Roche’s VP Digital Health, Stephen Ranjan, on the importance of clinical validation in the age of AI

Blog roches vp digital health stephen ranjan on the importance of clinical validation in the age of ai

In the latest installment of our BrightInsight Digital Health C-Suite Series, we spoke with Stephen Ranjan, vice president of digital health at Roche's Personalized Healthcare Division, about the importance of clinical validation, Roche’s approach to AI, and the inspiring success of digital health in the diabetes space. Here’s a recap of the discussion. You can watch the interview here, and other interviews in the 2024 JPM Digital Health C-suite series here.

Digital’s role in personalized care

Personalized healthcare is about providing each individual patient with the right treatment, based on their individual characteristics. This can be either from a provider perspective, helping them find the right treatment using data, or from a patient's perspective, using their lifestyle and other comorbidities to really help them better manage their disease.

AI and digital health continue to play a key role in providing each individual with the correct treatment. "We see it when it comes to patient identification or risk stratification, being able to look at patient data, especially the electronic health records data, and really identify the right patient." That can be for disease screening, or for patient selection for treatment.

In disease management, patient data from digital health solutions enable better support for patients once they're on treatment.

"For both of these, you need the AI technology to help anticipate or predict what's next best for that individual."

Why clinical validation is key for SaMDs

Companies developing Software as a Medical Device (SaMD) products need to demonstrate specific, positive impact on patient outcomes. "Before [a medication] comes to the market, we're investing a lot in making sure the treatment is safe and efficacious for our patients. In the same way, the digital health technology has to go through that same clinical validation."

Regulatory agencies naturally play a key role, as evidenced by a state of digital health guidance documents put out by the U.S. Food & Drug Administration (FDA) in recent years, covering topics including clinical trials for SaMDs, and working in conjunction with pharmaceutical products. "We'll continue to also see evolution in how we do the clinical validation, different types of techniques to take advantage of decentralized ways of collecting that data and generating the necessary clinical evidence."

Roche’s approach to digital health and AI

The Swiss pharma giant looks at digital health from an end-to-end perspective, from early drug discovery to market entry. "We are looking at technologies that help us do better [not only] in drug discovery, and with target selection, but all the way through the clinical development programs." The goal is understanding how digital health technologies can best drive better outcomes in conjunction with pharmaceutical therapies. For a traditional pharma outfit, that entails change management to help internal stakeholders understand the relevance of new technologies, and how they fit into the existing business. "There's a lot of education and upskilling that we have to focus on internally. But more importantly, as we think about clinical validation, we also have to think about how to adapt and evolve our own internal processes." Those are well-defined for the drug development process, but less so when it comes to adding new technologies. "How do you balance the risk? How do you make sure that you're introducing this new technology at the right time? This is where our group helps make sure that we're selecting the right technology at the right time of the clinical development program."

Roche’s expertise in the AI sphere extends into both its pharmaceutical and diagnostics operations, especially in drug development, "really looking at how to use AI or generative AI to help identify hard-to-find targets, or how to tackle complex diseases."

Inspiration from the diabetes space

Former experience in the Type 1 diabetes space with closed loop systems, which combine a drug treatment, a drug delivery device, and SaMD, serve as a North Star of sorts. "For me, it's this sort of integration of all these capabilities that we as Roche are kind of excited about, and I see this kind of expanding to other therapeutic areas, where at the end of the day, if we as an organization can find the way to put these together, patients are benefiting. They're having to think less of their disease and live their life."

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