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EBOOK Industry’s Leading Digital Health Platform Insights on Digital Health Technology Survey 2016: How Digital Health Devices and Data Impact Clinical Trials
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May 30, 2020

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Page 1: Insights on Digital Health Technology Survey 2016pages.validic.com › rs › 521-GHL-511 › images › Digital_Health...EBOOK Insights on Digital Health Technology Survey 2016: How

EBOOK

Industry’s Leading Digital Health Platform

Insights on Digital Health Technology Survey 2016:

How Digital Health Devices and Data

Impact Clinical Trials

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EBOOK Insights on Digital Health Technology Survey 2016: How Digital Health Devices and Data Impact Clinical Trials

Table of Contents01 Executive Summary

02 Key Findings

03 Demographics

04 The Role of Digital Health Technologies in Clinical Trials

04 Digital Data: From Mobile Apps to Wearables

06 The Role of Digital Health Technologies

07 The Business Drivers Behind Digital Health

09 Selecting the Right Endpoint

10 Bringing in the Benefits

12 Clinical Outcomes: Which Therapeutic Areas Offer the Biggest Impacts

13 The Challenges of Digital Health

15 Summary and Conclusions

16 References

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EBOOK Insights on Digital Health Technology Survey 2016: How Digital Health Devices and Data Impact Clinical Trials 1

Executive Summary

The digital health revolution—aided by the growth in connectivity, the global availability of smartphones and the decreasing size of sensors to make wearables smaller and more discrete—has provided drug devel-opers access to a wealth of real-world, participant-generated data that is enabling better insights and streamlined clinical trial processes.

Developing drugs is a challenging process. Only around one in 10 drugs in Phase 1 actually make it through to the market.1 This high attrition rate is one factor contributing to the high costs of drug devel-opment. According to the Tufts University Center for the Study of Drug Development, developing a drug from bench to market costs an esti-mated $2.6 billion.2

Late-stage clinical trials make up a large portion of those costs, as they involve larger numbers of patients and can run for longer durations of time. This means recruitment and retention of patients and the collec-tion of high quality data is absolutely vital.

In clinical trials, patients are carefully selected to meet ultra-specific criteria and their adherence to the treatment regimen is closely moni-tored. This is not the case outside of trials in the real world, where life gets in the way and people are all shapes and sizes, doses are missed and other conditions can exacerbate disease progression.

Due to these variables, real-world outcomes may not reflect those seen during study conduct. In light of this reality, regulators, payers and providers are increasingly demanding real-world data that demonstrates the efficacy of the drug in the everyday world.

Against that backdrop, Validic conducted a survey of the BioPharma Dive readership, including 166 biopharma and life sciences industry researchers, executives and technology/software professionals to provide insight into the benefits and challenges of using digital health data and devices in clinical trials.

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Key Findings

1. The use of digital technologies is growing: Over 60 percent of survey respondents stated they have used digital health technol-ogies in clinical trials and an impressive 97.4 percent plan to use digital technologies more in clinical trials in the next five years.

2. Applications are moving from mobile apps to wearables: The most commonly used devices in clinical trials currently are mobile apps and in-home clinical grade devices. Future use is likely to focus more on wearable activity trackers and sensors. This maps to increased use of these types of devices by consumers. Less than 3 percent stated they would not use devices and digital data in the future.

3. The roles of digital data are changing: Currently, the use of digital health technologies is mostly focused on recruitment, remote patient monitoring and medication adherence. There is some use in post-market research and fostering patient communities. One hundred percent of respondents saw technology as improving medication adherence. Patient communities are expected to be one of the biggest growth areas.

4. Business is driving digital health: Three of the biggest drivers selected by respondents—reducing trial costs, streamlining trial processes and demonstrating real-world efficacy—are all driven by the bottom line: cutting drug development costs and ensuring an adequate return on investment. Patient-centricity, the increased focus on the patient experience, is also a key driver.

5. Finding the right endpoint is key: More than two thirds of individuals surveyed thought improving medication adherence was the most important outcome for drug developers, as patient recruitment and retention are challenges across clinical development.

6. Real-time data access is an important benefit: Real-time informa-tion, flagged by over half of respondents as one of the top benefits of digital data, supports early decision-making in drug development. This frees up drug developers and sites to monitor the responses of patients more closely.

7. Chronic disease remains important: Chronic conditions, particu-larly cardiovascular disease and metabolic disorders, are a focus for many pharma and biotech companies because of the size of the market and the increasing aging population. Seven in 10 of those surveyed thought digital health data could have the greatest impact in improving care for chronic disease populations.

8. Challenges remain: The use of digital data and devices in clinical trials is still relatively new. Respondents were most concerned about the accuracy of data generated by digital health devices.

Real-time information, flagged by over half

of respondents as one of the top benefits of

digital data, supports early decision-making in

drug development.

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EBOOK Insights on Digital Health Technology Survey 2016: How Digital Health Devices and Data Impact Clinical Trials 3

Demographics

The survey received responses from 166 people. Over 40 percent of respondents were from pharma and biotech companies, with the remaining responses coming from contract research organizations and technology and software providers.

Because of the specialized skill set needed to source and analyze digital data, many companies are outsourcing this part of the drug development process. These results reflect the Cutting Edge Information 2015 survey that found that around 70% of companies were outsourcing their data capture, and about half were outsourcing its analysis.3

What is your role with the company?

31% Executive leadership

23% Clinical operations

15% Innovation

13% Sales

10% Marketing

08% IT

43%PHARMA/BIOTECH

What kind of company do you work for?

57%CRO, TECHPROVIDER,OTHER

What is your region of operations?

North America

Central or South America

Western Europe

Central and Eastern Europe

AsiaGlobal

64%

3%5% 3% 3%

23%

0

10%

20%

30%

40%

50%

60%

70%

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EBOOK Insights on Digital Health Technology Survey 2016: How Digital Health Devices and Data Impact Clinical Trials 4

The Role of Digital Health Technologies in Clinical Trials

As technology becomes more accessible and affordable, the role of digital health data is growing in clinical trials. As of September 2015, there were at least 299 clinical trials using wearables, according to Bloomberg.3 Supporting that increased prevalence, two thirds of survey respondents have already used digital health technologies in clinical trials, and almost all expect to increase their use within the next 5 years.

Digital Data: From Mobile Apps to Wearables

Mobile apps and in-home clinical-grade devices were used most commonly in clinical trials, closely followed by wearable activity trackers and sensors.

Mobile apps, which are downloaded to tablets or smartphones, are likely to be accepted by trial participants given higher levels of famil-iarity with apps. In 2015, almost two thirds of people in the U.S. owned a smartphone and almost half owned a tablet.4,5 Health-related apps on smartphones are also very popular.

Do you plan to utilize digital

health technologies more over

the next 5 years?

Have you used digital

technologies in clinical trials?

97%YES

3%NO

64%YES

36%NO

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EBOOK Insights on Digital Health Technology Survey 2016: How Digital Health Devices and Data Impact Clinical Trials 5

In a survey conducted in June 2015, 58 percent of smartphone users had downloaded a health-related app, and 41 percent had downloaded more than 5 apps. These included diet and physical activity trackers and apps that help people to learn exercises.6

In-home clinical grade devices, such as heart rate, blood pressure and blood sugar monitors, can provide teams running clinical trials with accurate and reliable data. If these devices are connected via Wi-Fi or Bluetooth, this data can be accessed in real time.

However, the vast majority of clinical devices are not currently Bluetooth-enabled. New technology leveraging optical character recognition (OCR), such as Validic’s VitalSnap™, can help overcome this

challenge. It enables users to capture health data from non-connected medical devices via their smartphone’s camera, and the data are auto-matically transferred to the clinician. This technology gives researchers the ability to integrate digital health data from the non-connected devices that are already clinically validated and being used in the trial.

Wearable activity trackers, which are already used in trials by around a fifth of respondents, can range from those similar to the consum-er-grade devices to sophisticated, FDA Class II accelerometers.

Wearables can be as small and as unobtrusive as a Band-Aid. MC10’s tiny adhesive biostamp, for example, incorporates flexible circuits, allowing for size reductions to the point the wearer hardly feels it.3 The presence of such trackers can also trigger reminders to be sent to patients to take drugs as required by the study.

Respondents were enthusiastic about the growing use of devices, with only a small number saying that they would not use devices in the

This technology gives researchers the ability

to integrate digital health data from the

non-connected devices that are already

clinically validated and being used in the trial.

Wearable activity trackers

I have not used digital

technologies in trials

Mobile appsIn-home clinical-grade devices (glucometer,

blood pressure cu�, etc.)

Sensors (injectable

sensors, sensor-enabled

pill bottles, syringes etc.)

67%

55%64%

53%

75%

33%

45%36%

47%

25%

Would like to include in future trials Have included in trials

0

20%

40%

60%

80%

100%

What kinds of digital technologies have you included orwould like to include in trials? Select all that apply.

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future. While the use of in-home clinical grade devices and mobile apps looks stable, the growth is expected to be in wearable activity trackers and in sensors.

To be effective, and to ensure that people continue to use them, any digital devices must be easy to learn and use, particularly for the senior population, who are most likely to have chronic conditions. Things to take into account include font size, color, size and shape of buttons, size of screens and the user’s experience of technology. This could also include incorporating the technology into something that is already familiar, such as a watch, clothing or contact lenses. It is important, though, not to make assumptions about the senior population and their use of technology – in 2015, 30 percent of Americans ages 65 or older owned smartphones, 55 percent owned a computer and 32 percent owned a tablet.5

Providing a benefit to the user will also increase effectiveness. Supplying patients with feedback on disease status or reminders to take medications, as well as ways to access information and education about the drug and/or illness, can increase engagement with digital health devices, creating a positive feedback loop.

The Role of Digital Health Technologies

Currently, the use of digital health technologies is mostly focused on recruitment, remote patient monitoring and medication adherence, with some use in post-market research and fostering patient communities.

Patient recruitment for clinical trials can be challenging, particularly in rare diseases where the communities of patients are small. Using digital communication and analysis of digital health data can allow researchers to find the individuals for their clinical trials and widen the trial’s geographic reach. Contract research organizations may also have their own repositories of patients who have already been involved in past trials and who may be willing to take part again. This speeds up recruitment and allows prescreening for specific inclusion and exclusion criteria. An example of this is Quintiles’ ‘Digital Patient Unit.’7

In 2015, 30% of Americans ages 65 or older

owned smartphones, 55% owned a computer

and 32% owned a tablet.

Would like to use Have used

0

20%

40%

60%

80%

100%

Have you used or would you like to use digital technologies for the following applications? Select all that apply.

Subject recruitment

Remote patient

monitoring

Post-market research

Medication adherence

Patient communities

54% 57%

68%61%

74%

46% 43%

32%39%

26%

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These communities also support long-term follow-up, which feeds into post-market research. Other sources of post-market digital health data include analysis of electronic medical records to track physicians’ prescribing patterns.

The Business Drivers Behind Digital Health

The cost of drug development continues to escalate, meaning the market prices of innovative drugs, particularly biologics, are often very high. As a result of this, payers, providers and consumers want proof of the value and cost effectiveness. If payers and consumers have to pay a high price, they want confirmation that the drug does what the devel-oper says, both in clinical trials and in the real world. This need for a demonstration of efficacy and real-world value is one of the key drivers behind the implementation of digital health.

Clinical trials are costly. In order to ensure a return on investment and an ability to invest in future research and development, companies are continually trying to reduce trial costs and streamline trial processes. Respondents to the survey selected these as key drivers for uptake of digital health.

By automating the collection of data through digital health devices and apps, researchers have access to more accurate and objective data, and quicker. This allows companies to focus clinical trial staff on more productive parts of projects, such as patient support or data analysis. Improving the collection of data streamlines clinical trial processes, ulti-mately helping to get drugs to market quicker.

What of the following are the key business

drivers for using digital health at your

company? Select all that apply.

73% Demonstrate efficacy and real- world value

68% Reduce trial costs

68% Patient-centricity

59% Streamline trial processes

46% Precision medicine

35% Competitive differentiator

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Remote data collection from digital health devices has the potential to reduce the number of site visits, which lowers the need to provide transport or reimburse travel costs. It also lightens the burden of clin-ical trial involvement for patients, as they won’t need to spend as much time traveling or miss other commitments, such as work, as often. This contributes to the patient-centricity of the study—another key driver highlighted in this survey.

Patient-centric clinical trials can also be achieved by listening and responding to patients within digital communities, from patient forums to Twitter and Facebook. While the analysis of this kind of free text data is challenging, it helps companies to understand what patients’ unmet needs are, and what will help them to stay compliant. Data mining and analytics companies can monitor these kinds of conversations and carry out analyses that provide companies with better insight.8 Patient-reported outcomes, where patients are encouraged to enter their own data and contribute to endpoints that are more relevant to their everyday experiences, could help improve patient engagement, although questions remain about accuracy.

Personalized or precision medicine is increasingly becoming part of everyday treatment, as more targeted drugs move through clinical trials and onto the market. Investment into personalized medicine is also growing, headlined by President Barack Obama’s national Precision Medicine Initiative.8

Access to digital health data is helping pharma companies develop targeted medicines by increasing their understanding of who their target patients are and helping them access small subgroups of patients. Digital health devices also allow researchers to run what are effectively one person clinical trials, where information from a lot of n=1 studies is collated and aggregated, potentially identifying treatment

Personalized or precision medicine

is increasingly becoming part of

everyday treatment.

97% of respondents believe that digital

technology will improve clinical trial

cost effectiveness.

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regimens for subsets of patients, or supporting development of drugs for rare diseases.8

Almost all of the respondents felt that digital health technology could improve the cost-effectiveness of clinical trials.

Selecting the Right Endpoint

Digital health devices and sensors can collect a variety of different types of data. One of the most challenging parts of clinical trials is ensuring patients adhere to trial protocols. This includes taking the drug at the right time (morning, afternoon, evening), under the right conditions (before or after meals) and at the right intervals and number of doses (one tablet three times daily, or three tablets once daily). Reflecting that reality, medication adherence was the most commonly chosen endpoint respondents wished to measure with digital health technologies.

Consumer grade activity trackers, such as Fitbit and Garmin, are commonly used by people who want to monitor their own health and activity levels. But these consumer grade devices are increasingly being used in clinical trials as well. As of June 2016, there were 104 completed, current or pending Fitbit studies in the ClinicalTrials.gov website, including studies in obesity, diabetes and cancer.

Due to user-friendly designs and features, including paired apps, these activity trackers tend to be more appealing to consumers, which increases the likelihood of long-term usage of and engagement with the device. Many activity trackers can also monitor sleep and heart rate, and some can also monitor blood pressure, which are all endpoints that between 51 percent and 59 percent of respondents felt were important.

What endpoints would you like to measure

with digital health technologies? Select all

that apply.

72% Medication adherence

67% Activity

59% Heart rate

54% Blood pressure

51% Sleep

46% Glucose

39% Pulse oximetry

33% Weight

28% Breathing

28% Temperature

23% Nutrition

23% Spirometry

10% Smoking

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Blood glucose is an important measure for people with both Type 1 and Type 2 diabetes, and its tracking is important in studies both in treatment and prevention. There are a number of digital health devices that can record data on blood glucose for home and clinical trial use, allowing monitoring that can help assess outcomes and provide feed-back for patients, especially those using insulin. Between a third and a quarter of respondents were interested in data on breathing, spirometry, nutrition and weight.

Bringing in the Benefits

Around half of the respondents picked real-time information as the most important benefit of digital health data. Getting real-time results from a clinical trial provides visibility into how the trial is progressing and flags any problems. This can allow early interventions (if allowed by the trial protocol).

Just under 25 percent of respondents felt digital data helped identify early signs of disease progression. Iterative or adaptive clinical trials allow modification of the parameters of the study based on observa-tions allowing for changes to dose or timing, the recruitment of different populations, or an early halt to a trial due to success or failure.

Access to real-time data will help inform these kinds of decisions. Knowing when to stop a trial early is also important in more traditional randomized controlled trials as well, as it reduces the risk of harm to patients. This kind of data also allows companies to make rapid go/no-go decisions about whether to continue development of a drug, which saves R&D money and allows selection of a subsequent drug candidate to proceed more quickly. This early decision-making was seen as a benefit by more than one in 10 respondents.

What are the 3 most important benefits of

digital data?

49% Real-time information

39% Automated and objective data collection

36% Remote monitoring

There are a number of digital health devices

that can record data on blood glucose for

home and clinical trial use, allowing monitoring

that can help assess outcomes and provide

feedback for patients, especially those

using insulin.

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Digital health devices, providing real-world insights and allowing the collection of previously unattainable real-world data, can also help support the development of pragmatic clinical trials. These evaluate the effectiveness of interventions in conditions more like the real world, not so much if and how a treatment works, but whether it works in everyday use.9

The automation of data collection was chosen as an important benefit by almost 40 percent of respondents. Being able to collect data auto-matically and continuously reduces errors in transcription by either the clinical trial staff or the patient and lowers the workload of both groups.

Automated data collection also helps people who have cognitive or physical impairments that inhibit their ability to manually record outcomes. Real-world and pragmatic studies can be expensive. But the cost saving benefits of digital health data, such as the automated data collection and remote monitoring could potentially offset these higher costs.

Remote monitoring also opens up clinical trials to patients who other-wise would not be able to take part, because they live too far from clinical trial centers, or who have physical, visual or cognitive impair-ments that mean they struggle with transport. This is reflected by the quarter of participants who selected ‘reduced office visits for partici-pants’ as an important benefit to digital health adoption.

Despite the apparent (and realized) benefits, it is still relatively early days for many companies in the world of digital health data. While a quarter of respondents have seen a return on investment, two thirds have stated that it is still too early to tell, which is largely due to the fact that digital health technologies haven’t been used in trials very long and

drug development cycles are on average 10 years. On a more positive note, no respondents answered ‘no’ to the question, Have you seen a return on investment for your use of digital health data?

Remote monitoring also opens up clinical trials

to patients who otherwise would not be able

to take part.

It is still tooearly to tell

NoYes I’m not usingdigital healthtechnologies

67%

23%

10%

0%0

20%

40%

60%

80%

100%

Have you seen a return on investment foryour use of digital health data?

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As well as saving money, another route to improving return on invest-ment, or at least covering additional costs, is using a digital health device or app as part of value-added services post launch. These can improve coverage by payers or providers by improving the cost-ef-fectiveness of a particular drug, as well as driving better adherence, resulting in ongoing income from repeat prescriptions.

Clinical Outcomes: Which Therapeutic Areas Offer the Biggest Impacts

Digital health devices have an obvious role to play in clinical trials of chronic disease as they can monitor changes over long periods of time. This is reflected in the finding that almost three-quarters of respondents selected chronic conditions as one of the areas where digital health will make the biggest impact. It also reflects the prevalence of chronic diseases in the U.S., which affect around half of all adults in the U.S. and are behind seven of the 10 leading causes of death. Around 86 percent of the healthcare spend in the U.S. is on chronic disease. Rising levels of these types of conditions is one of the drivers behind the ongoing increases in direct and indirect health costs.10

The predominance and significance of chronic disease is also exhib-ited in the selection of cardiovascular disease by almost two thirds of respondents and metabolic diseases by over half. CNS disorders were selected as a key therapeutic area by half of the respondents, while one in three selected oncology.

Aging populations mean an increase in cognitive diseases such as Alzheimer’s disease and other forms of dementia. In response, more companies are conducting clinical trials to look at therapeutics that can treat or reverse cognitive decline. Wearables and remote monitoring

Digital health devices also play a role in clinical

studies for prevention of chronic disease.

Digital health devices have an obvious role

to play in clinical trials of chronic disease as

they can monitor changes over long periods

of time.

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will play an important role in providing data from people whose age and cognitive deficits would otherwise make participation difficult.

Digital health devices also play a role in clinical studies for prevention of chronic disease, for example lifestyle factors such as diet and lack of exercise that increase the risk of obesity, diabetes and cancer.

On the other hand, a third of respondents selected acute conditions as an area which could benefit from greater adoption of digital health. Data generated from digital devices could be particularly helpful for proving the value of some of the newer curative therapies for serious infections by recording outcomes over longer periods. As an example, Gilead’s antiviral, Solvadi (sofosbuvir), hit the headlines because of its $84,000 price tag when it was approved by the U.S. Food and Drug Administration. Sovaldi is a potentially curative treatment for hepatitis C, effective in around 90 percent of cases. According to data from the PwC Health Research Institute, while the initial cost is indeed high, the savings over the patient’s lifetime due to better health should easily offset the high costs.11

The Challenges of Digital Health

The use of digital health data and devices in clinical trials is still relatively new, and drug developers have concerns about the challenges these new technologies will bring. Chief among respondents’ concerns was data accuracy. Looking at rank order, with 1 being the top concern, the greatest concern is the accuracy of data. This is frequently a worry for new technologies and is one which should be alleviated as technology improves.

In which therapeutic areas will digital health be

most impactful? Select all that apply.

73% Chronic conditions

63% Cardiovascular disease

53% Metabolic disorders

47% CNS disorders including Alzheimer’s disease

34% Acute conditions

34% Rare diseases

32% Oncology

21% Musculoskeletal disorders

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Digital health is growing fast, and there are many device manufacturers working in the space. This makes it difficult to discern which technolo-gies are most appropriate for the clinical trial setting. The responses to the survey reflect this confusion.

Once data has been collected, it is important to know whether it is stan-dardized and can be integrated into clinical trial platforms and systems. Otherwise, the data is either impossible to use or costly to analyze.

What are the key concerns you have when it comes to usingdigital health data? (Rank order, 1 being the top concern.)

1Accuracy of data

5Integrating data from devices into your clinical trial platformor system

921 CRF Part 11 compliance

2Standardizationof data

6Patients’ ability and willingness to use digital health devices

10I’m afraid digital health data will demonstratenegative results for the drug or therapy

3How to analyze the data in a meaningful way

4Knowing what device to use

7Physicians’ ability and willingness to use digital health devices

8Lack of guidance from the FDA on devices

11I’m afraid the FDA will reject trials results that include digital health data

Physicians can be reluctant to use digital

health devices, feeling inundated with pitches

to use this app for that drug or one device

for another study. This could hinder wider

adoption of digital technologies.

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Physicians can be reluctant to use digital health devices, feeling inun-dated with pitches to use this app for that drug or one device for another study. This could hinder wider adoption of digital technologies.

Companies should therefore emphasize ease of use for digital health tools, incorporating benefits for the physician as well as the patient.

Summary and Conclusions

Advances in digital health devices and data could allow drug devel-opers to carry out more detailed and real time analyses of data from clinical trials. This has the potential to increase the speed at which drugs progress through clinical trials, as well as accelerating decision-making by companies on which programs to pursue. While digital health remains new, with attendant concerns about how the resulting data can be used, there is significant optimism over how a digital revolution could transform drug development.

Advances in digital health devices and data

could allow pharma and biotech companies to

carry out more detailed and real time analyses

of data from clinical trials.

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10 Kvedar JC, Fogel AL, Elenko E, et al., Digital medicine’s march on chronic disease. Nat Biotechnol 2016.34(3): p. 239-46. 10.1038/nbt.3495.

11 LaMattina J, Forgotten In The Sovaldi Price Debate: Hep-C Patients And Healthcare Savings. Forbes 2014.

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