4 lessons learned in launching CAR T therapies
Insights and strategies for delivering cancer treatment
Prior to CAR T therapies, our most common methods of treating cancer have been burning, cutting, or poisoning patients with radiation, surgery, and chemotherapy, respectively. Thankfully, we’re on the path to something better. The often-quoted phrase “patients are waiting” could not be truer for patients who don’t stay in remission after their first episode of treatment. The development of this relatively new immunotherapy, CAR T, has garnered excitement from researchers, oncologists, and patients alike. The University of Pennsylvania has been a leader in this research since 2010. Novartis was the first CAR T manufacturer for this therapy approved for commercial use in 2017. A few months later, Kite Pharma (now part of Gilead) was second and is currently running a study to assess CAR T as a first-line therapy!
If you spend any time around CAR T, you’ll quickly discover it is a challenging product to make. Today, most CAR T is an autologous product — a onetime, made-for-one-individual treatment where the patient is also a donor to their own therapy. The ability to scale manufacturing for single made-to-order products is a challenge, especially when one of the raw materials comes from sick patients. A small but growing number of companies are developing allogeneic therapies, where a single donor is used to create a therapy for many patients.
Fortunately, many people are working to advance the manufacturing process and reduce the time it takes to develop the therapy for each recipient. Slalom has worked with multiple clients, bringing therapies to market and running clinical trials, and we’d like to share four lessons learned that we’ve picked up along the way.
1. People and processes before technology
In the awe and wonder that comes with advances in technology, too many believe that technology will magically accelerate the tools and services to deliver CAR T at scale. Processes that don’t work well or are hardly defined are poor candidates for technology. A well-orchestrated business process, where clear roles and responsibilities have been defined and exercised, is key to leveraging technology for speed, automation, and quality control.
2. Your GxP SOP isn’t ready for this
Most systems that touch CAR T manufacturing are subject to good practices (GxP) controls and standard operating procedures (SOPs). Many of these legacy quality controls were not created with modern software development lifecycle (SDLC) methodologies in mind. Most organizations have SOPs that were written when waterfall project management was the norm. Startups are not immune either; many experienced quality leaders are recruited from established companies and haven’t developed SOPs for modern development practices. Business leaders often feel they have to define everything they might need up front — whether or not they really know what they need — which often leads to bloated requirements that take longer to deliver. Modern software development prioritizes iterative development to focus on delivering the highest value functionality first. The promise is shorter development cycles with greater value delivered sooner. GxP SOPs often fail to recognize the benefit of test automation, code as infrastructure, iterative release cycles, and the nuance of software as a service (SaaS) and platform as a service (PaaS) models.
3. Every handoff is an opportunity for a fumble
For those who aren’t familiar with American football, handoffs occur when one player hands the ball to another. When handoffs are poorly executed, the team may lose ground or possession of the ball altogether. In business, process handoffs that aren’t well defined can cause delays, mistakes, and sometimes harm. CAR T is complex and, by any definition, a team endeavor. Orchestration to effectively manage key events like treatment site activation, patient enrollment, apheresis management for autologous therapies, manufacturing, bridging and preparatory treatment, and drug product delivery is a challenge and often without a single clear, accountable business owner. Some things aren’t in our control, like the exact duration of T cell expansion, but we can manage handoffs by ensuring the delivery source and target have good communication, process health metrics, and structured opportunities for collaborative improvement.
4. “Everyone has a plan until they get punched in the mouth”
This quote is from professional boxer Mike Tyson when asked about match planning against his opponent. Mike’s comment is a great reminder that it isn’t just the plan but what happens when the plan doesn’t go as expected. The first three FDA-approved CAR T manufacturers struggled to meet the patient demand at commercial launch. Manufacturing capacity, raw material supply gaps, unplanned customer scheduling behavior, and unanticipated label requirements from the FDA have all contributed to commercial delivery challenges. Organizational resilience is critical to effectively responding to events that are unknown or unanticipated. One possible solution is prelaunch postpartum exercises conducted to brainstorm all the things that could go wrong and develop contingency plans to address them. NASA implemented this tactic after the Challenger explosion.
The promising path ahead
CAR T-cell therapy marks a profound shift in our approach to cancer treatment, offering hope and healing where once there was limited recourse. Helping organizations develop and launch CAR T therapies has been some of the most impactful work many of us have had the privilege to experience. By embracing these lessons learned and navigating with resilience, the industry moves toward a future where cancer is not merely managed but defeated. The people and the mission provide the motivation to get through the hardest days. If your organization needs help bringing these lifesaving therapies to market, reach out to Slalom; we’d love to assist you in becoming the standard of care.
Slalom is a next-generation professional services company creating value at the intersection of business, technology, and humanity. Learn more and reach out today.
