Validating the Collective Picture - Jonathan Minko, Cambridge Consultants (Digital Health Summit @ CES 2017)
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Biomarkers are clues to diseases–their presence and progression. Can today’s consumer devices and plethora of other data sources yield a new wave of digital biomarkers to deliver more accurate understanding of disease progression and therapy response? This talk will take a deeper look at how healthcare systems can benefit from a complete understanding of individuals, and how personalized medicine can be delivered not just via genomic analysis but also by weaving in lifestyle data.
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Validating the Collective Picture - Jonathan Minko, Cambridge Consultants (Digital Health Summit @ CES 2017)
- 1. 4 January 2017 CES2017-P-002 v0.9 Commercially ConfidentialDigital Health Summit Jonathan Minko
- 2. 4 January 2017 CES2017-P-002 v0.92Commercially Confidential At Cambridge Consultants, we help innovative companies develop products and systems across industries.
- 3. 4 January 2017 CES2017-P-002 v0.93Commercially Confidential What are Biomarkers?
- 4. 4 January 2017 CES2017-P-002 v0.94Commercially Confidential Digital Biomarkers There is a plethora of lifestyle data that are likely to inform and manage health state.
- 5. 4 January 2017 CES2017-P-002 v0.95Commercially Confidential Data is accumulated from personal devices constantly & everywhere. Information can be extracted from data to build intelligence.
- 6. 4 January 2017 CES2017-P-002 v0.96Commercially Confidential $263 million invested in 2016in wearable and bio-sensing digital health ventures.
- 7. 4 January 2017 CES2017-P-002 v0.97Commercially Confidential shorten drug trials Improve clinical trials. Using digital markers may enable us to: lower recruitment better quantitative end points
- 8. 4 January 2017 CES2017-P-002 v0.98Commercially Confidential CVForBiomarkers rare event detection or exploratory use candidate for validation & inclusion in panels reliability or intended use lacking for validation lower weighted in panels fit for purpose studies Biomarker Weighting Level of FDA Controls
- 9. 4 January 2017 CES2017-P-002 v0.99Commercially Confidential
- 10. 4 January 2017 CES2017-P-002 v0.910Commercially Confidential Paths to market: Launch with a Minimum Viable Product (MVP), start gathering data Build brand awareness and improve patient engagement Work towards a more robust solution that can give the required claims for longer term Provide services as a gateway to clinical validated digital biomarkers
- 11. 4 January 2017 CES2017-P-002 v0.911Commercially Confidential Provide value from data. Data Feed Value provide information nudge behavior Descriptive Analytics (What happened?) Diagnostic Analytics (Why did it happen?) Predictive Analytics (What will happen?) Prescriptive Analytics (How can we make it happen?) From hindsight to insight to foresight.
- 12. 4 January 2017 CES2017-P-002 v0.912Commercially Confidential Alternative business model Through tracking and improving outcome. *CMS expects 50% of all payments to be via alternative models by 2018 consumer healthcare applications care networks virtual care services medical device manufactures *
- 13. 4 January 2017 CES2017-P-002 v0.913Commercially Confidential Think Partnership.
- 14. 4 January 2017 CES2017-P-002 v0.914Commercially Confidential Hitting the sweet spot. science, technology & systems Requirements for deploying a successful, viable biomarker solution. market proposition business model
- 15. 4 January 2017 CES2017-P-002 v0.915Commercially Confidential
- 16. 4 January 2017 CES2017-P-002 v0.916Commercially Confidential NEW DELHI TOKYO SINGAPORE CAMBRIDGE BOSTON >700 engineers, scientists, designers and consultants developing breakthrough technologies SEATTLE SAN FRANCISCO
Notes de l'éditeur
- Background / Viewpoint Experience and Cambridge Consultants
- Defining Traditional Biomarkers and Background Traditional biomarkers – A naturally occurring molecule or gene - Indicator of a physiological condition, disease, etc. Presence of certain antibodies correlated to an infection or certain proteins indicate tumors Measured often to indicate therapeutic response of a drug or treatment Today – there are several validated and accepted biomarkers for which people test regularly during clinical trials as well as for treatment – these most often require blood tests and careful analysis in the lab. What if there was another simpler indicator? That could provide early signs, signs of progression? Without requiring a trip to a clinic or a visit to your PCP.
- Digital Biomarkers Explained There is!! With the advent of consumer technology – quantified self movement – there is a plethora of lifestyle data available or easily acquirable - and that data is likely to correlate with disease. Ability to use that data to inform disease state and manage it – has coined the phrase digital biomarkers. A riff on the original biomarkers which of course involve chemistry. Digital biomarkers are personally generated physiological and behavioural measures collected through digital tools.
- Where is the data now? Data is starting to accumulate.
- Corporations are Investing
- What are the benefits of adding digital biomarkers to traditional bio marker use Use digital markers instead of traditional ones – may enable one to shorten drug trials, lower recruitment, allow for better quantitative end points Validation and regulatory approval is required before this becomes common practice – but data collection and trials are already under way e.g. Biogen in MS This will become mainstream in a few years time, but we are not going to focus on this one today… but rather the second application – more broadly applicable
- Tiers of Biomarkers and the Quantity of Data (Finish Diagram and possibly combine with previous slide to trim slide count?) Using similar qualifications for classic biomarkers, the digital biomarkers should be Fit for purpose Establish Intended Use Establish Performance Criteria Comparison to Gold Standard – Traditional Markers? Weighted importance for digital biomarker related to intended use CV (coefficient of variation) Note: sets of validated biomarkers in panels could lead to self management of chronic disease
- Daily Monitoring of Chronic Disease (Example of Parkinson’s Disease) Personalized care plans (The need for adjustment of medication when fighting this disease) Remote tracking (Mobility issues – less need to travel to clinic) Regular data points rather than sporadic indicators (Providing better health and quality of life not just quantity) Movement Posture Quality of Sleep Cognition Remove bias from impaired perception (Some diseases affect the patient’s impression of their health) Nitric Oxide and Asthma, logging of environmental data, humidity, temperature, air quality Precursors to Heart attack, Hypertension, trouble sleeping (obstructive sleep apnea), impaired vision, loss of cognitive ability, The relationship between stress and illness is complex and the susceptibility to stress varies from person to person - workplace Stress Responsible For Up To $190B In Annual U.S. Healthcare Costs (HBR, 2015) . Understanding and managing this stress could yield significant savings and a productive workforce Evolution of employer plans that give a benefit for health evaluations, fitness tests etc. to actually using markers
- Paths to Market Requirements straight to biomarker unlikely on 1st product / approach. // Claim vs. Diary of information Providing evidence of improved outcomes based on digital biomarkers, and being able to claim as such, will require significant clinical trials and can take a long time. However, there is benefit in getting a digital health solution to market quickly, independent of the regulatory or marketing claims, as it will provide the opportunity to gather data (similar to a phase 4) as well as learn from real-world use of the solution. Moreover, there is no better time than today to start building brand awareness and improving patient engagement. Take the approach of launching with a minimum viable product (MVP) when it comes to an eHealth solution that does not require regulatory approval and work toward a more robust solution that can give the required claims for the longer term. Validation. Services as a gateway to clinical validated digital biomarkers. Gathering trial data, and trials to prove the biomarkers (longer and happening in parallel.)
- Getting Value from the Data Completing 12,000 steps in a day means nothing unless information can be derived from it that is valuable, such as where a person’s health is headed. Real value comes from answering questions such as: How does heart rate and breathing impact how medicine is metabolised? How is medication efficacy affected by daily caffeine intake? Are there better outcomes from eating a more protein-rich diet? Historical analysis will show trends in the data and can provide an early warning system Data patterns can highlight inferences that may predict an oncoming exacerbation for that individual Analytics provide window of opportunity for individual and HCP to re-evaluate and take appropriate steps to change things ahead of a relapse. ------ We are starting the journey, toward user value, vision is needed not just data
- Alternative payment models and biomarkers use in business cases – start feeding in business models // evidence is starting to emerge that tracking is being accepted.. Are we likely to see payers want evidence that therapy is working and worth funding. Leave the statements to open questions, Current business models are undergoing disruption and creating systems to improve outcomes and create value provides payment opportunity Where will the breakthroughs be in using this technology Medical Device Manufacturers Consumer Healthcare Applications Virtual Care Services Care Networks (Cleveland & Mayo Clinic) Vertical care networks Welldoc is the first mHealth product to secure reimbursement as a diabetes management Insurers pay out $100 a month in reimbursement for use of the mobile-enabled diabetes management program BlueStar. Once it is prescribed by a physician, companies can add BlueStar to their prescription benefit plans Novartis signed a risk sharing deal with two major insurance carriers in the US for its new heart failure drug – Entresto CMS : Centers for Medicare & Medicaid Services, comment on integrated care networks?
- Tips for Success: Think partnership – you don’t have to do it by yourself Typical path to market for the start ups has traditionally been acquisition by one of the big companies. Large established companies develop their own product and bring it to market themselves. I am not just talking about these – technology companies partnering with fashion designers to create lifestyle wearables. Google and Warby Parker, Fitbit and Tory Burch, Misfit and Swarovski, and Intel and Oakley are just a few. In tomorrow’s brave new world, other avenues will need attention. Entire ecosystems cannot and need not be built by medical device companies. You can rely on partners, even from outside the healthcare field to provide complimentary skills and building blocks to pull the solution together. Large companies are making equity investments rather than early acquisitions – they are relying on innovation happening faster outside their four walls. Pharmaceutical companies are interested in supplementing their drug portfolios with devices and diagnostics that can help provide complete all around therapy. We are seeing several non-traditional companies entering healthcare and making big investments. Who knew Google would be interested in contact lenses or Apple would hire MedTech heavy weights? And what about the recent partnership between IBM, J&J, Apple and others – these companies plan to leverage each others strengths as well as data to extract greater value and potentially provide new solutions. The world is changing! Its time to do things differently.
- Balance: A Requirements for Deploying a Biomarker Solution // Looking for the sweet spot when finding digital solutions and biomarkers, Digital technology can provide powerful tools that will help healthcare businesses transform not only themselves but the industry in general. Three things must line up for this to happen… Business Model: (previous slide) Changing healthcare landscape can provide opportunities for new solutions Market Proposition: Consumers must believe there is a benefit and that using this service will improve health and provide value Science & Tech: New disruptive technologies and improvements (wireless, sensors, energy harvesting, low power electronics) are only adding more options and ways to capture this data and build solutions.
- Call to Action! Tomorrow is too late. These things take time – the earlier you start, the better impact you can make. Harnessing digital biomarkers can improve outcomes and patient health and provide a differentiator for your business. Find ways to start building in the groundwork to providing these solutions and services to prepare yourself for coming changes.