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July 4, 2023 | Interviews

Bayer Consumer Health’s EvendonChallis on the ‘Huge Potential’ of OTC
Digital Therapeutics, AIby David Ridley

HBW Insight speaks to Bayer Consumer Health's head of R&D and chief
scientific officer David Evendon-Challis about the opportunity presented bya new generation of OTC digital therapeutics as well as by AI-driven selfcare.

There’s been a “lot of talk about digital therapeutics within the consumer health industry,” withthe excitement around this space “growing rapidly,” according to Bayer’s David Evendon-Challis.
“When there’s an opportunity for digital to not just be a health companion, which is useful inmany instances, but actually to provide a service directly, that is really interesting. I think that
there's huge potential within consumer health for these kinds of products,” said EvendonChallis, who is Bayer Consumer Health’s head of R&D and chief scientific officer.
Defined by the Digital Therapeutics Alliance as “delivering evidence-based therapeuticinterventions driven by high-quality software programs to prevent, manage, or treat a medical
disorder or disease,” the digital therapeutics sector has seen tremendous growth and investor
interest during the pandemic. (Also see "‘Training People To Be Healthier’: Digital Therapeutics
Programmed For Growth" - Medtech Insight, Dec. 13, 2021.)
Digital therapeutics have been developed for a wide range of applications, such as women’s
health, cardiovascular conditions such as hypertension, pulmonary disease such as asthma andCOPD, neurological disorders such as Alzheimer’s and Parkinson’s disease, and gastrointestinal
disease, enabled in large part by technological advancements.
An exciting recent example is Akili Interactive’s mobile video game therapy for attention
deficit/hyperactivity disorder (ADHD), launched recently at the inaugural Digital Therapeutics
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2Alliance Summit in Washington, DC.
Based on the same technology as Akili's EndeavorRx therapy for children, EndeavorOTC isavailable without a prescription in the Apple App Store for adults 18 and older with ADHD. (Alsosee "Akili Introduces Adult Version Of Video Game Therapy To Lessen ADHD Symptoms" - Medtech
Insight, June 7, 2023.)
Clinical trial results show that using EndeavorOTC improved participants’ ability to focus by anaverage of 85%, with over one-third of participants no longer exhibiting an attention deficit
following treatment. Furthermore, almost three quarters of participants reported quality-of-life
improvements including completing tasks on time and managing multiple tasks at once.
Depending on what it learns from the early feedback, the company says it may decide to ask theUS Food and Drug Administration to clear EndeavorOTC as a prescription therapy or it may
pursue over-the-counter labeling.

What It's All About“I think this is great,” Evendon-Challis enthused, asked about the product as an example of what
digital therapeutics might offer consumer health. “I think sometimes we think health has to bealways very serious and look like a pill in a white box. But the reality is, we're all people and if wecan integrate something into our lives in a really simple way, with a fantastic product experience,
that's the key.”
For Evendon-Challis, EndeavorOTC represents what consumer health is really all about. “Forexample, we have to make sure that our Berocca effervescent immunity tablets taste great, thatpeople enjoy using them and can incorporate them into their routine. It's the same with these
digital therapeutics. If something is hard work, if it's more like homework, then people aren’t
going to do it. If gamification can help, we absolutely need to be part of that.”
Bayer Consumer Health is taking
digitalization very seriously, so much sothat it recently created a business unit –Precision Health – focused entirely on
identifying “digital and digital-supported
consumer healthcare opportunities.”
Working with start-up companies andother digital health providers while also
improving Bayer’s existing digital
capabilities, precision health is about
offering a holistic and personalized
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‘Faster, Better, More Efficient’ – Why
Bayer Is Investing In ‘Precision Health’
By David Ridley
June 22, 2023
Like other big global OTC players, BayerConsumer Health is stepping up its
investment in digital self-care. In the first part

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approach to self-care that increases trustin the company’s consumer healthbrands, Evendon-Challis explained.

AI Opportunity
Along with digital therapeutics, Bayersees artificial intelligence as another big
opportunity within this space, noted
Evendon-Challis. “Sure, there's a lot ofhype, but I think it's justified.”of an exclusive interview, HBW Insightcatches up with the company's head of R&Dand chief scientific officer David EvendonChallis to dig deeper into the rationale forsetting up a new 'prescision health' business
unit, including why a holistic andpersonalized approach to digital self-careincreases trust in long-loved and sciencebacked brands.

Read the full article here
Although still in its infancy, AItechnology can offer consumers a whole
new world of self-care products, fromautomated shopping experiences to body enhancing bio-wearables to camera-based skindiagnostics. (Also see "HBW Insight’s Key Takeaways From 2021: #3 Keep Your Eye On AI" - HBW
Insight, April 5, 2022.)“But equally important is what AI can do behind the scenes” Evendon-Challis pointed out. “AI
has huge potential as a foundational technology, to be applied across the whole productdevelopment life cycle.
“As an R&D person,” he continued, “when I think about the potential of AI, I think about theinsights it can generate with regards to everything from product formulation and stability tocreating claims and designing packing.
“AI has an amazing potential for improving productivity and unleashing creativity, I would say.
So, I'm really excited about both sides of that.”

Seeing Patterns
Thinking specifically about Bayer’s new Precision Health business, Evendon-Challis
acknowledged the power of AI in leveraging datasets generated by the use of self-care digital
health products to provide personalized insights to consumers. “Finding patterns in big datarequires AI, so it's a super-critical technology for us.”
However, this is where the regulation gets a bit tricky. Currently, both EU and US regulators areattempting to create frameworks for AI that balance innovation with consumer protection.
In the US, the FDA is exploring a new risk-based review framework that would allow for
modifications to AI algorithms based on real-world learning and adaptation while ensuring
patient safety. (Also see "Rise Of The Machines: FDA Artificial Intelligence Guidance Is Coming" http://hbw.citeline.com/RS153804© Citeline 2023. All rights reserved.

4Medtech Insight, April 2, 2019.)
The new pathway will look at the manufacturer, rather than the product, and will take into
account a number of metrics about the manufacturer to decide whether the company istrustworthy, and whether it has processes in place to ensure post-approval reliability and safety.
In the EU, the European Commission is taking a more cautious approach. The Artificial
Intelligence Act – recently endorsed by the European Parliament – proposes to up-schedule
many AI-based medical devices that are currently medium-risk under the existing Medical
Devices Regulation. (Also see "EU AI Act Proposal Adopted By Parliament In Landslide Plenary
Vote" - Medtech Insight, June 14, 2023.)“Under the proposed rule, medical devices and software as a medical device that use AI would beconsidered high risk products,” clarified EU medtech regulation expert Amanda Maxwell,
speaking to HBW Insight. “So, that's serious. It's costly and very time consuming to get a productlike that onto the market.” (Also see "Artificial Intelligence In Consumer Health: Reality, Challenge
And Opportunity" - HBW Insight, April 5, 2022.)

Second Nature
Nevertheless, Evendon-Challis was not too concerned. “When it comes to regulation, you know,
the consumer health industry is used to this. We're a relatively new industry and having a goodand consistent regulatory framework is important. We definitely aren't there yet when it comesto regulating AI, so I think we should be having these policy conversations.”
However, he stressed that the consumer health industry needed to be part of theseconversations. “It's really important that digital health tools show value so AI isn’t just aboutsocietal and individual information security risks. It's important that we demonstrate how digital
can help meet broader policy priorities around better access to healthcare, for example.”“I think in future it’s going to be really important to make that distinction between somethingthat is there to provide a bit of information, or to help with ‘wellness,’ which may bring anxieties
around data security and privacy, and something that is there to actually do some work to
diagnose or to treat you,” he predicted.
“These are very different things, and I think they need to be treated differently,” he concluded.

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