Developing a Commercialization Roadmap for Cell Therapy Operations
Clarkston Consulting recently partnered with a biotech client on a commercialization roadmap for cell therapy. Read a synopsis of the project below or download the full case study.
Download the Commercialization Roadmap for Cell Therapy Case Study Here
A clinical-stage biotechnology organization developing precision genetic medicines is preparing to launch their first commercial autologous cell therapy in the U.S. within a year.
As they transition from clinical to commercial operations, the company evaluated whether to outsource commercial capabilities to a partner or build them in-house. This decision hinged on the overall commercial strategy, high-level investment estimates, and minimal capabilities needed to ensure regulatory compliance and still allow the business to scale over time. Senior leadership engaged a consulting partner who could advise and develop capability roadmaps and associated resource estimates based on two commercial model options.
Clarkston’s Commercial Launch Advisory team and Cell Therapy industry experts were engaged to recommend systems capabilities across 11 functional areas to ensure preparedness for commercial operations. The team conducted a series of interviews to understand business requirements and their alignment to the overall commercial model strategy.
Once capability requirements and current state assessment were completed, Clarkston completed a prioritization exercise across 70 systems capabilities to illustrate which capabilities were required as a foundation regardless of commercial model decision, which capabilities were already in place and ready for commercialization, and which systems or reporting capabilities were required to invest in to meet business requirements. The prioritized capabilities were then charted on a roadmap based on resource availability, implementation timing, dependencies, and compliance measures to ensure readiness for commercialization at the time of anticipated product launch.
The Clarkston team delivered two roadmaps and associated rough order of magnitude cost estimates to serve as a strategic planning asset when finalizing their commercial operations and systems capability planning decisions.
