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?”
In the autumn of 2005, investigators in New York and New Jersey began pulling apart a scheme that sounds more like a plot from American Horror Story than a case from a modern courtroom. A company called Biomedical Tissue Services, run by former oral surgeon Michael Mastromarino, had been quietly harvesting bone, skin, tendons, and …
AlloClae™™ is marketed as a source of ready-to-use, donor-derived volume. It is not a conventional filler or living fat transplant, and no one has directly studied whether GLP-1 therapy changes what happens after injection. In Part 1 of this series, we ended with an obvious question: if someone continues taking a GLP-1 medication after losing …
Continue reading “THE GLP-1 FILES, PART 2: Will the Fat Even Stay?”
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.”