Maximizing the probability of commercial success in the preapproval phase

By Paul Bridges , President, Global Head of Consulting

In the three years leading up to product launch, drug developers can spend up to $150 million, outside R&D investment. Despite those costs, 58% of drugs fail to meet revenue expectations, according to a 2023 study by Deloitte.1 Research by our life sciences consulting arm, Health Advances, reports a similar finding: 32% of drugs underperform at launch, and of those that underperform, 58% continue to do so.2

The simple explanation is that biotech developers tend to be laser-focused on completing clinical development and satisfying regulators, often considering launch and commercialization too late. Understanding the commercial landscape that you're entering, to inform your early programs, can make all the difference. And while most biotechs can’t realistically hire a commercial team three years before launch, there are key preliminary steps to take during the preapproval phase. This includes developing a landscape assessment to support early development decisions and to map out a plan for launch excellence.

To explore these concepts further, focusing on actionable insight for biotechs with first-time launches, I sat down with three experts: Mike Davitian, partner from Health Advances, Brian Duda, principal consultant from Parexel Access Consulting; and Matthew Gordon, VP RWE Strategy from Parexel Real World Research. The following is a high-level overview of the fourth podcast in our five-part series.

The vital importance of a commercialization strategy

There is no such thing as a relaunch for medicinal product, especially if the clinical data does not speak for itself. Most drugs that underperform at the outset will continue that trajectory throughout their lifecycle. If you haven’t fully considered factor such as patient needs, payer expectations, or manufacturing and supply chain complexities, you won’t likely get another chance to change relevant stakeholders' perceptions.

Smaller biotechs (in particular) can underestimate what it takes to bring a product to market, starting their commercial efforts 12 to 18 months before an anticipated regulatory approval. In fact, commercial strategy, evidence generation, and medical affairs requirements should be analyzed much earlier in clinical development and ideally be in full force at least 24 to 36 months before the planned launch. This strategy should include a framework for broad engagement with all market participants, such as potential partners, patients, payers, and regulators.

It’s essential to understand that one of the biggest challenges in the early stages is risk mitigation. Landscape assessments can go a long way in reducing risk by providing insights into the competitive environment, payer considerations, clinical treatment processes, and patient challenges. This knowledge can be invaluable in guiding your development programs.

A pragmatic look at planning ahead

But is all this planning ahead realistic? Besides putting a primary focus on regulatory approval, management teams are also typically juggling multiple priorities. Consider the earliest iterations of your planning for launch as an overview, not necessarily a full-scale detailed activity plan. Market access planning can start early in clinical development with a commercial roadmap or at least a high-level proof of concept that identifies key milestones and investments. Here, you can outline the value proposition and target customers, and how to influence and reach them based on those strategic goals. You can begin to map out the resources, organizational structure, and activities needed to achieve the program objectives. That will help you prepare for more formal planning later, in a Phase II trial.

Priority within an integrated evidence plan (IEP) is often on the clinical endpoints delivered from a protocol perspective. But you can also leverage other opportunities for evidence generation in the context of post-marketing requirements. By including medical affairs and RWE perspectives early, your commercial roadmap informs clear objectives for an integrated evidence plan. This is essential for understanding the patient treatment journey and plan for patient-centered development.

The importance of investing in commercial planning early holds true even if your biotech intends to seek partners or an exit strategy. Assessing the market to define a competitive landscape and deliver value story may be too costly and time-intensive if considered too late. Also, the ability to share commercial strategy adds value to partnering discussions.

Ready to take the next step in refining your commercialization strategy? Reach out to our team today to start a conversation about how early planning and landscape assessments can help ensure your product launch is a success. Let's explore actionable insights tailored to your needs and set your biotech on the path to excellence.

References:

[1] https://www2.deloitte.com/us/en/insights/industry/health-care/key-factors-for-successful-drug-launch.html

[2] https://healthadvances.com/application/files/5516/9341/5245/launch-excellence-life-cycle-healthadvances.pdf