Regardless of your industry, one of the most exciting and sometimes scary aspects of creating something that has never existed before is determining where and how to begin the process – as well as how to evolve and maintain the relevancy of what you are creating.
In the early days of cell therapy, one of the biggest challenges was the management and streamlining of a process that required a very rigorous timeline in order to be effective. More than a decade ago Dendreon Pharmaceuticals (Seal Beach, Calif.) set out to create an infrastructure system that would do just that, thus establishing a process to deliver complex therapies that serves as a blueprint to this day.
We created an entirely new therapeutic category in 2010 with FDA-approval of the industry’s first personalized cell therapy(also called immunotherapy)for men with advanced prostate cancer. The immunotherapy treatment process begins with collecting a patient’s own immune cells. After being shipped to a manufacturing site, a custom treatment is created by programming a patient’s immune system to find and attack cancer cells. This custom treatment is then transported to a medical facility andinfused into the patient. Note that all of these steps must occur within 72 hours or the immunotherapy cannot be used. Each patient repeats this treatment process three times over approximately 4-6 weeks.
But the process of delivering this treatment began well in advance of the FDA’s nod. In 2007, without any blueprints, we embarked on a journey to create a system called Intellivenge to manage the execution of the entire immunotherapy treatment process from “arm to arm.” Our process is multifaceted and requires precision logistics, timing and resources to be successful. We also set a goal of ensuring that it could scale to a commercial level. This required the ability to manage the ever changing volume and infrastructure needed to handle every detail, from scheduling the patient’s cellcollection and coordinating the couriers and airlines needed for transportation, to manufacturing resources and coordination with providers to administer the treatments to patients once shipped back to their offices. Even real-time manufacturing resources and possible weather delays that could impact delivery and production were taken into account.
Clinical trials were underway as we built the system and a commercial version was complete in 2009. Over the past decade, we evolved and updated the system, learning from both our successes and failures, as well as taking into account user feedback, changing patient needs and the availability of new technologies – such as ERP systems integrations, business intelligence solutions, data base integrations and cloud computing.
Regular releases with a very focused scope allow you to more easily change course when you receive real world feedback
When creating a system from scratch, it’s important to follow the principle of “keep it simple.” Start by developing basic functionalities and get them into the user’s hands to determine what works and what doesn’t. Take the good, address the bad and iterate. With our IT and Technical Operations teams working as partners, we have found through experience that large monolithic releases can take too long, squander precious time and resources, and they never perform as expected.
Regular releases with a very focused scope allow you to more easily change course when you receive real world feedback. Once we began to use Intellivenge in production, the holes in our processes were quickly identified and filled. To this day, continuously obtaining feedback from users is leveraged to build enhancements and refine functionality. Your system or solution will never be complete, as you must always be able to scale and evolve to meet the needs of users.
For those embarking on a journey to develop like systems, whether it be for cell therapy or other manufacturing and delivery processes, here are some additional pieces of advice and lessons learned:
• Establish a cross-functional (not siloed) team of subject matter experts.
• Always develop your system with the end user and capabilities in mind, but also the flexibility to scale and evolve.
• Implement agile development methodologies. Agility is key for many industries, including biotech.
• Create a cloud-native solution, which will ensure you have an integration platform that gives you the ability to rapidly develop integrations and automations that will optimize capabilities and outcomes.
• Make sure that all of the applications you develop have a strong APIs (application programming interface), even if you won’t leverage them initially. Consider iPaas and aPaas options before starting from scratch.
• Performance testing is an important key to success. When creating a complex scheduling model that has to evaluate constraints for thousands of resources for each treatment, minor performance problems can quickly turn into serious issues, costing everyone involved precious time, money and resources.
• Communication up and down the entire process is essential, and you should always have the ability to use the system for managing exceptions. This is a critical tool that will enable you to monitor the execution of the processes and to notify all of those involved in delivering a successful outcome.
Going where your industry has never been isn’t easy, but if done properly, the payoff can be life changing. Take the time to build your systems piece by piece. Utilize the work you’ve previously done to create a roadmap for those who will follow, giving your organization the ability to continuously make improvements – which after all is one of the keys to not only deliver ROI, but also maintaining and growing market share.