Case Study IV: Technical Operations Launch Readiness
Situation: A biotechnology company developing life-changing therapies for rare diseases was completing work required for licensure while scaling up manufacturing for commercial launch. The company realized that to deliver on both of these critical goals while preparing for future challenges, they would need to streamline the way they worked together and the way they tracked projects. The company sought help from Spannerwerks to establish right-sized CMC project management that would grow with the company and strategic planning to anticipate the future.
Insight: Companies nearing drug approval and commercialization can benefit from guidance when navigating this inflection point. Success often requires expertise and support during a time of accelerating growth.
Solution: Spannerwerks partnered with technical leads to map out the milestones and critical path for the highest priority project of BLA and launch. A specialized PM toolkit, created by Spannerwerks, allowed the team to visualize the path forward, work toward universal milestones, and anticipate and mitigate risks. This toolkit was quickly deployed on a second project, then a third. Efficient planning and management for critical projects allowed the company to look to the future. Building plans and shared project knowledge in Phase 1 positioned the team for Phase 2. Spannerwerks partnered with the SVP of Technical Ops to set up an LCM (Life Cycle Management) committee chartered with setting long-term goals and scenario planning.
Results: In a few short months, Spannerwerks established an efficient set of tools for planning and communication for the highest priority projects key to corporate success. The toolkit was tailored to scale across all projects and initiatives, easily accessed by all levels of the organization. The milestone dashboard and reporting tools supported accurate, frequent reporting to senior management. With the plans, toolkit, and Life Cycle Management Process in place, we helped the company refine their candidate search and seamlessly transitioned the project management function to a new head of CMC PM and Strategy.