Edward Foley

There’s a particular energy that surrounds a small, emerging biopharma company approaching its first drug launch. It’s a mix of excitement, fear, ambition, and sheer logistical overwhelm; equal parts moonshot  and tightrope . For regulatory advertising and promotional consultants, this territory is familiar. It is exhilarating, messy, and incredibly high stakes. And it never fails to reveal the same truth: scientific brilliance does not automatically translate into commercial readiness. In...

We’re no longer talking to the same people — or in the same way Traditional pharma advertising and promotional strategies that once targeted healthcare professionals, consumers, and payers now require an additional focus: AI platforms. The life sciences and healthcare industries are undergoing a transformative phase with the rise of Generative AI (GenAI). These AI systems, which include Large Language Models (LLMs) like ChatGPT and Gemini, create new content based on their vast training...

I've been working in industry long enough to remember the infamous "14 Letters" that FDA sent out simultaneously to multiple pharmaceutical manufacturers in response to violative paid search ads. That was a day of infamy, and as luck would have it, I happened to work at a company that received 2, so I was able to see the impact first-hand when FDA decided to use enforcement tools to signify a shift in policy, or at least a firm reminder of the rules. As a Regulatory professional, I had come...