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Lilly names chief AI officer
Pharmaceutical giant Eli Lilly has announced the appointment of Thomas Fuchs as its first chief AI officer. Mr. Fuchs previously served as director of the Hasso Plattner Institute for Digital Health at Mount Sinai, New York, where he helped lead research in computational pathology. He is also the founder of several companies, including cancer diagnostics startup Page AI.
Earlier this week, I wrote about Eli Lilly’s latest AI drug development deal.
Telemedicine companies express dissatisfaction with DEA
Telemedicine companies that ramped up prescribing of controlled substances during the pandemic are frustrated as the flexibility that allowed their businesses to grow is expiring. More than a year has passed since the Drug Enforcement Administration last extended pandemic waivers, but the agency has yet to make good on its promise to issue new rules by this fall. Many observers believe it will be impossible to finalize the rules by the end of the year.
As I have reported with my colleagues Katie Palmer and Mohana Rabindranath, information gaps can lead companies to rely on hearsay, hire former bureaucrats as leaders, and lead companies to lose shape. You are forced to spend energy on no future plans.
Companies believe some of the leaked guardrails are impossible to comply with, such as the requirement that prescription drug monitoring programs in all 50 states be checked on a patient-by-patient basis. But they are making creative plans to meet the requirements for in-person prescribing, including sending doctors to temporary clinics to conduct dozens of consultations a day. Some of these plans may not be sustainable. Some businesses say they may be forced to close due to in-person prescribing rules.
Read the full story about the confusion here
Guide to Epic Carequality Reports
After data-sharing startup Particle Health sued electronic health records giant Epic Systems for antitrust violations, the two companies sued a little-known nonprofit over an earlier spat that ultimately led to a lawsuit. They requested that the report be made public. This report has been published. STAT’s Brittany Trang did the hard work of poring over the report so you don’t have to.
Carequality, which runs a framework that allows healthcare organizations to securely share patient data, investigated Particle earlier this year for allegedly abusing its access. The investigation revealed that some Anonymous Particle customers improperly accessed patient records for reasons unrelated to treatment and were removed from the Care Quality Network. Nevertheless, the report found that Particle’s process for vetting customers was robust, even if no issues were uncovered.
Both companies say Carequality’s findings support their claims. Epic said it has confirmed that some of its Particle customers violated the rules. Particle claims that Epic’s original claims are invalid. While some of these interactions may seem trivial, they can have significant implications for the future of data sharing and medical records.
There are too many nuances to cram into a newsletter, so keep reading for the full analysis of the report.
FDA leaders discuss the future of AI in clinical trials
Artificial intelligence is a buzzword everywhere these days, and it definitely applies to the pharmaceutical industry. Companies are leveraging AI not only to find the next hit, but also to support clinical trials that need to prove its safety and effectiveness. In a new interview, the Food and Drug Administration’s Tara Fakhouri sheds light on the agency’s thinking on new technologies.
Fakhouri co-leads the AI Council established by the FDA’s Center for Drug Evaluation and Research in late August and serves as the agency’s associate director for data science and AI policy. In an interview with STAT’s Katie Palmer, she talked about what the agency has seen so far regarding the potential of AI in regulatory filings and digital twins in testing. What are the biggest obstacles to the continued use of AI to improve clinical trials?
“I think the biggest challenge right now is data,” she says. “We often hear that we don’t have enough data or we don’t have the right data. What we don’t have is access to data.”
Read the full interview here
Fundraising, deals and other news
AI assistant company Suki announced a $70 million Series D investment. The round was led by Hedosophia and brings the company’s total funding to $165 million. Maven Clinic, which focuses on women’s health, has raised $125 million in a 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 has raised $100 million in a Series F round led by Georgian with participation from Health Catalyst Capital, Canaan and others. Exits & Outcomes reported that Mahana Therapeutics, which received marketing approval for a new digital treatment for irritable bowel syndrome in 2020, is in the process of winding down its operations due to bankruptcy. Amazon announced it will open pharmacies in 20 more cities next year, giving 45% of its U.S. customers the ability to get prescriptions delivered the same day. JAMA has introduced JAMA+ AI, which provides a “window” into artificial intelligence coverage across the journal’s network. In addition to showcasing the work, this initiative includes bonus content such as Q&As with authors, videos, and podcasts.
what we are reading
Is the future of AI in medicine just hype?, STAT 2024 Nobel Prize in Chemistry: Three scientists win for groundbreaking research on proteins, STAT
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