On April 2, 2026, the U.S. Food and Drug Administration issued a warning letter to a Michigan-based manufacturer of drug products called Purolea Cosmetics Lab. At first glance, it looked routine: cGMP violations, missing process validation, inadequate quality controls. But buried in the letter was something unprecedented: a dedicated section titled “Inappropriate Use of Artificial …
Continue reading “FDA Just Issued Its First AI Warning Letter: Medical Affairs Should Pay Attention”
On March 25, 2026, I attended MAX: Medical Affairs eXcellence Forum, Canada’s first forum dedicated entirely to medical affairs in biopharma. Organized by Agilis Health and held at the Sheraton Toronto Airport, it brought together 140+ professionals spanning Medical Affairs, Pharma, Clinical Research, Regulatory, and Medical Communications for a full day of candid, high-calibre conversation. …
In the first three articles of this series, we looked at AI where people can see it: reading scans and drafting treatment plans, tutoring students and simulating patients, and even helping design the next generation of medicines. But some of the most profound changes are happening out of sight, in the operating system of the …
Traditional drug development is one of the most expensive and failure-prone endeavors in science. Bringing a new drug to market typically takes over a decade, with cost estimates exceeding two billion dollars and failure rates upwards of 90% [1]. Less than 10% of target drugs even make it to Phase I Trials. AI is now …
Continue reading “AI in Healthcare (3): The Molecule Will Design Itself Now—AI in Drug Discovery”
Artificial intelligence is reshaping medicine faster than most health systems can keep up, and few people have a clearer view of that frontier than Dr. Muhammad Mamdani, director of the University of Toronto’s Temerty Centre for AI Research and Education in Medicine (T-CAIREM). On Friday we listened with interest as Dr. Mamdani spoke candidly about …