Stratified Medicine in the UK: How can we help? Dr Loic Lhuillier, Programme Manager Stratified Medicine Innovation Platform Stratified Medicine and Pharmacogenetics Hinxton, 14/01/2015 26/02/2015
InnovateUK (formerly Technology Strategy Board) • The Technology Strategy Board – set up in 2007 to support UK economic growth • We look at the challenges that offer market opportunities • Identify where the UK has real capability – and where the timing is right • We work with communities and other organisations – finding the right form of support for companies in these areas In 6 years.... Over 2000 CR&D projects launched We have supported 5,000 businesses and 150 research organisations 4000 business partnerships and almost all the UK’s universities Together with partners and business, over £2bn invested in UK innovation
Connecting Funding Building
Stratified Medicine Innovation Platform • Launched October 2010 • Aims to realise the potential of stratified medicine in the UK • With partners will invest up to £200m (6 rounds of competition to date) • Supporting 100 individual businesses, 40 Universities/RTOs and 13 NHS Trusts/Boards • Works in partnership across government and with the private and third sector to maximise UK potential for economic growth and patient benefit
Stratified Medicine:Technology Roadmap • To deliver the UK vision • Build a community of people who will help • Take a strategic view of investment options – Identify the barriers – Programme activity to overcome them – Align investments in support of the programme activities
Themes – then and now 1. Incentivising adoption 2. Increasing awareness Adoption 3. Patient recruitment – consents and ethics 4. Clinical trials 5. Data – collection, management and use Development 6. Regulation and standards 7. Intellectual property 8. Bio-banks and biomarkers Research 9. Increasing the impact of R&D investment
A support ecosystem for Stratified Medicine Roadmap Update meeting, 26 th March, London
An Evidence Map To produce a clear set of guidelines setting out the critical path and required evidence for the discovery, development, approval and evaluation of tests • Focus on IVD including data (bioinformatics, data integration) • Section on CDx and the integration of test development and drug development • The map should: o be simple and accessible, pointing to further sources of information o give information on which parts of the discovery/development pipeline the various funding organisations will support UK Diagnostics Forum meeting, Oxford, May 2015 2/26/2015
A Precision Medicine Catapult
Catapults A new force for innovation & growth 7 • Part of a world-leading network of technology and innovation centres Catapults • Bridge the gap between businesses, 2014 academia, research and government • Long-term investment to transform the All Catapults up UK’s ability to create new products and and running services • Open up global opportunities for the UK and generate sustained economic £1bn growth for the future • Being established and overseen by Private & public sector investment Innovate UK
We plan to address 2 of the barriers to PM PM test commercialisation pathway Biomarker Proof of Lab Clinical Clinical Market Market discovery principle validation validation utility approval uptake • Commercialising new tests is slow and costly, with the returns not justifying the risks • Performing precision medicine clinical studies (i.e. combining diagnostics and therapies) is complicated
Our proposed solutions • Lower the costs and risks of bringing new PM tests to market by • Setting up a test development and validation lab • Offering rapid and easy access to clinical settings to show these tests work in the real world • Make PM clinical studies easier by • Creating a PM-focused clinical trial system of 30- 40 hospitals and a PM pathology lab service.
Development lab • Rapid prototyping, development and validation of new tests, algorithms and diagnostic instruments • In vitro diagnostic focused • Help SMEs • Understand and capture the commercial opportunity • Produce clinically reliable and robust tests and diagnostic platforms • Test products in real clinical settings • Accelerate approval and reimbursement of PM products
PM test-bed • Dedicated infrastructure to deliver PM clinical trials – A network of 30-40 hospitals – Covering 15-20 million population A centralised PM pathology lab service Rapid regulatory approval Easy sample and clinical data access Fast enrolment of as many patients as possible
Disease focus • Our target diseases are ones likely to have a real world impact within 10 years • Cancers (particularly the common ones: lung, breast, colorectal, prostate) • Infection • Inflammatory conditions like rheumatoid arthritis.
Thank you Loic.lhuillier@innovateuk.gov.uk +44 (0)7917132454 2/26/2015
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