Advancing Digital Therapeutics: The Science of Software as Medicine
By: Vera Kovacevic, PhD
Interviewee: Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer, Click Therapeutics
Advancing Digital Therapeutics: The Science of Software as Medicine
By: Vera Kovacevic, PhD
Interviewee: Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer, Click Therapeutics
Digital therapeutics are reshaping modern healthcare by integrating software with rigorous clinical science.
At the forefront of this transformation is Click Therapeutics — a company that has steadily built a platform leveraging neuroscience, neuromodulation and data-driven technologies to create prescription-grade digital therapeutics.
Recently, the FDA released a draft guidance on Prescription Drug Use-Related Software (PDURS), a regulatory milestone that underscores a commitment to advancing the clinical rigor of digital therapeutics.
This development goes hand-in-hand with Click Therapeutics’ vision for a future where innovative digital interventions complement traditional therapies, enabling personalized and adaptive patient care.
In a recent interview with Xtalks, Dr. Shaheen Lakhan, Chief Medical Officer of Click Therapeutics, provided a comprehensive overview of the science driving these novel therapies and the evolving landscape of clinical research in digital therapeutics.
His insights, rooted in robust clinical standards and advanced neuromodulatory techniques, offer a clear perspective on how this emerging field is addressing unmet patient needs while laying the foundation for the next generation of treatment modalities.
Prescription Digital Therapeutics: Science and Evolution
Prescription digital therapeutics (PDTs) represent a new class of treatments that use mobile applications to deliver therapeutic interventions directly through smartphones.
“In essence, it is using what everyone pretty much has either in their pocket or in their hands, a smartphone using applications that sit on their smartphone to either treat, manage or prevent a disease or condition. This is basically software as medicine,” explains Dr. Lakhan.
This concept is developed through a collaborative process involving scientists, physicians, engineers and product specialists — working closely with patients — to ensure that these interventions are built with the same clinical rigor traditionally reserved for drugs.
Historically, medicine has undergone periodic revolutions — from small molecules to biologics and, more recently, to cell-based therapies and genomic editing. Today, Click Therapeutics represents the next wave, often referred to as PDT 2.0. This evolution moves beyond conventional behavioral interventions and cognitive behavioral therapy to incorporate neuromodulatory techniques and artificial intelligence (AI).
This shift is about harnessing the brain’s neuroplasticity through targeted exercises and digital interventions that personalize treatment for each patient.
By integrating advanced technologies, PDT 2.0 not only mirrors traditional drug development through controlled clinical trials evaluating efficacy, safety and tolerability, but it also leverages the flexibility of digital platforms to adapt interventions in real time. In doing so, these therapies pave the way for a more dynamic and personalized approach to patient care — blending clinical rigor with technological innovation.
“In essence, it is using what everyone pretty much has either in their pocket or in their hands, a smartphone using applications that sit on their smartphone to either treat, manage or prevent a disease or condition. This is basically software as medicine.”
— Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer, Click Therapeutics
“In essence, it is using what everyone pretty much has either in their pocket or in their hands, a smartphone using applications that sit on their smartphone to either treat, manage or prevent a disease or condition. This is basically software as medicine.”
— Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer, Click Therapeutics
Integrating Software with Traditional Therapeutics
Integrating software with traditional therapeutics is a novel opportunity in modern medicine. Dr. Lakhan explained that combining digital interventions with conventional drugs creates an unprecedented level of personalization and immediacy in treatment delivery.
“When you pair standard therapeutics, chemical drugs or biologics with the software components — the software enhanced drugs — that’s when you get the ultimate level of personalization, immediate delivery. If there are some safety effects related to the drug, we could actually mitigate or buffer against it.”
This insight emphasizes that when digital components are integrated with pharmacotherapy, the resulting synergy allows treatments to be fine-tuned to each patient’s unique needs. Dr. Lakhan further highlighted the regulatory implications of this integration by noting, “If you study that with the drug, whatever you could get extracted out of that software can go now into the drug label.”
Recent FDA draft guidance on PDURS has begun to formalize the framework for developing these hybrid therapies. By meeting the rigorous standards required for both software as a medical device and conventional drugs, companies like Click Therapeutics are paving the way for a future where the benefits of digital innovation are formally recognized in drug labeling.
This integrated approach not only validates the clinical efficacy of combining digital interventions with traditional therapeutics but also opens up new avenues for personalized medicine, ensuring treatments are both adaptive and precisely targeted to patient needs.
The Digital Working Alliance and Personalized Interventions
Central to Click Therapeutics’ approach is the establishment of a “digital working alliance” with patients — a foundation that Dr. Lakhan believes is vital to effective digital care. He explained that the initial interaction between the patient and the digital therapeutic is deliberately designed to build trust, mirroring the bond typically formed in traditional face-to-face settings.
This strong foundation not only fosters a trusting relationship but also sets the stage for delivering personalized interventions. The digital working alliance ensures that patients feel engaged and supported from the very start, which is critical for adherence to the therapeutic regimen.
Building on this foundation, Click Therapeutics integrates AI within its platform to further enhance personalization. Dr. Lakhan explained how the system continuously adapts based on individual patient responses:
“Our therapies get smarter with every patient. And it’s not just a tagline in a marketing statement. Literally, the way that we built our therapeutic platform is that we learn from the individual use of a patient: what’s the right time to intervene for maximal engagement? What's the right style, tone, sentiment to get folks in?”
By merging standardized clinical protocols with AI-driven personalization, the digital therapeutic platform continuously learns and refines its approach. This dynamic feedback loop will in the future, as it learns more from patients, enable the system to determine the optimal timing and type of intervention — whether that involves neuromodulatory exercises or behavioral tasks — tailored precisely to the patient’s evolving needs. Consequently, the platform offers the benefits of immediate access and enhanced patient engagement.
“I envision a future where every drug is paired with the software component.”
— Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer, Click Therapeutics
“I envision a future where every drug is paired with the software component.”
— Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer, Click Therapeutics
A Data-Driven Future in Clinical Research
Dr. Lakhan’s insights underscore that the future of digital therapeutics is not about replacing traditional medicine but about enhancing it through technology.
Click Therapeutics’ rigorous clinical trials are designed to meet the same endpoints as conventional drug studies, ensuring that the digital component not only demonstrates its own clinical benefit but also augments the effect of traditional pharmacotherapy.
This integrated approach addresses unmet patient needs more effectively and could span multiple therapeutic areas — from psychiatry and neurology to pain management and cardiometabolic diseases.
Looking ahead, Dr. Lakhan emphasized that digital therapeutics are inherently data-driven.
“We apply all of the clinical rigor that went into the last a hundred years of modern drug development into prescription digital therapeutics. So that’s the very first separation is how is it different from wellness apps and even digital therapeutics that aren’t prescription.”
This data-centric approach enables the platform to continuously learn from patient interactions, optimizing interventions and improving adherence in real time. By integrating advanced data analytics into their R&D efforts, Click Therapeutics is positioning itself as a leader capable of transforming patient care on a global scale.
“I envision a future where every drug is paired with the software component.”
Such a vision underscores the transformative potential of digitized therapeutics to make healthcare more personalized, accessible and effective — ushering in an era where traditional and digital innovations seamlessly integrate.
The science behind digital therapeutics combines robust clinical research with innovative software development. Click Therapeutics exemplifies how rigorous validation, neuromodulation and AI-driven personalization can forge a new, evidence-based paradigm in patient care.
As technology and medicine collaborate further, the promise of targeted, effective and accessible treatments may reshape healthcare globally, complementing traditional approaches while breaking down barriers to access and personalization.
ABOUT Shaheen Lakhan
Shaheen Lakhan is the Chief Medical Officer (CMO) at Click Therapeutics. He is a physician-scientist, biotech executive and biopharma board director with more than 20 years of experience in healthcare, academia and industry focusing on neuroscience research and development.
Dr. Lakhan is board-certified in both neurology and pain medicine, with clinical training from Cleveland Clinic and Massachusetts General Hospital. His interests lie in transforming medicine and democratizing health care through prescription digital therapeutics and novel drug-delivery platforms. His clinical development experience spans Phase I-IV drug and medical device trials including HEOR, RWE, IIS, and decentralized studies earning his programs breakthrough, orphan drug, priority review and fast-track designations. He has facilitated the approval of several first-in-class drugs and medical devices. With over 100 peer-reviewed publications, books and book chapters to his name, he was conferred the President’s Call to Service Award for Lifetime Achievement by Pres. George W. Bush and The US Congressional Award Gold Medal by Representative Nancy Pelosi and Senator Harry Reid.