A meeting can run flawlessly and still produce very little decision value. Six advisors just spent four hours dissecting your data. The follow-up report calls it a success with broad alignment, valuable insights, and strong engagement. Six months later, no one on the sponsor side can say whether that alignment was the result of real …
Continue reading “The Anatomy of an Advisory Board Part 1 — Could the Board have Changed Your Mind?”
There is a strange paradox taking shape in aesthetic medicine, predicated in large part by GLP-1 therapies for weight loss. No longer a niche treatment, a Gallup survey conducted in May and June 2026, reported that 11% of US adults are currently taking a GLP-1 medication for weight loss, up from 3% in 2024 [1]. …
Continue reading “THE GLP-1 FILES, PART 1: Digging Holes to Fill Them?”
A Higher Bar, A Wider Net: What ICH M14 and the New RWE Standards Mean for Medical Affairs In Part 1 of this series, we traced the arc from Frances Kelsey’s 1960 stand against anecdotal evidence to the emergence of real-world evidence as a formally recognized category of regulatory science. The story was one of …
Continue reading “RWE: From Regulatory Footnote to the Future of Medical Affairs, Part 2.”
In the fall of 1960, a newly hired pharmacologist named Frances Kelsey received her first assignment at the FDA: review a drug called Kevadon [1]. It was, by all appearances, a routine case. The drug was already sold across Europe and Canada, prescribed to pregnant women to ease morning sickness. The manufacturer’s application was thick …
Continue reading “RWE: From Regulatory Footnote to the Future of Medical Affairs, Part 1.”
Do you ever wonder why pharmaceutical ads on Canadian TV stations are so radically different from US ads? That’s because Canada has distinctly different regulations, stemming from Health Canada, regarding pharmaceutical advertising. In Canada, the Pharmaceutical Advertising Advisory Board (PAAB) is the independent, not-for-profit preclearance agency recognized by Health Canada to review and approve pharmaceutical …
Continue reading “What Canadians Don’t See: Inside the Rules Governing Pharmaceutical Advertising”