Bringing CAR T products to market: A new approach to product launches
Dennis Fournogerakis and Nathaniel Swenson, Ph.D.
CAR T therapies have revolutionized oncology patient care. But to ensure the often lifesaving benefits of these therapies reach the right patients, life sciences companies must navigate complex decision-making and treatment processes to maximize uptake.
Unlike mass-market therapies, which are typically self-administered on a dosage schedule, CAR T therapies require a much more involved process. Once prescribed by an oncologist, a patient visits an approved treatment center where his or her T cells are collected and then sent to a laboratory to be altered. Then, the T cells are returned to the treatment center, where the oncologist infuses them back into the patient.
FDA has approved five CAR T products since 2021. And there are currently more than 500 CAR T products in clinical therapies. As more CAR T products come to market, strategic, data-backed product launches will be critical to ensure these innovative therapies reach the patients who need them.
For life sciences commercial leaders, the product launch plans they use for mass-market therapies will not work for their CAR T products. The complex treatment process of CAR T therapies require a more complex launch plan as well. Commercial teams must carefully and strategically identify treatment centers for the product to launch, thoughtfully expand the team to best support patients and physicians during the time-sensitive treatment process, and incorporate flexibility and agility into their data management processes to account for the many vendors involved in the CAR T commercial lifecycle.
A thoughtful, strategic approach to a company’s CAR T product launch will not only support continued commercial success, but also ensure the innovative treatment quickly reaches the patients who need it most.
Identify treatment sites
CAR T therapies cannot be administered at just any medical facility. Treatment sites must go through a thorough onboarding and training process to be approved to administer CAR T products. This process can be time intensive, so commercial teams must begin to identify and begin onboarding treatment sites well before product launch.
To start, the manufacturer will need to meet with a potential site’s executive and legal teams to earn buy-in and establish the certification and treatment delivery process with the site. Then, the manufacturer must conduct thorough training with site staff – including direction on placing product orders, testing the procedure through “dry runs,” and learning how to manage patient side effects.
Because of this extensive process, manufacturers often must limit the number of sites available at launch. To ensure an effective product launch with a limited number of sites, the commercial team should collect and analyze a range of data – including claims, prescription and bone marrow transplant data – to create a shortlist of potential launch sites. The commercial team should analyze the data to gain an understanding of the potential patient population and where they are located to ensure target launch sites are optimally placed to maximize patient reach.
As more CAR T products come to market, commercial teams should also review the launch strategies of their competitors. Due to the intensive onboarding process required of treatment centers, a site may not be interested in obtaining certification for multiple therapies that treat the same disease. But, a site that has already been through the onboarding process may be more inclined to obtain certification for therapies that cover other diseases than their current CAR T treatments do.
Expand the sales team
In addition to the complex certification process, the commercialization of CAR T therapies is also complex. To support patients and treatment sites, manufacturers must consider additional team structures and roles.
One major difference from mass-market therapies is the increased importance in key account managers (KAMs). As the main contact between the manufacturer and a potential site, the KAM role is critical to successful site certification. They manage the entire onboarding process, from leading initial partnership meetings to facilitating staff training. The unique role of a KAM requires different skillsets from a traditional sales rep. KAMs must be natural project leaders and able to support multiple sites through the many steps of the certification process.
MSLs and nurse educators are also extremely important to the success of a CAR T product launch. These roles work closely with KAMs during the certification process, training efforts and procedure “dry runs.” They help staff understand how to manage extracted T cells – including packaging them, shipping them to the lab and receiving them back from the lab. MSLs and nurse educators also support site staff with the therapy’s ordering system, administration and side-effect management. This is an ongoing process, beyond the site’s initial certification, as new staff must also be trained on the therapy’s
Manufacturers must also establish other customer support roles, such as the cell therapy scheduling team, to ensure treatment sites are well supported. Since a patient’s T cells are shipped offsite and returned, careful coordination and frequent communication between the manufacturer, apheresis site, delivery couriers, and the treatment site are critical to a therapy’s success.
To provide the best level of support to their customers, companies might consider implementing a ‘single point of contact’ model for certain tasks. By organizing the team so that a treatment site communicates with the same contact each time, the manufacturer can build a trusted relationship and better understand the specific needs of each treatment site, which can vary widely. In addition to offering more customized and efficient support, the specialization of roles can also allow faster onboarding for new hires and a more organized approach to treatment site support.
Add flexibility to data processes
Another consideration for commercial teams launching CAR T products is the need for an agile data management process. Throughout the product life cycle, new data streams will need to be added to existing data processes, for example when new data feeds need to be established to and from additional commercial partners and teams. In addition to a company’s internal teams, external vendors often get involved with tasks such as managing website updates, order fulfillment, or patient services support. All of these teams need timely access to the commercial data; a thoughtful data management strategy will minimize any access barriers. Further complicating the matter, data streams can be interdependent. For example, data received from the REMS (risk evaluation and mitigation strategies) team can make up a critical component of downstream feeds to other vendors and vice versa. The data management strategy must consider these dependencies to ensure all vendors receive accurate data at the appropriate frequency.
Creating a data management strategy that accounts for all of these data streams and incorporates governance frameworks to ensure the data is properly organized and managed, even if the specific requirements are not well-defined beforehand, is an important part of the commercial effort for any product. But, due to the complex manufacturing and logistical needs of CAR T treatments, as well as the high-touch relationship between treatment sites and the manufacturer, a well-managed data strategy is critical to the commercialization of CAR T products.
Data generation begins early on in the treatment site onboarding process. For example, commercial teams must develop a robust system to track whether treatment sites have passed each of their many requisites, including trainings, certifications, and establishment of infrastructure for cell therapy. Later on, there will be claims data and data associated with the ordering of the CAR T product early in a patient’s treatment lifecycle. Then, the shipment of the patient’s T cells to the manufacturer’s lab and back to the treatment site will create new data streams.
The manufacturer must incorporate all this data into its existing processes to facilitate real-time analytics that inform ongoing patient treatment strategies. A robust and organized data infrastructure will also help the company accommodate various data delivery schedules and ensure all parties (e.g., the REMS team, the logistics team, the sales and market access support teams, external vendors, as well as internal commercial dashboard reporting) are able to access the data they need, when they need it. To create this infrastructure, a company needs a clear data governance strategy to ensure data is properly integrated, organized, analyzed and distributed. An agile and flexible data management strategy is key to managing the wide range of data requirements and dependencies involved in CAR T commercialization.
From streamlining the treatment site onboarding process to offer a CAR T product at more hospitals to developing a sophisticated data management strategy to ensure efficiency and accuracy at every step of the patient’s treatment life cycle, commercial teams must take a fresh look at the launch strategy for their CAR T products. As more CAR T products come to market, manufacturers can learn from past launches and their competitors to fine-tune their launch strategies and more quickly bring these life-saving treatments to patients.
Dennis Fournogerakis is a partner and Nathaniel Swenson, Ph.D., is an associate manager at Beghou Consulting.