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Category: Drug Development

FDA Just Issued Its First AI Warning Letter: Medical Affairs Should Pay Attention

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 …

When the Data Exists but Doesn’t Travel: Lessons from RISE Together 2026

On March 30, 2026, I attended RISE Together: Data Sharing Across the Rare Disease Ecosystem [1] expecting a discussion about the platforms and infrastructure needed to move data more efficiently across systems. Instead, what surfaced over the course of the day was something more fundamental, and more difficult to resolve. The rare disease field is …

Medical Affairs Has a Communication Problem: MAX 2026 Challenged the Field to Fix It

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. …

AI in Healthcare (3): The Molecule Will Design Itself Now—AI in Drug Discovery

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 …