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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.

Every horse race has a starting bell, a push to move as fast as possible, and a finish line. In many ways, the launch of a new drug can feel similar. But the metaphor only goes so far — launch preparation is not simply about speed, and in this case, the “horses” keep changing, and the track is anything but predictable.

A better metaphor is that of an orchestra, with many instruments contributing distinctly at specific times. All play the same piece of music but contribute based on their respective roles.

Over the past 20 years, The NemetzGroup has been involved in the launch of more than 50 different drugs and has had input into the strategic commercialization plans of many more. While no two launches are ever exactly the same — based on the team, company, and unmet need the drug hopes to address — there are certain patterns and similarities that we see repeating. Unfortunately, not all of these are positive.