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In our biopharma world, we frequently hear the term “Key Business Questions (KBQs).” And while it’s often thrown around as a buzzword (or buzz phrase, in this case), it has quite a bit of practical value when its full depth is explored.

In the biopharma industry, the Target Product Profile (TPP) is a critical tool for guiding the development and commercialization of new drugs.

In the ever-evolving biopharma landscape, success hinges not just on innovation but also on a clear roadmap guiding clinical and commercial development.

Reflecting on my career and the significant societal and technological shifts during those years, I see it as split between two generations, each half so different from the other.

In the not-so-distant past, physician prescribing data was essentially a commodity with limited breadth or depth for the purposes of drug development and commercialization. Two primary third-party providers aggregated data from essentially the same sources.

This past December, the FDA finalized its guidance on rare diseases with the publication Rare Diseases: Considerations for the Development of Drugs and Biological Products. This FDA guidance has been in draft form since 2019.

Commercializing a pharmaceutical asset in one country is hard enough. Doing it on a global scale, with multiple country differences, is exponentially more difficult.

I grew up in the Midwest — the middle child in a large family. We were each tagged with certain labels and expectations: the smart ones, the overachievers, and the ones still trying to find themselves (and that was before it was fashionable).

In this post-COVID era, our clients have experienced a culture shift — driven by remote work, digital transformation, accelerated innovation, and a focus on employee well-being. Changes in supply chain, clinical trials, and regulatory dynamics have accentuated all of this.