What is digital health? In broad terms, it is the convergence of digital technologies with medicine, health and society to boost treatment efficacy and deliver more personalized and precise patient care. It is an expansive and growing field, covering everything from mobile health apps to sensors to wearable gadgets. But a key component of digital health is the area of digital therapeutics.

Digital therapeutics can deliver interventions directly to patients using evidence-based, clinically evaluated software to treat a wide-range of behavioral, mental, and physical diseases and disorders. Unlike other devices, digital therapeutics are held to the same standard as medication or other therapies. It is an expanding sector with global sales projected to hit nearly $8 billion by 2025, according to Allied Market Research.

For this inaugural article of a new series on digital therapeutics, WuXi AppTec Communications spoke with Click Therapeutics CEO David Benshoof Klein about the future of the industry and how Click is developing its technology.

Click Therapeutics, based in New York City, is one of the early pioneers in digital therapeutics. David Benshoof Klein is the former Managing Director of Opus Point Partners, which created, financed and operated more than ten life science companies. He has been a guest lecturer at Columbia University and NYU Stern School of Business and has served as a senior consultant at Pfizer and strategic advisor at various publicly traded and private life science companies. He holds a BA from Brandeis University.

WuXi App Tec: How would you define digital therapeutics?

David Benshoof Klein: Digital Therapeutics, simply defined, are software applications that treat a disease. Just like traditional pharmacologic therapies, they are clinically validated through robust clinical trials, and are developed in accordance with relevant FDA, ISO and IEC standards. This sets them apart from other health apps that focus on supporting wellness, patient education, clinical decision support or enabling live teletherapy. In addition, many digital therapeutics, including Click’s, are meant for use as part of a clinical treatment paradigm as prescription products that can only be accessed via a healthcare practitioner.

WuXi AppTec: Will biotech and pharma companies develop digital therapeutics, or do you see this as a separate industry?

David Benshoof Klein: I really see the industry as separate from pharma–akin to a new class of biotech company. The expertise required for digital therapeutics is quite distinct from pharma and biotech, so we’ll continue to see traditional players actively seek to access the space through partnerships with digital therapeutics companies. Click’s collaboration with Otsuka in depression is the most significant of such collaborations in the industry to date.

WuXi AppTec: Why are digital therapeutics necessary in the practice of medicine today? What are the benefits?

David Benshoof Klein: One of the great inefficiencies of medicine over the last twenty years, I believe, has been our tendency to impose purely pharmacological solutions on behavioral problems. In reality, modern healthcare is about more than just biology; it relies on social, cognitive and behavioral interventions to provide truly functional treatment.

Across disease areas, treatment guidelines continue to recognize that drugs are only one part of a larger toolkit that physicians must have at their disposal, and in many cases recommend non-pharmaceutical options as a first-line approach. Digital therapeutics are vital to ensuring that this treatment paradigm is successfully delivered. They provide safe, effective and convenient treatment modalities that can be easily scaled to dramatically improve access to care. On top of this, they also bolster classic pharmaceutical approaches by generating real world evidence and facilitating greater adherence.

The need for digital therapeutics is clear now more than ever. In the past few months, we have all seen how quickly our healthcare system can be overwhelmed and how limited currently available treatment options can be. The COVID-19 pandemic, as terrible as it has been, has only strengthened the case for digital therapeutics.

WuXi AppTec: Can you share how you see COVID-19 affecting the digital therapeutics industry and healthcare as a whole?

David Benshoof Klein: I think this pandemic has really forced us, as a society, to reevaluate how and when we interact with others. In medicine, for instance, how do we provide patients with the care that they need without putting them in harm’s way or crowding hospital wards? Already we’ve seen a rapid shift from hospital and clinic-based care towards the use of remote treatment whenever possible. With this change has come increased acceptance and adoption of technologies like telemedicine and digital therapeutics. Importantly, the people driving these shifts are the major stakeholders in our industry: patients, physicians, payers, and policymakers. As a digital therapeutics company, we’ve always expected this would happen, but never this quickly.

Ultimately, we’ll be feeling the effects of this pandemic for years to come. The steps that we have taken as a community to combat the spread of COVID-19 will give rise to a host of behavioral conditions like depression, anxiety and insomnia being treated almost exclusively remotely, while also highlighting underlying disease areas that may exacerbate the virus, like obesity. All of these conditions are extremely well suited for digital treatments. Given that payers and providers are quickly realizing the benefits of digital therapeutics, I think we will be well prepared to tackle this next wave of post-COVID healthcare challenges.

WuXi AppTec: Even with all of the benefits, are there any risks associated with Digital Therapeutics, such as privacy?

David Benshoof Klein: Yes, of course privacy should be a central focus of any organization, especially a technology-enabled digital therapeutics company. At Click, our privacy team is dedicated to ensuring that we adhere to all of the relevant laws and industry guidelines and to incorporate privacy by design as we develop our products.

At the end of the day, though, digital therapeutics actually lack many of the safety risks associated with traditional pharmaceuticals, positioning them even more strongly in cases where polypharmacy may be an issue.

WuXi AppTec: What are the regulatory guidelines for digital therapeutics? Are they still evolving, and if so, what needs to be clarified?

David Benshoof Klein: Digital therapeutics that make treatment claims, like Click’s, require marketing authorization from applicable regulatory bodies (e.g. via 510(k) or de novo pathway in the US, or CE marking in the EU).

Overall, the regulatory landscape is definitely still evolving, but recent guidance has been extremely encouraging–the FDA recently issued new guidance in response to the COVID-19 pandemic geared specifically towards digital therapeutics and digital health products, further evidencing how regulatory bodies are embracing the immense potential of digital therapeutics.

WuXi AppTec: Are business challenges for digital therapeutics different from biopharma drug development?

David Benshoof Klein: As a digital therapeutics company, we sit at the intersection of technology and biopharma. This unique position brings with it a unique set of business opportunities and hurdles. One huge benefit is that we can develop our treatments at a much lower cost and shorter time to market than a small or large molecule, and often with a significantly higher probability of technical and regulatory success and potentially even greater upside.

The main challenge, and an area in which I think Click really excels, is balancing the diverse expertise (e.g., technology, product, design, science, clinical development and operations, quality management systems, privacy and security, etc.) required to agilely develop a digital therapeutic that drives outcomes and is in accordance with applicable regulatory and quality standards. You also need to build a product that patients actually want to use, which is part and parcel to achieving those clinical outcomes. This is not something that just any digital health or pharma or biotech player can do overnight, or in some cases, ever.

WuXi AppTec: How will patients access digital therapeutics and how will they be reimbursed? Will they have more impact on certain groups?

David Benshoof Klein: Traditional approaches like pharmacy and medical benefits definitely are one option, but there is also potential for more innovative value-based models, direct-to-payer models and direct-to-consumer prescription models via telemedicine. It’s also possible that reimbursement will vary based on the product area. In any event, the positive impact that digital therapeutics will have is clear: without geographic and distribution barriers, the most at risk and underserved populations will have unprecedented access to the healthcare they need.

WuXi AppTec: What kind of digital therapeutics is your company pursuing? What diseases are you targeting? Why?

David Benshoof Klein: Click is developing a portfolio of digital therapeutics designed to treat a wide range of disease areas. We are highly evidence-driven in our selection of therapeutic areas to target, focusing on high burden diseases where clinical data support the use of non-pharmacologic approaches and our clinically validated engagement platform can drive meaningful outcomes for patients. Click’s pipeline includes Smoking Cessation, Major Depressive Disorder (MDD), Acute Coronary Syndrome, Chronic Pain, Migraine, Insomnia, Obesity and more.

WuXi AppTec: How do your digital therapeutics work? What do they accomplish? Is your approach different from other digital companies?

David Benshoof Klein: Click’s digital therapeutics are intended to treat diseases either alone or in combination with pharmacotherapy. To do this, they leverage a growing library of proprietary, clinically validated translational and discovery cognitive and neurobehavioral mechanisms.

As a “mobile-first” company, our products are designed from the ground up by our in-house discovery and technology teams to maximize clinical efficacy and engage users natively through their phone. Our algorithms can then learn from user activity to personalize the experience, tailoring the therapeutic to each patient’s specific needs. This has enabled us to build the strongest patient engagement platform in the space with a proven ability to scale (our first marketed product, Clickotine, is available in over 11.5 million lives and counting). With these approaches, Click is really well positioned to tackle new diseases quickly and agilely and drive the growth of the digital therapeutics industry as a whole.

WuXi AppTec: Some closing thoughts please. What will be the lasting impact of

digital therapeutics on new medicines?

David Benshoof Klein: I believe that digital therapeutics will fundamentally change the way medicine is developed, perceived, delivered and monitored.

WuXi AppTec: And finally how will digital therapeutics change over the next 5-10 years?

David Benshoof Klein: Over the next several years, as patient and provider adoption accelerates, I see digital therapeutics becoming standard of care across a wide variety of disease areas. And for those areas where traditional therapeutics are necessary, I firmly believe that digital treatments and traditional biopharmaceuticals will not be viewed as separate approaches, but rather two sides of the same coin.