Using Targeted Market Research to Improve Future Adoption of Cell and Gene Therapies
The Cell and Gene Therapy (CGT) commercial landscape is evolving rapidly. There are more than 1,400 CGT developers worldwide, with over 2,200 clinical trials underway, many of which will hit the U.S. market within the next few years. These products are likely to be both operationally complex and expensive.
Those key characteristics- complexity, and cost, leave little room for manufacturers to make errors in designing commercial distribution plans. This is especially true when considering sites of care that will use a product. Multiple factors, including the need for access to equipment (temperature-controlled storage, laminar flow hoods, etc.), specialized staff, and clinical requirements with early CGT products, required these products to be administered in hospitals. Therefore, manufacturers’ understanding of hospital operations was, and remains, essential in successfully commercializing a CGT.
Hospitals – from community health systems to academic medical centers to Integrated Delivery Networks (IDNs) – are as unique as their patients. They each have internal processes for managing novel therapies that have evolved significantly in the last few years, making it unwise for manufacturers to design site-of-care strategies based on “how things used to be.”
The commercial introduction of the first CGTs required many hospitals to develop new operational pathways for increased budgetary impact and logistical coordination for tiny patient populations. In working with hospitals across the globe to understand how they prepared for these product launches, we’ve realized that there is a high level of concern for what’s coming next. These hospitals took years to prepare to launch a handful of novel products. Preparing for hundreds of similar (yet, slightly different) products keeps administrators and pharmacy directors up at night.
To ease the anxiety that goes with a growing portfolio of CGTs, manufacturers can support hospitals by developing product protocols that work within existing hospital infrastructures and processes.
How is that even possible?
One answer is employing thoughtful market research. Asking the right questions of a diverse sample of hospital customers across the various markets where a CGT will launch is a vital – though often overlooked - step in CGT commercial planning.
During Phase I development, some forward-thinking manufacturers actively engaged in detailed commercial market research with hospital systems. That may seem too early, but the benefits of understanding and being able to modify operational complexities that would likely negatively impact future adoption outweigh the risks of the research being “wasted” on a product that might not progress through clinical development.
Starting a market research project might seem daunting, especially if your organization is still early in clinical development. These four questions are a good place to start:
Who? The role of clinicians in the ultimate commercial success of CGTs diminishes once the decision to treat has been made. However, hospital administrators, pharmacy directors, nursing staff, Cell Lab managers, and CGT program directors are essential to making CGTs work in the real world. Be sure to understand the concerns of these stakeholders, as they will be responsible for the day-to-day management of your product's logistics, reimbursement, financial viability, and patient coordination.
Where? Geography matters when it comes to hospital care delivery. Expect significant differences between how hospitals in Europe and the U.S. manage a CGT. Additionally, hospitals in California, Illinois, and New York manage aproducts even more particularly. The same is true in hospitals located in different European countries.
Why? Every product has unique attributes that must be considered in commercial planning. If a product is shipped and stored on LN2, it may have a long administration timeline, or the preparation requires a particular skill. What may seem insignificant in clinical development may be critically important in a commercial setting, or vice versa. Exploring the details of potential problem areas will ensure no surprises when it’s too late to make significant changes to the product design (e.g., packaging) or planning.
How? Identifying the variations in how a product journey has been designed versus how it will work in the real world is essential. Collaborating with key individuals at hospitals to map the flow - from product ordering and receipt to preparation and administration - can help uncover any nuances between working assumptions and reality.
Hospital market research can be a game-changer for CGTs preparing for commercial success, especially as the market expands. If finding the right people and asking the right questions seems impossible, don’t fret. Archbow is in a position to quickly and effectively engage with these institutions on your behalf. Our experienced team understands CGTs and knows how to ask the right questions of the right people in the right ways. Contact us today to get started.
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Archbow Consulting helps pharmaceutical and biotech companies in the USA and Europe design, build, and optimize product distribution and patient access strategies. Archbow was founded by industry veterans to meet a need in the marketplace for consulting options that offer diverse real-world experience, can leverage deep connections across the industry, and can also provide actionable strategic guidance. We invite you to learn more about our team, services, and client’s success, and connect with us via email, LinkedIn, Twitter, or subscribe to this blog which you can do below.