Hand over

Many of us recognise intellectually that we need others’ knowledge to address the opportunities and challenges we face in our day-to-day jobs in pharma, yet we still lack the time or motivation to collaborate.

Engaging with third parties all too often feels inefficient (search and coordination costs eat up time), risky (Can I trust a provider to really deliver for me?), and low-valuation facing a commercial challenge close to a Costa?

Digital therapeutics are one of the most exciting areas in the pharmaceutical industry today.

The rising clinical evidence and use of digital therapeutics in recent years have led to the emergence of software-enhanced drugs, where software, such as an app, is designed specifically for a target drug either to enhance its therapeutic effect or tackle challenges where the drug alone is not sufficient to address.

We’ve passed beyond the days of using software as a digital tool – but now validated to deliver clinical outcomes.

This opens opportunities to deliver transformative impact on the treatment and management of conditions – while driving direct enterprise value to the drug pipeline.

There are three key examples of how software-enhanced drugs can deliver added clinical value to patients and the patient experience across a wide range of therapeutic areas.

The first is to harness the unique therapeutic modality of software to address undruggable targets.

This is evident in conditions such as major depressive disorder, where software can be used to retrain cognitive function while drugs such as selective serotonin reuptake inhibitors (SSRIs) regulate the level of serotonin.

This multimodal approach to target depressive symptoms results in patients achieving incremental benefits compared to medication alone.

The second is to treat the patient as a whole and address his or her complete well-being.

In therapeutic areas such as oncology, where drugs target and suppress the growth of cancer cells through novel mechanisms, patients still face physical and mental challenges that lead to a significant deterioration in their quality of life.

Here, software can help patients manage their anxiety, depression, treatment-related pain and fatigue – all while the drug aims to bring patients to remission.

The third is where software directly enhances the therapeutic impact of the drug.

In the case of weight-loss drugs, GLP-1s have demonstrated their efficacy, leading to widespread use of the medication.

However, while manufacturers push the boundaries of achievable weight-loss percentage, patients face adverse events and tolerability issues, leading to drop-offs and unsustained weight loss.

Software can help patients manage drug-related side effects, helping them stay on treatment as prescribed.

It can also help clinicians to intervene early before hospitalisation if side effects become more serious, as well as understand any social reasons why patients are not adhering to their prescribed medication.

This is important and can influence outcomes for patients.

Software can also help create and reinforce lifestyle changes in the patient, such as diet and exercise to promote lean muscle-mass retention, that increases the sustained effectiveness of the treatment.

Software-enhanced drugs are differentiated from the 350,000 health apps available for download on the App Store in ways that these are clinically validated, FDA-regulated software designed with evidence to support an added clinical benefit when used with the target drug.

Unlike consumer apps, the software constituent of software-enhanced drugs undergoes rigorous randomised controlled clinical trials – much like those of drug trials.

They are tested against a sham-control app, a ‘placebo-like’ app that doesn’t deliver clinical benefits, alongside drugs.

As a result, the evidentiary data demonstrating the software’s ability to deliver added clinical benefit can be used to update existing and future drug labels of the target drug.

In addition, the software constituent is regulated as software as a medical device (SaMD) by the FDA, with requirements to meet regulatory and quality standards.

The data generated by SaMD is reliable, secure and compliant for HCP decision-making, payer discussions and future FDA submissions.

Following the pandemic, digital-centricity within healthcare remains a permanent expectation.

From decentralised trials to telehealth visits, stakeholders are increasingly adopting digital-centric experiences in their interactions within the healthcare industry.

In the world of AI, pharma’s unique and defensible advantage lies in its deep well of proprietary clinical and scientific data to drive its core business of creating innovative medicine.

Collecting and activating these unique data assets with AI represents a new ‘blue ocean’ of opportunity.

This creates an uncontested market space for whichever entity first develops the capabilities to master it, fundamentally altering the flow of value in the industry.

This technological opportunity does not exist in a vacuum.

It’s converging with the drive to focus on outcomes and integrate technology into core business models to deliver tangible value.

Patients, physicians, payers and regulators are all, for their own reasons, creating immense pressure for the very things AI is uniquely suited to deliver: proof of real-world value; personalised support and evidence-based outcomes.

Digital therapeutics provide us with a continuous link to patients, providing new insights into the long-term effects of medication and the ongoing progress of a patient’s health.

This creates an extremely strong body of evidence to help inform clinical decisions and treatment options.

Furthermore, software-enhanced drugs provide an additional touchpoint to engage with patients, helping them to create a routine and encouraging ongoing participation in their healthcare journey.

We know that patients are already actively looking for digital solutions to support and complement their treatment to enable them to get the outcome they want and take control of their health.

The case for the use of software-enhanced drugs has been bolstered by the FDA’s draft guidance on prescription drug-use related software (PDURS), which clarified how software may be included within a drug label if appropriate evidence is demonstrated.

The digital therapeutics and pharmaceutical industry have continued to progress through working groups, such as the PDURS task group at the ATA (American Telemedicine Association), and continue to engage with the FDA early in the product development process to ensure innovative products reach the hands of patients.

Often, regulators have been slow to respond to change, but the issuance of this draft guidance and collaboration with the industry demonstrates how they can move with emerging trends.

This has been a real example of the benefits of partnering with regulators to bring them along with a new technology and help them stay at the forefront of change.

While innovation can be exciting, for this powerful vision to become reality, innovation of life-saving therapies must be built on the same unshakeable foundation of evidence and quality standards.

This isn’t just a discussion of new technology: it’s a call to a new standard, where the rigorous validation pioneered in digital therapeutics and clinical trial innovation becomes the essential key.

By demanding undeniable proof for every breakthrough, we can ensure that new innovation not only captivates the imagination but earns its rightful place in a patient’s treatment – creating a future where technology and therapy converge to build a healthier, more hopeful world.

The ultimate imperative is to develop the capabilities to both collect the right real-world data and activate it effectively with AI to design better drugs, accelerate approvals and demonstrate real-world value.

Lisa Moneymaker is Chief Strategy Officer at Medidata and Steven Lee is Strategy Director at Click Therapeutics