Developing tools to break the rules: Fostering innovation in cell therapy manufacturing

Just over a year into my journey as senior vice president of Cell Therapy Development and Operations at Bristol Myers Squibb (BMS), I continue to be humbled, amazed and inspired by the science and life-saving potential of cell therapy technology. Cell therapy represents a shift in how we treat diseases, offering the potential for expanded lines of treatment and improved outcomes in hematological cancers, early success in solid tumors and transformative potential for autoimmune related diseases.

Chimeric antigen receptor T-Cell (CAR-T) therapy, a powerful example of this approach, involves removing a patient’s T-cells, modifying them in-vitro to recognize a specific target before returning them to the patient to fight disease. It is a fascinating science that currently requires complex, labor-intensive processes to realize.

Unlocking the full promise of cell therapy hinges on our ability to develop innovative manufacturing processes that enable a reliable and scalable supply in an economically viable way that incentivizes innovation without constraining access.

Sustainable, reliable and robust cell therapy supply requires innovation in four dimensions:

There are many perspectives on what value generating innovation is, and I find myself thinking about Errik Anderson’s “Rules, Tools & Fools” TED Talk. Errik described value-generating innovation as developing tools, that break the rules that constrain productivity.

• Rules refers to the assumptions we make that dictate how work is done and constrain the efficiency of how work is executed.
  
  
• Tools are the innovations, devices, processes and technologies that help us to overcome the rules (or constraints).  

I use this framework to identify some of the “rules” and the “tools” that we need for value creating innovation in cell therapy manufacturing: 

Framing the opportunity for value creation is a necessary first step in enabling innovation, but it is unfortunately not sufficient. Innovation also requires “operationalization” through a systematic process and most importantly, integration into the culture of the business to empower ideation and experimentation.

I see “operationalization” of innovation in four steps:

• Stimulation of the workforce to innovate requires a deliberate process to identify and make cross functional problems visible. At BMS, fostering a culture of diverse perspectives and systematic idea-sharing processes accelerates innovation by refining problem statements and prioritizing follow-up on ideas, driving engagement and investment in top solutions.
  
  
• Effective prioritization of ideas at BMS allows focused investment on accelerated implementation. This hinges on basing decisions on outcomes rather than intermediate inputs, employing a clear decision-making system and robust communication to ensure impactful execution and adaptive management of resources and priorities.
  
  
• Integration of ideas into pipeline or life cycle products. While simple, it’s vital; only invest in innovations that can be implemented. Many innovations have been shelved because the implementation and realization path were not defined early enough. This requires the development and maintenance of an interwoven product, site and technology strategy that deliberately integrates innovation (sometimes on the critical path – there is no advancement without risk) into product development or life cycle management.
  
  
• Implementation of innovation requires deliberate investment, resilience and agility. Innovation is more expensive and will take longer than we think. Be honest about execution timelines and resources, expect things to go wrong and pivot when they do. Sometimes, where to go next is “nowhere” – squash the idea and try another one. In an idea-culture there are always more good ideas than execution resources, so don’t be afraid to pivot to the next idea.

Our inspiration for innovation is a deeply rooted desire to serve our patients. We innovate every day to serve just one more patient – if we can treat 10 patients today, we should aim for 11 tomorrow. If we can treat 11 patients tomorrow, we should aim for 12.* It’s our team’s passion, ambition and drive that make us one of the leaders in the cell therapy landscape. Everything we do is for these patients, and it’s the work we’re putting in now, today, that is going to help shape this treatment paradigm for years to come. 

Scaling cell therapy manufacturing demands a collective effort, a willingness to share knowledge, and a commitment to pushing the boundaries of what's possible. Within the next frontier in innovative manufacturing and supply, the learnings we take from and the tools we create for cell therapy will transcend across industries and allow us to continue to break the constrictive rules of supply.