision paper EU TP Global Animal Health
Final version August 2005
Strategic Research Agenda Published May 2006
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ETP Global Animal HealthThe Vision Aim

• To facilitate and accelerate the development and
  distribution of the most effective tools for
  controlling animal diseases of major importance
  to Europe and the rest of the world, thereby
  improving human and animal health, food safety
  and quality, animal welfare, and market access,
  contributing to achieving the Millennium
  Development Goals.

6
ETP Global Animal HealthThe Strategic Research
Agenda

• The SRA defines, in a very broad sense, the
  research necessary to deliver the Vision.
• SRA has 2 overarching objectives-
• to deliver new and improved tools for the control
  of major diseases and
• to deliver the recommendations in the SRA which
  in turn will facilitate the development and
  delivery of new tools

Published May 2006
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Deliverables - 1

• Protect Europe from the incursion of epidemic
  animal diseases and zoonoses eg. Avian Influenza,
  Bluetongue
• Deal rapidly and effectively with disease
  outbreaks in Europe should they occur.
• Facilitate world trade and the alleviation of
  poverty by reducing the impact of these diseases
  in developing countries.
• Reduce worldwide levels of disease and thereby
  indirectly protect Europe from disease spread by
  people or trade.
• Bring more focus into research towards new tools
  for dealing with animal diseases.

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Deliverables - 2

• Increase the translation of technology into
  actual products.
• Bring the developed tools faster to the market.
• Ensure the legal and regulatory process is
  optimised to avoid unnecessary hurdles which
  limit disease control options and decrease the
  competitiveness of the industry.
• Enable disease control authorities both within
  the EU and other countries to provide a swift and
  efficient reaction to new disease outbreaks.
• Streamline research, development and regulatory
  efforts in order to ensure consumer safety
  without compromising the efficiency of product
  development.
• View projects in the context of feasibility,
  applicability, need and availability of existing
  products within the time frame of the Strategic
  Research Agenda (SRA).

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ETP Global Animal HealthThe SRA Six Themes

• Strategically important issues
• High societal relevance
• Linked to Europes future growth,
  competitiveness, and sustainability
• Dependant upon major research and
  technological advances
• Medium to long-term scope
• Important consequences for animal health
  research
• Aligned with other Community policies and
  strategies
• Significance for developing world

4 Improve Technology Transfer 17
5 Regulatory Societal Issues 8
1 Prioritise animal diseases 8
3 Fundamental research 5
6 Global Perspective 5
2 Gap Analysis 8
SRA
Finalised and submitted to the EU Commission in
May 2006
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ETP Global Animal HealthImplementation of the SRA

• SRA Provides a Roadmap
• Research Requirements
• Actions to achieve Aims not all research
• Six Themes
• Recommendations Identified
• Now Identify Deliverables
• Collaboration is Critical
• Efficient Use of Resources
• Better Case for Funding

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ETP Global Animal HealthImplementation of the SRA
Next stage
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ETP Global Animal HealthAction plan

• Introduction
• Developing the action plan
• Overview of the Action Plan
• Chapter 1 Introduction
• Chapter 2 Themes
• Chapter 3 Priority Diseases
• Way Forward

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ETP Global Animal HealthAction plan

• Steering Council5 July 2006
• Discussed the implementation plan
• Decided to call it an action plan
• Agreed to establish working groups
• Agreed to call them co-ordination groups
• Secretariat and EB to decide members
• Agreed to add a 4th to cover Global Partnerships

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ETP Global Animal Health Action
PlanCo-ordination Groups

• Terms of Reference
• Consider how the recommendations in each of the
  themes can be implemented and establish who
  should be responsible.
• Set out the deliverables for each of the
  recommendations.
• Provide details of performance measure,
  milestones and target dates for delivery of each
  of the recommendations.
• Provide an analysis of potential cost and
  consider the strategy to acquire resources.
• Where appropriate prepare documentation to be
  used by the funding organisations as the basis
  for the calls for proposals to deliver the
  necessary research.

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ETP Global Animal HealthThe SRA 6 Themes

• Prioritise animal diseases (8)
• Conduct gap analyses (8)
• Ensure high quality relevant (5)
  fundamental research
• Identify the enabling factors to improve the rate
  of technology transfer (17)
• Consider regulatory/societal issues (18)
• Maintain a global perspective (5)

CG1
C G 2
C G 3
C G 4
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ETP Global Animal Health Action Plan Meetings

• 16 Nov 06 CG1 Carolin Schumacher
• 17 Nov 06 CG3 Steve Dean
• 20 Nov 06 CG2 Paul van Aarle
• 21 Nov 06 CG4 Christianne Bruscke

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Action PlanCo-0rdination Group 1

• Chair Carolin Schumacher
• Secretariat Technology Platform
  Secretariat
• Aim of the Implementation Group
• To develop an action plan for the recommendations
  of themes 1 2 and 3 in the SRA to assist in
  enabling the Global Animal Health Platform to
  achieve the aims of the platform. This is to
  facilitate and accelerate the development and
  distribution of the most effective tools for
  controlling animal diseases of major importance
  to Europe and the rest of the world.

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ETP Global Animal HealthAction Plan

• Series of action points identified as follows-
• What is to be delivered
• How is it to be delivered
• Who is responsible for the delivery
• Who will deliver it
• How will it be funded
• What are the milestones and target dates
• What are the indicators of success
• What are the risks

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ETP Global Animal Health Action Plan

• Establish Costs of Research
• Establish Timelines for Research
• Who should carry out Research?
• Who should Fund Research?
• Need to conduct Research on Disease
  Prioritisation Model (Chapter 2) as first step
• Need to complete Gap Analysis (Chapter 3) as
  second step

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ETP Global Animal Health Action Plan
Recommendations
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ETP Global Animal Health Action Plan for SRA
recommendations

• 1. Recommendation number(s)
• Single or in groups depending on the most
  effective mechanism to deal with the subject
• 2. Objective
• What is to be delivered?
• 3. Tasks
• What are the specific tasks involved?
• 4. Milestones /timetable
• What are the milestones and target dates/ short
  ,medium or long term. i.e. 1,5,10 years
• 5. Outputs and deliverables
• What are the indicators of success?
• What are the risks?
• How is it to be delivered?
• Who is responsible for the delivery?
• Who will deliver it?
• 6. Monitoring.
• 7. Funding
• 7a Funding required
• 7b Funding sources
• How will it be funded?

.
22
ETP Global Animal HealthAction plan

• Introduction
• Developing the action plan
• Overview of the Action Plan
• Chapter 1 Introduction
• Chapter 2 Themes
• Chapter 3 Priority Diseases
• Way Forward

23
ETP Global Animal HealthAction plan

• Overview of the plan
• Chapter 1
• Introduction
• Structure
• Funding
• Management
• Chapter 2
• Themes Recommendations within themes
• Detailed Proposals

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ETP Global Animal HealthAction plan

• Overview of the plan
• Chapter 3
• Prioritisation Model
• Disease Information
• Gap Analysis
• Annex 1 Categories of Disease
• Annex 2 Prioritisation Model
• Annex 3 Bluetongue Disease Information
• Annex 4 Bluetongue Gap Analysis

25
ETP Global Animal HealthAction plan

• Introduction
• Developing the action plan
• Structure of the Action Plan
• Chapter 1 Introduction
• Chapter 2 Themes
• Chapter 3 Priority Diseases
• Way Forward

26
ETP Global Animal HealthAction plan

• Chapter 1
• The Action plan is intended to explain the
  research and information gathering exercises that
  need to be completed to deliver the
  recommendations in the SRA. It will also act as a
  communications tool explaining the specific steps
  that need to be taken to deliver on the Vision
  and the SRA.

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ETP Global Animal HealthAction plan

• Chapter 1
• The first stage is to identify and prioritise the
  diseases of importance as recommended in Theme 1
  of the SRA.
• The second stage contained in Theme 2 of the SRA
  is to assess the gaps in the knowledge and
  understanding of these diseases and to identify
  where research needs to be targeted. At the same
  time the gaps in the availability of products
  must be evaluated.

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ETP Global Animal HealthAction plan

• Chapter 1 Key Components
• A number of components. These include,
•  Identify the desired outcomes
• The actions to achieve them
• Agree timing and set milestones
• Assign lead responsibility and supporting
  activities
• Suggest funding sources
• Prioritise as high or medium and timescale as
  immediate, medium term or long term.

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ETP Global Animal HealthAction plan

• Chapter 1
• The SRA serves to provide an input for-
•  
• Future EC Framework Programmes which will involve
  close cooperation with EC, Member States and
  European Parliament representatives.
•  
• Future national research programmes where it will
  provide better opportunities to align and
  coordinate national programmes
•  
• Public/private research partnerships exploring
  ways to develop an integrated approach to
  developing new tools to control animal diseases.
•  
• Industry which has an important role working in
  partnership to develop new products, which can be
  delivered in the field.

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ETP Global Animal HealthAction plan

• Funding Management
• Input to FP 7
• Coordinate National Programmes
• Promote Public/Private Partnerships
• Involve Industry
• SC to review Plan over time
• Advisory group on Funding? consider
• Experts to develop proposals for each Disease
• Mirror Groups will play an important role

31
ETP Global Animal HealthAction plan

• Introduction
• Developing the action plan
• Structure of the Action Plan
• Chapter 1 Introduction
• Chapter 2 Themes
• Chapter 3 Priority Diseases
• Way Forward

32
ETP Global Animal HealthThe SRA Six Themes

• Strategically important issues
• High societal relevance
• Linked to Europes future growth,
  competitiveness, and sustainability
• Dependant upon major research and
  technological advances
• Medium to long-term scope
• Important consequences for animal health
  research
• Aligned with other Community policies and
  strategies
• Significance for developing world

4 Improve Technology Transfer 17
5 Regulatory Societal Issues 8
1 Prioritise animal diseases 8
3 Fundamental research 5
6 Global Perspective 5
2 Gap Analysis 8
SRA
Finalised and submitted to the EU Commission in
May 2006
33
Action PlanFirst Stages

• The first stage is to identify and prioritise the
  diseases of importance. The second stage is to
  assess the gaps in the knowledge and
  understanding of these diseases to identify where
  research needs to be targeted. At the same time
  the gaps in the availability of products will be
  evaluated. With the implementation of the
  recommendations from these two themes it will be
  possible to select priority diseases and identify
  the research needed to fill the gaps in knowledge
  along with the actions needed to develop new and
  improved tools for control of those diseases.

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ETP Global Animal HealthAction plan Chapter 2

• SRA Recommendations
• Format in the action plan
• SRA Recommendation
• Deliverables
• Tasks
• Priority
• Funding
• Character of work
• Lead organisation

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Prioritsation of diseases

• SRA Recommendations 1, 2,
•  
• Objective A method of prioritising animal
  diseases and zoonoses would enable funders to
  focus research in a manner which would allow the
  objectives of the ETPGAH to be met. To achieve
  this, a methodology is required which could
  provide a consistent and acceptable means of
  prioritising animal diseases and infections of
  major importance for the EU and worldwide.
  Further development of the prototype is needed to
  takes account of the overall level of risk of a
  given animal disease, the availability of
  suitable products or technology, the feasibility
  of control, the impact on economies, human
  health, food safety and public/consumer
  perception, etc. The process should be developed
  to a stage where the model is peer reviewed and
  used by decision makers as a decision support
  tool.

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Prioritsation of diseases

• Deliverables The main deliverables will be-
• A working model for prioritisation which is peer
  reviewed and accepted by funders.
• Publication of the prioritisation model
• Production of peer reviewed prioritised list of
  diseases of importance
• Publication of the list
• Ultimately an IT solution with an interactive
  model
• Regular use of the model to determine funding
  priorities

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Prioritsation of diseases

• Tasks
• Finalise and peer review the criteria identified
  for assessment and the scores to be allocated to
  each of the criteria for use in the model
• Provide an evidence base for each disease by the
  collection of information in a standard format
  which can be converted into scores.
• Score each disease against the criteria to
  identify the importance of the disease to Europe
• Further development of the paper based
  prioritisation model
• Develop an IT based decision support tool
• Produce an interactive tool to help with
  prioritisation of research funding.

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Prioritsation of diseases

• Priority High and immediate
• Funding National Funders, EC Framework 7
  Cooperation,
• Character of work specific project, applied
  research, decision support tool
• Lead Organisation ETPGAH

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ETP Global Animal HealthAction plan Chapter 2

• SRA Recommendations
• Have we got the layout correct
• Have we covered all the issues
• For each theme and item have we got the
  comprehensive objective
• Are the deliverables acceptable, is anything
  missing, are they to ambitious
• Are the tasks correct to deliver the objectives
• What about the priority, method, classification
  for each
• Funding are they correctly identified
• Is the character classification correct
• Who should lead.

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ETP Global Animal HealthAction plan Chapter 2

• Theme 1 Prioritisation of Animal Diseases
  Infections
• 1.1 Prioritisation of Diseases (1-3-03)
• 1.2 Emerging Threats to Europe (1-3-05, 1-3-06,
  1-1-05)
• 1.3 Wildlife Diseases (1-3-04, 1-1-05)
• 1.4 Supporting Activities (advice, coordination,
  partnerships)

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ETP Global Animal HealthAction plan Chapter 2

• Theme 2 Gap Analysis
• 2.1 Gap Analysis for Priority Diseases (1-3-02,
  1-4-17)
• 2.2 Gap Analysis of New Technologies (1-3-02)
• 2.3 Gap Analysis of Current Research (1-3-02)
• 2.4.Gap Analysis of Available Products

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ETP Global Animal HealthAction plan Chapter 2

• Theme 3 Fundamental Science
• 3.1. Support and Strengthen Fundamental Sciences
  in the EU
• 3.2. Establish a European Centre for Epidemiology
  and Infectious Diseases.
• 3.3 Specific Requirements for Fundamental
  Research

43
ETP Global Animal HealthAction plan Chapter 2

• Theme 4 Enabling Factors
• 4.1. Quality Assurance
• 4.2. Intellectual Property rights
• 4.3. Overcoming Barriers to Technology Transfer
• 4.4. Networks and Centres of Excellence
• 4.5. Education and training
• 4.6. Infrastructure

44
ETP Global Animal HealthAction plan Chapter 2

• Theme 5 Regulatory and Societal issues
• 5.1. Regulatory issues
• 5.1.1 Drivers for Regulation
• 5.1.2 Developing and effective Risk Benefit
  assessment methodology
• 5.1.3 Modernising Guidelines and monographs
• 5.1.4 Relevance and importance of Environmental
  Risk Assessment
• 5.3.5 Barriers to harmonisation
• 5.2. Diagnostic Tests
• 5.3. Societal issues
• 5.4. Community Animal Health Policy (CAHP)

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ETP Global Animal HealthAction plan Chapter 2

• Theme 6 Global Partnerships.
• 6.1 Introduce Joint Research Programmes
• 6.2 Provide Sustainable Financial Support
• 6.3 Promote Research Partnerships

46
ETP Global Animal HealthAction plan

• Introduction
• Developing the action plan
• Structure of the Action Plan
• Chapter 1 Introduction
• Chapter 2 Themes
• Chapter 3 Priority Diseases
• Way Forward

47
ETP Global Animal HealthAction plan

• Chapter 3
• Chapter 3 Research Requirements for Priority
  Diseases
• 3.1 Introduction
• 3.2 Prioritisation of diseases
• 3.2.1 Initial stages
• 3.2.2 Categories for diseases
• 3.2.3 Prioritisation model
• 3.2.4 Future action on prioritisation.
• 3.3. Research Requirements for the priority
  diseases. (sum of gaps)
• 3.3.1 Initial stages.
• 3.3.2. Development of the gap analysis
• 3.3.3 Bluetongue as an example
• 3.3.4 Future action on requirements.

48
ETP Global Animal HealthAction plan

• Chapter 3
• 3.2 Prioritisation of diseases
• 3.2.2 Categories for diseases
• .

49
ETP Global Animal HealthAction plan Theme 1
Prioritise animal diseases

• Was the original list the correct method of
  prioritisation?
• Can the diseases be prioritised in a more logical
  manner?
• How do we deal with multiple disease complexes.
• As well as prioritising diseases could we
  prioritise possible success.

50
ETP Global Animal HealthAction plan

• Chapter 3
• 3.2 Prioritisation of diseases
• 3.2.2 Categories for diseases
• Group 1Epizootic diseases and diseases for
  surveillance
• African Horse Sickness
• African Swine Fever
• Avian Influenza
• Bluetongue
• Contagious Bovine Pleuro Pneumonia
• Classical Swine Fever
• Foot Mouth Disease
• Peste des Petits Ruminants
• Rift Valley Fever
• Ruminant Pox Virus
• Swine Vesicular Disease
• West-Nile Virus
• .

51
ETP Global Animal HealthAction plan

• Chapter 3
• 3.2 Prioritisation of diseases 3.2.2
  Categories for diseases
• Group 2  Zoonoses and food-borne diseases
• Rabies
• Nipah
• Anthrax
• Brucellosis
• Bovine Tuberculosis
• Q Fever
• Trypanosomiasis
• Leishmaniasis
• Leptospirosis
• Chlamydia
• Cystercicosis
• Echinoccocus
• Food-borne bacterial Salmonella
• E. Coli
• Campylobacter
• Cryptosporidium

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ETP Global Animal HealthAction plan

• Chapter 3
• 3.2 Prioritisation of diseases 3.2.2
  Categories for diseases
• Group 3 Major food-producing animal disease
  complexes
• Parasitic gastro-intestinal diseases
• Liver Fluke
• Coccidiosis
• Nematodes
• Paratuberculosis (Johnes)
• Mastitis  Staph.aureus mastitis
• Environmental/Streptococcal mastitis
• Small ruminant mastitis
• Swine enteric
• Respiratory Swine
• PRRS CG3 HN
• PCV II
• SIV
• A. pleuropneumonia
• Mycoplasma
• Respiratory Bovine

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ETP Global Animal HealthAction plan

• EPIDEMIOLOGY AND RISK
• Speed of spread
• Number of species involved
• Persistence of infectious agent
• Spreading potential to susceptible populations
• Wildlife diseases risk potential threat to animal
  health and public health
• Disease Knowledge
• Wildlife diseases that are at threat
• Dynamic (temporal, spatial, species variability
• IMPACT ON WIDER SOCIETY
• Disease Impact on Production
• Economic direct impact (including cumulative cost
  eg enzootic vs epizootic)
• Economic indirect impact (social, trade)
• Impact on specific production and supply channels
• Security of food supply/Benefit for developing
  world

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ETP Global Animal HealthAction plan Criteria

• IMPACT ON PUBLIC HEALTH
• Impact on Public Health and Food Safety
• Risk of occurrence
• Impact of occurrence
• IMPACT ON INTERNATIONAL TRADE
• Impact on International Trade and EC trade due
  to existing regulations
• CONTROL MEASURES
• Effective prevention and control practices
• Tools for surveillance
• Tools for prevention crisis
• Tools for control and implementation
•  
• Success of prevention and control in other
  countries
• Technology (Vaccine/Treatment) / Tool
  Availability
• Commercial Diagnostic Tools Availability

55
ETP Global Animal HealthAction plan

• Introduction
• Developing the action plan
• Structure of the Action Plan
• Chapter 1 Introduction
• Chapter 2 Themes
• Chapter 3 Priority Diseases
• Way Forward

56
Action Plan Conclusions

• Timescale 2007
• 19 April S/C Amendments
• 7 May Redraft with agreed changes
• 11 May Revised action plan to all stakeholders
  for comments
• 31 May Deadline for comments
• 8 June Redrafted version to the E/B for
  endorsement
• 30 June agreed final version for 2007

57
Action Plan Conclusions

• Once the Action Plan is completed and agreed with
  stakeholders the platform will be responsible for
  monitoring progress and undertaking an annual
  review of activities.

58
Action Plan Conclusions

• 1. The plan is intended to be a flexible working
  document, subject to regular review and up dating
  by the Steering Council of the ETPGAH to ensure
  that the SRA is on target and that the
  recommendations are being delivered.
• 2. The Steering Council will evaluate the success
  of the platform in meeting its primary aims
  linked to the Lisbon agenda of improving the
  competitiveness of Europe.
• 3. The success of the platform in delivering new
  and improved tools for the control of major
  diseases will also be measured

59
ETP Global Animal HealthUseful links for
information

• CORDIS Web Site
• http//cordis.europa.eu.int/technology-platforms/h
  ome_en.html
• CORDIS partner search http//fp6.cordis.lu/fp6/pa
  rtners.cfm
• Seventh Framework Programmehttp//europa.eu.int/
  comm/research/future/index en.cfm
• IFAH Global Animal Health Platform
• www.ifah.be/europe/euplatform/platform.htm

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ETPGAH Contact Details

• Thank You!
• European Technology Platform for Global Animal
  Health (ETPGAH)
• Rue Defacqz, 1
• 1000 Brussels, Belgium
• Tel. [phone]
• Fax [phone]
• E-mail info_at_ifahsec.org
• Website www.ifahsec.org/Europe/EUPlatform/Platfor
  m.htm