Applying design to cost to radically cut production cost and turnaround time for a groundbreaking cell therapy

Vision

A leading biotech, having recently completed Phase II trials, needed a significantly lower cost and faster turnaround time (time to patient) to bring their innovative cell therapy to market in less than 18 months.

Challenge

• Engaging 50+ stakeholders across CMC to redesign production cost and timelines from the ground up.
• Stakeholders were distracted by also scaling up to manufacture supply for Phase III trials.
• Developing ambitious milestones which could accomplish significant improvements in less than 18 months.

Solution

The company partnered with us to build an innovative production strategy and provide program management support. Together, over a 10-week engagement, we:

• Mapped the Phase II production value stream as a baseline, then engaged the Tech Ops team to capture existing ideas for cost and turnaround time reduction.
• Challenged the team to identify further cost reduction opportunities to meet target production costs and turnaround time.
• Modeled the impact of re-engineered processes and automation on staffing levels and material, keeping a running tally of end-to-end production cost and turnaround times.
• Built a 100-page, 10-chapter Playbook across the end-to-end value stream supporting functions, capturing and structuring ideas to guide the development of a phased integrated program plan.
• Worked to gain senior executive buy-in to the production strategy.

Impact

• Developed a high-level plan to reduce cost to manufacture the cell therapy by a factor of 25, establishing an industry milestone
• Created a pathway to reduce turnaround time to deliver personalized medicine to patient by 50% from Phase II trial times
• Established high level targets for bills of materials and staffing levels across 18 months to guide implementation.