By Deborah Borfitz

January 21, 2025 | Like two other major advancements in the past 200 years, the stethoscope and X-ray imaging, digital health technologies (DHTs) are giving “a whole new perspective” on human health, according to Kai Langel, CEO of DEEP Measures. Earlier innovations enabled doctors to hear and see inside the human body, and the addition of digital measures of health offer a view into people’s everyday lives when they’re outside the clinic setting.  

DHTs are already being used to gain objective, real-time insights about experimental compounds to inform internal go/no-go clinical development decisions, he says, but the holy grail is to use the insights to get drugs approved based on meaningful aspects of health improvements that affect the way people live their lives. This is “where the floodgates start opening up,” and patient-centricity is going to need more than lip service. 

Before thinking about specific technology to use, everyone should be clear on what should be measured and why it matters to patients, Langel says. “It is the starting point for everything.”  

Langel will be driving the point home during a unique “storytelling” style panel session at the upcoming Summit for Clinical Ops Executives (SCOPE) 2025 in Orlando. The subject of the story is a real patient with atopic dermatitis suffering from nocturnal itching, and what it takes to integrate a digital device into a clinical development program to affect this outcome. 

Panelists are Martha Azer, Pharm.D., an associate director of regulatory policy at Johnson & Johnson (J&J); Carrie A. Northcott, Ph.D., head of digital sciences at Pfizer; Bola Grace, Ph.D., senior director of digital biomarkers at GlaxoSmithKline; and Scottie Kern, executive director of the eCOA Consortium at the Critical Path Institute (C-Path). J&J, Pfizer, and GSK are customers of DEEP Measures.  

The objective of the session is to paint a holistic picture of where everyone fits into the supply chain for deploying DHT in a study and how it impacts patients, says Langel. “Too many people are only focused on specific steps on the journey related to their function, like the technology, or focus only on the next trial and they really need to think of all the steps along the way to relevant impact with patients.” 

Questions posed to the panelists will initially focus on what life looks like for the patient and how the disease impacts the family, what Langel calls the "first chapter of the story,” followed by how to measure all that, present the data to regulators, harmonize the evidence-building process between different companies, and partner with regulatory authorities to create a more effective ecosystem. That will keep the dialogue squarely on how those high-impact issues would be addressed by an intervention—and “all the things that need to be in place to deliver a final solution to this patient,” he says.   

The same story presented at the conference could be replicated with other patients and disease types, Langel adds. It’s the approach taken by DEEP Measures to optimize the use of DHTs by helping everyone in the ecosystem “execute all the right steps in the right order to make sure that we collectively use our collective resources... to bring value to patients,” he adds. The idea here is to avoid the costly and time-consuming “false starts” that result when beginning from the wrong place. There are also several opportunities on the journey to leverage pre-competitive collaboration as the best strategy to get the work done.  

Not every new DHT is of value to patients in a way that is meaningful to them, even if the readouts can be trusted. Innovations sometimes have “a solution in search of a problem” which, in some cases, is never found, Langel says.  

That is unlikely to be a problem for solutions measuring nocturnal scratch in patients with atopic dermatitis where sleep disturbances are a confirmed meaningful aspect of health. Attendees of SCOPE will be invited to the exhibit booth (202) of Replior, another DEEP Measures customer, to have access to both DEEP and Replior experts to field their questions about DHT adoption and utility in general and learn more about a new smart-ring-based modality Replior is developing with DEEP’s support to measure scratching activity.  

Difficult Journey

Patient-centricity is certainly important to the U.S. Food and Drug Administration (FDA) when reviewing marketing submissions, says Langel, as suggested by drug development guidance documents it has issued. Regulators now expect to see more evidence that medicines are addressing issues patients most care about and are perhaps voicing to their doctor, such as knee pain that prevents them from walking their dog or involuntary movements that make it difficult to drive. 

For the first drugs to be approved based on patient-centric DHT-derived precision measures, digital measures will have to be primary or secondary endpoints in clinical trials, he continues. Pharmaceutical companies need to think beyond the context of a single trial, ensuring consistent evidence generation for the entire program and ideally achieving more harmonized measures across the entire ecosystem. This will help support regulatory decision-making and ensure fair comparison of evidence supporting a diversity of interventions developed by different companies.  

A drug program involving multiple trials often runs for more than a decade and technologies change over that period and older versions can become obsolete, making it hard to generate consistent evidence, points out Langel. The added conundrum, when viewed across companies and their clinical drug programs, is how regulators are to make apples-to-apples comparisons to identify the best drugs deserving of marketing authorization. 

To gain that level of regulatory acceptance will require harmonizing the way DHT performance gets measured and evaluated, he says. Getting a drug approval based primarily on this new kind of evidence is an extremely high-value opportunity that comes with a lot of significant barriers that need to be collectively addressed. 

The Digital Medicine Society has been one of the key coordinating parties, Langel adds, by bringing companies together to align on terminologies and the validation of novel digital clinical measures. DEEP Measures has developed technology and services that help with this kind of coordination and development work in practice, supporting both collaborative approaches as well as individual company implementation in specific drug programs.  

As such, DEEP Measures frequently act as a matchmaker between pharmaceutical companies, technology developers, and academia. Having a fit-for-purpose technology is, by itself, not enough to solve the complex of real-world problems faced by patients but must be supported by a robust dossier of analytical and clinical evidence, he says. 

Among the most valuable use cases for DHT adoption in clinical trials are interventions for neurodegenerative brain disorders such as Alzheimer’s and Parkinson’s that progress slowly and limit activities of daily living in ways that are difficult to measure in the clinic, says Langel. Likewise for mental disorders like depression, patients typically relapse at some point and catching those signals at the right time with the right intervention would be hard to do in an institutional setting. 

First Movers 

Langel says he landed in the industry “accidentally” 25 years ago as one of the early pioneers in electronic clinical outcome assessments when he began building electronic patient diaries for clinical research. He subsequently started the world’s first decentralized trials company that created a platform for remote clinical trials. 

Being a forward-thinking pioneer, Langel found his way to the innovation team at Johnson & Johnson in 2017, where he observed firsthand some of the challenges in developing digital measures, he continues. DEEP Measures started as a theoretical framework for coordinating and cataloging the necessary activities and it quickly gained traction with all the relevant stakeholders, he reports. That prompted Langel and his colleagues to solve these challenges with a technological solution and eventually to spin out an independent company from Johnson & Johnson that could serve the entire ecosystem to drive adoption of digital measures in the clinical development space. 

Hundreds of digital health technologies are in development across a range of use cases, Langel says. In addition to sensors for detecting nocturnal scratching seen in patients with atopic dermatitis and psoriasis, other high-value areas include measures of cognition and voice biomarkers for people with neurodegenerative disorders. 

Many tech companies can’t even imagine some of the potential applications of their devices, says Langel. It’s unlikely that the developer of a bed sensor would know about the utility of its tool for measuring sleep disturbances in post-menopausal women, he offers as an example. The solution could in fact be applied to various use cases where the definition of the measure would differ depending on the context of use and population.  

A more coordinated approach to the development and deployment of DHTs could ultimately help regulators be more efficient, says Langel. At present, companies measuring the exact same thing are approaching the FDA with repetitive questions that DEEP Measures can consolidate and offer a more effective workflow for all parties.  

The U.S. is the leading market for DHTs, which is where most of the development work is being done, he adds. The FDA is also a key thought leader whose moves regulators elsewhere tend to follow. The agency is actively collaborating with other parties to improve methods by which digital measures are developed, and evidence is reviewed, by the agency.  

In a proof-of-concept project with the European Medicines Agency (EMA), European Federation of Pharmaceutical Industries and Associations, and industry, DEEP Measures was co-creating and testing new methods and concepts to inform the optimization of the EMA’s Qualification of Novel Methods Procedure. 

Besides the EMA and the FDA, several other authorities are potentially involved in reviewing similar solutions and evidence, including global regulators and, in the EU, health technology assessment bodies and notified bodies. DEEP Measures, along with its member companies, are coordinating strategies to improve transparency and develop efficiencies between these different authorities, Langel says.