Logistics Decisions Will Impact the Success of New Cell and Gene Therapies
By Pete Belden |
Cell and gene therapies create the opportunity to significantly transform how diseases are treated and cured. By replacing, manipulating or engineering cells and/or genetic material to fight disease, advances in this field offer a wellspring of hope for enhanced patient outcomes and a new era for medicine.
The challenges of cell and gene therapies lie in their defining qualities, their uniqueness and their connectedness to the patients they treat. Because cell and gene therapies require such precision and new models of thinking for everything from clinical trials to data collection to patient access, commercialization strategies must be reexamined—and in some cases, completely redeveloped.
We see this distinctly in supply chain decisions, where a wholly new type of product demands a wholly new definition for supply chain expertise and effective support. At AmerisourceBergen, we’ve served as the supply chain and commercialization partner for nearly every single biologic and specialty pharmaceutical product that has entered the market over the past 20 years. And based on that expertise, we see several key areas of distinction between specialty products and new, cell and gene therapies—areas that manufacturers should carefully consider in their commercialization planning.
Here are three such examples:
... a wholly new type of product demands a wholly new definition for supply chain
expertise and effective support.
1. First, there is no distinct handoff from clinical to commercial manufacturing of cell and gene therapies.
Why this matters: Decisions made during clinical development influence the future viability of the product to an unprecedented degree. As a result, timelines and commercialization best practices shift. Manufacturers should consider the barriers that will limit patients’ access and customers’ utilization of the product preferably at least two years prior to launch.
What manufacturers can do: Even though cell and gene therapies stand apart from rare disease, oncology and other highly complex therapeutic areas, some of the best practices in those areas still carry over—or, at a minimum, are extended or expanded upon with cell and gene therapies’ more rigorous requirements. When evaluating commercialization solution providers, examine their prior success navigating extreme complexity, as well as their previous work in guiding clients through unchartered markets.
2. Because autologous therapies are comprised of living cells with a limited lifespan, there are exponentially more variables involved in therapy production, transport and administration.
Why this matters: The increased scope of product needs will require manufacturers to be prepared to coordinate significantly more services as they bring products to market. Some of the many services that a manufacturer may require include: the fulfillment of kitting at the apheresis site, the coordination and tracking of shipments, temperature monitoring and real-time temperature tracking, notification of interruptions or changes, chain of custody tracking, product data monitoring and advanced cryopreservation and cryoshipping technologies that add an element of flexibility in the supply chain.
What manufacturers can do: Especially given the one-of-a-kind nature of these products, their cost and time of production and their ability to transform or even save lives, manufacturers need to prioritize the selection of specialty logistics partners that have proven expertise and a robust, standardized infrastructure to support global needs. Manufacturers should also ask logistics partners about their experience with contingency planning to assess their capabilities for resolving a variety of unexpected situations.
3. While the complexity of cell and gene products favors minimizing manufacturing sites, patients who may benefit from these therapies may be dispersed around the globe.
Why this matters: Complexity of processes and geographic constraints can create logistics scenarios that differ substantially from traditional and even specialty pharmaceutical products. For example, Phase I studies for a cell therapy may happen at one location and move to multiple sites for Phase II and III studies, with apheresis happening at one of those sites. When the product moves to commercialization, manufacturing and apheresis may each occur at several sites.What manufacturers can do: Manufacturers should demand specialty logistics solutions that work in harmony with the need of patients and the qualities of the product. That means apheresis scheduling in a patient hub program links to an available manufacturing slot, which triggers logistics preparations like shipment with temperature-controlled packaging and a time-definite pickup, which should in turn initiate invoicing. When working with logistics providers, all of the points from A to Z can be coordinated together, and manufacturers are able to focus on further clinical innovation or advancing other aspects of commercialization.