NIHR Invention for Innovation (i4i)

Transcription

1 NIHR Invention for Innovation (i4i) Martin Hunt i4i Programme Director

2 Content Overview of NIHR NIHR i4i Programme What we fund Case studies Funding Process

3 NIHR: Vision To improve the health and wealth of the nation through research i4i Invention for Innovation

4 1b external research investment was attracted Over 3,000 industry studies supported 41.1m generated in 2014/15 through exploitation of IP 21,499 people took part in dementia research supported by NIHR More than 260,000 people took part in NIHR research studies More than 250 NICE guidelines used NIHR-generated evidence 114 licences deals and 6 spin out companies launched 135m invested in cancer research 111 patents granted in 2014/15

5 i4i: Who we are, what we do NIHR translational funding scheme Support collaborative R&D and clinical adoption i4i Focus on innovative medtech solution De-risk projects for follow-on investment Patient benefit Led by Programme Director, Martin Hunt Supported by a team of Programme Managers

6 i4i Bridges the Medtech Valley of Death Project plan & Innovation Team Value for money Proof-ofconcept IP & commercial strategy Clinical need Regulatory Patient and public involvement NHS adoption plan Basic research produces proof of concept data Technology that is attractive to follow-on funders and investors for commercialisation The Graveyard of Good Ideas i4i Invention for Innovation

7 Medtech Funding Landscape Basic Research Translational Development Clinical Evaluation Adoption & Diffusion Innovate UK NIHR i4i Feasibility Studies Innovate UK/ Biomedical Catalyst Primer Award NIHR EME NIHR HTA SBRI Healthcare MRC MRC/ Biomedical Catalyst Confidence in Development Concept (CiC) Pathway Funding Scheme (DPFS) WT/Seed Awards WT/MRC Joint Global Health Trials BBSRC EPSRC Charities Angel Investors Crowd Funding Venture capital Companies i4i Invention for Innovation

8 Facts & figures 3 funding streams i4i Product Development Awards i4i Challenge Awards i4i Connect Up to 36 months 101 active projects 3.25M largest award ~ 95M total spend

9 i4i portfolio Stroke, 5.4% Respiratory, 5.4% Skin, 3.1% Blood, 0.8% Cancer, 16.9% Reproductive health & Childbirth, 6.2% Cardiovascular, 6.9% Renal & Urogenital, 5.4% Other, 0.8% Ear, 0.8% Oral & Gastrointestinal, 5.4% Eye, 10.0% Neurological, 3.1% Muscoloskeletal, 6.9% Generic health relevance, 3.1% Metabolic & Endocrine, 3.1% Mental health, 1.5% Injuries & Accidents, 3.8% Inflammatory & Immune System, 0.8% Infection, 10.8%

10 i4i portfolio Yorkshire & Humber 9% West Midlands 5% West of England 4% Wales 5% East Midlands 8% Eastern 3% Greater Manchester 5% Health Innovation Network - South London 8% Wessex 4% UCL Partners 14% South West 3% Oxford 8% North West Coast 8% Imperial College Health Partners 8% Kent, Surrey & Sussex 3% North East Coast and North Cumbria 4% All AHSN regions are represented

11 i4i portfolio Funded portfolio, % organisation per type SME Involvement 2% 11% HEIs NHS No SME 47% SME Led 11% SME co-app 42% 26% Research Institutes 61% SMEs

12 i4i Connect An SME* must be the lead applicant 6-12 months funding 50k to 150k Aims to prepare projects for an i4i PDA/Challenge application or follow on funding Scope of funded activities as for PDA Fast turnaround funding Stage 1 opened 16th August and closed on 13th September with projects starting in December * SME defined as a headcount less than 250 and annual turnover no greater than 50 million

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14 i4i Invention for Innovation

15 RAND Report 1 Rare funder of high risk early innovation Funding process helps proposal improvement Willing to support beyond the usual suspect Instrumental for follow-up funding Open to diverse healthcare needs Adaptable and responsive funding source Less bureaucratic than other funders Valuable support from i4i team We felt we had the opportunity to drive our platform and technology forward The i4i team was instrumental in raising the visibility and the overall impact of the work When we seek advice from NHS stakeholders they are more willing to help if you have an NIHR award 1 The NIHR Invention for Innovation (i4i) programme. A review of progress and contributions to innovation in healthcare technologies

16 i4i highlights 130 projects awarded >200 organisations ~ 95M invested 102M funding leveraged

17 i4i Case Studies

18 Novel endoscopic GI tract tools Creo Medical Ltd awarded 75k in 2010, 970k in 2013 and 940k in Developing CE-marked electrosurgical system for quick, safe and accurate removal of pre-cancerous gastroenteric lesions Patient benefit: Reduced risk of post-operative bleeding and higher chance of full removal of potentially cancerous tissue Estimated NHS savings 111M per year if adopted Recent public share offering on the London Stock Exchange (AIM) raised 20m that will allow commercialisation of research funded by i4i.

19 Low-cost visual aid University of Oxford, 548k awarded in 2012 and 392k in 2017 Unique technology to enhance sight Detects and displays nearby objects Huge impact on quality of life and independence Won Google Impact Challenge ( 500k) Currently in clinical trial Spin out company (Oxsight) raised 2m from Chinese investor As the i4i grant enabled the development of the prototype it also put the team into a position to generate further funding for the final steps towards commercialisation. Source: RAND

20 Early detection of osteoporosis Osteoporosis related fractures are estimated to affect half of women and 20% of men over the age of 50 Prof Tim Cootes at the University of Manchester was awarded 867k in 2016 to continue development of software that will automatically identify early signs of osteoarthritis in radiographic scans of vertebrae before they produce clinical symptoms Early identification will allow preventative treatments to be started avoiding longer term, more expensive therapy to reduce symptoms Commercial development and distribution will be via an SME (Optasia Medical Limited) that already participates in the radiography software market.

21 i4i in the news 26 th June 2017 Magnets used to control flickering eyes 26 th June 2017 The scientist who helped create a new prostate cancer scan 22 nd January 2017 In search of the stroke detector 5 th January 2016 The bionic eye changing a women s life

22 Why apply to i4i? Dedicated Medtech funding programme Uncapped awards Source of early funding for SMEs Risk oriented programme Commercially oriented panel supported by peer review Milestone-based awards to de-risk Guidance and advice Favourable independent review by RAND 1 1 The NIHR Invention for Innovation (i4i) programme. A review of progress and contributions to innovation in healthcare technologies

23 The i4i Application Process Dr Lee Allen NIHR i4i Team

24 i4i "Starter for 10" Minimum of two organisations Lead applicant must be based in England Must have proof-of-concept Work plan must exclude animal studies Challenge Awards Challenge Awards NHS organisation/service provider involvement Must reach first in man as a minimum

25 Key facts Application process Timelines What we fund What we do not fund 2 stages rebuttal to peer reviewers panel presentation 2 months from outline to shortlisting 6/7 months from outline to notification R&D Health economics Regulatory IP & commercial Manufacturing Clinical trials up to Phase II Basic research Small molecules Studies on animals and/or animal tissues

26 Funding process Stage 1 Hit the deadline! Preliminary scrutiny Stage 2 External peer & lay reviewers Panel assessment Ratification Outcome notification

27 Risk mitigation path Due Diligence Science scrutiny IP & Commercial scrutiny Financial scrutiny Legal scrutiny Contracting Monitoring Enabling Delivery Impact Periodic catch up on advancement and generated impact Post-project monitoring Progress and financial reports Milestone-based payments Site visits Research Steering Group Intellectual Property Management Group

28 i4i Success rate 879 applications scrutinised (Stage 1) 13.8% 130 applications awarded ( 95m) 25.8% 53.3% 232 applications shortlisted (Stage 2)

29 A successful application Proof-ofconcept Project plan & Team Patient and public involvement Innovation Regulatory NHS adoption Clinical need and impact on NHS/patients IP & commercial strategy Value for money

30 Be clear about Evidence of proof-of-concept Clinical unmet need and patient benefit Level of innovation Project plan Detail Methodology Risk management

31 Project team Demonstrable experience to carry out the project All key areas covered Scientific/technical Clinical Project management IP & commercial Regulatory Gaps addressed (consultancy/sub-contractors) Company can lead

32 IP & commercial strategy IP arrangements between partners Ownership of background/foreground IP Appropriate agreements in line with NIHR policy Competitive landscape/fto analysis Exploitation plan Route to market/nhs adoption IP and commercialisation strategy Regulatory requirements Potential sources of onward investment

33 Type of IP generated New local guideline Improved checklist or questionnaire New patient medical/clinical data New national guideline New software tool New research tool New comprehensive toolkit for patient care New database design New or improved medical device Copyright Copyright, trademark Data Copyright Copyright, trademark e.g. new material, assay Copyright, trademark Database right, trademark Design, patent, trademark & Know How

34 PPI (Patient and public involvement) Active involvement of patients and the public expected Relevant patient/user groups Engagement at an early stage Request of adequate resources Plain English summary Help available from various sources Think of this as a route to Impact

35 Words of wisdom Don t leave it until the last minute Clear and achievable deliverables Accurate budgeting Clinical trials: Approvals Recruitment rate Link with Clinical Trial Unit Statistical input

36 The Panel presentation Presentation and Q&A session Up to three presenters Know your audience Frame your story Practise Keep to time...being a bit nervous is not a disaster!

37 Help! NIHR Infrastructure Research Design Service Health Technology Cooperatives Diagnostic Evidence Cooperatives Clinical Research Network Medtech and In vitro diagnostic Cooperatives (MICs) from 2018 Academic Health Science Network (AHSN) University of Leeds In-house technology transfer experts i4i Secretariat i4i Invention for Innovation

38 i4i Product Development Awards: Call 15 Call 15 Launch 1 st November 2017 Stage 1 deadline 13 th December 2017 Invitations to stage 2 14 th February 2018 Stage 2 deadline 11 th April 2018 Panel meeting 12 th and 13 th June 2018

39 i4i Challenge Awards Call 7 - Mental Health: Call Launch 1 st February 2018 Stage 1 deadline 4 th April 2018 Invitations to stage 2 23 rd May 2018 Stage 2 deadline 26 th September 2018 Panel meeting November 2018

40 Thank you i4i Invention for Innovation NIHR Central Commissioning Facility 15 Church Street Twickenham TW1 3NL Contact us for advice and specific guidance: T E i4i@nihr.ac.uk W Disclaimer: Please note that all case studies present independent research funded by the NIHR. The views are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.