Part I of this series asked one question: what decision could this board materially change? Without a live uncertainty and real consequence attached to the advisors’ input, a board can run flawlessly and still produce nothing but polished slides and a report citing “broad alignment.” In part 2 of this series, we look at how …
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?”
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.”