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From Hippocrates to Delphi: A Practical Guide to Clinical Guideline Development Part 1: Not All Guidance Is Created Equal

This is the first in a five-part series on the science and methodology behind clinical practice guidelines and consensus statements. The series “From Hippocrates to...

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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....

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The review bottleneck everyone complains about is a symptom. The real problem starts earlier, and it’s far more fixable than most teams realize.

Your Publication Plan Isn’t Failing at MLR: It’s Failing at the Outline

Here’s a pattern I’ve seen repeatedly. A medical affairs team builds a publication plan. Timelines align to a congress deadline. Authors are confirmed. A solid...

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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...

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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...

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