Technology Strategy BoardDriving InnovationStratified Medicinein the UKVision and Roadmap
Stratified Medicine in the UKStratified Medicine in the UKVision and RoadmapSummary                                       ...
Vision and RoadmapThe Stratified Medicine Innovation Platform     This document presents a summary of the           A Shar...
Stratified Medicine in the UKA Shared Roadmap                                                            The UK Stratified...
1. Incentivising adoption of SM in the NHS                                                                                ...
2. Increasing stakeholder awareness                                                                                       ...
3. Patient recruitment (consents & ethics)                                                                                ...
4. Clinical Trials                                                                                                        ...
5. Data                                                                                                            Barrier...
6. Regulatory Framework and Development Pathway                                                                           ...
7. Intellectual Property                                                                                                  ...
8. Bio-Banks and Early Biomarker Detection                                                                                ...
9. Increasing and Leveraging UK R&D investment                                                                            ...
Stratified Medicine in the UKStratified Medicine                            The SMIP programme management group           ...
Vision and RoadmapGlossaryABHI       Association of British Healthcare IndustriesABPI       Association of British Pharmac...
Stratified Medicine in the UK     Technology Strategy Board     North Star House     North Star Avenue     Swindon     SN2...
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Technology Strategy Board Vision and Roadmap

  1. 1. Technology Strategy BoardDriving InnovationStratified Medicinein the UKVision and Roadmap
  2. 2. Stratified Medicine in the UKStratified Medicine in the UKVision and RoadmapSummary Background fewer new drugs. Data shows that, starting with 5,000-10,000 candidate molecules,A consortium of government bodies and Even the best medicines are not equally it can take up to 15 years, and cost moreleading charities has joined forces to effective in all patients. Disease processes than $800m, to get one new drug toaccelerate the development and uptake of and treatment choices can vary from market. The sustainability of this modelstratified medicine in the UK. The person to person even though they may of drug development is increasinglyTechnology Strategy Board, Medical have similar symptoms. It is estimated that being questioned and many suggest thatResearch Council (MRC), Cancer only 30-70% of patients respond positively using molecular biology to select likelyResearch UK (CRUK), Arthritis Research to any particular drug. Recent advances in responders could lead to reducedUK (ARUK), Department of Health (DH), science, particularly in molecular biology development times, fewer failures, andScottish Government Health Directorate and genomics, mean that it will become lower costs. Diagnostics companies are(SGHD) and National Institute for Clinical increasingly possible to identify the an important part of the solution, butHealth and Excellence (NICE) have underlying molecular mechanisms of developing and commercialising robustformed a partnership to take forward the disease. Developing diagnostic tests that tests can be expensive and difficult.Stratified Medicine Innovation Platform. indicate the molecular cause of a diseaseTogether they will invest around £200m enables the development of new treatmentsover five years in the area of stratified that can more precisely target the disease,medicine. Stratified medicine can be as Herceptin does for certain forms of Stratified Medicinesummarised as identifying the right breast cancer. Predicting in advance Innovation Platformtherapy for the right patient at the right time which groups of patients will respond to ain the right dose. particular therapy and providing treatment Global society faces many challenges. accordingly is known as stratified By applying technology and innovation weThis publication sets out a shared vision can help to meet these challenges and, at medicine (or personalised medicine).for the UK to be the best place to develop, the same time, open up new opportunitiesand have adopted, stratified medicine. It Across the world, healthcare models are for business. Innovation platforms focusalso outlines a technology roadmap that facing greater challenges, both physically on specific societal challenges wheredescribes nine thematic areas which, if and financially, in providing for a growing, government is taking action throughadvanced successfully, will help accelerate ageing population with an increasing policy, regulation, procurement or fiscalthe development and uptake of stratified burden of disease. The upward trend in measures. By improving co-ordinationmedicine in the UK. The vision and spending means healthcare is becoming between the key players from industry,roadmap grew out of a series of workshops a more and more significant part of a academia and government, innovationattended by more than 100 people nation’s GDP, and the long-term platforms can identify barriers to meetingrepresenting a broad range of stakeholders sustainability of current models of the challenge, map possible routes to provision is increasingly questioned. overcoming the barriers, and align activities A stratified approach has the potential to support innovative solutions. The aim is to address some of these issues and at to deliver a step change in the ability of UK the same time improve patient outcomes. businesses to provide solutions for the Costs are increasing too for the supply global marketplace, boost UK economic side. Pharmaceutical R&D productivity performance, and provide higher-quality, is decreasing, meaning higher costs for better value healthcare services.02 | Technology Strategy Board
  3. 3. Vision and RoadmapThe Stratified Medicine Innovation Platform This document presents a summary of the A Shared Vision(SMIP) seeks to build on the UK’s strength views heard from these sessions in the formwithin global healthcare industries and put of a UK Vision for Stratified Medicine in 2025, The vision is for the UK to be the bestit at the centre of the next generation of and a roadmap to achieve it. It attempts to place to develop, and have adopted,medicine. It is a five-year programme to capture some of the excellent stratification- stratified medicine. This will benefitaccelerate the development and uptake of related activity currently going on in the patients by improving outcomes, helpstratified products and services. The UK, but cannot claim to be comprehensive physicians to select the most appropriate or an agreed consensus from all of the therapies, increase the cost-effectivenessinnovation platform is a consortium of represented groups. The current version of of health service provision and helpseven partner organisations all working the roadmap is a starting point. It will business to innovate more successfully.towards a common vision. The partners constantly evolve as new people This vision was developed over a series ofare Technology Strategy Board, Medical contribute to it, and better understanding workshops which explored what the UKResearch Council (MRC), Cancer Research is developed. Those interested in engaging landscape should look like in 2025. TheUK (CRUK), Arthritis Research UK (ARUK), further with the SMIP are encouraged to join key aspects of the vision are given in theDepartment of Health (DH), Scottish the special interest group on _Connect box below:Government Health Directorate (SGHD) ( National Institute for Health and -medicines-innovation-platform).Clinical Excellence (NICE). Each of thesepartners in the programme managementgroup serves a different constituency buteach has agreed to align activities towards A UK Vision for Stratified Medicinea common goal with benefits for all K The UK should be the best place to develop, and have adopted, stratifiedstakeholders. Together they will invest medicine. This will benefit patients, provide cost-effective solutions for the NHSaround £200m in stratified medicine. and other healthcare providers and create opportunities for business K There should be an increased collaborative culture throughout the sector basedAchieving the rapid development and around shared resources, and systems should be in place for effective datauptake of stratified medicine in the UK will collection, sharing, governance and use across sectors (including NHS,be a difficult and complex task. It needs all business, academia, regulators and NICE)components of the UK infrastructure towork together around a common plan and K It should be quicker and less expensive to develop new drug-diagnostic combinations and have them licensed, and success should be reflected intowards a common goal. The SMIP has increased UK economic growthstarted the process of building a sharedvision for stratified medicine in the UK K It should be possible for all NHS patients to be involved in medical research ifand a plan to achieve it. An early statement they wish, including through use of patient information and records, in order toof a UK vision was refined and validated inform the next generation of successful therapiesthrough widespread community K There should be a smooth reimbursement process for stratified therapies andengagement, including through workshops diagnostics, and an intellectual property (IP) framework that encourages innovationwhere more than a hundred people from K The UK health system should have established stratified care pathways, andmore than 70 organisations helped to evidence should be available to show that patient outcomes are improved whereshape and refine the vision and plan. stratified medicine is used Technology Strategy Board | 03
  4. 4. Stratified Medicine in the UKA Shared Roadmap The UK Stratified Medicine Roadmap The UK Stratified contains a panel for each of these themes.A technology roadmap identifies the Each panel describes how things arelong-term objectives in an area and seeks Medicine Roadmap: perceived to be now and articulates ato understand the possible routes to The Nine Themes vision of how they might be in 2025. Somesatisfy them. It can be used to guide the of the barriers to achieving this vision are 1. Incentivising adoptiondevelopment of new products, processes presented and activities that wouldor services, and to help shape the future 2. Increasing awareness accelerate the development of stratificationdirection of an emerging technology. are proposed. Some of the excellent work 3. Patient recruitment –Developing a roadmap has three major already in train is highlighted. Many topics consents and ethicsuses. It helps reach a consensus about a are closely interlinked and some occur inset of needs and identifies a range of 4. Clinical trials more than one panel: for a stratifiedpossible solutions to satisfy them; it medicine system to work effectively in theprovides a mechanism to help forecast the 5. Data – collection, UK, many of these issues will have to berequired deployment of those solutions; management and use progressed at the same time. Theand it provides a framework to help plan 6. Regulation and standards Stratified Medicine Innovation Platform onand coordinate technology and system its own will not be able to achievedevelopments. 7. Intellectual property everything that needs to be done, but anThe stratified medicine roadmap describes 8. Bio-banks and biomarkers attempt has been made to show what ourthematic areas which, if advanced own contributions might be. In order to 9. Increasing the impact save space in the following panels,successfully, will help accelerate the of R&D investment acronyms are used. These are detailed indevelopment and uptake of stratifiedmedicine in the UK. The themes were a glossary at the end of the document.identified at a series of workshopsattended by a broad stakeholdercommunity that included commercialcompanies developing therapeutics,diagnostics and data handling solutions;medical charities; and representativesfrom the healthcare sector includingclinicians from across a number oftherapeutic areas, pathologists,commissioners, managers andrepresentatives of public sector bodies.In addition, there were academicsrepresenting research in all of the maintopics around stratification of patients.The roadmap captures the range of viewsexpressed by this broad group ofstakeholders. It calls for activity in ninethematic areas.04 | Technology Strategy Board
  5. 5. 1. Incentivising adoption of SM in the NHS Barriers Reimbursement mechanism for SM related Dx tests not Budgets and processes in NHS not designed for A smooth integrated system: fair & beneficial to all always clear leading to unequal provision diagnostic/drug combinations stakeholdersCurrent Perceptions Slow test adoption - commissioning structure a barrier Only few clinical decisions based on genetic tests Equitable access to the right tests for the right patients at the right time Future State Infrastructure is not equally distributed and may be Uncertain markets for point of care testing vs. sub-scale in some locations centralised testing Infrastructure available to all with equal access to treatments Differing requirements for in-house tests compared to Dx companies can struggle to provide data for industry developed tests independent NICE assessment Tests reimbursed at a level that is cost effective and incentivises new development Current NHS genetics policy and services not Uncertain pathology capability in emerging techniques designed for large-scale testing Patient/public engagement and acceptance Aggressive national pathology cost savings may Pathology budgets stretched and not linked to care discourage adoption of new techniques Informed commissioning (quality, cost, turnaround etc) pathways No long-term strategic planning in NHS for SM services Slow adoption of tests without Rx company support Enablers Overall framework development by NICE diagnostics arm is an enabler for Human Genomics Strategy Group value assessment Enhancing NHS informatics capability National commissioning or funding for stratified medicine, both tests and Increasing evidence base leading to treatments more widespread clinical acceptance of the value of genetic tests Value assessment of Dx/Rx combinations to inform commissioning Minimally-invasive biomarker tests Examples of current UK activity Potential Role of SMIP NHS/DH initiative to improve cancer gene testing Help provide evidence to support policy development for HGSG review of commissioning, innovation and service delivery in all genetic medicine commissioning and procurement Ability to use Cancer Drug Fund to buy associated complex diagnostics Help supply chain to develop new business models Value-based pricing review of drug procurement in NHS Support health economic assessment of diagnostic testing to inform SMIP/CRUK SMP large-scale demonstrator programme in cancer NHS pricing Pathology modernisation Support CRUK SMP and other demonstrators by funding associated Nicholson Review of Innovation in the NHS technology development OLS Senior Industry Group addressing business-NHS engagement Interim support for innovative molecular diagnostics in adoption phase NIHR/NOCRI work to improve access for clinical trials Help represent businesses in NHS policy/commissioning development Trade Associations (ABPI, BIVDA, ABHI, etc.) work with NHS on new commissioning structures
  6. 6. 2. Increasing stakeholder awareness Barriers Evidence base not conclusive in all therapeutic areas Lack of public awareness of the complexity of Patients understand stratification and accept that gene-medicine interactions treatment access may depend on a complex test Some patients may see stratification as a methodCurrent Perceptions of rationing Lack of high-quality, clinically approved, education Stratification tests included in education materials material for patients and practitioners around patient care pathway Future State Variable knowledge of how to apply a test in clinical practice Pace of change of evidence base Appropriate testing for multiple biomarkers incorporated in clinical care pathway Emerging models for clinical decision support do The difficulty of integrating clinical imaging and not always convince clinicians laboratory data Test usage inconsistent across providers Enablers More awareness among front line staff of clinical utility and benefits Development of tests for use at point of prescription (pharmacy/GP) or patients able to test themselves Agreement and sharing of genetic medicine health economic analyses Centralised communication resource to suit a range of health professionals Tools for physicians to provide clear interpretation of complex test results Better engagement with patient support groups in disease specific areas Physician-driven development of education materials for healthcare professionals involved in genetic medicine Patient access to global communication channels Examples of current UK activity Potential Role of SMIP Education working group of the HGSG Develop decision-making tools for physicians Various bodies already developing guidance materials Develop communication resource for education of health professionals Appointment of NHS Chair in Pharmacogenetics Involve patient support groups and Royal Colleges in SMIP CRUK large-scale demonstrator in cancer programme development Accelerate and communicate programmes that demonstrate validity of approach Help extend approach into other therapeutic areas
  7. 7. 3. Patient recruitment (consents & ethics) Barriers Identifying and recruiting appropriate patient cohorts Data held in a range of databases and formats across A streamlined process for trials consent and patient can be time-consuming healthcare providers recruitment, and trials are safeCurrent Perceptions R&D approval process can be complex and time- Data quality may be low in data that has not been Consent for broad and unspecified future use, consuming monitored and audited supported by appropriate regulation of personal data Future State When patient consents are study or site-specific, data Inconsistent processes and standards for research Single, and internationally valid, consent and ethics cannot be used for other purposes consents approval Sometimes local ethics and R&D approval process can Privacy concerns around data storage and use Primary care has important role in patient recruitment inhibit larger national studies Excessive caution from some (unrepresentative) Use of data and samples for research based on Problems with national programme for IT has held back minority pressure groups ‘opt-out’ rather than ‘opt-in’ novel data solutions Enablers Structure of NHS gives unique opportunity to deliver standardised research consent Implementation of Academy of Medical Sciences recommendations on streamlining research regulation Novel IT solutions for capturing, communicating, storing and analysing data Connection of ethics committee with patient groups, starting with current disease Public engagement about use of samples and genetic data for research areas of focus like cancer Development of an overarching ethical framework Policy communication, IT enablement & governance. Cost of storing massive data sets decreasing Education and public awareness campaign demonstrating wider benefits to the Patient groups support non-restrictive consents and effective R&D approvals community of participation in research Development and widespread use of generic consent forms Collaboration in clinical trials recognised in clinician performance assessment Examples of current UK activity Potential Role of SMIP Academy of Medical Science report and recommendations Engage with patient groups on programme development and benefits of consent Leading hospitals already running generic consent for all patient samples Support Government implementation of AMS recommendations HGSG working on this area Consulting with stakeholders on routine/generic consent Plan for Growth actions on research approvals and recruitment to studies NIHR Translational Research Partnerships process for research consent in inflammatory disease Various data access and sharing initiatives (Generation Scotland, Cancer Registries, General Practice Research Database) Improved national and international data standards are enabling data sharing
  8. 8. 4. Clinical Trials Barriers Localisation of commissioning and independence of Uncertain impact of localisation agenda in healthcare Reduced time and cost to conduct clinical trials providers leads to varied and complex implementation and changes in commissioning Reduced time to start complex genetic researchCurrent Perceptions of national clinical trials Relative higher prices for trial activities in UK versus projects NIHR involve patients group BRIC countries Future State Reduced cost to recruit the appropriate subjects to Networks such as NCRI encourage and enable enable stratified medicine national trials All patients are able to participate in clinical Delays before patient recruitment starts is often the trials/population-based genomic research time-limiting step in studies Centralised solutions to access rare genetic types AMS report describes the situation well (e.g. web-based platform) Exclusion of inappropriate patient populations on grounds of safety genotypes Selection of appropriate patients for efficacy testing Enablers AMS report and recommendations Develop robust online (internet) recruitment National initiatives to improve trials environment (CRUK, NOCRI, etc) Develop standards within NHS for provision of patients into clinical trials Public increasing their levels of participation in research Better connection of infrastructure including IT systems and Biobanks Faster ethics approval based on patient choice and critical health ‘need’ Examples of current UK activity Potential Role of SMIP NIHR Clinical Research Networks, including cancer, could help in stratified medicine Similar to role in patient recruitment NOCRI helping industry engagement with NIHR trials infrastructure Help create critical mass to accelerate trials process NIHR common frameworks and guidelines to reduce patient recruitment times Communicate unmet needs (prioritisation) Demonstration of a consistent database of patient accessible records. Develop web-based recruitment tools
  9. 9. 5. Data Barriers Routine data collection and quality variable across the Morale issues following NPfIT failure Population-wide consented patient data available for UK, better in Scotland analysis by researchers Most data has not been consented for accessCurrent Perceptions NHS Information Centre as central repository and Routine use of anonymised patient data sets by NHS & Default position is to not make anonymised data access point for data but currently not meeting industry to improve patient outcomes Future State available for research researcher requirements Increased use of routine data in post-marketing Bespoke systems do not or cannot communicate Government data transparency drive (opengov) surveillance without significant investment No national programme for IT Routine collection of health economic data around SM Data protection issues seen as a barrier within trusts Range of IT systems in use Enablers Massive data sets Implement IT practices and routine generic consent for use of appropriately anonymised clinical data for research Public support for research between institutions IT capabilities improving Large-scale demonstrator programmes (regional or Encourage more open working between academia, therapeutic-area focused) NHS & industry Simplification of data protection rules around patient data Cultural/policy encouragement to share data Build in and embed quality systems into NHS data handling Examples of current UK activity Potential Role of SMIP Generation Scotland Develop tools to allow secure data mining of patient data across distributed data sources Individual routine consents Demonstrate that access to data repository by NHS & industry will CRUK/Eastern Cancer Registry partnership & SMIP investment in data handling improve patient outcomes and/or make UK a much better place to Ongoing improvements to cancer registries do research Establishment of Patient Reported Outcome Measures (PROMS) by Dept Health in England
  10. 10. 6. Regulatory Framework and Development Pathway Barriers It can cost over $800m to take a safe and Lack of smart and adaptive study designs Novel design of clinical trials makes smaller cohorts of effective drug to market, and take 7-9 years from patients possible Lack of a single body controlling quality ofCurrent Perceptions first in-man trials diagnostic labs Coordinated regulation of pharmaceuticals industry New drugs sometimes only marginally better than (Rx) and diagnostic industry (Dx) Future State Need for regulatory guidance development for standard care but more expensive drug-diagnostic combinations Companies make more progress within existing Different degrees of regulation for pharmaceuticals, regulatory framework diagnostic tests and laboratories/hospitals Enablers Regulatory guidance for co-development Facilitate co-development of drugs and of diagnostics and treatment diagnostics by alignment of the regulatory processes DH and BIS encouraging EU Commission to improve regulatory framework Setting up of an expert committee (akin to the Committee for Advanced Therapies set up by the ATMP Regulation) Examples of current UK activity Potential Role of SMIP EU Commission on the revision of the IVD directive Help in novel clinical study design NHS QIPP agenda includes work on quality and standards Encourage discussion with regulatory agencies
  11. 11. 7. Intellectual Property Barriers Laboratory-developed tests using unlicensed IP in NHS Questions around effective regulation of laboratory- IP with enhanced licensing for NHS use acts as a driver discourages development of new diagnostic tests by developed tests of ‘step change’ innovationCurrent Perceptions industry No single approach to NHS licensing of test technology Publicly funded labs are free to develop safe Laboratory-developed tests can sometimes save the and effective tests that do not infringe on other Future State Patent thickets – multiple IP on sequence reduces NHS money IP rights-holders economic attractiveness of panel testing Some NHS laboratory-developed tests are being Competition between commercial and laboratory- technically and clinically validated and externally quality developed tests benefits patients assured Current IP for gene sequences (BRCA/Myriad etc) subject to legal challenge Enablers Patent box tax incentive Develop IP protection on the test, not the underlying gene sequence Excellent technology platform & biomarker science base Provide a strong home market (NHS) with value based pricing (product & service) and willingness Business models for developing & exploiting new to adopt new tests & existing IP that provides fair return on investment whilst maintaining reasonable end A stronger domestic industry with global outlook, user cost able to capitalise on excellent science base Examples of current UK activity Potential Role of SMIP EU In-Vitro Diagnostic consultation in process Provide support for diagnostic companies and co-development OECD guidelines for licensing genetic inventions Support SMEs in early IP filing HGC recommendations on IP and DNA diagnostics Commission health economics studies Support development of new business models and pricing mechanisms
  12. 12. 8. Bio-Banks and Early Biomarker Detection Barriers No central overarching database of biomarkers or Localised clinical and research databases are hard to UK-wide database of biobanks is used for biosignatures use for national level research stratification studiesCurrent Perceptions Many biosamples not clinically annotated Lack of technology platforms for use in clinical biomarker All tissue collected with consent for broad clinical research research and data capture Future State Limited standardisation of tissue collection or consent Require policy framework for biomarker validation Routine, effective collaboration on biomarker ID Not everyone sees the value of centralised biobanks Many biomarkers do not have associated therapies A range of early biomarkers identified for future Stand-alone, incompatible tissue and data validation infrastructures Coordination for Biomarker research via mandated UK Biobank has recruited 0.5m people central database In silico trials to ID biomarker Enablers Accreditation system for biobanks Improved biomarker discovery and validation through new approaches Improve coordination of funding for biobanks Linking of databases and biobanks Standardisation of procedures, including sample handling storage and consent process Improving IT to enable metadata approach across multiple systems Ensuring biobanks store comprehensive clinical data Increase in pharma collaboration and pre-competitive Broad & enduring consent or implement opt-out activity rather than opt-in for data analysis in research Examples of current UK activity Potential Role of SMIP UK Biobank programme standardising access procedures Help develop standards for biobanks Generation Scotland Map existing UK databases and biobanks Routine generic consent at sample-acquisition in major teaching hospitals Support development of sample handling & preservation technologies NIHR/NOCRI Translational Research Partnerships Support development of biosignature analysis and data storage techniques Encourage widespread adoption of best practice Help connect existing infrastructure to create critical mass Enable access to infrastructure to accelerate development of new tests and therapies
  13. 13. 9. Increasing and Leveraging UK R&D investment Barriers Developing new drugs has becoming increasingly Different parts of the system have different objectives Taking drugs from discovery phase to expensive commercialisation is faster and cheaper, enhancing Bridging the gap between research and commercialCurrent Perceptions business performance and encouraging investment Pharmaceutical businesses are re-evaluating their R&D exploitation investments Stratified medicine offers improved value for money for Future State The RAE/REF do not incentivise academics to help customers including NHS Turbulence in financial markets has impacted commercialisation availability of equity and debt finance Improved co-ordination of public and private funding The sector is extremely large and complex, so major Public sector funders have not always aligned their change is non-trivial activities University funding is changing NHS needs to save money Enablers Creating a coordinated UK programme Better coordinated UK and EU funding streams Incentivise stakeholders to share pre-competitive data Understand the value of cooperative investment Stakeholder support for SM Taking an international perspective Full audit of UK capabilities /IT, biomarkers, Dx, Rx, clinical etc Examples of current UK activity Potential Role of SMIP ABPI work in this area Commission health economic studies OSCHR work in this area Help develop new business models for stratified medicine Nicholson Review of innovation in the NHS Ensure coordination of partner activities NorthWest exemplar Help create critical mass through a UK-wide programme Stratified Medicine Innovation Platform investments to date Engage in international programmes
  14. 14. Stratified Medicine in the UKStratified Medicine The SMIP programme management group would greatly welcome input from otherInnovation Platform players. The Medicines and HealthcarePartners products Regulatory Agency (MHRA) and the National Institute for Health ResearchThe innovation platform seeks to make the (NIHR)/ NIHR Office for Clinical ResearchUK the best place to develop, and have Infrastructure (NOCRI) have alreadyadopted, stratified medicine products and started working closely with the innovationservices. This is an extremely ambitious platform, and it is hoped that others wouldvision that will require activities across also like to participate. There will be areasmultiple technology areas, policy streams where others are better placed to lead,and government departments. Each of the and we can support their programmes.Stratified Medicine Innovation Platformpartners has a specific remit and cancontribute significant resources andexpertise from their core areas of How to engage with uscapability. Together, the group covers a For the UK to achieve the vision set out inbroad spectrum of interests. By aligning this document, significant advancementsactivities, many of the issues described in technology and changes to systemsabove can be progressed. and processes will be required. This cannot be achieved by any singleThe Technology Strategy Board aims to organisation and will entail coordinatedhelp businesses to develop innovative new activity across the entire healthcare sector.products and services, while the Medical This UK Stratified Medicine Vision andResearch Council funds outstanding Roadmap can form the focal point forresearch in the science base and has a companies, public sector bodies andmajor initiative in stratified medicine. government to coordinate their efforts.Cancer Research UK is the world’s leading The innovation platform partners havecancer charity dedicated to saving lives begun this coordinated activity and wouldthrough research, and Arthritis Research welcome help and advice from othersUK has an interest in achieving better whose actions could help accelerate theoutcomes for patients in its disease area: journey towards the ultimate goal.both have stratified medicine at the centre A web-based community has beenof their strategies. The Department for created to encourage engagementHealth and Scottish Government Health ( are government departments -medicines-innovation-platform).whose main role is to improve health and This will be supported by the innovationachieve better health, better care, and platform and will highlight futurebetter value for all. The National Institute workshops, funding calls and ongoingfor Health and Clinical Excellence is discussions on specific stratified-tasked with assessing medical medicine-related topics. We would alsointerventions, both therapies and encourage others to use this forum to sharediagnostics, and recommending their use information, raise awareness, identifybased on value calculations. partners and generate yet more momentum.014 | Technology Strategy Board
  15. 15. Vision and RoadmapGlossaryABHI Association of British Healthcare IndustriesABPI Association of British Pharmaceutical IndustryAMS Academy of Medical SciencesATMP Advanced Therapy Medicinal ProductsBIS UK Department for Business, Innovation & SkillsBIVDA British In-vitro Diagnostic AssociationBRIC Brazil, Russia, India and ChinaCRUK Cancer Research UKCRUK SMP Cancer Research UK Stratified Medicine ProgrammeDH Department of HealthDx diagnosticHGC Human Genetics CommissionHGSG Human Genome Strategy GroupIP intellectual propertyIT information technologyIVD in-vitro diagnosticNCRI National Cancer Research InstituteNHS National Health ServiceNICE National Institute for Health and Clinical ExcellenceNIHR National Institute for Health ResearchNOCRI NIHR Office for Clinical Research InfrastructureNPfIT National Programme for ITOECD Organisation for Economic Co-operation and DevelopmentOLS Office of Life SciencesOSCHR Office for Strategic Co-ordination of Health ResearchPROMs patient reported outcome measuresQIPP quality, innovation, productivity and preventionR&D research and developmentRAE/REF Research Assessment Exercise/Research Excellence FrameworkRx therapeuticSM stratified medicineSMIP Stratified Medicine Innovation Platform Technology Strategy Board | 015
  16. 16. Stratified Medicine in the UK Technology Strategy Board North Star House North Star Avenue Swindon SN2 1UE Telephone: 01793 442700 © Technology Strategy Board October 2011 T11/065016 | Technology Strategy Board