Stratified Medicine –Opportunities for Business 24th January 2013
Session 1 – Setting the Scene 09:40 Welcome Address – Toby Reid, BioCity Nottingham 09:50 National Vision for Stratified Medicine – Dr Alasdair Gaw, Technology Strategy Board 10:10 Keynote Speech – Colin Callow, NHS National Innovation Centre 10:30 Leicester Diagnostic Development Unit – Professor Tim Coats
Regional StrengthsMedical Technology Companies Drug Delivery ›50% of all companies Reproduced from HM Government’s Strength & Opportunity Report 2011
Regional Strengths Life science research power Research Power = University Research Strength + Level of Start Up Activity 77% concentrated in 4 regionsReproduced from BioCity’s UK Life Science Start-Up Report 2010
Nottingham Science Sector1 in 5 jobs in a science-related sector20% growth in life sciences sector between2000-2010Currently 15% of people employed inNottingham work in health related careersSector is forecast to continue to grow in linewith national trends up to 2026
BioCity – Introduction129,000 sq ft of office and laboratory space3 buildings
BioCity – Story so Far2002 – Site donated to NTU2003 – Opened Innovation Centre2006 – Opened Stuart Adams Building2008 – Opened Laurus Building2012 – Opened BioCity Scotland
BioCity – Story so Far Growth in Occupancy (sq ft) 120,000 100,000 80,000 60,000 40,000 20,000 ‐ 2003 2004 2005 2006 2007 2008 2009 2010 2011
BioCity – Story so Far Start-up population based in UK bioincubators 18 16 14 12 10 8 6 4 2 0 2005‐2009 2006‐2010
BioCity – Business Model Existing Companies +££’s AccommodationGrowth Companies Rental Income +££’s Access to Finance Other Services Financial +££’s Additional Income Investment-££’s +££’s Business Support Time/Resource -££’s Investment New Companies
Companies at BioCity3 Types of CompanyBusiness support• PR, Bookkeeping, Regulatory Affairs, Patent AttorneysScience as a service• Contract Research OrganisationsIP developers• One or series of products on patented IP
BioCity – NowLargest Bio-Incubator in UK – interactive community70 companies employing 500 people£35m of external venture capitalMobius Life Sciences FundAuthor of UK Life Science Start Up Report
Nottingham Creative Quarter Nottingham’s City Deal: £10m Nottingham Technology Grant Fund £40m Venture Capital Fund £1m Accelerator programme £1m Creative Quarter Loan Fund
BioCity Focus - 2013Sustaining the environment for business successImproving the environment for business conceptionFocus is often on investment readinessStart-up readiness and increased birth rate- The reality is that we have a low rate of IP based start ups compared to the number of patent applications16 Footer Title
Constituent Parts Business StagesHospitals/NHS- clinicians, practitioners Investors - Access to finance 1. Generating IdeasUniversities/Space IDEAS- technologies, expertise Incubators 2. Commericalising + - Environment for business launchingBusiness Schools- entrepreneurial talent Business Support 3. Executing + Scaling - Dedicated programmesLarge Corporates - Experienced management- customer, funder, exit 17 Footer Title
Challenge How do we pull it all together to help generate more, better formed business opportunities and create a local environment in which they are more likely to be successful?
National Vision for Stratified Medicine Dr Alasdair Gaw Technology Strategy Board
Stratified Medicine Innovation Platform Imaging as an enabling technology Dr Alasdair Gaw Lead Specialist www.innovateuk.org
The Technology Strategy BoardThe UK Innovation Agency•Promoting technology-enabled innovation for • Business benefit, economic growth, and quality of lifeInvestment Criteria• Does the UK have the capability?• Is there a large market opportunity?• Is the idea ready?• Can the Technology Strategy Board make a difference?
Priority ThemesSustainability Built Food Transport Healthcare Energy Environment DevelopmentHigh Value ManufacturingDigital Services Electronics, Advanced Photonics and ICT Biosciences Materials Electrical Systems
http://www.innovateuk.org/COMPETITIONS _CONNECT SBRITechnology Strategy Share knowledge through Develop innovativeBoard funding KTNs and other networks products to meetcompetitions government needsCATAPULTS KTP SMARTA network of world-leading Partner with academics to (Grant for R&D)technology and innovation develop new business Innovation funding for SMEscentres capability
SMART: Grant for R&DProof of Market Proof of Concept Prototype DevelopmentThis grant enables companies to A grant to explore the technical This funding is used byassess commercial viability, feasibility and commercial companies to develop athrough: potential of a new technology, technologically innovative• market research market testing product or process: product, service or industrial and competitor analysis • initial feasibility studies process:• intellectual property position • basic prototyping • small demonstrators• initial planning to take the project • Specialist testing and/or • intellectual property protection to commercialisation, including demonstration to provide basic • trials and testing, including clinical assessing costs, timescales and proof of technical feasibility • market testing funding requirements. • intellectual property protection • marketing strategies • investigation of production and • identifying routes to market assembly options. • product design work It also includes pre-clinical research • phase 0 pre-clinical studies for studies for healthcare technologies medicines. and medicines, including target identification and validation.Duration – up to 9 months Duration – up to 18 months Duration – up to 2 yearsMaximum grant – £25k Maximum grant – up to £100k Maximum grant – £250kFunding proportion – up to 60% Funding proportion – up to 60% of Funding proportion – up to 35%of total project costs total project costs of total project costs for medium enterprises; up to 45% for small and micro enterprises
UK Capabilities• Very strong in Commercial Life Sciences – In vitro diagnostics • -200 companies 4000 FTE, £1.1billion – Pharma /Biotech • >42billion pa, 67,000 FTE 20% of top 100 drug – 4% of GDP• Very strong Medicine & Life Science base – 2 of top 3 in World rankings • 20% of all medical science publications from UK – 20 world leading institutes in disease • Cancer, Respiratory & Inflammatory disease, Diabetes, Neurological disease, Cardiovascular – 37 Nobel Laureates in medicine physiology and chemistry – £10 billion investment 2009
The Changing Face of R&D• Precompetitive Public-Private Partnerships & Open innovation platforms – Shared costs, establish widely acknowledged standards, Provide adequate weight of evidence, faster achievement – Understanding Core Disease• Biomarker specific benefits – (Inter) National consensus on the means to identify disease manifestations in subsets of patients – Qualified biomarkers and patient-centered outcomes for patient stratification and assessment of efficacy • Cross industry and academic acceptance • Improved clinical studies, rigorous methods, • More effective data packages for Regulatory Bodies – Makes Stratified Medicine a reality
Stratified Medicine• Choice of effective therapy dependent on either – A companion diagnostic test – A clearly identified group of patients defined by • in vitro diagnostics • Biomarkers • Defined algorithms • Clinical responses • Clinical Imaging/non-invasive detection – A molecular level understanding of the disease – Availability of both tests and drugs to clinicians Right Treatment, Right Patient, Right Amount, Right Time Optimal Benefit
Stratified Medicine Innovation Platform• Launched October 2010• Accelerate Development and Uptake of Stratified Medicine – Improve Patient Outcomes – Provide Cost Benefit to the NHS and The Healthcare Industry – Deliver wider UK economic benefit• Key Partners – Department of Health, Scottish Government Health Directorate – NICE, Medical Research Council, Technology Strategy Board – Arthritis Research UK, Cancer Research UK• Consultation and Advice – MHRA, NIHR• The combined 5 year Investment amounts to £200 Million Putting UK healthcare at the heart of a revolution in the diagnosis and treatment of disease
SMIP supporting the UK economy• Pharma attracted to and remains in the UK – Growth of the industry – UK leads in drug discovery and development• Med Tech companies remain and grow in the UK• Smaller Biotechnology companies strengthened• International sales of tools for stratification (diagnostic systems, endoscopes, tests, medical devices etc)• Clinical trials carried out in the UK benefits: – Contract research organisations – The NHS and patients• A fertile ground for innovation across multiple sectors The potential Global Sum of the UK parts is considerably greater than the parts Life Science = £1billion inward investment in 2012
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 investmenthttps://ktn.innovateuk.org/web/stratified-medicines-innovation-platform
Stratified Medicine Innovation Platform• £50 Million TSB (£200Million partners)• Round One £9.5 million: – Development Business Models • Biobanks, Companion Diagnostics – Inflammatory Biomarkers • Rheumatoid arthritis, Osteoarthritis, COPD – Tumour Profiling • Oncology multi screen assays• Round Two: £6.5million TSB +£1Million DH – Adverse Effects and Non responders • Patient trials for regulatory acceptance
SMIP Round Three: £7.5m TSB + co-funding Advancing in-vivo imaging as an enabling technology Scoping workshops Clinical customer focused workshop - 15 Nov 2012 Provider orientated workshop - 11 Dec 2012 Plan: • Briefing documents published and competition opens March 2013 • Events at Innovate and NHS Expo March 2013PHOTONICS COMPETITION: Anticipated for imaging in healthcare 2013
Keynote Speech Colin CallowNHS National Innovation Centre
Supporting the developmentof pioneering healthcare innovation
InnovationThe intentional introduction and applicationwithin a role, group, or organization, of ideas,processes, products or procedures, new to the relevant unit of adoption, designed tosignificantly benefit the individual, the group, or wider society [West, 1990]
“For the foreseeable future NHS must meetincreasing demands within ever constrainedresources and at the same time continuously improve quality”.
Unprecedented Healthcare Demands a growing population with an extending lifespan an increase in its own capability, fuelled by advances in knowledge, science and technology ever-increasing expectations from the public it serves.
Current NHS Health & Social Care System• Services struggling to keep pace with demographic pressures, the changing disease burden, rising expectations.• Too much care is still provided in hospitals & care homes, and treatment services continue receive higher priority than prevention.• The traditional dividing lines between GPs and hospital- based specialists and services mean that care is often fragmented and integrated care is the exception rather than the rule.• Society and technologies are evolving rapidly & changing the way patients want to interact with service providers. Current models of care appear to be outdated• Care still relies too heavily on expensive individual professional expertise despite patients and users desires to play a much more active role in their care and treatment
Current health and social care delivery system• Failing to keep pace with the populations needs and expectations.• Incremental changes to existing models of care will not be sufficient in addressing these major challenges• A much bolder approach is needed to bring about innovative models that are appropriate to the needs of the population that are : – high quality, – sustainable – offer value for money.
Policy Implications• Simply doing more of what has always done is no longer an option.• the need to do things differently by radically transform the delivery of services.• Innovation is now considered the way – the only way – to meet these challenges.• Innovation must become core business for the NHS.
Translating Policy into ActionNHS leaders need to take a strategic viewrather than focusing on short-term fixesdesigned to preserve existing services.IHW is a policy initiative that will : – decommission outdated models of care; – support NHS organisations to innovate and adopt established best practices; – recognise the potential of new providers as an important source of innovation; – develop a culture that values peer support for learning and innovation; – encourage development of infrastructure at the local level to develop & support innovation and new models of care.
Innovation in the NHS• NHS recognised as a world leader at invention• Spread of those inventions has been slow , with even the best of them failing to achieve widespread use• Increasing recognition that innovation has a vital role to play
Why is it currently difficult to innovate in the NHS ?•Diffusion of new ideas inlarge, disaggregatedorganisations like theNHS remains difficult•Urgent need tosystematically identifyand overcome barriersand develop and spreadthe very best ideas
Factors affecting the diffusion of innovation• How well it fits into the culture or operational style of a health organisation or practices,• How it affects workflow and work processes,• What other technologies or services will it displace or change,• How easy it is to implement /maintain/sustain,• What the mechanism for reimbursement?
Realising the benefits from innovative solutions • Change gurus and researchers tell us that up to 75% of change initiatives fail to achieve their objectives • Our leaders tackle many change priorities simultaneously in different ways • Every leader has a different set of experiences and ideas about critical success factors • NHS often fails to identify and make best use of available resources, skills and knowledge to support a systematic www.changemodel.nhs.uk approach to implementation
Recipes for success ?4 common denominations that determine outcomes :• Performance integrity• Duration• Commitment – Leadership / Participants• Effort – the 10% ruleHarold Sirkin et al , HBR, 1000 global case studies
Effort• There is an NHS tendency to launch major innovation and improvement initiatives without taking account of the extra responsibilities for innovation projects on top of busy operational jobs.• If anyone’s workload increases >10% as a result of the initiative, it is likely to run into problems.• Organisations need to calculate the extra time and effort required to execute the change and create the space for it to happen
Commitment• There must be active, visible backing for the change from the most influential senior leaders• In addition, the innovation is unlikely to succeed if it is not enthusiastically supported by the people working within the new structures and systems that it creates.• Staff need to understand the reasons for change and believe it is worthwhile
Duration• Common belief that NHS innovation projects need to execute change quickly.• What really matters is having formal, senior management-led, review processes.• A long innovation project, reviewed frequently and effectively is more likely to succeed
Performance Integrity• Selecting the right mix of team members to deliver the change• Selecting the most results-orientated people with credibility and influence and effective change skills.
Adopting the right mindset whenmeasuring the impact of innovationWhat mindset doyou bring aboutperformancemeasurement? Reference: L Solberg, G Mosser and S McDonald (1997) The Three Faces of Performance Measurement: Improvement, Accountability and Research, Journal on Quality Improvement, 23 (3): 135 - 147.
Performance Integrity – Impact MeasurementRenewed interest in effective measurement and evaluation : – The challenge is the nature and accuracy of its development – Process often seems confusing with a plethora of models, formulas and statistics – Misunderstanding of the evaluation process and misuse by some organisations
Performance Integrity – Demonstrating valueA more formal, consistent and rigorous approach tothe planning, measuring and reporting impact• Formal review and validation of assumptions• Prospective analysis using appropriate data agreed in advance by front line clinicians managers and commissioners• Greater clarity about aims and objectives• Greater clarity with regards to the perspective from which any evaluation is assessing
Framing the innovation case How to convince the Chief Executive to support an innovative solution? Clinical Case Financial Case Management Case Unmet need Your assumptions Articulate the problem and Benefiting Population Baseline comparison proposed solutionCurrent Clinical Practice No of patients Impact on operations Expected Outcomes affected/benefit Relevant impact indicators Business Model Impact on pathways andProposed Clinical Practice Baseline costs services Evidence base Savings forecast Barriers to adoption Clinical Champion ROI/BCR Key risks
The Clinical CaseThe intention of the clinical case should be to present the:• Innovative solution and the core claims in relation to intended clinical benefits• target patient population that will benefit• the current clinical practice that will be impacted by the innovation• the proposed clinical practice and outcomes
The Financial Case• Explanatory notes and assumptions underpinning the savings forecast• The impact of the innovation against a baseline that truly represents current practice• No. of patients whose care would be affected and the number that would benefit• Baseline costs that drive the current clinical practice (e.g. staff costs, procedure specific costs, etc)• Savings forecast, at the level of the NHS
The Management Case• Description of the problem and the solution aligned to strategic priorities• Overview of the clinical and financial benefits taken from the Clinical and Financial Case• Key impacts on care pathways, staff, training, decommissioning, facilities, other departments and other services• Key impacts resulting from adoption , e.g. shifting care from one staff group to another, or from one organisation to another• Key risks to the realisation of the claimed benefits
Drivers for Successful Innovation Adoption Common language and success metrics Urgency and pressure for innovation and change Appropriate / compensating rewards Organisational cultures supportive of experimentation and new ideas Capacity and capability to promote and lead innovation and change Effective validation data Effective risk management
Leicester Diagnostic Development Unit Professor Tim Coats Leicester Royal Infirmary
Leicester Diagnostics Development Unit Tim Coats Professor of Emergency Medicine University of Leicester , UK email@example.com
Emergency Medicine Risk Stratification Bayesian Decision Making Threshold for action depends on balance of risk Two people experience risk: - The patient - The doctor Depends on having biomarkers
DDU Concept Could novel detection methods identify new biomarkers for risk stratification? Technology transfer from space science and atmospheric chemistry Collaboration: - Cardiovascular Sciences / EMAG - Space Science - Atmospheric Chemistry Industry - Intelligent Fingerprinting – TSB funded
Facility Take the technology out of the lab to the patient Create a unique facility which allows the study of critically ill emergency patients Bridge the ‘valley of death’ of technology development Bring experience of clinical efficacy testing to device development
Equipment• IR Imager: temperature distribution• Hyperspectral imager (2nm resolution): spectral features• Context Colour Imager• Mass Spectrometer: Breath Analysis• Nitric Oxide Analyser: Breath Analysis• Respiratory Function Cardiovascular State via:• Thoracic Impedance Monitor• Supra-sternal doppler• Deep tissue oxygenation• Transcutaneous oximetry
Current Status Equipment integrated and running Database design completed Data automation complete Initial study underway (40 of 505 patients) Initial cardiovascular data from Infection and Breathlessness
Staff Coats / Sims / Monks PhD students x3 (2 from chemistry, one from physics) Research Nurse / CRO 3.0 WTE (CLRN funded) BSc student Technician
Development pathway for a Biomarker within the Leicester DDU
Stratification Sepsis patients after resuscitation – by conventional measurements all look the same, and have a 20% in- hospital mortality. Using deep tissue oxygenation by Near Infra-Red Spectroscopy – if <70% there is a 2/3 chance of death. Next stage – we can stratify according to risk, but does intervention in the high risk group make a difference to outcome?
Summary Emergency care is risk stratification Good emergency physicians are good Bayesian thinkers New biomarkers are required Leicester DDU gives a unique conjunction of emergency care and technology
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