The commercial planning process in the pharmaceutical industry is conventionally seen as a time-intensive, budget-eating commitment with little return on investment. The fact is, the process doesn’t need to be a process at all. Ideally, commercial planning begins with critical questions, whose answers quickly, efficiently, and clearly provide you with clear pathways to success, adding value to your product—and to your business. By asking questions early, and understanding the critical issues as you approach launch, you can better allocate your budget to address the challenges of your market.

But when should you start commercial planning? And how? If you’re a commercial leader with a clinical stage product, or a leader considering commercial ramifications of critical decisions, even in stage 2 or earlier, the time to start adding strategic commercial thinking to your mindset is now.

Early trial endpoints can define your brand

With critical medicines often being granted NDA submission approval before completing a phase 3 clinical trial, an early commercial mindset—during phase 2, even phase 1 trials—can help your organization be prepared for positive developments. And by including commercial thinking in early stage clinical trial endpoints, you can begin to shape your brand, and its perception, earlier than ever in the marketplace.

Will your product be perceived as a critical component of lifesaving therapeutic intervention, or as a therapy that enhances quality of life? There’s a time and place for each of these perceptions, but your input early in the clinical trial endpoints and in target product profile generation can help determine how your therapy is defined in the minds of your customers over the long term. And this definition has vast implications for your product’s positioning—and value—in the marketplace as you approach launch. Understanding where your products characteristics meet the needs of the marketplace is a critical component to your early commercial thinking.

Longer relationships bring greater trust

Understanding key audience sentiment earlier in the process can drive your brand’s success through launch. One common assumption is that KOLs on a company’s board of directors or key relationships with principle investigators represent the total mindset of an audience; this assumption may drive resistance to additional research into sentiment. While these critical individuals are important, a more comprehensive sentiment analysis comprised of a wider range of customers can help surface critical insights that may affect your strategic thinking—and your approach to market. For example, you may discover the wider audience perceptions around a condition do not match the KOL community; the disease may be perceived as less severe, or emerging understanding of its mechanisms of pathology may not have reached a broader audience. These potential misperceptions among the wider audience can have ramifications for your brand as you approach launch, and may require more active tactical applications. And the earlier you understand these kinds of disconnects within the physician community, the earlier you can take action to address them.

Patient communities also represent a key, early contingent for consideration in your commercial strategy. Understanding their mindset around their conditions, existing therapies, and even competitor molecules and organizations can give you critical insights that may influence your approach to commercialization. For a growing number of organizations, patient communities play a key role in clinical trial design; in smaller communities, patients, families, and caregivers can offer critical guidance through all stages of product development. Patient communities can also serve as powerful allies in discussions with regulatory authorities, helping add historically underrepresented voices to the development and approval process. Reaching out early can help you deepen your relationships with these critical communities, allowing you to truly understand your audiences and their needs.

How is your disease perceived?

Unless there’s active outreach, a community’s perception of disease can often be antiquated. For physicians, the last time they engaged in discussion around certain conditions could have been during medical school. Patient communities may also take their cues from physicians, and may not fully grasp the potential consequences of their condition, or new understanding about its pathology or emerging thinking about therapeutic strategies.

For commercial leaders, understanding and managing perception around disease in early stage clinical trials is mission critical. If a disease is misunderstood or if its severity is underappreciated, there are dramatic implications for product valuation, as well as other factors, including diagnostic urgency and product adoption. Simply put, there is no such thing as a high value therapy for a low value disease. Understanding, and actively communicating, the true nature of the condition as you approach launch can have dramatic implications for your success.

How We Can Help

Together, we can help you ask and answer the critical questions, so you can be more commercially prepared earlier in your process.  These questions might include:

At PRE Commercial, we have deep experience in finding answers to these questions, as well as exploring unconventional lines of thinking that can lead to market moving insights regarding your product, disease environment, and corporate brand.

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