Eli Lilly has an AI chief, telehealth’s DEA troubles, and FDA’s thinking on AI in clinical trials
by Mario Aguilar · STATYou’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.
Lilly appoints Chief AI Officer
Drug giant Eli Lilly announced Thomas Fuchs as its first chief AI officer. Previously, Fuchs was director of the Hasso Plattner Institute for Digital Health at Mount Sinai in New York where he helped lead work on computational pathology. He’s also the founder of several companies including cancer diagnostic startup Paige AI.
Earlier this week we wrote about Eli Lilly’s latest AI drug development deal.
Telehealth companies describe frustration with DEA
Telehealth companies that ramped up prescribing of controlled substances during the pandemic are in a state of frustration as flexibilities that allowed them to grow their businesses are set to expire. It’s been over a year since the Drug Enforcement Administration last extended the pandemic waivers, and the agency has not yet delivered on a pledge to issue new rules by this fall. Most observers believe it will be impossible for them to finalize rules by the end of the year.
As I report with my colleagues Katie Palmer and Mohana Ravindranath, the vacuum of information has forced companies to spend energy planning for a future they don’t know the shape of, relying on hearsay and hiring former officials to guide them.
Companies believe some of the leaked guardrails would be impossible to comply with, like a requirement to check prescription drug monitoring programs in all 50 states for each patient. But they’ve hatched creative plans to fulfill in-person prescribing requirements, like flying in doctors to a temporary clinic to perform dozens of visits a day. Some of these plans wouldn’t be sustainable — some companies tell us that in-person prescribing rules could force them to shut down.
Read our whole story on the mess here
Your guide to the Epic Carequality report
After data sharing startup Particle Health sued electronic health records giant Epic Systems alleging antitrust violations, both companies asked a little-known nonprofit to release its report on their earlier spat that eventually escalated into the lawsuit. Now the report is out, and STAT’s Brittany Trang has done the hard work of slogging through it so you don’t have to.
Carequality, which operates a framework that allows health organizations to safely share patient data, earlier this year investigated Particle for allegedly misusing that access. The investigation found that some of Particle’s customers, which are not named, had improperly accessed patient records for reasons that didn’t not involve treatment and were removed from the Carequality network. Nevertheless, the report found that Particle’s process for vetting customers was robust, even if it hadn’t uncovered the problems.
Both companies claim that Carequality’s findings bolster their case. Epic said it confirms that some Particle customers violated rules. Particle claims that Epic’s original claims were invalidated. Some of this back and forth may seem petty but it could have significant ramifications for the future of data sharing and medical records.
There’s way more nuance than I can cram in my newsletter, so please read on for our whole analysis of the report.
FDA leader on the future of AI in clinical trials
Artificial intelligence is the buzzword everywhere these days, and that’s definitely true in drug industry. Companies are using AI not only to help find their next blockbusters, but also to support the clinical trials that must demonstrate their safety and effectiveness. In a new interview, the Food and Drug Administration‘s Tala Fakhouri unpacks the agency’s thinking on the new technology.
Fakhouri co-leads an AI Council that FDA’s Center for Drug Evaluation and Research established in late August and is an associate director for data science and AI policy at the agency. In the interview with STAT’s Katie Palmer, she discussed what the agency has seen so far in terms of AI in regulatory submissions and the potential of digital twins in trials. Asked the biggest impediment to the continued use of AI to improve trials?
“I think the biggest challenge right now is data,” she said. “We hear a lot that we don’t have enough data or we don’t have good data. What we don’t have is access to data.”
Fundraises, deals, and other news
- AI assistant company Suki announced $70 million in Series D investment. The round was led by Hedosophia and brings the company’s total fundraising to $165 million.
- Women’s health-focused Maven Clinic raised a $125 Million Series F round led by StepStone Group. Existing investors General Catalyst, Sequoia, Oak HC/FT, Icon Ventures, Dragoneer Investment Group, and Lux Capital also invested. The company’s valuation was reported at $1.7 billion.
- Diabetes data platform Glooko raised a $100 million Series F round led by Georgian, with participation from Health Catalyst Capital, Canaan, and others.
- Exits & Outcomes reported that Mahana Therapeutics, which in 2020 earned de novo marketing authorization for a digital treatment for irritable bowel syndrome, is in the process of winding down due to insolvency.
- Amazon announced it will open pharmacies in 20 more cities next year allowing 45% of U.S. customers to receive same-day-delivery of prescriptions.
- JAMA introduced JAMA+ AI which will provide a “window” into artificial intelligence coverage across the network of journals. In addition to showcasing work, the effort will include bonus content like Q&As with authors, videos, and a podcast.