Digital TrialsIsraeli Startups at the forefront of the Digital R&D Revolution January 2019

Introduction Clinical Trials, a marvel of scientific thought and process, are the epitome of human attempts to shield itself from illness and to overcome nature’s many perils. Within clinical trials, a successful methodology to discover, validate and ensure safety of biopharmaceutical products exists. Carefully designed processes that were preserved for years have ensured the isolation of signal from noise and led to commercialization of scientific breakthroughs that have affected millions. In the words of FDA Commissioner, Dr. Scott Gottlieb, “Prospectively randomized, placebo controlled clinical trials are often the most powerful tool that we have for answering fundamental questions about the safety and efficacy of new medical products.”1

On the other hand, they are a costly endeavor. Biopharma companies face tremendous pressures in price and risk when conducting clinical trials.2 In addition, the industry as a whole is slow and reluctant to adopt emerging technologies, such as Artificial Intelligence, Digital Platforms and Virtual Reality.3 It is, of course, understandable given the conservative nature of clinical trials and the biopharma industry. However, millions of patients remain waiting as treatment options face adoption barriers.

1. Scott Gottlieb, “FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation”, FDA Voice, US Department of Health and Human Services, August 28, 2018.2. Dawn Anderson, Jonathan Fox and Natasha Elsner, Digital R&D: Transforming the Future of Clinical Development, Deloitte Center for Health Solutions, 2018.3. Id.

Digital R&D: Stakes Increase as Biopharma Companies Have Yet to Reach Digital Maturity

A recent Deloitte study explored the road to adoption of emerging technologies. The report focuses on the promise of digital technologies for R&D processes, but also the hurdles towards their adoption. Additionally, the report reviews the kinds of technologies available today and timeframes for their adoption.The study included interviews with 43 leaders in the biopharma industry and examined to what extent companies adopted digital technologies in the context of R&D and Clinical Trials, concluding that generally the industry has been very slow to adopt such technologies, stating: “[e]ven the most advanced organizations are simply piloting several technologies in different areas of clinical development, focusing on piecemeal solutions or new tools to support existing process.”4

Reasons for the slow adoption of digital technologies range from immature data infrastructure to

cultural and organizational barriers. However, as the study suggests, there is significant value in unlocking the full potential of digital R&D and clinical environments.The benefits of digitizing clinical trials are substantial. As the industry uses clinical trials to get drugs to market as fast as possible, the challenge is to do so at a reduced cost and with improved data quality. Digitizing clinical trials can dramatically speed trials up and reduce time to market and costs. The benefits of digital trials are many, and it might be helpful to outline a few in order to fully realize the magnitude of these benefits:• Traditionally, the difficulty to recruit

patients leads to longer time to market. Digitizing the Study Start-Up stage enables investigators to design a more realistic protocol: from Easier methods to find patients who want to join to unique ways to identify patients with

4. Id.5. Greg Reh and Mike Standing, Survey finds biopharma companies lag in digital transformation, Deloitte Insights 2018.

Genomics and Real-World Evidence and. In turn, these help speed up the recruitment process and the overall study timeline.

• Additionally, trials are very labor intensive, forcing teams to manually enter data into electronic data capture systems. Automating and digitizing data improves data quality, results and reduces administrative costs.

• Finally, as traditionally physicians and sponsors have difficulty in seeing the trial data immediately, trial length increases. Digital improvements in direct data capture allow physicians to see patient data between office visits, resulting in better care and faster responsiveness.

Another Deloitte study, in collaboration with MIT Sloan Management Review, found that many biopharma companies are pursuing digital transformation efforts, but the majority are still not maturing.5 The study found that, while the industry understands the importance of digitization, only a few organizations are truly maturing. While digital maturity does not solely depend on innovation, biopharma companies need to change their attitudes towards operations. Facing the pressure of rising costs and complexity and the need for an industry-wide digital transformation, the industry needs to work harder to adopt digital technologies and to work together with entrepreneurs and innovators to infuse itself with innovation. The industry should not limit itself to internal innovation, but rather open up to collaborating with startups. Global companies should invest resources and efforts in developing relationships and collaborations with startup companies and other

The industry needs to work harder to adopt digital technologies and to work together with entrepreneurs and innovators to infuse itself with innovation. The industry should not limit itself to internal innovation, but rather open up to collaborating with startups.

stakeholders in innovation ecosystems (e.g. Venture Capital firms, Incubators and Accelerators) to digitize clinical trials, rather than focus solely on internal R&D programs.This report argues that Israel is a good place to start developing these ecosystem relationships and collaborations.

LandscapeThe landscape above describes our view of clinical trial innovation in Israel. This list is not exhaustive and Deloitte welcomes your additions.

2bPRECISE

ATLAsense Biomed

Augmentiqs

BeaconCure

Beyond Verbal Communication

BioBeat

BrainMARC

CardiacSense

CartaSense

CliniWorks

ContinUse

Data2Life

Datos

diagnostics.ai

DocBoxMD

Docomotion

EarlySense

EIMindA

Emedgene

View of clinical trial innovation in Israel

PatientRecruitment

E-Source & ConnectedDevices

Data CleaningAutomation

Trial Efficiency

Data Aggregation &Centralization

GenomicData

Patient/ InvestigatorInput

DigitalEndpoints

Diagnostics & Predictive& Trials

TherapyAdherence

E-Consent

Emerge Medical Solutions

Genoox

Hello Heart

Igentify

LifeMap Sciences

Materials.Zone

MDClone

Medasense Biometrics

Medisafe

Mediseen eHealth

Medorion

Neurosteer

Nucleai

Nym Health

Oxitone

PillTracker

Pomicell

RespiDx

RMDY

Sight Diagnostics

Somatix

SpacePharma

TagDox

Taliaz

Telesofia Medical

TytoCare

Vaica

Vaica Medical

Valera Health

Variantyx

VRHealth

Zebra Medical Vision

Created by:

Patient/Investigator Input

Data Aggregation and Centralization Genomic Data Patient Recruitment

Therapy Adherence Digital Endpoints Trial EfficiencyDiagnostics &

Predictive & Trials

your health TM

your health TM

your health TM

E-Source & Connected Devices

S E E T H E S M A R T P A T HS E E T H E S M A R T P A T H

E-Consent

your health TM

S E E T H E S M A R T P A T HS E E T H E S M A R T P A T H

Data Cleaning Automation

Trial Design Trial Startup Study Closeout

Trial Conduct

Digital Trial Landscape

Methodology Methodology. This report, published by Deloitte’s Innovation Tech Terminal, focuses solely on clinical trials. The world of Digital R&D is broader than the scope of this landscape, including areas not covered here, such as Drug Discovery. The report limits the scope of this work to clinical trials to reduce complexity and enhance clarity.This report leveraged the work done by Deloitte’s Digital R&D study and adapted the study’s taxonomy for clinical trials’ stages and the target areas for disruption. Then, we screened the Israeli startup ecosystem and mapped 53 individual startups based on the taxonomy we have adopted and adapted (described below).6

Categories. Clinical trials, in this report, branch into four categories, each with their own subcategories relating to target areas for disruption:

6. After an initial landscape was built, we have reached out to the startups included for validation and feedback purposes.

Trial Design Trial ConductTrial Startup Study Closeout• Patient/Investigator

Input• Data Aggregation

and Centralization• Genomic Data

• E-Source & Connected Devices

• Therapy Adherence• Digital Endpoints• Trial Efficiency• Diagnostics &

Predictive & Trials

• Patient Recruitment• E-Consent

• Data Cleaning Automation

1. Patient/Investigator Input: 1. Patient Input provides trial

designers a crucial viewpoint: that of the patient, which is conducive to better design of the trial and informing critical decisions, such as the importance of endpoints and which actions can be done remotely. Investigator Input includes information by investigators and non-patient trial participants (i.e., brand representatives, scientists, CRO representatives), that can inform protocols, recruitment criteria, etc.

2. This category includes technologies that can collect, collate and curate such input.

Trial Design:2. Data Aggregation and

Centralization:1. Data Aggregation and

Centralization means the collection and collation of medical data to inform trial design.

2. This category includes technologies that can collect medical data, aggregate it and create centralized data lakes for the trial, as well as technologies that standardize and normalize medical data in preparation for the trial.

3. Genomic Data:1. Databases from genetic testing

companies and national genomics projects can be a source for identifying incidences of certain conditions or co-occurrence of conditions in populations, or genetic characteristics associated with certain conditions. This can inform patient selection criteria and cohort design, particularly for oncology and rare disease trials.

2. Therefore, this category includes technologies that allow the collection, aggregation and manipulation of genomic databases, datasets and profiles.

4. Patient Recruitment:1. Traditionally, finding the

right patients for a trial was a difficult and labor-intensive task, primarily using historical data, patient prescription use, epidemiological data and other sources to find patients within a specific set of inclusion/exclusion categories. The ability to trace the right patients from structured and unstructured sources (e.g. EHR records and telemedicine session recordings, respectively) provides trial administrators with the capacity to locate and recruit patients more efficiently, and helps find patients that are more suitable. In addition, Patient Recruitment means streamlining the recruitment process that is often riddled with cumbersome procedures until enrollment is complete.

2. This category includes technologies that can assist trial administrators in finding and recruiting patients, by analyzing structured and unstructured sources and by eliminating cumbersome processes associated with trial enrollment and recruitment.

5. E-Consent: 1. Informed consent process

ensures that patients clearly understand the risks and benefits of trial participation, both when they enroll and on an ongoing basis. Informed consent is a regulatory as well as an IRB requirement for stakeholders, with a goal of protecting patient interests and ensuring ethical conduct of the trial. Maintaining and updating consent documentation can

Trial Startup:be complicated in different instances, such as when multi-center trials are involved, and when patients speak multiple languages. E-consent can expedite the consent process and reduce paperwork while providing trial participants with a better understanding of the study through different technologies.

2. This category includes technologies that can provide patients with digital informed consent.

Trial Conduct:6. E-Source & Connected Devices:1. E-Source refers to the digital intake and recording of data that

is relevant to clinical trials, whether it is clinical, administrative or compliance-related. Paperless information can serve clinical trials and increase the efficiency of the entire trial process. Capturing data digitally enables performing trials remotely or through connected devices, which can significantly promote efficiency and make trials more patient-friendly. EHR integration is a key consideration in this category, as the EHR is one of the primary sources for digital data. With EHR integration, investigators can avoid setting up costly sites for manual capture of data into the electronic data capture system. In addition to the EHR, there are a variety of e-sources to integrate to trial systems, such as wearables, administrative systems, LIMS and others.

2. Connected Devices, often referred to as Smart Devices, are digitally enabled devices that, combined with software, perform digital tasks, such as recording data automatically.

3. This category includes technologies that allow capturing data digitally from a variety of sources, or technologies that generate digital data that is relevant to clinical trials.

8. Digital Endpoints:1. Digital Endpoints are digitally

recorded, patient-generated data. Thanks to advances in sensors and digital platforms, coupled with becoming virtually ubiquitous, have made it easier to continuously collect this data. Digital Endpoints allow the automatic capture of data relevant to patients and the efficacy of the treatment.

2. This category includes technologies that allow capturing digitally patient-generated data throughout the trial.

9. Trial Efficiency:1. Since trials are costly,

technological improvements to trial conduct can save investigators time, lower costs associated with trial conduct and shorten treatments’ time-to-market. For instance, using digital technologies to automate processes (e.g., as digitizing standard protocols or generating action items for physicians and nurses) can greatly enhance trial efficiency.

2. This category includes technologies that digitize and streamline trial conduct (e.g., as automation and predictive analytics) enhance efficiency by lowering the costs of running a trial.

7. Therapy Adherence:1. Adherence to therapy

ensures that the effect of an investigational drug fully reflects in the data. However, high adherence rates can be hard to achieve and verify using traditional methods. Digital tools enable investigators to gain confirmation that they properly administered the therapy in question. Adherence solutions can also alert investigators of non-adherence.

2. This category includes technologies that allow investigators to monitor and confirm patient adherence to the therapy, as well as to gain insights via analytics or gain real-time alerts of non-adherence.

10. Diagnostics & Predictive & Trials:

1. Predictive Technologies allow investigators and trial administrators to predict a trial’s outcome by utilizing various Artificial Intelligence methods, such as Machine Learning. These algorithms can shorten trial conduct or bring the onset of In-Silico trials, eliminating the actual conduct of the study altogether. Diagnostic tools enhance investigative capabilities in similar fashion, however not necessarily with the use of Artificial Intelligence.

2. This category includes technologies that predict a trial’s outcome before receiving actual trial results, via diagnostic and AI tools.

11. Data Cleaning Automation:1. Cleaning and automating data is particularly helpful to reduce

time spent after trial conduct in preparing results for submission, ultimately rendering trials shorter and cheaper. Additionally, data automation means using digital tools to analyze study data to investigate data correlations, trends and results.

2. This category includes technologies that enable automatic analysis of study results and extract meaning, correlations or trends from these results.

Study Closeout:

Findings and Guiding PrinciplesThe Mystery of the Missing Ecosystem:In this report, we view the Israeli ecosystem from a very specific lens: that of clinical trials. Clinical trials, in the Israeli ecosystem, is somewhat of a latent area of innovation. Unlike other areas in the field of Healthcare innovation, such as Medication Adherence and Care Delivery, the field of clinical trials is not a topic that immediately comes to mind when thinking of the Israeli innovation ecosystem. Today, only a handful of startup companies in Israel actively pursue solutions focused on clinical trials. An initial keyword search often leaves one to wonder why such a prolific ecosystem as Israel does not produce more solutions in an area that is ripe for disruption. At the same time, the Israeli innovation ecosystem is a global leader in innovation in both Life Sciences and Healthcare,7 and is currently experiencing a diffusion of digital solutions into these two fields, from more mature fields (e.g. Cybersecurity, Retail and Fintech). In other words, what is going on here?A deeper inspection provides a possible answer. While many companies do not consciously pursue disruption of clinical trials, the companies included in this report demonstrate that global companies can powerfully implement many of the technologies found in Israel in their own clinical trials, with varying degrees of adjustment required.

7. Israeli Advanced Technology Industries, Israel's Life Sciences Industry IATI Report 2018.

While many companies do not consciously pursue disruption of clinical trials, the companies included in this report demonstrate that global companies can powerfully implement many of the technologies found in Israel in their own clinical trials, with varying degrees of adjustment required.

The framework adopted by this report painted each company with the different colors of clinical trials: Some companies leverage their digital capabilities to provide Patient or Investigator Input, while others possess algorithms that can empower investigators’ capacity to make sense of the data they gather. The specific contribution notwithstanding, this report’s analysis indicates the existence of a hidden, quasi-ecosystem that can assist global companies to overcome the increasing pressures that are associated with clinical trials. Network effects and benefits that are often associated with ecosystems require more than the mere presence of startup companies. For the same reason, global companies will not capture the full potential of Israel by the virtue of their presence, or by simply conducting clinical trials here, or for providers to adopt random digital technologies for healthcare. An active, deliberate conversation about going digital in the context of clinical trials is missing. In the same fashion, a conversation about how to solve the pressures that CROs and biopharma companies are experiencing is missing. More than anything, the industry needs better, bolder conversations about the role of open innovation in clinical trials, in the spirit of conversations that take place in Cybersecurity, Retail and Healthcare. A conversation is not the endgame, but the start.Additionally, this report found that a large number of the startups surveyed fit into more than one category, with their executives showing willingness to serve clients in any way their technology allows, be it in the areas of Investigator Input, Recruitment, and Digital Endpoints or, most importantly, all of the above. This suggests that startups’ attitudes, and perhaps technologies, lean

towards being a platform rather than a point-solution. Lack of focus notwithstanding, this flexibility can greatly serve global clients as they are pursuing clinical trials’ innovation.

Many Israeli startups are now focusing on genomic information aggregation and analysis. Using such tools, biopharma companies can synthesize new products more quickly and run quality tests at a fraction of the current cost and time. The use of rapid genomic sequencing can also add efficiency to analysis and testing. Additionally, trial design may be enhanced using genomic databases and genome sequencing techniques.

#1Biopharma companies can utilize Israel’s advanced genomic databases and technology to improve trial design and increase clinical efficiency.

Guiding Principles for Global Companies:Clinical trials are part of a complex tapestry of issues, processes and, lately, technologies, that are rapidly changing in the Life Sciences and Healthcare industry. While startups abound, searching for the right solution can be a costly endeavor that requires resources and endurance. Without guidance the search can lead global companies to the undesirable result of passing on the opportunity altogether.These suggested principles will help start the conversation can help companies form their strategies with respect to the Israeli startup ecosystem. When experimenting with open innovation in the field of clinical trials, the following guidelines can assist global companies take their first steps in Israel, form a strategy and decide on focus areas.

Some Israeli startups can now predict the likelihood of trial success using cognitive technologies, while others are able to aggregate patient information and automatically match subjects to trials. The Israeli ecosystem is home to unique machine learning startups that improve patient therapy adherence, which is a major global improvement that drives product value.

As technology in the R&D space improves, biopharma companies are increasingly focusing on consumer experience to remain competitive. As IoT connected devices allow real-time patient input, and crowdsourcing technologies make feedback easily accessible to biopharma companies, such players can turn their sights to the Israeli ecosystem, which offers many innovative startups that help bridge communication gaps between patients and Clinicians. Indeed, many solutions in Israel leverage the advancements in User and Customer Experience and in digital technologies. These advancements complement new approaches to customers, such as the Omni-Channel approach. This combination of technologies and approaches change, for example, Therapy Adherence and Trial Efficiency.

AI-driven technology will raise the current quality standard for clinical data analysis.

As digital R&D becomes more patient-centric, startup companies are similarly growing their IoT, crowdsourcing, and connected device capabilities to increase patient engagement.

#2 #3

With digital endpoint technology and connected devices, clinical trials can now accumulate clean and reliable real-world data without electronic paperwork. As the role of Real-World Data is increasing,8 many Israeli technologies can power biopharma companies’ efforts to collect and analyze such data. In the future, digital endpoints and captured biometric health outcomes could shift the clinical ecosystem toward value-based contracting, increasing productivity and reducing costs.

#5Companies creating streamlined data collection systems will advance study precision.

Through E-Source, E-Consent, and robotic process automation, companies can eliminate repetitive procedures regarding consent and medical coding. Streamlining this infrastructure can accelerate clinical workflow timelines. Israel’s plethora of AI and cognitive technologies serves fertile ground to accelerate operational excellence of clinical trials. While many are not captured in this report, most generic technologies could be easily redirected towards the clinical trial landscape.

Biopharma companies can increase execution efficiency by taking advantage of Israel’s excellence in process automation.

#4

8. Brett Davis, Jeff Morgan and Sonal Shah, The Future of Real-World Evidence, Deloitte Center for Health Solutions 2018.

Guiding Principles for Israeli Startup Companies:As biopharma companies and CROs struggle to implement technologies and make sense of the ever-shifting landscape, it is important for startup companies to keep in mind that the road towards digitizing clinical trials is a two-way street. In other words, startup companies can, and should, learn how to tailor their efforts, offerings and stories in ways that will make them more attractive to the larger players, in efforts to attract clients, collaborate and form partnerships, and develop new products. This strategy will help awaken this quasi-ecosystem and leverage network efforts that are needed for Israeli startup companies to play a pivotal role in overcoming the challenges clinical trials face on a global scale.A mirror image of the previous section, guiding global companies in their voyage into the Israeli ecosystem, the following guiding principles can provide startups with ideas about their own engagement with global companies.

Digital technologies can transform clinical development by incorporating quality data from new sources, improving patient care through real-time updates, and creating assisting technologies to analyze collected data. Digitized processes can also improve clinical execution by reducing the amount of manual effort needed on a variety of tasks, thus driving greater product value.

#1Startups should focus on creating new data collection mechanisms that eliminate the need for separate Clinical Trial Master File and Electronic Data Capture systems.

Biopharmaceutical companies rarely have time to understand the continuously evolving technological landscape and regulatory processes, resulting in slow integration of digital technologies. Startups can provide insight into disruptive digital R&D and regulation of their specific domain expertise. Additionally, Israel’s startup ecosystem is rich in core technologies that are vital to the digital R&D revolution, and can offer innovative solutions relating to data centralization and patient care.

Current data platforms have siloed systems for data collection that make it hard to interpret results efficiently. As biopharma companies start to think about the future of digital R&D 3-10 years from now (securing or delivering data through Blockchain, analyzing results with Natural Language Processing, running predictive virtual trials, for example), they first need to create fundamental, integrated tools that eliminate the multiple-system infrastructure. This growth could come from cognitive technologies, genomic-driven insights, or connected devices. Startup companies that are able to offer large players centralized data infrastructures can enjoy enhanced attention and willingness to engage from an industry otherwise conservative and closed.

Startups can educate biopharma companies on the intricacies of emerging technologies.

The future of clinical innovation relies on strong, centralized data infrastructures.

#2 #3

Conclusion: Israel as a Catalyst for Clinical Trials

Throughout this report, the role that Israeli technologies can play in the global pursuit to reduce clinical trial costs and improve results was examined, in the ultimate goal to accelerate the process for bringing safe and effective treatments to the world at large. This report suggests, leveraging a previously established Deloitte frameworks, that Israel can play a pivotal role in this pursuit, by highlighting technologies that digitize the four stages of clinical trials: Trial Design, Trial Set-Up, Trial Conduct and Study Closeout.The report’s analysis shows that Israel is home to a reservoir of technologies that could easily be applied in the clinical trial process and support the global pursuit. This reservoir, or quasi-ecosystem, means that Israel should be one of the first places to look for open innovation in clinical trials. Israel’s track record as the Startup Nation,9 coupled with a

Israel is home to a reservoir of technologies that could easily be applied in the clinical trial process and support the global pursuit.

9. Dan Senor and Saul Singer, Start-up Nation: The Story of Israel’s Economic Miracle 2009.

vibrant Life Sciences and Healthcare ecosystem and the increasing diffusion of digital technologies across industries create a “perfect storm” that will allow biopharmaceutical companies and CROs to fuel their efforts to digitize clinical trials effectively, and perhaps cheaply.This will not be easy. A conservative industry coupled with a nimble, yet technology-focused quasi-ecosystem may not be the most intuitive combination to produce the breakthroughs clinical trials so desperately need. This report suggests that what is needed is a conversation, an interactive discussion about how to work together in harmony. Indeed, the industry will need guidance on where to focus and how to engage with startup companies, and how to build successful use-cases that will allow the effective implementation of digital technologies. At the same time, startup companies must be precise and armed with knowledge when approaching the industry. In turn, this report offers a few conversation starters.While the day-to-day operations of clinical trials can be as daunting and mundane, the industry needs to take a step back and recall that infusing clinical trials with digital technologies could save this day-old method from its perils, and immensely contribute to human health. This effort is not just about the bottom line, but more importantly, about improving patient outcomes. With stakes being so high, let us not let humanity foot the bill.

The authors of this report wish to the thank Dawn Anderson for the inspiration for this report, for her support throughout the process of this report, vast knowledge and expertise with clinical trials and for her helpful comments; Natasha Elsner, Sonal Shah and Wendell Miranda for their guidance, expertise and assistance. Their inputs and insights greatly contributed to the design, structure and thesis of this report.The authors would also like to thank Max Delahanty for providing editorial guidance and for helping to perfect this report through different editions, and to Or Elmaliah for her orchestrating the design and marketing for this report.

Acknowledgements: Author

Contributor to the Report

Additional ContactsArod Balissa Life Sciences & Healthcare Domain Manager, Innovation Tech Terminal, Deloitte IsraelAbalissa@deloitte.co.il

Sharon Cohen PartnerLife Science &Health Care Industry LeaderDeloitte Israel sharonc@deloitte.co.il

Amit HarelDirectorInnovation Tech Terminal LeaderDeloitte Israel aharel@deloitte.co.il

Anna HaighSummer Analyst Deloitte Innovation Tech Terminal Student, Stanfordahaigh@stanford.edu

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