Big Health Data ebook

BIG HEALTH DATAHow B ig Data & eHea l th t e chno log i e s t oge the r a r e

the key t o p rec i s i on med ic i ne

eHealth toolsin Big Data?

What is the role of

“Big data technologies make it easier to work with large datasets, link different datasets, detectpatterns in real time, predict outcomes, undertake dynamic risk scoring and test hypotheses.Other sectors have already proven the value of big data. For instance, technology and web-based companies such as Google and Amazon rely on big data techniques to develop, targetand enhance services.” – ABPI ‘Big Data road map’ report

For the biopharmaceutical industry to carry a success ‘big datastrategy’ it must assimilate and partner with the eHealth technologieswhich are improving access to and analysis of patient data. Inclinical care, these data sources include the following:

Healthcare data: Structured and unstructured data from anonymisedelectronic health records and biometric data sources. This data maytake the form of prescription, compliance and response patterns,pathology reports, probabilistic models of outcomes or phenotypedpatient cohorts for stratification.

Remote monitoring, including smart devices: In our digitizedworld, the impact of phone apps and sensor-based wireless tech isonly going to grow. These smart devices support patientengagement, therapeutic adherence, clinical trial recruitment andeven give clinical insight into disease progression & biomarkers.

Genomic data: Although it is a long, on-going process, the genomicimpact on eHealth systems (including EMR) will reach all levels ofdata: population, disease, patient, tissue and organ banks, cellularand genome sequencing. Precision medicine is derived from theimplementation of clinical insights through sequencing methods andtranslational technologies. Additionally, the growing movement andinnovations within direct-to-consumer genetic testing will also be adisruptive force in health research.

Patient generated health data (PGHD) and digital engagement: There isincreasing examples of information being created by the patient or caregiveroutside the clinical setting. Strengthening patient (consumer) engagement in theirhealth improves medication adherence, therapeutic outcomes, clinical care andultimately brings value to pharmaceutical products. The future will bring greaterinvolvement by drug-makers in disease management technology which is innatelylinked to goals in pharmacovigilance and evidence development for payers, HTAbodies and regulators.

Presentation: Datebale DataWanted - It's Not Enough to

Just Be Big

Dr Trent Haywood, SVP,CMO, BlueCross BlueShield

Talking on leveraging datafrom one of the largest

pharmacy chains in the world

Dr Howard Golub, VP ClinicalResearch, Walgreens

A example of pharma's monetary commitment to these digital health tools(and its interface with data analytics) is the $100m “beyond the pill” investmentfund established by Novartis and Qualcomm in January (2015). As NagrajKashyap, SVP of Qualcomm Ventures said in a statement

“The adoption of mobile technologies is already having a positive impact onhealthcare practices and patient experiences around the world……This jointinvestment company with Novartis will allow us to combine their expertise inhealthcare solutions with our knowledge of mobile technologies to accelerateinnovation in the field of digital medicine.”

Of course, the Swiss drug giant already selected Qualcomm Life as a partner forits global Trials of the Future program, with the first observational project toevaluate the use of mobile devices for patients with chronic lung conditions.

Featuredspeakers from

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The importance of

And how can we get it?

Healthcare data

Look at the US healthcare sector. Data silos between payers, providersand pharma are crumbling, enabling the powerful integration of digitizedpublic historical and real-time data. Health-data applications, which haveuntil now been focused on data management and retrospective insights, arebeing used for clinical drug development, create models for proactive patientcare, give real-time analysis to guide individualized treatment protocols(everything from medical imaging to genomic) and improve efficiency of care.

It's hard to imagine an industry that stands to gain more from going digitalthan healthcare. The United States spends more on healthcare than anyother country in the world, at an estimated 17.7% of GDP [1]. It is also theonly nation to not have a healthcare budget, traditionally "spending what itneeds to spend", and in 2013 this resulted in an estimated expenditure of$2.8trillion [2]. The 2010 Affordable Care Act (ACA) was set up to expandhealth insurance from 85-95% of the populous but also to slow this risinghealthcare costs. However even though more consumers are gaininginsurance, they are paying a greater portion of their health plan premium andout-of-pocket (OOP) cost-sharing of all types [3]. The 2015 'Permanent DocFix' or officially the 'Medicare Access and CHIP Reauthorization Act(MACRA)" was passed to address these issues, shifting reimbursementfrom fee-for-service to pay-for-performance programs (such as AlternativePayment Model and Merit-Based Incentive Payment System) and replacethe Medicare Sustainable Growth Rate method enacted by the BalancedBudget Act of 1997. With these drivers towards value-based payments,there are profound impacts for drug pricing and reimbursements models inthe pharma business, and demonstrating evidence for value is a greaterpriority than ever before.

Featuredspeakers from

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Matt Pitts, VP EnterpriseInformatics, Highmark Health

Dr Thomas Tsang, CMO,Merck Healthcare Solutions

References1. Economist Intelligence Unit 2014; 2 MACPAC 2013 Report to Congress; 3. Deloitte Center for Health Solutions 2014

Moving in parallel with these health insurance reforms, in 2009, the HealthInformation Technology for Economic and Clinical Health (HITECH) Actset aside $27billion for an incentive program that would encouragehospitals and providers to adopt electronic health records (EHR). Whilstthere is constant debate on the overall cost of care reduction by thesesystems - for example, a 2013 study in Medicare & Medicaid ResearchReview described the results as mixed, whilst the MassachusettseHealth Collaborative have shown them to be overwhelmingly positive -there is a clear advantage for clinical decision making. A 2011 meta-analysis of HIT-implementation studies found that published reports wereover whelming positive but at that point only 10% of US physicians wereusing a fully functioning EHR system (compared to 90% in theNetherlands, UK and New Zealand).

For pharma, this mix bag of cost reduction measures and installation ofhealth IT systems, brings its own unique challenges and opportunities.To gather evidence on the value of their drugs (or indeed find new patientpopulations or indications) and reduce healthcare cost burden, the industryis partnering with payers and providers to explore EHR for clinical caretrends. Furthermore it is developing its own real-world data collectionplatforms (everything from wearables to social media and onlinecommunities) to expand the variety of the data collected.

Featuredspeakers from

our conference

Dr Kenna Mills Shaw, ExecutiveDirector, Personalized CancerTherapy, MD Anderson Cancer

Center

Dr Alan Go, Chief Cardio &Metabolic Conditions, Kaiser

Permanente

Commercial departments are not the only ones who benefit from these Health IT systems.The biopharmaceutical research divisions are partnering with this medical ecosystem to fosternew drug development. Scientific innovations can stem from Health IT in the following ways: - Using genomic data, predictive algorithms and clinical analytics, researchers can assesshow to bring precision medicine to patients (eg. diagnosing a subset of patients in cancertreatments which will respond to a particularly therapeutic mode of action)- Patient recruitment and clinical trial stratification- Identifying unmet medical needs- 'Real world' real-time analysis and pharmacovigilance, including data mining in spontaneousreporting system [pivotal trends in the regulatory environment in the US and Europe]- Clinical trial (and other medical practice) data sharing to stimulate new ideas for research andavoid unnecessarily duplicating investigations.

Speakers Research Case studies

The pre-competitive ‘Project Data Sphere’ initiative, an online resource to share clinical trialdata for use in cancer research and involving AstraZeneca, Bayer, Janssen, Celgene, Pfizer,Sanofi and Memorial Sloan Kettering Cancer Center.

World’s first phase III pRCT in COPD between GSK, Salford Royal NHS Foundation and theUniversity of Manchester (published in 2014)

Google, Illumina, Merck, the New York Genome Center, join 142 other members based in 21countries to establish the Global Alliance for Genomics and Health. The initiative is set up toshare genomic and clinical data by establishing a common framework of internationalstandards (2014).

Silicon Valleywakes up to digital health

The last 12 months has marked a major shift in venturecapital towards digital health solutions. Back at the endof 2013, Social + Capital's Founder, ChamathPalihapitiyah told the Digital Health Investor Simmit:

"Every interaction in every area related to health is justso shitty. The software is crap, the services are crap,the people are crap. So there is a lot of value thatpeople like us can add"

His firm now has some of the leading disruptiveinnovators in its portfolio - Flatiron Health, PropellorHealth, Neurotrack, Simplee, Breakthrough Behavioral,Syapse and Better. This approach has not been lost onother firms. Google Ventures has shifted one third of itscapital towards health & life science (2014), up from 9percent two years previously. Union Square Ventures'Fred Wilson has said he will only invest in healthcarefor the next five years, whilst Andreessen Horowitz hasadded Balaji Srinivasan, an unknown healthcare dataexpert from academia, as its most recent partner.Founders Fund partner Peter Thiel backed theirinvestments in dozens of healthcare-focused startups,with his words:

"We would never designed a system like this if we werestarting from scratch. If technology involves doing morewith less, than US healthcare is the core of "anti-technology" in this country".

Digital investment is hot. VCs are looking for startups inthis whirlwind of consumerization in health andwellness, including everything attached tocrowdsourced diagnostics, EHR, patient monitoringdevices, wearables and body sensors, patient-doctorcommunications, online health portals.

Dr Roy Baynes, SVP, GlobalClinical Develop.Merck 

Makes smart pill bottles to measure & improvemedication adherence. Health complications from

non-compliance costs healthcare system hundreds ofmillions of dollars per year.

AdhereTech

Develops a platform for clinicians to have real-timeinformation at their ‘fingertips’, enabling better

decisions and better outcomes.

London-based startup works by collectingdata from hospital databases and collatingthem into a central source, which doctors

can quickly scan from an iPad.

@Point of Care

Medopad

The Meaningful Use requirements in theHITECH Act means providers will now need to

give patients access to a specific sets of clinicaldata. Company specializes in organizing EHRs

on its customers’ behalf.

MediSafe

Picnic Health

Cloud-based medication management platformis designed to understand the causes of non-adherence & uses info in real time to create

better patient engagement. Has 300,000 users& data on 12m doses.

eHealth Startups

Electronic health record platform is used byover 112,000 medical professionals,

providing both real-time data&patient’scharts to support clinical decisions.

Practice Fusion

Uses predictive software to tell doctorswhich antibiotic prescriptions is mostlikely to work for each patient.

LuminaCare

'Decision Making Engine for Food. Providesindividuals with tools to manage nutrition

requirements

GorMonjee

eHealth technologies are becoming increasingly sophisticated andgaining acceptance among payers, physicians, patients andpharma. Whereas 2 years ago we may be having a data analyticsconference based solely on genomic, bioinformatics and drugdiscovery software interfaces, now we have a healthcareecosystem eager to leverage patient engagementtools.

Our informed 'ePatient' is not satisfied with an onlinestrategy consisting of just creating a 'drugname.com'website, but is motivated to take a greater responsibility intheir clinical decisions. We have patient communities eagerto take advantage of mobile technology to improve theirhealth and increase the convenience of their healthcare.

Mobile engagement is also driving by provider's andinsurers' adopting performance-based payments, includingaccountable care, and the release of a 10 year health ITinteroperability road map by the HHS' Officeof the National Coordinator for Health IT; the2014 Oct draft stating that by 2017 to 2020 peoplewill be routinely "accessing and contributing" to theirEHR information.

This value-based healthcare model has driven pharma to play a greaterrole in delivering a better experience for patients, improving clinicaloutcomes and reducing the total cost of care. Digital health tools - suchas web portals, body sensors and apps - are becoming increasinglypopular among patients and physicians, which means that drug makersmust take a more holistic approach to clinical care.

Taking a digitally integrated approach to patient caremay take various forms, of which these innovationsforming the basis of a vibrant startup community asdescribed above:

* All these companies are speaking at our eHealth Forum

- Smart devices such as food-tracking apps, wireless blood pressurecuffs or movement tracking gadgets- Community and personalized content. In many ways these forumshave been pioneered by PatientsLikeMe (SVP also speaking at ourmeeting) and have comprehensively shown that patients benefitfrom social support, empathy and expertise of their peers - Direct patient engagement allows medical stakeholders tounderstand the patient 'journey' and tailor treatment protocols,clinical guidelines and next generation of medication as appropriate.

Featuredspeakers from

our conference

Responsible for settingAmgen's digital health

strategy as well asincubating &

commercializing digitalhealth products in drug

portfolio

Dr Kal Patel, Head, DigitalHealth Group, Amgen

Dirk is developing anInnovation Hub within

Bayer Healthcare in SiliconValley. His key interests areremote patient monitoring,

Big Data, vital signsmonitoring.

Dirk Schapeler,Director,Digital Health,Bayer H'care

Wearables, Quantified Self

Smart phones, personal trackers

Remote monitoring

"Pharma has discussed the need to focus "beyond the pill" for many years....ACA(Affordable Care Act) has put deadlines and deliverables to the goal of measurablyimproving clinical outcomes. From lowering blood pressure to quitting smoking,reducing panic attacks to managing diabetes, wearables enable patients to monitor theirown health with far more specificity and greater ease than ever before"- Intouch Solutions

90% of chronic patients in the US would accept amobile app prescription from their physician

Digitas Health

QuanttusEst 2012

Clinical & consumer-friendly wearable device.

Can be used to identify predictive trends

Speaker: Dr Shahid Azim, Founder

Wristworn device to track blood pressure

MC10Est 2008

Embedding technology in bendable materials.

Data collected includes temp, heart rate, brain

activity, exposure to radition

Speaker: Dr Roozbeh Ghaffari, CTO

Flexible electronics maker. Products include

biostamp on skin worn like a band-aid

AliveCorEST. 2011

Approved by FDA to monitor basic heart rhythms.

Can detect if atrial fibrillation is detected

Speaker:Dr David Albert,Founder, CMO

Mobile ECG runs on smartphones & tablets

Some of the companies presenting at October conference

Leadership of LillyOncology biomarkers andpatient tailoring (preclinicaland clinical). interested in

wearable devices

Dr Melemed, SrDirector, OncologyTailoring, Eli Lilly

Basekline is one of theimportant projects

undertaken by the lifescience division of Google .The project is designed to'understand what it meansto be healthy, down to the

molecular and cellular level'

ImpactEst 1997

Has the largest database of clinical research

(215 peer reviewed,145 independent) on

concussion management.

Speaker: Michael Wahlster, CEO

Provides clinicans with neurocognitive

assessment tools

MendorEst 2005

Mendor Discreet has been called the iPhone of

glucose meters

Speaker: Kristin Ranta, CEO,Co-Founder

Develops disruptive diabetes management

solutions

Featuredspeakers from

our conferenceGenomic data

Dr Joseph Corkery, Sr ProductManager, Google Cloud Platform

Dr Nicholas Marko, Chief DataOfficer, Geisinger Health System

Dr Jessica Mega, Head ofBaseline Study, Google X

Genetic tests can reveal a patients response to certain medicines (whetherthat's linked to possible side effects, biomarkers on tumour malignancies, etc)and as EHR become converted to digital forms, we will see more clinicaldecision making being done through eHealth solutions.

Pioneer organizations in this research include:

- Electronic Medical Records and Genomics (eMERGE) Network, aNational Human Genome Research Institute-funded consortium engaged inthe development of methods and best practices for using EHR as a tool forgenomic research. Their current work is advancing knowledge in multipledisciplines at the intersection of genomics and health-care informatics,particularly for electronic phenotyping, genome-wide association studies,genomic medicine implementation and ethical & regulatory issues.

- Regeneron Pharmaceuticals and Geisinger Health System, one of thelargest integrated health system in the US serving approximately 3 millionresidents, have announced a major research collaboration focused on studyingthe genetic determinants of human disease (2014). During the initial five-yearcollaboration term, the payer plans to collect samples from more than 100,000patient volunteers, while the biotech will perform sequencing and genotyping togenerate de-identified genomic data.

- For a European example, you can look at Genomics England, which hasenlisted the help of 10 companies (including AbbVie, AstraZeneca, Biogen,GSK, Roche) to oversee a one year trial of the Genomics Expert Network forEnterprises (GENE) Consortium. The companies will get access to aselection of sequencing data from patients with cancer and rare diseases inorder to look for therapeutic opportunities.

"Connecting and comparing genomes by the thousands,

and soon by the millions, is what’s going to propel

medical discoveries for the next decade. The question of

who will store the data is already a point of growing

competition between Amazon, Google, IBM, and

Microsoft." - Technology Review (Nov 6, 2014)

Dr Jean-Claude ZenKlusen, Director,Cancer Genome Atlas,NCI

Digital EngagementIn the post 'blockbuster' world of drug development, pharma are looking for holistic offerings (includingthese 'beyond the pills' digital platforms) to create value in their products, both for patients and physicians.This digital transformation is being driven by generic competition and the healthcare cuts, as describedearlier.

However it is not just business threats that have stimulated this movement. By connecting with nichepatient communities, you can recruit for clinical trials more efficiently (therefore reducing the staggeringcost of new drug development), monitor drug safety and clarify benefit/risk (a key stumbling block inregulatory and payer approval). Big Pharma are developing sophisticated apps to allow patients to selfreport and send information to their doctors (eg. Novartis with its multiple sclerosis symptom tracker,SymTrac or Sanofi's blood sugar tracking device plus app, IBGStar). With updated FDA guidance onmobile medical apps (March 2015) you will also see these efforts play a role in regulatory submissions andpost-approval initiatives.

Additionally on the pharma side, you must also factor in the drug pipelines of today. Although it is givingpricing and reimbursement experts a headache, rare diseases are a competitive business model atpresent. I think this was vividly shown by the approval of Soliris, a therapy for around 200 people with arare blood disorder, by the NICE (UK) in January. Even with such a small patient population, the annualcost for NHS will total £82 million per year. For a small biotech looking to establish a rare diseasepipeline, digital engagement offers a very cost effective way of communicating and recruiting patient.

We no longer have a patient in their hospital bed taking the doctors word to be gospel. They are more ‘engaged’ with the treatment choices of their careand ‘empowered’ through the critical use of leveraging data throughout the world-wide-web. A ‘Google’ phenomenon. As one blogger put ‘Epatients are thehackers of the healthcare world’ and this doesn’t just mean our patient is taking more responsibility for their conditions - through apps, real-world tracking, asmentioned earlier – but also voicing their opinion on new therapies, including those in clinical trials, and drug treatment options.

'ePatients are the hackers of the healthcare world'

Two Conferences.One Exhibition. 100+ Speakers. See more details atwww.bigdataleadersforum.com