Failure to launch

Several years ago, the Harvard Business School professor and author Clayton Christensen presented a dramatic and sobering fact: 80% of product launches fail. Christensen, whose theory of innovative disruption influenced countless tech and Fortune 500 companies, was not referring to the pharmaceutical industry—but he could have been.

A 2020 study in looked at 25 first commercial biotech product launches, revealing almost 50% missed their first-year revenue targets. FiercePharma reported in January 2021 that over the last 15 years, 40% of their drug launches underperformed Street forecasts by more than 20%. These statistics represent more than just numbers—they represent lost opportunity—and lost impact on patient lives. As an industry we can, and should, do better.

As you’re well aware, drug development is infinitely complex, with multiple mitigating factors that must be addressed in the precommercial space; however, one consistent theme that successful launch organizations share is comprehensive organization-wide preparedness with a clear focus on the commercial mission. Teams that work together to define and plan, with the patient in the center, are more likely to successfully launch, meet (and beat) expectations, with immediate benefit to the organization’s enterprise value.

One powerful document

One of the most important tools used by manufacturers is a Target Product Profile, or TPP. The TPP document is intended to summarize the drug development program—using drug labeling terms, concepts, and goals—and align it with the commercial goals of the product. A version of this tool is used by most drug development teams, it is recognized by regulators (FDA 2007) with language that typically matures into the product label text in the US and SmPC in Europe.

This document—with carefully consideration of categories and content—is one of the most powerful tools in the commercial planning process. First, its creation provides the opportunity to bring all departments to the table in the early development phase, with the intent of casting a commercial lens over the program—and with a clear, actionable patient benefit at its center. Second, the project’s goalposts are now in writing, expectations are set, and teams can drive toward the same endgame. The document will evolve as the program progresses, but it’s critical to get the foundation right from the start.

The Challenges in Developing a TPP

The TPP can struggle to find a home within an organization. At its core, the document features critical product label categories including indication and usage, therapeutic area, dosage form and administration, efficacy, safety/side effects, with additional sections added as the clinical program progresses. This foundation in regulatory sometimes lends to that department kicking off the process, or it can be clinical, program management, or commercial. Given its breadth of topic coverage across the program, it is ideal to have a SOP within the company assigning a lead and outlining the process.

Formalizing the document structure and content direction is key. To leverage its full strategic intent a TPP must include key inputs that define the market. The addition of these categories guide the team to consider market drivers, including disease characterization, diagnosis and treatment landscape, patient population and health journey, and competitive environment. Each category has specific questions to be answered, allowing nuances specific to the market to be considered.

These fundamental market categories should be rooted in data, researched, and debated with the full team and used to frame the program. The better the team is at articulating commercial goals against market realities, the more likely a program will achieve its potential.

Carefully consider your target

It is called a “target” because the final profile is not set until product approval. To consider a variety of target potentials many TPPs include different scenarios which are commonly labeled – best-case, likely-case, and worst-case. In our experience, these categories should be carefully considered. Three may be one too many and the inclusion of the word “worst” implies you may arrive there and find it acceptable. We recommend the scenario planning framework of “base case” and “ideal”. With this, teams should plan for the ideal and use the base case to guide a program cutoff consideration point.

The TPP should be embraced by every drug development team, early and often, as a powerful collaboration and commercial planning necessity. Many aspects contribute to a product’s launch success and this early strategic tool is one of them.

How We Can Help

It is never too early to start developing your commercial plan and setting the stage for a successful future product launch. Engaging across departments and utilizing strategic planning tools will help pave the way to launch success.

Our experience in market development and product launch, as well as our suit of proprietary market intelligence tools, can help you better understand your market, disease, and treatment environment, and point towards potential decisions that can impact your precommercial approach.

Contact us to learn more about our approach and how we can collaborate together.

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