When it comes to clinical trials, oftentimes the majority of a patient’s experience happens “off stage” in their home or community. For example, medication adherence, or nonadherence, has been a major pitfall in medicine. Studies have found that roughly one in five new prescriptions are never filled, and of those filled up to 50% are taken incorrectly. 

Startups have taken notice and the digital health industry has increasingly seen more tools to assist researchers. One of those companies hoping to tackle this problem is AiCure. Founded in 2010, the company tracks adherence, retention and deception. It can aggregate the data and provide feedback to researchers. 

Laura Shafner, chief strategy officer and founder of AiCure, spoke to MobiHealthNews in an email Q&A about the challenges, opportunities and future of digital health. 

MobiHealthNews:  What were some of your biggest hurdles in starting the company?​

Shafner: The first hurdle was understanding the business need. A good idea doesn’t necessarily translate into someone else thinking they need it. In order to jump start the company, we applied to the National Institutes of Health for funding via their SBIR (Small Business Innovation Research) mechanism. We had no idea at the time how competitive the grants were — nor what the grant writing process entailed — but in the end we were very fortunate and awarded over $7 million dollars. 

Not only did the early funding allow us to build and test early prototypes of the platform, but the hours and months spent researching and reading about the problem enabled us to become subject matter experts in the area of virtual patient monitoring of medication intake. What started out as a hurdle — how to bring in undiluted funding into the company — turned out to be extremely valuable to our commercial development.

MobiHealthNews: Increasingly, pharma is teaming up with digital health companies. Could you talk to me a little bit about where you see digital solutions solving pharma problems? 

Shafner: New digital technologies offer a centralized, standardized approach to capturing, analyzing and predicting patient behavior — from confirming medication ingestion to assessing the likelihood of a patient dropping out of a trial. In addition, advances in computer vision, machine learning and smartphone adoption mean that we are able to acquire previously unattainable patient data and move beyond specific diagnostic categories to better characterize real-world patient functioning outside of the clinic setting (mood, expressivity, movement, fatigue, etc.). Sponsors can leverage these rich digital profiles comprising multiple data layers to directly impact patient engagement, operational efficiencies, protocol design, clinical trial methodologies and novel endpoint development. Better and faster efficacy results will depend on a multi-pronged approach, ultimately centered around the patient. 

MobiHealthNews: In the past a lot of your clinical trials were around validating camera-enabled medication adherence. What is your focus now?

Shafner:  We remain focused on helping pharmaceutical and biotech companies leverage different applications of artificial intelligence to accelerate drug development, addressing two main challenges: outdated measures of adherence and a poor understanding of patient response to treatment. 

Given the core platform focuses on accurately measuring medication ingestion, we knew that a daily touchpoint with the patient was also [a] tremendous opportunity to engage with the patient to further understand how people experience their illness and treatment. Many of the current scales and assessments used as clinical endpoints may not be sensitive enough to measure the full efficacy of the medication. Subjectivity, administration in the clinic, paucity of data points, variance in rater quality all mean that signals that the drug may be working are frequently lost in the noise. Using AI to capture behavioral insights with high accuracy and sensitivity offers therapeutic intelligence that has the potential to be used as a compliment to existing assessments and in the development of novel digital endpoints. 

MobiHealthNews: What advice would you give women looking to found their own companies?

Shafner: I would give men and women similar advice — starting a company is exhilarating and exhausting, in different measure over time. While it is unrelenting and you must be 100% committed, if you are passionate about the problem you are trying to solve then it is incredibly rewarding. 

In terms of being a woman in tech and pharma, there is no doubt that board rooms and leadership teams alike remain male-dominated. However, the economic necessity to innovate — to reimagine the future of clinical trial research and clinical care — is helping to make for a more equal playing field, challenging long-held assumptions and benefiting a more diverse set of skills. Especially when it comes to the intersection of healthcare and technology, a more nuanced and less binary approach is often the strongest. A seemingly very advanced technology or solution that is difficult to operationalize or impractical in everyday life may be no better than the status quo. Being able to have a 360-degree view is essential — I sometimes think women may excel in this realm more than men.