American Pharmaceutical Review,  July 2016

The adoption of technology for use in the pharmaceutical industry has historically been sluggish and often late to arrive when compared to other industries.

This is primarily due to concerns regarding both the physical safety of patients and the protection of private patient information. While the consumer market has been quick to take advantage of social media outreach, cloud technology and mobile software applications (apps), the pharmaceuticals industry has been hesitant despite potential value. In particular, mobile apps - known more commonly in the healthcare and pharmaceuticals space as mobile medical apps (MMAs)  could positively affect patients and the industries that serve them. However, MMAs have been largely stifled by regulatory precautions, review bottlenecks and a lack of clear guidelines that help explain the expectations of the FDA. With considerable pressure from the medical community, major pharmaceutical and IT companies as well as congress, all eyes are now on the FDA to resolve this confusion in an effort to encourage the development and use of MMAs to improve the overall patient experience.

Despite current hurdles, the mobile health (mHealth) market  a broader category that includes apps ranging from pharmaceuticals to general health tracking - has seen growing success with acquisitions such as athenahealth’s 2013 purchase of Epocrates for over $290 million, proving that the app market demands attention. In 2015 alone, more than 3 billion mHealth apps  including the FDA’s own Drug Shortages and Orange Book (OB) Express - were expected to be downloaded from the App Store and Google play [1]. Also in 2015, in response to mounting industry pressure, the FDA attempted to clarify the market by dividing MMAs into the following three categories based on the amount of oversight required: more, some, or no oversight [2]. While this categorization was a step in the right direction, it clearly leaves questions that need answering if companies are going to invest in developing and promoting a mobile product for use by patients, physicians, or those within the pharmaceutical industry (researchers, trial participants, etc.). The FDA is promoting this categorization as a risk-based, case-by-case approach to oversight, but the elusive “hands-off ” category of no oversight continues to confuse the industry [2]. In general, there is a significant gray area with apps related to prescription drug use falling into each of the three categories.

As MMAs can potentially simplify patient communication, improve medication adherence, off er pharmaceutical companies insight into patient behavior and aide physicians when determining a diagnosis and assigning the best treatment options, the opportunities in this space are vast. However, additional regulatory clarification is needed and pharmaceuticals companies must develop a better understanding of the MMA market to ensure that the next generation of MMAs truly serve patient, physician and industry needs.

Growth in Technology is Creating and Strengthening the Foundation for Apps

As demands to improve manufacturing processes, increase productivity and drive costs down continue to mount, the importance of electronic data capture (EDC) has grown, with cloud-based EDC systems becoming increasingly favorable. With that, the use of social media has continued to surge. An active social media presence allows companies the opportunity to listen to and interact directly with consumers. Though the potential return in the way of information and brand awareness is massive, costs are minimal. Cloud-based EDC systems are similarly valuable in that they often require low capital investment, are easily scalable and have a relatively low operating cost, making them ideal for use with clinical trials — typically the most expensive aspect of today’s drug development [3,4]. Additionally, cloud based systems help bridge large geographic divides and often simplify mergers and acquisitions by avoiding problems that can arise when trying to blend disparate computer systems [3].

According to the 2015 Nice Insight Pharmaceutical and Biotechnology Outsourcing survey, these benefits extend into outsourcing as well with 62% of respondents stating that Cloud Based Data Management Services presented the greatest opportunities for cost and/or time savings in regards to R&D [5]. Additionally, both Mobile-Enabled Innovations for Recruiting and Communicating with Participants and Mobile Technology for Remote Monitoring were seen as favorable opportunities by 38% of respondents [5]. In other words, while many companies believe that cloud storage can greatly streamline the process of communicating and documenting during R&D work, the interest in offering mobile access for both communication and data gathering is clear.

Though stand-alone apps are not required for these services, as trial participants and researchers may be able to input results and data, access information and interact seamlessly from nearly any web enabled device, apps allow for additional customization, functionality and usability, including notifications, and can be built to seamlessly interact and sync with cloud storage. While these cloud systems and mobile applications can potentially simplify clinical trial logistics while also helping to control costs, the benefits of mobile can extend beyond trials and into the commercial market with many mHealth apps currently able to gather more patient information than some clinical trials.

The Effect of Regulations and Inherent Limitations

Currently at the forefront of the patient-facing mobile technology discussion is the need for clear expectations surrounding clinical decision support software (CDS). Cloud storage and the growth of internet of things (IoT) technology allows clinicians to access clinical decision support in real time and at the point of care [6]. This software can help improve diagnoses and treatment by providing additional education and guidance to physicians and their patients. Unfortunately, the potential benefit of these applications has not been fully recognized due to the current lack of federal regulations.

In fact, a recent survey from the Clinical Decision Support Coalition - an independent group dedicated to preventing the over-regulation of CDS - showed that one third of respondents had abandoned plans to develop this technology as a result of regulatory uncertainties [6]. Though these uncertainties may be limiting pharmaceutical app development, many pharmaceuticals apps that have received approval and are in use today are still not performing as well as might be expected or hoped.

The app development activities of a pharmaceutical company are unique in the app categories that it pursues, the number of private and/or professional users that comprise an app’s target market and the number of apps it produces [7]. Though the background of many of today’s mHealth developers is technical rather than medical, with pharmaceutical companies claiming only 5% of the developer space, each of the leading pharmaceuticals companies has, on average, 60 apps. This is a significant number given that a typical mHealth app developer has only 1-2;[1,7] however, the penetration of these apps has been relatively limited. A 2014 report from research2guidance shows that these same pharmaceutical companies have only amassed 6.6 million combined app downloads since 2008 with less than 1 million active users [7]. In part, this lack of performance is likely due to the fact that unclear regulations are stifling development and preventing these apps from become as effective as needed, but it is also likely that these low numbers are due to intentional audience limitations.

A significant number of pharmaceutical apps are targeted to private users for things such as trials. A good example of such an app is Roche Pharma Research & Early Development’s Parkinson’s monitoring system app, which allows for round-the-clock measurement of PD functions; it is currently only used in phase 1 clinical development.8 Another example in this category is Bristol Myers Squibb’s International Immuno-Oncology Network, restricted to those with network login credentials. Though these limitations impact app usage numbers and, specifically in regards to apps used in clinical trial, the long term user base, these limitations are necessary and expected. However, additional and resolvable issues also plague the pharmaceuticals app space.

Understanding the App Market to Embrace Success

It is critical to understand the MMA market, the needs of the user and the possibilities within the mobile technology landscape to find success with an app. As mobile technology has evolved, several application program interfaces (APIs) have become available to app developers, allowing for the capture of significant, health-related user data, but pharmaceutical companies and other established healthcare players have been found to have the lowest API connection rate among mHealth developers [1]. To make matters worse, most companies do not take advantage of cross referencing between apps. Few have a consistent app style guide despite continuity of both design and user experience (UX) being essential when attracting and retaining users [7]. In the past, pharmaceuticals companies have also used as many as 17 different names for publishing entities, making it nearly impossible for their target market to find an app and / or explore a company’s additional offerings [7]. Finally, ensuring that an app is regularly updated is also important to help guarantee functionality. This also serves to show potential users that the app is still active and regularly maintained, though many pharmaceutical MMAs have not been updated in well over a year.

With the inherent challenges that exist in the app development market and the current lack of regulatory clarity from the FDA, successfully penetrating the MMA and larger mHealth app market is challenging and its potential benefits - to not only the market, but also the company - should be carefully explored before investments are made. As the FDA works to provide the market with a better understanding of what will be regulated, how those regulations apply and the timeline required for approval, competition in the app space will likely increase as companies strive to take advantage of new ways to market, educate and serve their customers. In the meantime, outreach on mobile platforms - including efforts to develop an approachable presence of social media channels - can help pharmaceutical companies begin to better understand the needs of their customers in this space.

References

  1. Research2Guidance., mHealth App Developer Economics 2015: The current status and trends of the mHealth app market. Nov 2015. http://research2guidance.com/r2g/r2g-mHealth-App-Developer-Economics-2015.pdf
  2. Wechsler, J., Medical Apps Tricky for Pharma. April 2015. http://www.pharmexec.com/medical-apps-tricky-pharma
  3. Singit, R., Cloud Computing in Pharma: It’s never too late to reap the benefits. Pharmaceutical Manufacturing. Oct 2015. http://www.pharmamanufacturing.com/articles/2015/cloud-computing-in-pharma/
  4. Walker, N. Advanced Technologies Cited As Essential For Clinical Trial Challenges. Nice Insight. Sep 2015. http://www.niceinsight.com/articles.aspx?post=2636&title=Advanced+Technologies+Cited+As+Essential+For+Clinical+Trial+Challenges
  5. The 2015 Nice Insight Pharmaceutical and Biotechnology Outsourcing Survey.
  6. Wicklund, E., FDA Urged to Clarify Clinical Decision Support Regulations. mHealth Intelligence. Feb 2016. http://mhealthintelligence.com/news/fda-urged-to-clarify-decision-support-regulations
  7. Pogorzelska, Z., Why Pharma companies fail to have an impact on the mHealth app economy. Mobile Health Economics by Research2Guidance. http://research2guidance.com/why-pharma-companies-have-no-substantial-impact-on-the-mhealth-app-economy/
  8. Roche., Roche app measures Parkinson’s disease fluctuations. http://www.roche.com/media/store/roche_stories/roche-stories-2015-08-10.htm