Covid-19 exposes holes in clinical trial system

Despite the wealth, technological resources, and scientific prowess of the United States, the country's response to the Covid-19 has been notoriously slow in all kinds of ways — including its testing of medicines for efficacy. The result: More people will die from Covid-19, STAT’s Matthew Herper writes.

Starting and running randomized clinical trials is particularly laborious — which has been problematic during such a fast-moving pandemic. But RCTs, as Matt writes, are hugely important.

The problem is about technology and process. Without better electronic health record software and a standardized clinical trial process, it's hard to move much faster.

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BARDA director leaves abruptly

The director of the Biomedical Advanced Research and Development Authority has left his post abruptly, STAT has learned. Rick Bright, a leading vaccine development expert, is moving from his office at the government agency to a narrower role at the NIH.

BARDA invests in drugs, devices, and other infectious disease outbreaks, and has been central to the government's response to the coronavirus pandemic.

Although managerial discord at BARDA has predated both the pandemic and the current administration, Bright’s departure still comes at a particularly inopportune time, STAT’s Nicholas Florko writes.

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Biotech execs congregate remotely to discuss strategy

How do you run a biotech company during a pandemic? That was the subject of WebEx call earlier this week — in which 170 industry execs and venture capitalists virtually brainstormed how best to proceed with research, raise funds, mitigate holdups with clinical trials and, importantly, work from home. Another question on the top of biopharma’s minds: When can they bring employees back to the offices?

“There’s just a lot we have to chew through. And it’s easier to do that in a group,” one biotech CEO told STAT’s Kate Sheridan.

Akili rolls out its prescription video game

A game designed for kids with ADHD is being launched in an unusual rollout, after the FDA last week relaxed regulations on low-risk mental health devices in a move to expand remote access to psychiatric care.

The company, Akili Interactive Labs, hasn’t yet achieved approval for the therapeutic game, Endeavor. But after years of waiting, it’s being rolled out to the general public.

Parents, caregivers, and physicians can fill out an application form to help children between the ages of 8 and 12 play the game. They must have a diagnosis of ADHD. If the team at Akili determines that the child’s qualified for access to Endeavor, they’ll be allowed to play.