1. Virtual Physiological Human Short presentation of the ARGOS VPH Policy Brief Marco Viceconti Istituto Ortopedico Rizzoli, Italy 1

2. Target areas: VPH Modelling and simulation of human physiology and diseases with a focus on the Virtual Physiological Human (VPH). 2

3. The human body is currently investigated as if it is a jigsaw puzzle made of a trillion pieces We are trying to understand the whole picture by looking at a single piece, or at a few closely interconnected pieces We do need a frame, within which we can finally start to place the pieces all together, and the glue that connects them The frame is not the whole picture, but is the only way we might hope to see it one day The Human Jigsaw

4. Integrative research The Integrative Research approach requires a radical transformation on the way biomedical research is conducted That is why it is necessary to create a framework made of technology and methods This framework is called Virtual Physiological Human

5. What is the VPH? The Virtual Physiological Human is a methodological and technological framework that once established will enable the investigation of the human body as a single complex system. Organism Organ Tissue Cell Organelle Interaction Protein Cell Signals Transcript Gene Molecule

6. © 2011 VPH Institute Why VPH is eHealth? 6 Subject Specific Subject Specific Reusable Digital Artefacts Predictive models Capture knowledge Integrable

7. What is VPH? Cover all organ systems, all scales. Large-scale research initiative. Started in 2005, > €200m funding, > 2000 researchers in Europe. International ramifications in USA, Japan, Korea, Australia, China, etc. A network of Excellence, a congress, three special issues on TRS, a book* (or two?) a virtual institute 7

8. VPH Activity: moderators Marco Viceconti: responsible of the VPH NoE outreach program and coordinator of the VPHOP Integrated project Andrew McCulloch: member of the IUPS Physiome project and of the Multi Scale Modelling consortium of the USA Interagency Modelling and Analysis Group © 2010-2012 ARGOS Consortium8

9. Editorial Team Moderators Editorial Committee NoE Community Everybody (Public Consensus) MSM/IMAG Community © 2010-2012 ARGOS Consortium9

10. Activity plan Position paper – Draft of the position paper on VPH, preparatory of the policy brief – Presentation and discussion of the draft with selected experts in USA and Europe – Presentation and discussion of the revised draft at key IMAG and VPH NoE meetings – Closure and publication of the position paper Policy Brief – First draft of the policy brief, discussed at the ARGOS meeting in Washington, DC – Publication and call for comments of the draft policy brief – Consolidation and presentation of the draft policy brief at ARGOS Finale, Budapest © 2010-2012 ARGOS Consortium10

11. Policy brief: scope The policy brief should not replicate the scope of other road-mapping efforts in Europe or in USA, but focus only on the specific aspects of ARGOS: – Provide a observatory of VPH research, pointing to relevant documents for details – Revise critically these experiences, and point where the residual challenges are – With respect to such challenges understand where a US- EU cooperation is necessary – Identify which changes in policy would foster such cooperation © 2010-2012 ARGOS Consortium11

12. Terminology Infostructure Cyberinfrastructure Digital Infrastructure © 2010-2012 ARGOS Consortium12

13. VPH: time is ripe “One Life, One Knowledge: Technology To Integrate” The time is ripe to go to the next level: coordinate research efforts toward the complete integration of all data, information, and knowledge about human physiology and pathology into a global “digital infrastructure” © 2010-2012 ARGOS Consortium13

14. Expected Benefits VPH infrastructure produce socioeconomic benefits by: – Enhancing the understanding of diseases, promoting prevention and early diagnosis; – Accelerating the development pipeline and the assessment of safety and efficacy for innovative drugs and medical devices; – Assisting the medical professional in coping with the “information overload” problem – Fostering the development of new healthcare policies that promote a more holistic approach to complex diseases and to the promotion of an active and healthy aging. © 2010-2012 ARGOS Consortium14

15. We need joint policy But this will be possible only if Europe and United States elaborate a joint policy. The ARGOS VPH Policy Brief illustrates the reasons why we, the academic, industrial, and clinical stakeholders of the VPH initiative recommend the European and United States governments: © 2010-2012 ARGOS Consortium15

16. Rec #1: Work together Work together on a common policy to realign all VPH-type research efforts toward the creation of a global VPH digital infrastructure, by ensuring that all repositories of data and models, as well as all the methods and technologies developed during these research projects funded by governmental agencies are mutually interoperable and integrable. © 2010-2012 ARGOS Consortium16

17. Rec #2: Support MAG Support the establishment and the operations of an International Multistakeholder Advisory Group responsible of elaborating a collective vision, as well as the minimum set of standards and the technical guidelines that ensure the interoperability and the integrability of all VPH resources into the global VPH digital infrastructure, according to the vision of the Virtual Physiological Human. © 2010-2012 ARGOS Consortium17

18. Long-term sustainability The revolutionary nature of the VPH digital infrastructure requires special policies to its long-term sustainability, especially for: – Maintenance: transform the research prototypes into consolidated resources re-engineering, consolidation,, standardisation,, maintenance. USA NSF has recognized this problem  Scientific Software Innovation Institutes – Service: Deploy consolidated resources into services operated and curated persistence, reliability, security, etc. – Outreach: motivated organizations must be established and supported to operate these services to promote an outreach campaign – a) widest possible adoption and utilization – b) provides training and re-training to researchers and medical professionals – c) monitors the development and the adoption, providing decision-makers with factual and up-to-date evidence © 2010-2012 ARGOS Consortium18

19. Governance model Distributed, international, loosely coupled  the Internet Establish a permanent observatory on eHealth Establish a Multistakeholder Advisory Group (VPH/MAG) – Constantly revise the goals of the Cyberinfrastructure; – Promote standards for interoperability and integrability; – Maintain an worldwide research roadmap; – Develop regulatory guidelines and processes with regulatory bodies. Establish a globally distributed cyberinfrastructure: – Whose backbone is operated by a private no-profit organization; – Whose leaves are voluntarily interconnected infrastructure operated at regional, state, and/or federal levels (ICANN model) Commit the financial support © 2010-2012 ARGOS Consortium19

20. THANK YOU! © 2010-2012 ARGOS Consortium20 ARGOS Draft position paper: http://tinyurl.com/argospaper