What EU research policy can do for conditions such as chronic pain?

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1 The EU Framework Programme for Research and Innovation HORIZON 2020 What EU research policy can do for conditions such as chronic pain? K Berkouk, PhD Deputy Head of Unit, Non-communicable diseases and the challenge of healthy ageing Health Directorate, DG Research and Innovation European Commission

2 The global context Demographic change Increased burden of non - communicable diseases Raising health costs, increasing pressure on healthcare systems Increased costs for medicines and vaccines development Differences in outcomes, insufficient evidence on comparative benefits and overall value of current practices and approaches

3 Health Research in H2020 Excellent science 24bn* European Research Council Future and Emerging Technologies Industrial leadership 17bn* Marie Skłodowska Curie Research Infrastructures Eureka Eurostars-2 LEIT Biotech SME instrument Fast Track to Innovation SC1 Health 7.3bn (of 31bn*) Financial instruments IMI-2 Collaborative projects AAL-2 EDCTP-2 * Figure to be updated following EFSI investments in 2015

4 EU Health Research Translate science to benefit citizens Test and demonstrate new healthcare models, approaches and tools Promote healthy and active ageing Improve health outcomes, reduce inequalities Support a competitive health sector Provide evidence-base for effective health policies development

5 Pain research challenges How pain is generated and can this process be prevented, halted, modulated, blocked, reversed? How chronification of pain may begin and progress? Research is needed to decipher pain underlying mechanisms, develop effective therapies, meaningful diagnostics and comprehensive management approaches Identify biomarkers, brain circuitries, and other neurobiological mechanisms for the triggering and chronification of pain Establish faster & reliable diagnostic tool Assess high risk patients Identify potential drug targets Predict treatment response enabling improved stratified care

6 International Consortium for Personalised Medicine (IC PerMed) WHAT WHY Establish Europe as a global leader in PM research Support the PM science base through a coordinated approach to research Provide evidence to demonstrate the benefit of PM to citizens and healthcare systems Pave the way for PM approaches for citizens HOW Roadmap based on CSA PerMed Strategic Research Agenda (SRIA) Developing awareness & Empowerment Integrating Big Data & ICT solutions Shaping Sustainable Healthcare Translating Basic to Clinical Research & Beyond Bringing Innovation to the Market

7 Big data for health Big data and sharing Human Biomonitoring Initiative Omics Real world data HBM4EU actual exposure to chemicals and possible health effects 'IC PerMed' integrating Big Data and ICT BLUEPRINT - International Human Epigenome Consortium (IHEC) CageKid and BASIS sequencing kidney and breast cancers genomes - International Cancer Genome Consortium (ICGC) IMI Big Data - Better Outcomes and European Lead Factory Data sharing International Rare Diseases International Research Consortium (IRDIRC)

8 Patients at the heart of R&I In policy design Work programmes based on wide consultations: Advisory Group: representative of European Patient Associations workshops: participation patients Horizon 2020 topics are patient-centred Many events are triggered by patient organisations Partners In projects Through ethics board, safety monitoring board, and patient input platform Offer patients perspective on recruitment, study design, project communication Translate results in lay language, modify guidelines to better fit patients needs, contribute to dissemination activities Photographee.eu, # , Source: Fotolia

9 EU pain research what s being funded FP7 & HORIZON Collaborative Research Training & Mobility Innovation Frontier Research 105 Translational research acute pain chronic pain biomarkers imaging models technology prevention early detection clinical trials 168 million ( / April)

10 DOLORisk: Understanding risk factors and determinants for neuropathic pain Objectives 1) Identifying the influence of demographic factors; 2) identifying and validating genetic risk factors; 3) validating molecular pathways; 4) determining patient stratification based on physiological and psychological factors; 5) developing a risk model/algorithm; for neuropathic pain Understanding pathophysiology and risk factors for neuropathic pain Comprehensive approach covering basic research on molecular, patient and population level Providing a platform to improve diagnosis & patients stratification according to risk profile Employing preventive strategies Developing novel therapeutics

11 Chronic pain (examples) EUROHEADPAIN (FP7) will (a) identify pathways and biomarkers for the triggering and chronification of migraine attacks; (b) decipher the modulatory effects of (hypothalamic) brain circuitries on trigeminal processing, sensitisation, and chronification; (c) assess the effects and mode of action of migraine-provoking molecules; and (d) evaluate the efficacy and mode of action of second messenger-blocking drugs in the treatment of chronic migraine. NGN-PET (Horizon 2020): Developing mechanism-based therapies targeting neuron-glial interactions to treat chronic pain has the potential for improving the quality of life of patients. NGN-PET will develop and characterize in vivo and in vitro models for the identification, validation of molecular targets and the development new treatments. The consortium aims to integrate the developed model systems into high throughput screening platforms for pharmaceutical research and drug discovery..

12 SMEs funded via SME instrument, Phase I LUCY, Oct 2015: Cross-platform patient monitoring tool continuously collecting biomarkers on pain and mood disorder including doctor interface JEM Phase 1, June 2016: Subcutaneous implantable device - reducing pain for all patients in need of repetitive vascular access, e.g. oncology patients SET - Chronic Pain, July 2016: Using ICT data the SET device allows monitoring / adjustments for chronic pain treatment applying E-learning systems NANO-GROWTH, February 2017: Innovative transdermal delivery system using encapsulated therapeutic analgesic compounds to improve the quality of life of chronic pain patients while reducing costs for healthcare systems

13 Palliative care what s being funded FP7 & HORIZON Translational research 1 23 acute pain chronic pain (multidisciplinary) care management access to medication economic evaluation Collaborative Research Innovation Training & Mobility 28 million ( / April)

14 EPCRC The European Palliative Care Research Collaborative. Improved treatment of pain, depression and fatigue First major EU-funded palliative care research collaborative Established international classification systems and biomarkers Developed European, evidence-based guidelines for pain, depression cachexia Led to revised clinical guidelines on the use of opioids in cancer pain from the European Association for Palliative Care and informed national policies - UK NICE clinical guidelines for opioid use in palliative care

15 Underpinning EU Drug Strategy ( ) ATOME access to opiod medications in Europe Substantial increase of controlled medicines consumption in developed countries EU Drug Strategy ( ) aimed at controlling access to illicit drugs while ensuring access to prescribed controlled medicines (e.g. opioids) Evidence base for EU Drug Strategy ( ) aimed at controlling access to illicit drugs while ensuring access to prescribed controlled medicines (e.g. opioids) ATOME analysing factors responsible for inappropriate use of/access to opioids and developing policy recommendations to Health Authorities WHO guidelines 'Ensuring Balance in National policies on controlled substances" based on ATOME results Tailored policy recommendations on access to opioids for MS

16 Accelerating the delivery of therapies The world's largest public private partnership in health research IMI 2 billion IMI billion Developing the next generation of vaccines, medicines and treatments Low Back Pain in IMI2's Strategic Research Agenda ( ) EUROPAIN: increase understanding of chronic pain mechanisms; overall contribution 22.5 million IMI2 7 call - Pathological neuron-glia interactions in neuropathic pain ( 1,5M) EFPIA = European Federation of Pharmaceutical Industry Association

17 Planned Policy activities in & events Policy activities: Midterm review of the Digital Single Market (Communication includes digital transformation of health & care) Personalised Medicine (Staff working document) Health Technology Assessment in Europe European Open Science Cloud Supportive events: Scientific Panel for Health (Brussels, 9 June) European Open Science Cloud Summit (Brussels, 12 June) Workshop on personalised medicine for end users (Oct 2017)

18 Health, demographic change and wellbeing challenge Headlines Better health and care, economic growth and sustainable health systems Personalised medicine innovative healthcare industry global health sustainable and evidence based health and care systems Decoding the role of the overall environment for health and well-being Human exposome global changes and health Digital transformation in Health and Care ehealth and mhealth ICT for Active and Healthy Ageing Trusted Big Data solutions and Cybersecurity for Health and Care

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