Driving Innovation Challenge Statement• How to place the UK at the centre of a new era of stratified medicines:• Approach: to help accelerate the development and uptake of treatments based on the combination of diagnostic test and drugs ... to benefit the healthcare industry ... to improve patient outcomes ... and for wider UK economic benefit
Driving Innovation Programme Partners• Technology Strategy Board• Department of Health• Scottish Government Health Directorate• National Institutes for Clinical Excellence• Medical Research Council• Cancer Research UK• Arthritis Research UK
Driving Innovation Stratified Medicine Innovation PlatformTogether the partners will invest over £200million over a 5 year period will be investedto accelerate Stratified Medicine in the UK.The aim is to bring the government,researchers and business together in amajor initiative that will place the UK at thecentre of a revolution in the diagnosis andtreatment of disease.
Driving Innovation First calls • Tumour Profiling & Data Capture (£5.8m) – Working along side CRUK programme – Funded 6 projects • Inflammatory Biomarkers (£4.3m) – Working along side MRC:ABPI programme – Funded 4 projects • Business Models and Value Systems (£0.9m) – Funded three projects
Driving Innovation Technology Roadmapping• Build a UK vision for stratified medicine – ..... that the UK can deliver – ...... supported by the SMIP and PMG• Build a community of people who will help• Take a strategic view of investment options – Identify the barriers – Programme activity to overcome them – Investments in support of the programme activities
Driving Innovation Vision for 2025 • The UK should be the best place to develop, and have adopted, stratified medicine. This will benefit patients, provide cost-effective solutions for the NHS and other healthcare providers and create opportunities for business • There should be an increased collaborative culture throughout the sector based around shared resources, and systems should be in place for effective data collection, sharing, governance and use across sectors (including NHS, business, academia, regulators and NICE) • It should be quicker and less expensive to develop new drug-diagnostic combinations and have them licensed, and success should be reflected in increased UK economic growth • It should be possible for all NHS patients to be involved in medical research if they wish, including through use of patient information and records, in order to inform the next generation of successful therapies • There should be a smooth reimbursement process for stratified therapies and diagnostics, and an intellectual property (IP) framework that encourages innovation • The UK health system should have established stratified care pathways, and evidence should be available to show that patient outcomes are improved where stratified medicine is used
Driving Innovation Key Themes • Incentivising adoption • Increasing awareness • Patient recruitment – consents and ethics • Clinical trials • Data – collection, management and use • Regulation and standards • Intellectual property • Bio-banks and biomarkers • Increasing the impact of R&D investment
Driving Innovation Incentivising adoption Key message: Adoption of products into the healthcare system was seen key during the workshops. There are many activities ongoing in this area reflecting it’s importance to both Industry and health service Sound demonstration of value for money for products is seen as the key deliverable
Driving Innovation Increasing awareness Key message: Need to develop a sound information base and ensure that professionals and public are provided with evidence and a rational for Stratification. For professionals proof of effectiveness and value For public avoid the message that stratification is a form of rationing
Driving InnovationPatient recruitment – consents and ethicsKey messages:Often patient consents are restrictive and do not allow use in research projects beyond the immediate study. Broader consents are preferred.Ethical consideration needs to be given to later incidental findings particularly in the area of whole genome screening.
Driving Innovation Clinical trialsKey messages:Delays around identifying the appropriate patients and recruiting into trials is one of the key bottle necks in development. Any systems to pre-identify patient cohorts could save significant resource.New types of trial design will need to be discussed and approved by regulatory agencies
Driving InnovationData – collection, management and useKey message:There is a significant quantity of highly relevant data already in existence within the NHS and in Pharma companies. Finding some way to share this data appropriately could benefit all.Will require significant effort in data standardisation to enable open sharing.
Driving Innovation Regulation and standardsKey message:Regulation is a key gatekeeper in drug development, all products must be safe and effective (but how should trials be designed to show efficacy in preselected groups)There was a desire for more regulatory guidance around both trial design for stratified products and in the validation of tests and test protocols.
Driving Innovation Intellectual propertyKey message:This was raised as a concern by diagnostic companies who were concerned that “homebrew” tests did not face a level playing field.Quality systems being implemented nationally may help to improve this but companies would like to see strong IP protection for tests.
Driving Innovation Bio-banks and biomarkers Key messages: There is a recognition that access to appropriate samples with clinical annotation is key and that having linked Bio-banks with standardised systems would help Clarity or standardisation around what information is required to “validate” a biomarker
Driving InnovationIncreasing the impact of R&D investment Key message:The desire is to increase the impact of everyones R&D spend, public, private and third sectorThere was a widespread acceptance that no single organisation could make a difference alone. The key is coordinated activity in multiple areas simultaneously. Only by working together
Driving Innovation SummaryThere was a widespread acceptance that no single organisation can make a significant difference working alone. The key is coordinated activity in multiple areas simultaneously.
Driving Innovation Where Next? Adverse Events and Non-Responders ( up to £7.5m)• Developing tests to predict risk of suffering adverse events, or non response to current therapies. – Phase 1: Health economic valuation of product and impact on clinical care pathway – Phase 2: Funding of development of most successful projects from phase 1 – SBRI in partnership with Dept of Health
Driving Innovation Contact details • Dr Graham Bell (firstname.lastname@example.org) • Dr Alasdair Gaw (email@example.com) • https://ktn.innovateuk.org/web/stratified-medicines- innovation-platform