Perspectives

During the COVID-19 pandemic, pharma companies have had to improvise on how they think about setting up, administering and monitoring trials. New digital health entrants are helping manage these changes, and a few new trends are emerging. The most prominent is the use of technology that enables trial participants to accomplish their regimen remotely from clinical trial sites.

Alternative splicing performs a central role in expanding genomic coding capacity and proteomic diversity. However, programming of splicing patterns in engineered biological systems remains underused. Synthetic approaches thus far have predominantly focused on controlling expression of a single protein through alternative splicing. Here, we describe a modular and extensible platform for regulating four programmable exons that undergo a mutually exclusive alternative splicing event to generate multiple functionally-distinct proteins.

The healthcare market is enormous with over $3.2 trillion of annual spend in the United States in 2015, and the sector has had significant regulatory changes over the past seven years largely driven by the Affordable Care and HITECH Acts.

Since I first started investing in digital health in 2007, the sector has exploded. Digital health startups raised over $4 billion in venture capital in 2014 and will likely raise even more this year. Based on my observations, a large proportion of these startups are founded by folks who want to apply their background in tech to healthcare. Many are young, successful engineers and product managers who have a negative experience with healthcare and want to fix it. These pitches often start with a personal story. They want to disrupt the system from the inside.

2011 has been a big year for health sciences technology and, specifically, mobile health. Venture capital investors, looking for the next big thing, are beginning to invest in companies developing mobile applications in the health and wellness sector. Smartphones are making new health care applications feasible, and one doesn’t have to look far to see tangible examples of companies creating some buzz. Fitbit, Lark, Zeo, and Jawbone (UP) have all raised capital and developed hardware solutions often tied to Apple’s iOS or Android based phones. Hundreds of companies are targeting weight loss, wellness/ fitness and women’s health with software-only applications. Incubators like Rock Health are popping up, bloggers are beginning to write about the sector, and gamification has become a term commonly used in healthcare.

(Skip) Fleshman thinks that two major pieces are still missing to convince the big players to jump in: efficacy data and revenues. Digital health companies need to convince acquirers that their products work, and the bar for that is getting higher. “They want to see clinical evidence,” he said. “Is it moving the needle? And/or they want to see revenue generated. No one’s really proved that you can make a lot of money in this sector. Companies have maybe $20 million in revenue, but they’re just not ramping and scaling.”

“The tech community isn’t used to dealing with studies, FDA approval, publications, and reimbursement,” says Skip Fleshman, a digital health investor with Asset Management Ventures. “[But] the tech community wants things to happen fast. Obviously that doesn’t work in health care.”

Devices that track specialized biometrics will still appeal to athletes or patients who are highly motivated to improve their performance or chronic diseases, said Skip Fleshman, a partner at the venture capital firm Asset Management Ventures. But people who just want to lose a few pounds are much less likely to buy and stick with a wearable.

“The consumer stuff might be a wave that has passed,” said Asset Management Ventures partner Skip Fleshman, whose 50-year-old firm began looking at digital health five years ago. “There are so many wearables out there, we’re skeptical that people will actually pay [for them].”