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.”
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 …
Continue reading “When the Data Exists but Doesn’t Travel: Lessons from RISE Together 2026”
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. …