Vision 2015 for Veterinary Medicines within the framework of the ETPGAH. Declan O Brien, Chairman, Executive Board, ETPGAH

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1 Vision 2015 for Veterinary Medicines within the framework of the ETPGAH Declan O Brien, Chairman, Executive Board, ETPGAH OECD, Paris

2 Overview ETPGAH Objectives Vision Strategic Research Agenda & Themes Action Plan DISCONTOOLS & Work Packages Vision 2015 Conclusions

3 ETPGAH in a Nutshell Agree on the most important animal diseases Agree on the most important gaps Direct research towards filling those gaps

4 Stakeholder Driven European Associations relevant to Animal Health and Welfare and Food Safety: IFAH-Europe, COPA-COGECA (farming industry), EuropaBio, Diagnostics, FVE (Veterinarians), Eurogroup for Animals International organizations relevant to Animal Health and Welfare and Food Research Organizations e.g. OIE, FAO, WHO, ILRI, GALVmed European Regulatory Authorities Heads of Medicines Agencies, EMEA, EDQM Representatives from the European Research Community Universities, Institutes, Network of Reference Laboratories, Networks of Excellence Member State Representations CVOs, Mirror Groups European Institutions EFSA, European Commission (DG Research, DG SANCO, DG Development, DG Enterprise)

5 ETPGAH Output 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, Prepare an Action Plan to implement the Strategic Research Agenda Vision paper: EU TP Global Animal Health Final version August 2005 Strategic Research Agenda: Published May 2006 Action Plan: detailed, roadmap, quantify, identify funding sources; Published July 2007

6 The Vision 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. Published August 2005

7 Strategic Research Agenda The SRA sets out the views of stakeholders on the necessary short, medium and long-term research, development and delivery needs for global animal health over a period of 10 years. The SRA establishes a framework for guiding research over this period. Published May 2006

8 The Action Plan The Action Plan provides details concerning 28 specific areas where research and/or information gathering needs to be engaged in. The ETPGAH will be responsible for monitoring progress and undertaking reviews of activities. The ETPGAH will seek to provide input into developing research strategies and promote funding for the priorities identified in the Action Plan

9 SRA 6 Themes Prioritisation of Animal Diseases Gap Analysis Fundamental Research Enabling Factors Regulatory Issues Global Perspectives

10 Priorities & Gaps Which diseases are most important? Which gap in the disease is most important? National, EU or Global perspective? Stakeholders need to agree & focus limited resources on critical targets This is the work of DISCONTOOLS!

11 Fundamental Research We need to have the correct infrastructure We need to have the right people Have we enough or too much capacity to work with dangerous pathogens in large animals? Have we enough veterinary entomologists? The EMIDA ERA-Net is working to answer these questions and to manage capacity into the future

12 Enabling Factors - 1 Do we or do we not need GLP? Are we protecting intellectual property (IP)? Do we enable technology transfer? The EMIDA ERA-Net provides a vehicle through which appropriate standards can be established at different phases of development

13 Enabling Factors - 2 The ETPGAH supports DG Research in promoting the protection of IP IP protection enables a decision to be made to invest perhaps 100m in taking a good idea from the laboratory to the market! DISCONTOOLS is working on technology transfer

14 Regulatory Issues Need to enable innovation Regulate new technologies eg. Nanotechnology Protect human & animal health but balance against the zero risk pitfall Veterinary Directive will be reviewed with the review commencing in 2010

15 Global Perspective - 1 Diseases do not respect borders! Reduce Global disease burden Prepare for emerging diseases What is next AHS, RVF, West Nile??? FMD, AI & Bluetongue have changed the policy context

16 Global Perspective - 2 Global platform will be created under FP 7 call May involve Canada, US, Mexico, Brazil, Argentina, Europe, South Africa, Russia, India, China, Australia, New Zealand Agree Global priorities 20% of potential production lost to disease Link up & focus funding across Globe Tremendous benefit to donor Nations, World Bank, Foundations Discover new tools quicker huge benefit to broader society

17 Future of ETPGAH Oversee the implementation of the Action Plan it will not gather dust! Review the Vision, SRA and Action Plan over time Action Plan will be reviewed in 2010 Keep the cycle running to become increasingly efficient over time Continue to act as a vital communications hub between the stakeholders

18 Declan O Brien Project Co-ordinator Morgane Delavergne Project Manager DISCONTOOLS Objectives

19 Objectives Focus & prioritise research Stimulate delivery of new and improved diagnostics, vaccines & pharmaceuticals Develop database on 47 diseases from ETPGAH Develop prioritisation model Develop Gap Analysis model Ensure the deployment of new technologies in the animal health research area as rapidly as possible Develop blueprint for the identification and evaluation of new technologies 11th, 2009 December

20 Organisation Stakeholder driven as per ETPGAH 5 Work Packages Project Management Disease Prioritisation WP2 Gap Analysis WP3 Technology Evaluation WP4 Communication Project Management & Communication managed by Project Management Board 11th, 2009 December

21 WP2 Disease Prioritisation Disease database format for data collection Expert Group per disease to edit data Prioritisation Model on web Criteria Knowledge, Impact, Tools Scoring & Weighing Decide on final prioritisation Interactive website open to the public Receive and respond to input Dynamic continuously updated information 11th, 2009 December

22 11th, 2009 December

23 11th, 2009 December

24 WP3 Gap Analysis Gap Analysis methodology Criteria Diagnostics, Vaccines, Pharmaceuticals (Tools) Prioritise Gaps Important that Expert Groups focus on the tools Need broad input including Academia, CVO s & Industry Summarise Gaps and research required 11th, 2009 December

25 11th, 2009 December

26 11th, 2009 December

27 WP4 Technology Evaluation Evaluate current methodology What do other industries do? Aerospace, Biotechnology, Machinery, Mobile, Nanotechnology, Others? Develop model for use in animal health Literature searches including patent filing Workshops & Conferences Communicate methodology to research funders, research workers and development groups Deploy new technologies at earliest opportunity 11th, 2009 December

28 Cooperation Collaborative research Call 1 FP7-KBBE Deadline 2 May 2007 KBBE : Mining genomics information of farm animals to generate new information on the genetic basis of phenotypes important to sustainable animal production. (SRA 17,19 ) (3m )-3 years 1/11/08 KBBE : Coordination of European research in the area of animal health, including emerging threats, infectious diseases and surveillance. ERA-Net (SRA 13,35,37,47) (1m ) 3 years 1/4/08 EMIDA KBBE : Optimising research efforts for the development of the most effective tools for controlling infectious animal diseases (SRA 1,2,9,10,11,12,14 ) (1m ) 4 years 1/3/08 DISCONTOOLS KBBE : Development of rational strategies for the eradication of bovine tuberculosis (SRA 5,,11) (3m ) 3 years 1/10/08

29 Analysis of Recommendations in the Action plan Theme 1 Prioritisation of Animal Diseases & Infections No Item Status Project acronym comment 1.1 Prioritisation of diseases ongoing DISCONTOOLS Work package 2 FP7 start date 1 March Emerging threats to Europe partial Various FP7 1.3 Wildlife Diseases ongoing WILDTECH Novel Technologies for surveillance of emerging and re-emerging infections of wildlife 1.4 Supporting Activity ongoing DISCONTOOLS Work OECD, package Paris, 2 FP7 start date 1 March 08

30 Analysis of Recommendations in the Action plan Theme 2 Gap Analysis No Item Status Project acronym comment 2.1 Gap analysis for priority diseases ongoing DISCONTOOLS Work package 3 FP7 start date 1 March Gap Analysis of New Technologies. ongoing DISCONTOOLS Work package 4 FP7 start date 1 March Gap analysis of Current Research ongoing DISCONTOOLS Work package 3 EMIDA ICONZ FP7 start date 1 March 08 FP7 Start date FP7 start date 1 April Gap Analysis of Available Products ongoing DISCONTOOLS Work package 3 FP7 start date 1 March 08

31 Group 1 Epizootic diseases and diseases for surveillance FP6 and FP7 projects contributing to research Vaccine Diagnostic Pharmac eutical Control Strategy Capacity building African Horse Sickness FP7 FP7 FP7 FP7 FP7 African Swine Fever ASFRISK ASFRISK ASFRISK ASFRISK Avian Influenza FP6 FP6 FP6 FP6 FP6 Bluetongue FP6/7 FP6/7 FP6/7 FP6/7 FP6/7 Contagious Bovine Pleuro Pneumonia Classical Swine Fever CSFV GoDIVA CSFV GoDIVA CSFV GoDIVA CSFV GoDIVA CSFV GoDIVA Foot & Mouth Disease Discovac Discovac Discovac Discovac Discovac Peste des Petits Ruminants Rift Valley Fever Ruminant Pox Virus infection Swine Vesicular Disease West-Nile Virus ARBO ZOONET ARBO ZOONET ARBO ZOONET ARBO ZOONET ARBO ZOONET ARBO ZOONET

32 Group 2 : Zoonoses and food-borne diseases Vaccine Diagnostic Pharmaceutical Control Strategy Capacity building Anthrax Nipah virus infection Bovine Tuberculosis ICONZ TB_STEP ICONZ TB_STEP ICONZ TB_STEP ICONZ TB_STEP Brucellosis ICONZ ICONZ ICONZ ICONZ Chlamydia Cryptosporidium Cysticercosis ICONZ ICONZ ICONZ ICONZ Echinococcosis ICONZ ICONZ ICONZ ICONZ Food-borne bacterial: Salmonella E. Coli Campylobacter FP7 FP7 FP7 Food-borne viral (Hepatitis E Virus Leishmaniasis ICONZ ICONZ ICONZ ICONZ Leptospirosis Q Fever Rabies ICONZ ICONZ ICONZ ICONZ Trypanosomiasis Transmissible Spongiform Encephalopathies ICONZ ICONZ ICONZ ICONZ ICONZ

33 European Technology Platform for Global Animal Health: The Process DISCONTOOL 2008 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 EMIDA 2008 ICONZ 2009 Vision paper: EU TP Global Animal Health Launch Dec 2004 Final version August 2005 Strategic Research Agenda: Published May 2006 Action Plan: Published July 2007 Examples from FP7

34 EMIDA ERA-Net Sub-Call 1: Vectorborne diseases Development of underpinning knowledge and tools for early warning, detection & monitoring and novel control strategies. Sub-Call 2: Zoonoses and antimicrobial resistance, excluding microbial safety of products Development of underpinning knowledge and tools for early warning, detection & monitoring and novel control strategies. Sub-Call 3: Major infectious diseases affecting production Development of underpinning knowledge and tools for early warning, detection & monitoring and novel control strategies including genetics of resistance. Sub-Call 4: Aquaculture Development of underpinning knowledge and tools for early warning, detection & monitoring and novel control strategies, particularly vaccinebased approaches. 34

35 Vision Ongoing work on diseases will have delivered some new tools diagnostics, vaccines or pharmaceuticals - & will deliver more beyond 2015 Action Plan will be an ongoing source of ideas from the stakeholders DISCONTOOLS will have delivered the Prioritisation model & website will continue to generate consensus on the Gaps & will continue to act as a source of orientation for funding research

36 Vision Regulatory reform will have occurred bringing considerable efficiencies to the licensing process & will stimulate innovation via appropriate data protection EMIDA ERA-Net will have been transformed into a permanent mechanism to enable shared research across Europe. 25% of research will be funded via a common fund Global collaboration will be commencing with the major Global funders of research working together to define common priorities using the DISCONTOOLS Prioritisation model

37 Vision The Global burden of diseases such as FMD will be reduced and all parties will have aspirations to make major regions of the Globe free of diseases such as FMD Pressure on food supplies will continue to make research in agriculture a priority

38 Conclusions - 1 The ETPGAH Action Plan is being delivered EMIDA ERA-Net, DG Research & DISCONTOOLS part of delivery Regulatory reform & a Global perspective will be important future steps DISCONTOOLS is on course to deliver Prioritisation, to generate consensus on the Gaps & to assist in focusing research

39 Conclusions - 2 Unique methodologies to deploy technology more rapidly are being developed The delivery of the Vision 2015 ideas will necessitate hard work & determination! The very real prize at the end is the benefit to society of being able to control diseases in animals more effectively

40 Thank you! For more information: ETPGAH c/o IFAH-Europe AISBL 1 rue Defacqz, 1000 Brussels, Belgium Tel: animaltp@ifahsec.org DISCONTOOLS m.delavergne@ifahsec.org