Q&A With Marty Culjat, PhD, Global Head of Digital Medicine & Regulatory Innovation at Eversana

Marty Culjat
SVP, Global Head of Digital Medicine & Regulatory Innovation
Eversana

Marty Culjat, PhD, says that he expects there to be a digital solution to go along with every drug within the next 10 years. Many of these digital solutions are apps that can be utilized by pharma companies in different ways. Some have supportive capabilities (such as improving adherence), while others mainly work as a marketing effort for the drug. As the trend grows, however, the FDA is taking notice.

(MDT:) What steps has the FDA taken in the past to regulate pharmaceutical apps?

Culjat: Five years ago, the FDA started working on a framework for how they would look at regulation for companion apps and software to be used alongside drugs. Around 2016, they announced a draft framework about how they would regulate from the drug side and how a drug manufacturer would have to consider the regulatory implications of these products. This would depend on the risk profile and the intended use of the software solutions. Ultimately, they came up with a draft framework that laid out the options for where a company would need to interact with the FDA and what kind of submission would be needed based on those factors.

They came up with a framework where low-risk products that don’t have additive clinical effects on top of the drug would be considered promotional materials, the same way that any kind of marketing materials would be regulated. This means the companies would submit it and follow a fairly simple process.

(MDT:) Have there been any updates to this framework?

Culjat: They’re still working on the part of the framework for when you have an app or software that has an additive clinical effect to the drug. This means it could meaningfully improve adherence, behavioral effects, or therapeutic outcomes related to that drug. For example, if you have an oncology drug and you’re trying to help the patient manage their own disease or chemotherapy symptoms, there’s a lot of movement in the system about how products that could impact that be launched and regulated.

Going even further down the field, there are companies today developing products that are intended to help manage or reduce depression or anxiety for people that are undergoing chemotherapy. You also have that are developing digital solutions that can directly improve treatment outcomes by having an additive effect on top of the drug itself.

Depending on what you’re trying to do, there can be a lot of implications from a testing or risk standpoint. The goal is to be able to better understand how these products would be considered from a regulatory standpoint, depending on all of the various factors. The vast majority of products that are companion apps and software are pretty basic and are focused on the promotional side. These want to promote the drug or provide patient support.

You are seeing more and more pharma companies now developing digital therapeutics and prognostics, along with products that are able to help diagnose, screen, and treat disease. This is where there’s a lot of ambiguity for where these products should be considered today by the FDA. What we’re hoping to see in the guidance is clarity on how pharma companies would need to run clinical studies for products that would have these additive clinical benefits. It would hopefully provide clarity for the rigor provided in those studies, and what kind of FDA submissions are needed to help the commercialization of those kinds or products.

(MDT:) Do you foresee a point where there are health apps that require a prescription?

Culjat: There are already prescription digital therapeutics. If you are making treatments claims with a digital therapeutic, you generally need to have a prescription. In terms of having products that are being used alongside a drug, there certainly will be cases where you have these prescribed software solutions that are prescribed separately from the drug. In other cases, you’ll have digital solutions that are on the drug label, and the software solution would be part of the drug’s prescription.

There are digital monotherapies, and in some cases, there are combination therapies that are the drug plus software. There’s a gray area in the middle where there’s a therapy that isn’t a combination, but there’s a tie-in between the software and the drug.

(MDT:) What impact do you think this will have on the production of new health apps?

Culjat: It’ll have a marginal impact on health apps that do not have the additive clinical effect, but for companies who are looking to develop more robust solutions, it will provide a lot of clarity for how those products can be commercialized and how clinical trials should be run.

(MDT:) How commonly used are these apps today? Will they continue to grow in the future?

Culjat: We are seeing a lot of growth in pharma with companion apps. Many of those apps have a range of common intended uses, such as focusing on patient support, disease management, adherence to the drug, or even chat bots and telehealth coaches. Many of those intended uses are not regulated, and there’s a lot of growth in that area which should continue.

What we’re starting to see is more interest in these apps. They’ll have more clinical rigor. We’re seeing a lot of innovative pharma companies developing those solutions and I would expect this guidance to provide more of a framework for people to get those kinds of products on the market.