Digiceuticals
“We don’t make the drug, we make the drug work better”:
fact or fiction or too soon to tell?
Digiceu'cal? •  Whaaat? Related terms • 
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Nutriceu'cal Func'onal Food Cosmeceu'cal Nutricosme'c •  What they have in common: –  Some (regulatory) and valida'on “gaps” or, in the case of an academic enterprise…a lot of opportunity Why did I pick this topic? •  You: Center for Drug Safety and Effec'veness •  Me: not a drug developer •  Several big relevant conferences clustering now –  HIMSS this week –  DataPalooza next month –  DIA in June Pharma Companies (branded and generic) have embraced digital tools eg Heather Bell ex-­‐AZ now Sanofi VP Strategy and Emerging Opportuni'es •  “I think that mobile health [the use of smartphones, tablets, and other mobile compu8ng devices to record pa8ent informa8on] has the poten8al to be profoundly transforma8ve for healthcare” \ •  "I believe it will usher in a realm of predic8ve medicine, complete with what we might call digital biomarkers and digital drugs." Beyond the pill—collabora'ons between pharma and digital health Top 20 app makers by number of apps-­‐-­‐ Bayer, Merck, Novar's and Pflizer are leaders Two big categories •  General pa'ent generated informa'on •  Specific drug or disease-­‐state informa'on Why?: •  Short term: facilitate clinical trials •  Medium term: drive compliance and s'ckiness in face of compe''on •  Theore'cally: enhance pa'ent engagement and improve drug effec'veness Disrup9ve Innova9ons in Pharma trials 2014 Mobile Health 2.0: The Rise of Digiceu'cals The first wave of mobile health brought the pla`orm capabili'es of mobile health-­‐oriented data collec'on to the consumer space. The next itera'on will validate mobile data analy'cs, crea'ng a “digital biome” where data collected from the pa'ent’s pocket cons'tute digital biomarkers of disease. A pa'ent-­‐centric philosophy which creates an engaging and invi'ng environment for the user combined with back-­‐end data gathering can create an ecosystem where both pa'ent and inves'gator benefit. Apps which are inherently useful to the user and driven by analy'cs validated in rigorous trial sebngs may garner uptake and reimbursement not unlike tradi'onal pharmaceu'cs. This is Mobile Health 2.0, and the rise of Digiceu'cals. “Pa'ent-­‐centric drug development” •  Pa'ent generated data before during and acer trials Non-­‐tradi'onal Companies Entering Healthcare –  Apple –  Google –  Microsoc –  IBM –  Nintendo –  Samsung –  Intel –  GE –  AT&T –  Ford New players driving research tools “Now everybody can do their part to advance medical research. Medical researchers are doing some of the most important work in the world, and they’re commieed to making life-­‐
changing discoveries that benefit us all. To help, we’ve created ResearchKit, an open source socware framework that makes it easy for researchers and developers to create apps that could revolu'onize medical studies, poten'ally transforming medicine forever.” Moving beyond trial into more rou9ne clinical (not recrea9onal) use… •  1000+ apps = mass confusion •  With the market for mobile health apps expected to grow at more than 26.7% per year un'l 2018, according Markets and Markets, the need for reliable informa'on about these apps is increasing. •  void lec by FDA – 
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Happ'que IprescribeApps IMS UK Na'onal Health Service •  hep://www.mddionline.com/ar'cle/cura'ng-­‐services-­‐
help-­‐pa'ents-­‐docs-­‐evaluate-­‐mobile-­‐medical-­‐apps-­‐04-­‐03-­‐15 There are physicians early adopters, especially as part of a chronic disease treatment paradigm •  “Much of what I do as a physician could be beeer done by either machines or pa'ents themselves” • 
Dan Hoch, Neurologist, Mass Gen •  Fill in the dots between visits User friendly interfaces, sensor technologies embedded in various devices: CONSUMER FOCUSED : Compliance •  Most of the apps current designed by/for pharma are to improve health literacy and mo'vate pa'ents to take their medica'ons. •  According to CDC non-­‐adherence to medica'ons result in $290 billion in costs –  WHO es'mates that by 2020 the number of Americans affected by at least one chronic condi'on requiring medica'on will grow to 157 million –  Medica'on prescrip'ons never filled: 20%-­‐30% –  Medica'on not con'nued as prescribed in about 50% of cases Sources:hep://scriptyourfuture.org/wp-­‐content/themes/cons/m/
release.pdf,Osterberg 2005,NEJM, Ho 2009, Circula'on Are Mobile Medical Apps Good for Health? A new study by Research Now indicates that physicians and pa'ents say ‘Yes’ •  Study engaged 500 HCPs and 1,000 users •  Key findings: –  46% of HCPs say they will introduce mobile apps to their prac'ce in next 5 years –  86% of HCPs believe that health apps will increase their knowledge about pa'ents’ condi'ons –  96% of users think that health apps help to improve their quality of life –  72% of HCPs believe that health apps will encourage pa'ents to take more responsibility for their health Source: Research Now Group Currently more “faith” than data…. Fortune: “Apple’s new pla`orm will amplify a broad set of new opportuni'es we are calling “Digiceu'cals” — where socware, sensors and apps are standalone treatments for disease and integrated into comprehensive care plans alongside drugs and medical devices.” Source: Fortune, Mar 2015 Why Apple’s ResearchKit Signals Golden Age for HealthCare Zen Chu Maulik Majmudar Stanford implements ResearchKit •  Within 24hr of implemen'ng ResearchKit for a cardiac study at Stanford, 11,000 people had signed up •  Objec've: is to study ways to encourage people to modify their behavior to improve heart health by u'lizing the GPS and accelerometer on the phone to track ac'vity; and to determine what type of coaching is most effec've at improving fitness Ac've Task Modules in ResearchKit Category Task Sensor Data Collected Motor Ac'vi'es Gait Tapping Accelerometer Gyroscope Touch Screen Accelerometer Device mo'on Pedometer Touch ac'vity Accelerometer Fitness 6-­‐minute walk Accelerometer Accelerometer Device mo'on Pedometer Loca'on Heart rate Cogni'on Spa'al Memory Touch Screen Touch ac'vity Correct and actual sequences Voice Phona'on Microphone Uncompressed audio Big unresolved issues exist •  Data integrity, security, accessibility, integra'on…what is the real-­‐'me value of “big” data to the individual contributor? •  Digiceu'cal valida'on: both of func'onality (feature claims) and benefit claims •  Interface safety BASF •  In almost every brand awareness test, •  its 25-­‐year-­‐old North American commercial tagline – •  "We don't make a lot of the products you buy. We make a lot of the products you buy beeer" -­‐ ranks among the most recognized corporate slogans. “We don’t make the drug, we make the drug work beQer” My verdict: •  The jury is s'll out –  Beeer and more efficient trials: probably –  Beeer post market surveillance: probably –  More effec've drug use: possibly/too soon to tell –  More effec've management: possibly •  What is my take-­‐away? –  Not all digiceu'cals are created equally –  To be effec've similar rigor needs to be applied as is applied to other components of therapy –  The poten'al exists to “make the drug work beeer” How to accomplish this came together for me last week when I met with Alain Labrique •  There are undoubtedly too many apps to curate •  The focus on gebng them reimbursed is slow, tedious and has limited yield to date •  But we see the promise •  definitely need “prescrip'on-­‐strength” apps = structural integrity + analy'cal integrity +clinical validity “Prescrip9on-­‐Strength” App Development follows an analogous process to drug development Build Phased Drug Development Validate Design Ra'onal drug design (mechanism, formula'on) From this perspec've…. •  Digiceu'cal development should not wait un'l (acer) drug launch •  Pa'ent-­‐generated data can indeed generate clinically-­‐relevant digital biomarkers of disease or wellness state •  Physicians may prescribe them and in so doing take (some) responsibility for monitoring the pa'ent outcome (“Rx-­‐strength” vs. OTC) •  The system will need to accommodate “more con'nuous pa'ent management” which clearly makes physiological sense.