July 17, 2018

Digital Health is all the rave as of late.  From multinational pharmaceutical sponsors to freshly formed ventures in Silicon Valley—or China for that matter—there is a race to be a leader in this emerging space.

First a TrialSite News definition—what is Digital Health?  As generally our staff maintain a high confidence level in Wikipedia we can start there: https://en.wikipedia.org/wiki/Digital_health.  Suffice it to say that Digital Health represents “the convergence of digital technologies with health, healthcare, living and society to enhance the efficiency of healthcare delivery and to make medicines more personalized and precise.”

TrialSite News editorial and research staff will present a series of roundups on the topic of Digital Health.  First, we offer today a roundup of the top three multinational pharmaceutical sponsors and summarize a representative sampling of some of their initiatives.  If the readers seek more big pharma summaries then we will provide additional company summaries. Second, we seek to understand how Digital Health is expected to disrupt clinical research/investigative sites; principal investigators and their staff.  Third, we will review digital health in clinical trials from a patient point of view—what are the trends, themes and dynamics unfolding that we should keep an eye on and fourth how might Digital Health initiatives may bring together clinical sponsor, provider and payer in the future.

But first on to the biotech and pharmaceutical market for Digital Health.  Big Pharma is going digital? Below we summarize the top three pharmaceutical companies based on total revenue:  Pfizer, Roche and Sanofi. Again, If the TrialSite News readership enjoys this Roundup and requests more additional company summaries then we will do so.

Pfizer

Pfizer launched Healthcare Hub https://www.pfizer.com.au/collaboration/pfizer-healthcare-hub in 2017 to support budding companies in the health tech space. Key focus areas of the “Hub” includes 1) Disease awareness and information 2) Earlier detection and better diagnosis and 3) compliance and adherence. Pfizer seeks start-ups to “learn, experiment and collaborate with Pfizer—accessing mentoring and know-how in areas including market orientation, infrastructure, compliance, government relations and much more.”   https://healthcarehub.pfizer.co.uk/startup-mission-statement

Most recently Pfizer announced “winning pitches” for its London-based Hub including Medopad, an app platform for patients to log and share data during clinical trials or standard care http://medopad.com/ as well as In Healthcare, a remote patient monitoring company http://www.inhealthcare.co.uk/ and Perfect Ward, an app based tool that helps conduct and report healthcare inspecting results https://www.perfectward.com/. Each one of these ventures receives $70,000 grant in addition to a year of support and access to Pfizer regional partnership including UK-based National Health Service. Pfizer Health Hub of London is managed by Dr. Hamish Graham, https://www.linkedin.com/in/drhamishgraham/.   It turns out that some of the start-ups are relatively sophisticated. Medopad, a UK venture founded in 2011, has raised $32 million in A round and has approximately 70 employees based on initial TrialSite News research staff review. Medopad reports different health and life science solutions. Targeting “Clinical Trials” they tout “increasing the effectiveness of R&D.” and offer Real-time clinically proven patient monitoring, Symptom reporting (Phase I to Post -Market); Automatic data capture using connected wearables (e.g. vital signs, movement, cognition); Questionnaires for large scale insights; Rapid, cost-effective deployment when starting a new trial and Auditable, regulatory complaint consent gathering.   They are now seeking to penetrate the US market. Inhealthcare, founded in the UK has not landed any significant investment yet. For more see http://www.inhealthcare.co.uk/national-digital-health-platform/. Perfect Ward, founded by UK-based Jonathan Knight, is a smart but simple smartphone app that helps healthcare teams monitor the quality of their clinical areas and provide evidence to CQC. https://www.perfectward.com/.  Many other initiatives have captured Pfizer’s interest over the past few years.  Multinational corporations can at times struggle with experimentation. Pfizer’s worldwide innovation director Dan Seewald encouraged employees to look at things in innovative ways; try innovative approaches; experiment. https://youtu.be/L1UuSYDfD-A. Another interesting public link on  “How we implement digital transformation at Pfizer…https://www.slideshare.net/Digimediabe/how-we-implement-digital-transformation-at-pfizer-and-how-it-help-the-growth-ans-speed-the-development-of-new-products

Pfizer had also formed some years ago a “digital transformation strategy” which involved a series of modernization projects including the migration of many apps traditionally managed on premise to the cloud.  Pfizer also touts a center of excellence of analytics. And recently it launched a new collaboration with XtalPi for artificial intelligence (AI)-driven drug modeling. http://www.xtalpi.com/  Based in China and the Boston area, they have raised over $20 million.  They are working with Pfizer to co-develop an AI-powered platform to model small-molecule drugs as part of discovery and development efforts.

Roche

In 2017 Roche announced that it expanded its digital health strategy. It acquired a mobile diabetes platform to bolster its digital health services by acquiring mySugr to bolster its position in diabetes management.  https://www.roche.com/media/releases/med-cor-2017-06-30.htm Roche reported that A) mySugr would become an integral part of the company’s new patient-centered digital health services in diabetes care B) assure that healthcare providers could continue to use existing Accu-chek tools and C) the open platform for advanced data sharing capabilities and coaching services connects people with diabetes and their caregivers worldwide. By some estimates Roche had acquires mySugr for between $75 and $100 million. Founded in Austria by Fredrik Debong, Gerald Stangl, Michael Forisch and Frank Westermann during the time of the acquisition it was claimed that they had one million users and it was considered a market leader. The platform was available in 52 countries and 13 languages. Roche had previously invested over $5 million US in the venture in 2015. mySugr competitors include Lvongo https://www.livongo.com/ and glooko  https://www.glooko.com/ and it would appear those companies could be M&A targets for large healthcare organizations.

Recently Roche launched another digital health offering, a self-testing device for INV or blood coagulation levels, that can wirelessly connect to a smartphone app. Known as the CoaguChek Vantus system, https://usinfo.roche.com/coaguchek-vantus.html it is designed for Warfarin patients to monitor their coagulation levels and includes built in Bluetooth technology.  Patients can now see results on the app and have the results sent to their healthcare provider.

Roche continued to double down perhaps ahead of other tier one pharma companies.  Earlier this year they acquired Flatiron Health, the Alphabet (Google parent co)-backed cancer-focused digital health analytics upstart. https://www.roche.com/media/releases/med-cor-2018-02-15.htm  The play here: attempt to leverage real world patient information and big data to stimulate superior oncology R&D.  Founded in 2012, Flatiron developed a cancer-centric electronic health record platform that proposed to link some 250 oncology practices. Additionally, it forged a partnership with National Cancer Institute (NCI).  A key differentiator between Flatiron and some other comparable ventures was that Flatiron had managed to curate its datasets enabling it to “separate statistical noise” from actionable information.”

Roche continues its digital health-inspired acquisitive streak in the market by completing the acquisition of Foundation Medicine a leading molecular information company for over $2 billion.    Roche has perhaps made larger acquisitions involving information technology than most other big pharma. One the one had It represents a forward-thinking vision; strategy and it demonstrates a willingness to make significant bets. On the other hand, buying a technology is not enough. For true disruption requires people, process and technology innovation.  Roche maintains considerable risk averse, conservative, big pharma traits. It will need to in some cases “get out of its own way” and let others drive innovation rather than some of the more traditional leadership. On the AI and machine-learning topic Roche includes a series of videos highlighting its commitment to these rapidly evolving technologies. https://www.roche.com/toolbox/topic.htm?label=Artificial%20Intelligence

Sanofi

French-based Sanofi created Onduo with Verily Life Sciences in 2016 http://www.news.sanofi.us/2016-09-12-Sanofi-and-Verily-Life-Sciences-Announce-Launch-of-Onduo-a-Joint-Venture-to-Develop-Comprehensive-Diabetes-Management-Platform to “help people with diabetes live full healthy lives by developing comprehensive solutions that combine devices, software, medicine and professional care to enable simple and intelligent disease management.  Clearly there is some overlap here with the Roche diabetes management digital M&A play. Verily Life Sciences is an Alphabet (Google) spin off venture. The Onduo project is listed on their website. https://verily.com/projects/.  Sanofi’s Digital Health team TrialSite News has learned is roughly 20 employees and influenced by Ameet Nathwani. https://www.sanofi.com/en/about-us/governance/executive-committee/ameet-nathwani-md/

Rachael Sha is Sanofi’s Vice President of digital business development and licensing.  She was recently interviewed in MobiHealthNews and noted that the company is applying digital strategy across business and therapeutic lines with two strategic priorities including A) drug discovery and development and B) “dugs plus” or new products that incorporate hardware and software with drugs and superior outcomes.  TrialSite News believes that Sanofi is undertaking more partnering and less large acquisitions as compared to the Roche approach. Sha noted in her interview that they are open-minded when it comes to deal types and structures for digital health initiatives, form licensing through partnerships, JVs to acquisitions.  Not long-ago Sanofi announced a major partnership with Los Angeles-based Science 37. https://www.fiercebiotech.com/cro/sanofi-launches-new-virtual-trials-offering-science-37  enabling decentralized trials leveraging a telemedicine platform. The idea is that it shifts the focus to the patient allowing them to have more flexibility and freedom to who and when they can be seen by a principal investigator or study nurse.  Study retention may remain higher in theory if patients can participate at a time of their choosing in the “comfort of home relying on wearables and devices to remotely monitor them.” Science 37, formed in 2014, has raised over $70 million and is inking more pharma deals most recently with Novartis.  https://www.science37.com/.   TrialSite News will be having a guest author, Deborrah Norris, author of the Clinical Research Coordinator’s Handbook chime in on just how viable this telemedicine plus bundle of wearables trend will be from a compliance and monitoring perspective.

Sanofi has also forged a partnership with TriNetX, a database provider https://www.fiercebiotech.com/cro/trinetx-teams-up-sanofi-cornell-for-better-clinical-trial-design  to leverage the platform for de-identified patient data from electronic health records that are part of the TriNetX network of providers.  TriNetX was founded in 2013 and according to available records has raised about $2.5 million. TrialSite News staff include tech-savvy researchers who have been keeping an eye on this firm. We believe they are growing at a healthy pace as their employee numbers in LinkedIn have gone up considerably in the past 12 to 15 months.

Sanofi’s “drug plus” category includes assets such as Onduo which still appears to be coming out of sales mode as they have hired Sales and Marketing professionals.

Sanofi has recently inked a large potential deal with Scotland-based Exscientia, an AI-driven drug discovery and development venture  https://www.exscientia.co.uk/ for up to €250M in milestone payments. The partnership was set up to design new drugs with applications in diabetes and related co-morbidities such as cardiovascular disease.  Sanofi also recently signed a partnership deal with Boston-based Berg https://berghealth.com/company/ to leverage their analytics platform to determine why vaccines work for some people but not for others.   Apparently by leveraging the Berg platform Sanofi will be able to assess differing populations, demographics, etc. to determine whether certain vaccines will be more effective in one region or continent over another.

Source: TrialSite News

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