In an interview with PharmaShots, Ben Schlatka, Vice President, Digital Biomarker Solutions at Medidata share his views on the Agreement with Labcorp to expand decentralized clinical trial capabilities and digital biomarker discovery using Medidata Sensor Cloud

Shots:

• The companies collaborated to advance the use of medical-grade sensors & accelerate biomarker discovery in clinical research including an at-home version of 6MWT to measure functional capacity in patients with HF, pulmonary conditions, physical function disorders & rare diseases
• The companies will use Medidata Sensor Cloud to process sensor data within clinical trials across Labcorp’s clinical trial portfolio & advance DCT capabilities. The agreement will expand the digital biomarker discovery for medical devices and therapeutic areas
• The agreement focuses to develop a library of digital biomarkers to advance therapeutic research & digital diagnostics

Tuba: Can we know details of the deal/ collaboration with Medidata (upfront, milestones, overall deal)

Ben Schlatka: The collaboration between Medidata and Labcorp is a multi-year commercial relationship focused on supporting medical-grade sensors in clinical research. This is a first-of-its-kind collaboration around developing new digital biomarkers—perhaps even a portfolio of them. The first effort will be focused on an at-home 6-minute walk test, intended for cardiovascular applications.

The work is important because it aims to create more quantitative rigor to what had been traditionally subjective clinical tests and to move their context out of the clinic and into the home, where the disease occurs.

The 6-minute walk test is used widely across therapeutic areas, particularly in the cardiovascular space. The Labcorp/Medidata collaboration will create a digital version of this tried-and-true test to be used more broadly and frequently, with higher accuracy and insight, in remote out-of-clinic settings.

Tuba: Why Medidata, can you tell us what makes Medidata an ideal candidate for such a deal/ collaboration for Labcorp?

Ben Schlatka: Medidata has made a significant effort in building a globally scaled technology platform for connected medical device data, called Medidata Sensor Cloud. Our launch of the Sensor Cloud Network is intended to bring best-of-breed collaborators across sponsors, CROs, analytics providers, and sensor companies to develop new digital biomarkers in the context of clinical research.

Tuba: Do you think that this new model of Sensor Cloud can hasten biomarker technology and can be constructive for the patients?

Ben Schlatka: Absolutely. Medidata Sensor Cloud addresses some of the key limitations for using connected medical device data and sensors in clinical research, mainly technical, operational, and analytical barriers.

Technical challenges consist of varying data models, varying APIs, different regulatory approvals, and different ways of producing metrics—each of which is often unique to an individual device platform. Those provide significant challenges to sponsors when trying to globally deploy those devices in a research program.

Sensor Cloud addresses these challenges by pre-integrating high-quality medical devices and ensuring that data flows into a globally scaled private and secure repository, making that data available for analysis.

Operational challenges are the pragmatic ones. How do you train sites? And further—How do you train patients and support them in the context of a global trial, when you’re doing something in an unstructured and unsupervised setting, with a device they may not be familiar with?

Medidata has a Professional Services team, along with best-of-breed device partners, that offers a range of expertise to address those considerations through Sensor Cloud.

Analytical challenges include being able to make meaning out of sensor data in the context of the patient’s journey and during a clinical research program. This is often difficult given the technical and operational challenges mentioned, but also due to the silos that occur in clinical research programs.

Sensor Cloud connects that sensor data to other relevant aspects of the patients’ clinical data in a research program to perform a more holistic analysis of that sensor data.

Tuba: Discuss the home version of the 6-Minute Walk Test?

Ben Schlatka: Medidata and Labcorp are seeking to do a couple of things about the at-home digital 6-minute walk test. The first is to take the test more reliable and replicable, using medical-grade digital technology. The second is to switch the context in which the test is used from an in-clinic environment to an at-home environment - as the home is where the disease occurs - to give us a better window into patient performance in an unstructured, unsupervised setting. The last is to add some additional metrics to the 6-minute walk test, beyond just distance and time, that we believe will give us greater insight into patients’ health and wellbeing as it relates to both disease progression and treatment effect in a trial. 

A simple example would be adding key vitals to the distance measurement of the 6-minute walk test. It may sound simple, but it provides an entirely different lens to look at patient progress and function through a tried-and-true, well-understood test.

Tuba: What are the features of the 6-minute walk test being developed, how is it going to be different from something we usually see in the clinics?

Ben Schlatka: We’re switching the context that the test is performed in from clinic to home. Adding the ability to do this with digital tools in the home allows us to test a lot more frequently than a traditional protocol. Also, we’re incorporating additional physiological metrics to give us deeper insight into the patient journey.

Tuba: Can we have a flash upon your future goals of building a library of digital biomarkers?

Ben Schlatka: Medidata intends – both directly and through collaborations with innovators – to build clinically validated software packages that may even have a regulatory framework around them, thereby providing additional insight to medical-grade sensor data in the context of clinical research. We will be building this library on general assessments that have broad applicability, like the 6-minute walk test, but also in specific therapeutic areas where we’re looking at novel disease symptoms and patient-reported outcomes in the context of specific diseases.

The development of digital biomarkers is a process. You start by asking whether you can measure something, then ask if it has clinical meaning, and ultimately, whether you can repeat that measurement at a higher level of statistical relevance within a patient population. The ultimate endpoint of that journey would be a regulatory clearance on a software package that looks at sensor data and produces a clinical dashboard of relevance.

Tuba: How this sensor cloud technology will be different from [traditional] clinical trial experiences?

Ben Schlatka: A traditional clinical trial experience is often a site-based clinician or health care professional facilitated experience that is episodic and can be subjective. Medical grade sensor data, delivered by Medidata Sensor Cloud, has the opportunity to increase the frequency of data collection and quantitative rigor, reduce clinician error, and ultimately produce new insights while reducing the burden on patients. This is the promise of decentralized clinical trials—offering new context and new data that is rigorous, objective, repeatable, and flexible in the context of the patient’s life.

Tuba: Are you planning to work on more technologies associated with digital health? If yes what could be those?

Ben Schlatka: Yes, as an example, the collaboration between Labcorp and Medidata has had an immediate impact on the world of clinical research. Both companies see the promise of bringing new digital measures to the broader health care market over time.

As we develop new digital biomarkers and insights into patient health in the context of clinical research, it's the perfect testbed to be able to bring those into the world of clinical practice. So, what may be a digital assessment that gives us insight into a patient’s cardiovascular health in a drug program could ultimately become a digital diagnostic that assesses a patient’s cardiovascular health, or a digital companion that manages progress by taking a commercial therapy to recover from a health care event, in their home environment. 

Tuba: What is Medidata’s ultimate hope for the Sensor Cloud offering?

Ben Schlatka: Our plan for Medidata Sensor Cloud is that it becomes the industry standard for collecting and analyzing medical-grade sensor data, in the context of clinical research, and becomes the platform of choice for developing new digital biomarkers across a variety of diseases.
The interactions you have with a physician are not the whole story of your health. So, if you can passively collect more information and interpret it in meaningful ways, as if the physician was with you all the time, without violating your personal space and privacy, then that is extremely valuable as a construct in health care.

Source: Medidata

About Author: Ben Schlatka is the Vice President, Digital Biomarker Solutions at Medidata. He holds an MBA from the Harvard Business School and frequently lectures on the formation of disruptive science-based businesses. Ben earned a BBA from Isenberg School of Management, UMass Amherst. He is passionate about using digital technologies to transform the lives of patients, in both clinical research and clinical practice

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