03.12.26 -- Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions

In this edition of our Editorial Showcase, we’re introducing the first installment in our new Regulatory Reconnaissance series.

It begins with a From The Editor commentary below from Chief Editor Tom von Gunden. In that commentary, Tom refers/links to a guest column by consultant Doug Mead and includes the video and transcript from their conversation about using GenAI for conducting regulatory precedent research.

Start your journey here!

Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions

By Tom von Gunden, Chief Editor, Drug Delivery Leader

While I wouldn’t call myself an AI “holdout,” I also wouldn’t (yet) call myself an AI “champion.” My hesitation, perhaps even skepticism, stems primarily from attempted applications of AI tools pointed at a very specific editorial purpose. That is, taking the recordings from my videocast interviews and from online panel discussions in our Drug Delivery Leader Live virtual event series and carving them up into relevant short clips to facilitate viewer convenience in consuming the content. Even with careful instructions about the desired format and focus of the clips, the various AI tools I’ve applied to this task have thus far failed to satisfy. So, I create my own segments.

That being said, I remain open to the power of AI tools for unearthing and organizing for presentation data gleaned from massive information inventories and widespread sources. Thankfully, others more patient and diligent than I are demonstrating impressive results when pointing such tools in ways and in contexts that have even skeptical old me taking notice.

Using GenAI For Precedent Research

One such advocate is combination products consultant Doug Mead. Doug recently reached out to me to make me aware of valuable insights he had been deriving from leveraging GenAI search tools to bolster regulatory intelligence. The bolstering comes by way of search results that surface previous decisions and comments made by regulatory authorities along the way of product approvals, challenges, or denials.

As he demonstrates in his consulting practice, as well as encourages biopharma organizations to do themselves, Doug conducts this “precedent research” by framing queries aimed at regulatory agency databases, including, most prominently, those housed at FDA. Among the benefits of applying this approach during product development is avoiding pitfalls experienced by prior organizations navigating similar regulatory pathways with similar or related products.

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