The Cell and Gene Therapy (CGT) commercial landscape is evolving rapidly. There are currently more than 1,000 CGTs in development worldwide, 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 commercial design, especially when it comes to the site-of-care. Multiple factors, including the need for access to equipment (temperature-controlled storage, laminar flow hoods, etc.) and specialized staff, and the A.E. profiles of early CGT products, lead to CGTs being administered in the hospital, making a manufacturer’s understanding of hospital operations essential.
Hospitals – ranging from community health systems to academic medical centers to Integrated Delivery Networks (IDNs) – are as unique as the patients they serve. They each have their own 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 introduction of Kymriah® and Yescarta® to the marketplace drove many hospitals to map new internal operational pathways to account for increased budgetary impact and logistical coordination for very small patient populations. In working with hospitals across the globe to understand how they prepared for the Kymriah and Yescarta launches, we’ve come to realize that there is a high level of concern for what’s coming next. These hospitals took YEARS to prepare for the launch of TWO ultra-complex products. How they will possibly prepare for HUNDREDS of similar products keeps administrators and pharmacy directors up at night.
To ease the anxiety that goes hand-in-hand with a robust marketplace of CGTs, manufacturers can support hospitals by committing to developing therapies that work within existing hospital infrastructures and processes.
How is that even possible?
The answer lies in market research. Asking the right questions of a diverse sample of hospital customers across the various markets where a CGT will launch has become a vital – though often overlooked - step in CGT development.
As detailed in this case study, some manufacturers are actively engaging in detailed commercial market research with hospitals as early as Phase I. 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 can be daunting, especially if your organization is still early in clinical development. These four questions are a good place to start:
Who? The role of prescribers in the commercial success of CGTs is somewhat diminished once the decision to treat has been made. Hospital administrators, pharmacy directors, Cell Lab managers, and CGT program directors, however, are essential to making CGTs work in the real world. Be sure you’re talking to the people who will be responsible for the day-to-day management of the logistics, reimbursement, financial viability, and patient coordination of your product.
Where? Geography matters a lot when it comes to hospital care delivery. After all, it may be reasonably obvious to expect significant differences between how hospitals in Germany and the U.S. might manage a CGT, but the differences in how Germany and Switzerland or California and New York, manage those products may be more nuanced.
Why? Every product brings a unique set of attributes that need to be considered in commercial planning. Maybe a product is shipped and stored on LN2, maybe it has a long administration timeline, or maybe the preparation requires a particular skill. What may seem like a big deal in clinical development may not be overly meaningful in commercial delivery or vice versa. Exploring the ins and outs of each and every potential problem area will ensure there are no big surprises down the road when it’s too late to make significant changes to the product design.
How? It is essential to identify the variations in how a therapeutic journey has been designed versus how it will actually work in the real world. Collaborating with key individuals at hospitals to map the flow - from product ordering and receipt through to preparation and administration - can help to expose any nuances between perception and reality.
Hospital market research can be a game-changer for CGTs preparing for commercial success, especially as the market continues to expand. 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.