By Holly May, Chief Commercialization Officer, AVROBIO
Does commercialization strategy matter when you are years from having a commercial product?
In my experience in biotech, the answer is a resounding yes. Biotech is an industry that has a high rate of failure — 90 percent of drug candidates do not get approval. Even if approval comes, a study by Deloitte Center for Health Solutions that examined 149 new drugs launched between 2012 and 2017 in the United States found that over a third of those drugs underperformed in the year following launch. To help avoid that fate, my biggest piece of advice for young biotech companies, especially in the competitive gene therapy space where you don’t have a moment to lose because gene therapies are designed to be one-time treatments, is to instill a commercial mindset at least four to six years prior to launch.
It is easy to lose sight of the importance of a commercial mindset early in the life of a biotech company. Many companies fail to see or understand its value proposition or its critical role in the creation of clinical development plans. Unfortunately, because the access and reimbursement stakes are so high in this market segment, operating without a commercial lens and throwing a product over the fence to the commercial team a couple of years prior to launch with the expectation that they can take it to market and sell it is not a luxury biotech companies can afford.
Delivering a product to market that meets the needs of the entire stakeholder ecosystem – patients, health care providers, payers, HTAs and policy makers – is a vital requirement for success in today’s global marketplace. That is why early reinforcement of a commercial mindset with cross-functional teams is so critical.
If an emerging biotech is not asking questions and making decisions that ensure the medicine fulfills an unmet patient need, is differentiated from standard of care (if one exists), and demonstrates economic value to the health care system, market failure will be inevitable.
Commercialization Encompasses a Multi-Year Process Across the Company
Commercialization means making strategic decisions rooted in deep customer insights at key timepoints in a therapy’s and organization’s development that affect the downstream commercial success of that product.
I often hear the phrase “launch readiness” used interchangeably with “commercialization” – in my opinion, that’s not correct. Commercialization is more expansive than launch readiness, which occurs only 36 to 24 months prior to the earliest possible approval. Go-to-market processes like launch readiness are tactical subsets under the larger commercialization umbrella.
Commercialization, when approached strategically, encompasses at least a four- to six-year process, from the preclinical phase all the way through product launch. Designing a good commercialization process begins with defining the points in time when strategic decisions for the overall program need to be determined. Essentially, critical decisions should be made around an integrated set of choices that align with the stages of product development: preclinical program initiation, first-in-human studies, establishment of efficacy, filing and finally launch. This becomes the “North Star” for the program and roadmap for the best possible chance for commercial success. While it might sound like a clean, linear calendar of events – it’s not. The landscape shifts constantly and programs “learn” as they develop, so applying a commercial lens is a bit of an art and a science at every stage.
Importance of the Other Kind of Data: Market Insights
Making the most informed decisions requires gathering foundational inputs which must stand on the shoulders of deep customer insights. I believe strongly that one of the first overarching investments young biotech companies need to make, beyond hiring commercial experts, is in solid stakeholder insights. The customer voice can be ascertained through a variety of vehicles — blinded research, unblinded input, data analytics, competitive/industry intelligence, payer, policymaker, and regulator feedback. All are important in their own way.
A good place to start is to find a reliable market research firm, one that knows your therapeutic space. The types of insights market research firms can provide will enable a company to better understand patient needs, HCP decision-making, market landscape dynamics, the reimbursement and access landscape and more. To ensure you hire a good firm, don’t underestimate the power of past experiences and references.
Equally important to blinded research are face-to-face interactions with patient advisory groups, patients, caregivers and KOLs. The time and effort spent in 1:1 customer meetings or well-planned Advisory Boards is critical. However, without the discipline to “layer in learnings,” the investment can go unrecognized. The actual power of customer input is realized by the degree to which insights are integrated into program planning. A well-designed commercialization process ensures this connection.
Listening to the stakeholder ecosystem, early on, is the best approach. At AVROBIO, the input-gathering stage is very important, and includes not only customer insights but also informed answers to a set of milestone-specific guiding questions. We allot the necessary time required to gather and assimilate this information prior to pulling cross-functional teams together to begin “choice-making workshops.” These workshops are designed to produce a series of outputs which come together in the commercialization plan.
At each milestone, we update the existing outputs and add the necessary new ones which continue to inform the next phase of the development plan. For example, we iterate our target product profile (TPP) a minimum of three times. Subsequently, there is this nice synergy between milestone commercialization outputs and continual evolution of our program’s integrated development plans.
If done systematically, an early commercial mindset may help deliver a product to patients and families that meets the needs of all stakeholders while driving the highest business potential. It allows cross-functional teams to discuss and understand not only the clinical and regulatory risks but also the commercial risks and opportunities as well. Amongst other things this includes meeting the needs of payers/HTAs whose evidence expectations bar could be said to be higher yet than that of regulators’, prescribers,’ and patients’.
Using a commercial lens from the outset means coming prepared – it is not a dirty word. Developing and implementing a sound strategy at the earliest stages and making smart investments and decisions early on are essential guidelines to follow. They inform every decision you make, from the very start, to help you realize the goal of reaching as many patients as possible with life-transforming therapies. It could be the difference between success and failure.