1. Horizon 2020 in detail Jerome de Barros NCP Health

2. Basic concepts of Horizon 2020  The main European Union programme for research and innovation for 2014-2020  A core part of Key European policy initiatives: – Europe 2020 – Innovation Union – Responding to the economic crisis to invest in jobs and growth – Strengthening the EU’s global position in Research, Innovation and technology

3. SC1 Work Programme 2016/2017 in brief  Call “Personalised Medicine” - 21 Call topics: 34 in 2014/2015 (10 in 2016, 10 in 2017, 1 open in 2016 & 2017) - ‘Coordination activities (HCO)’ - 15 topics (17 in 2014-2015): 12 in 2016, 3 in 2017 - 2 SME Instrument topics: Supporting innovative SMEs in the healthcare biotechnology sector (Cell technologies in medical applications and biomarkers) Accelerating market introduction of ICT solutions for Health, Well-Being and Ageing Well Budget €500.17M (2016) €433.81M (2017)

4. Health Research & Innovation in H2020

7. Example Call topic Title: Clinical research on regenerative medicine Specific Challenge: Translating basic knowledge on regenerative medicine into the clinic is often delayed by the difficulty of undertaking "first in man" studies and carrying out the specific research needed for proving safety and efficacy of new treatments as well as reproducibility of their therapeutic effect. Moreover, financing for these steps in the new therapeutic field of regenerative medicine is particularly scarce, due to lack of established business and regulatory models. The challenge is to overcome these hurdles to in-patient research and to determine the potential of new regenerative therapies. Scope: Proposals should target regenerative medicine therapies which are ready for clinical (in-patient) research and should focus on one specific clinical phase of work. Any stage of clinical work (e.g., first in man, late stage trial, observational study) may be proposed though later stages are preferred; clinical work should represent the core of the proposal. To justify the clinical work proposed, phase I proposals must present appropriate preclinical and toxicology data, and later phase proposals must present appropriate preliminary results. Proposals should include authorization to conduct clinical trials and ethical approvals or provide evidence of regulatory engagement and that such approval is close. Preference will be given to proposals which are closest to having approvals in place for clinical work to start. Since the objective is to test new regenerative therapies, proposals may address any disease or condition but a justification for the choice must be provided. Proposers should also justify why the therapy proposed is regenerative and how it represents a new approach compared to any existing treatment. Sex and gender differences should be investigated, where relevant. To allow an adequate coverage in the field of regenerative medicine, proposals should take into account the projects previously funded under this topic in Horizon 202020. The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. Expected Impact: Obtain results by means of in-patient regenerative medicine research that allows new therapies to safely reach the next level of testing or medical practice. Stimulate growth and competitiveness of European regenerative medicine including European small and medium-sized enterprises and industry operating in the sector. Increase the attractiveness of Europe as a location of choice for development of new therapeutic options. Lever existing investments in fundamental research into regenerative medicine. Develop new approaches to currently untreatable diseases. Type of Action: Research and Innovation action

8. How to read the calls  Call title  This is the problem to be addressed  Specific Challenge  This explains the reason for the challenge  Scope  This provides some insights to possible approaches / solutions  It is not very prescriptive  Look for acronyms, legislation, specific countries, other EC initiatives  It will indicate the expected size of the project e.g. Euro 3 million  Expected impact  This is what the project must deliver  You must justify how your approach is the best way to achieve these impacts

9. PM-11–2016-2017: CR on regen med  Specific Challenge – Overcome hurdles to in-patient research (Translating basic knowledge on regenerative medicine into the clinic, undertaking "first in man" studies, financing, etc.) and to determine the potential of new regenerative therapies

10. PM-11–2016-2017: CR on regen med  Scope – Regenerative medicine therapies which are ready for clinical (in- patient) research – Focus on one specific clinical phase of work BUT later stages are preferred – Clinical work should represent the core of the proposal – Preference will be given to proposals which are closest to having approvals in place for clinical work to start. – Proposals should take into account the projects previously funded under this topic in Horizon 2020

11. PM-11–2016-2017: CR on regen med  Impact – Obtain results that allow new therapies to safely reach the next level of testing or medical practice. – Improve the therapeutic outcome of major chronic health issues with significant impact on disease burden of individual patients and health care systems. – Stimulate growth and competitiveness of European regenerative medicine including European SMEs and industry operating in the sector. – Lever existing investments in fundamental research into regenerative medicine – Develop new approaches to currently untreatable diseases (ambition)

12. PM-11–2016-2017: CR on regen med  Submission deadline: 13 Apr. 2016/ 11 Apr. 2017  Research and Innovation Action  Indicative budget: 30+30 M€  Suggested funding request: 4 - 6M€

13. Relevant documentation  Participants Portal documents – Call text in work programme – Topic conditions and documents – Eligibility – Evaluation criteria and procedure – Proposal templates – Other templates (i.e CT template) – FAQ – Etc.

14. Relevant documentation clinical trials/studies  Presentation on clinical studies (European Commission) – Definition – Information on the CT Template Mandatory for some calls (when included in call docs) – Mandatory deliverables – Essential information about CS to be included in DoA (part B) – Unit costs – Type of costs (Direct, etc.) – Recruitment sites – Deliverables and Ethics

15. Difficulties for participants  Overall success rate of the Health programme (SC1): 5.9% – Success rate Single stage: 10.3% – Success rate Two stage: 2.9%

16. Hints & tips – General  This is not easy money or a ‘life line’ for companies  If you are going to be the coordinator, have you got the professional capability to support the project?  Make sure that your idea aligns with what is being asked for - Don’t waste your time and the evaluators time trying to “shoe horn” it in where is doesn’t belong.  Follow the guidance provided.  There can be a long time between payments, so ensure your organisation, especially SMEs can cope with any cash flow issues

17. Hints & tips – Research strategy  Is research part of your organisation’s long term strategy?  Have you identified your R&D roadmap?  What are your strengths?  What are your weaknesses?  What are your connections?  Where should our focus be?  What are your connections?  Where should our focus be?

18. Hints & tips – Building a Consortium  Questions to think about: – Who has the best expertise/reputation? – Who should you approach to be part of a consortium?  Not everyone has to have the same size role  Don’t include partners because you think it will look good or to pad the proposal out - each partner should have a clear and defined purpose.  Make contact early  What are your connections?  Consider an advisory group

19. Hints & tips – Proposal outline Good to have a one page proposal summary to help focus ideas and for consortium building  WHY the project is being carried out  WHAT is expected to be achieved…what is not expected to be achieved : Objectives  WHO is going to do the work – The consortium and the synergy and complementarity of the partner  HOW the project is going to achieve the above – Work plan and phases of work – Means and resources to be used

20. Hints & tips – Proposal outline  Have a good proposal manager  Have a Good proposal writer  Tell a story: explain the benefit of your project idea  Keep the project’s structure simple  Consider carefully the balance of work between – Partners – Work package leaders  Don’t have too many deliverables

21. Hints & tips – Writing the proposal (1/2)  Refer to the evaluation criteria - there are three elements, each scored out of five:  Excellence - credibility of the proposed approach, ambition of the work, innovation potential, is beyond the state of the art (e.g. ground breaking objectives, novel concepts and approaches)  Implementation - how you will carry out the work and the quality of the consortium  Impact - Strengthening the competitiveness and growth of companies, effectiveness of the project to exploit and disseminate the project results (including IPR management)

22. Hints & tips – Writing the proposal (2/2)  Write in plain English – spell out acronyms and no jargon or slang  Respect the page limits - excess pages are discarded!  Be concise, less can be more  Get impartial colleagues to read it before submission  Check consistency between forms and written proposal

23. Hints & tips – Submitting the proposal  Register on the Participant Portal early  Make sure that your proposal is eligible!  Submit early, and often.

24. Hints & tips – General Guidance  Proposed work should start with reflections on how topic challenge can be best addressed  How will proposed work advance state-of the-art, feed into solutions? Generation of knowledge is only the starting point  What makes the proposal "special"?  Partnership: Not necessarily large in terms of numbers of partners but in terms of inputs and "roles"  Are disciplines, basic and applied aspects well connected?  How can findings be best disseminated, tested, demonstrated and applied – in different European settings?  How are users/stakeholders of research outputs involved in implementation of work?

25. Evaluation Award Criteria (15)  Excellence (5)  Credibility of the proposed approach  Soundness of the concept including trans-disciplinary considerations, where relevant  Extent that proposed work is ambitious, has innovation potential, and is beyond the state of the art (e.g. ground breaking objectives, novel concepts and approaches)  Impact (5)  …  Quality and efficiency of the implementation (5)  …

26. Evaluation Award Criteria (15)  Approach for group of ex aequo proposals requiring prioritisation 1.Address topics not otherwise covered by more highly-ranked proposals 2.Scores awarded for the criterion excellence 3.Scores awarded for the criterion impact (vice-versa for Innovation actions and SME instrument) 4.Size of budget allocated to SMEs 5.Gender balance among the personnel named in the proposal

27. Explore other alternatives

28. Help in accessing H2020 opportunities  Enterprise Europe Network – generic local support  Knowledge Transfer Network – thematic national support  National Contact Points – dedicated experts providing specialist H2020 advice  Innovate UK Brussels office  Catapult centres (Digital, Cell Therapy, Precision Med.)

29. Help in accessing H2020 opportunities  Feedback to/from EC on work programmes  Clarification of documentation and rules  Guidance on choosing thematic priorities and instruments  Scope queries with Project Officers  Advice on administrative procedures and contractual issues  Support with the application process (workshops and 1-2-1)  Feedback on draft proposals  Assistance with partner search – through network support (KTN)  Feedback on results

30. Jerome de Barros – Horizon 2020 Health NCP Mobile: 44(0)7799766352 Email: jerome.debarros@innovateuk.gov.ukjerome.debarros@innovateuk.gov.uk