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.
The truth is, as we work with emerging biopharma companies in particular, certain vital aspects of the end game — a successful launch — are downplayed (if not missed entirely) again and again.
Certainly, this can lead to an ineffective launch. Even worse, patients waiting desperately for a potentially innovative treatment may not get their needs met. Even when failure is avoided, there is often a mad scramble (higher cost, more stress, inefficiency) just prior to launch to make up for elements not appropriately considered or carried out earlier in the process.
With that in mind, today’s e-conversation highlights three of the most solvable errors we see occurring repeatedly in launching a new product, along with our suggestions for circumventing them.
Mistake #1. Planning in the Absence of Strategy
At the early stage of a drug’s development, the focus is on the science and progress of the asset. That’s understandable, of course; absent these, no patients will be served.
However, a successful product launch requires much more than just science shared between scientists. Without a comprehensive strategy that anticipates a successful outcome — one that resonates with the needs and aspirations of patients and healthcare providers — the best launch plan built at the very end of the process will inevitably lead to disconnected tactical activities, wasted efforts, missed deadlines, and rework. All of this drives up costs and slows down cross-functional efforts.
Strategy (asset, program, commercialization) must be the starting point. The strategic thinking at this stage involves understanding the landscape, identifying patient journeys, and aligning the product’s unique attributes with market demands.
A clear asset strategy sets the course for a meaningful launch. It ensures that efforts, resources, and dollars are well coordinated and that the company remains aligned on a vision for what the product will deliver for patients. It articulates the vision, shares the story, and shapes the market to educate everyone. All of this takes time.
Mistake #2. Overlooking the Patient Perspective
In the race through development to regulatory approval and commercial launch, emerging biopharma companies pay close attention to the details of the product, what they need to do to complete the rigorous clinical process, and what they hope the therapy’s impact will be in the market. They assume that if they do the clinical trials well, the patients, doctors, and payers will line up.
But no treatment, no matter how breakthrough, sells itself. A successful launch necessitates a deep understanding of patient experiences, needs, and challenges. The perspective of these critical stakeholders is essential.
Sometimes, the “patient-need gap” manifests in how the medication is formulated and delivered, especially relative to competitive alternatives. For example, regardless of the treatment’s efficacy, a patient who already wears an on-body device may have little interest (or ability) in making regular trips to a medical facility for infusions once the “new” competitive product is rolled out commercially.
Other times, there is a gap in patient finding (defined as identifying individuals diagnosed with the condition being studied). As a result, an awareness gap arises with the novel science and clinical trials underway.
Companies tend to be both over-reliant on the Contract Research Organization (whose focus is operational and standardized) and unaware of how important it is to develop direct relationships with patient populations and their trusted advocates. These relationships are critical. Delving into how patients connect within communities can provide invaluable insights into how best to engage, support, and empower them throughout their treatment journey, as well as help identify patients needing the treatment being studied.
Ultimately, patient advocacy is the “healthcare guardian” for a drug. The patient advocates might be the ones taking the medicine or friends/family of those needing the product. They provide a broader range of activities related to promoting and safeguarding the rights, interests, and well-being of individual patients within the healthcare system. Alignment is important because it helps ensure that patients’ needs, concerns, and voices are heard, fostering trust, compliance, and, ultimately, better healthcare outcomes while also enhancing the company’s reputation and sustainability.
Mistake #3. Inadequate Attention to Commercial Supply and Operations
Achieving a seamless transition from clinical trial supply to widespread, efficient commercial availability requires a well-orchestrated supply chain strategy. In practice, however, this tends to be the piece that everyone assumes will be done by someone else in the organization (if they think about it at all and early enough).
Numerous questions need to be addressed. How will the medication be stored? Will it be delivered at home, in an outpatient, or hospital setting? Will the primary and secondary packaging be patient-friendly? What is the commercial demand forecast? Will the product artwork and labeling be managed internally or outsourced? The list goes on and on. When you consider that an estimated 50 percent of pharmaceutical recalls are related to labeling or packaging artwork, it’s clear that the transition to commercial-scale production demands meticulous attention.
Commercial supply and operations extend beyond ensuring ample quantity of specific dosage forms. It encompasses gross-to-net financial planning, distribution logistics, inventory management, and robust contingency planning. Adequate time invested in defining the supply channel strategy and distribution network can prevent bottlenecks and setbacks that might otherwise derail a launch. And yet, over and over, we see companies underestimate how quickly all of this can get done.
“Later” Is Too Late
Like planning to pay for college, when it comes to developing and launching a new drug, the most difficult error to correct is lost time. Some things can’t be sped up, regardless of how much money or resources are put forward later.
By avoiding these three common mistakes and adopting a commercialization mindset from the start (e.g., does this product meet a patient’s unmet need, and how can we ensure this therapy gets to patients?), emerging biopharma companies can achieve their vision and execute their future launch strategy flawlessly.