Case Study II: Integrated Program Management to Bring New Drugs to Clinical Trials

Situation: A biopharmaceutical company had two innovative and promising protein-based immunotherapies in development. Leadership had the know-how to bring drugs to clinical trials but not the capacity to initiate a first-in-human trial. They were also cautious about hiring costly talent too soon. They reached out to Spannerwerks for help.

Insight: Rapidly establishing customized program management that adapts to your firm's needs is essential when bringing new drugs to clinical trials.

Solution: Spannerwerks quickly established the plan and the program management functions that integrated manufacturing with preclinical and clinical study plans and prepared for the regulatory filing. We created the reporting mechanisms for the firm's leadership and Board of Directors. Day-to-day, we managed to key milestones, tracked progress by workstream, conducted scenario planning, and addressed issues. Our work focused initially on the first drug product, then moved on to the second. With well-functioning program management processes in place, we seamlessly transitioned all activities to an internal hire.

Results: In less than a year, the first product went from preclinical proof of concept to first in human phase 1 study with results ultimately supporting a partnership with a global pharmaceutical company. Within another year, the second product entered clinical trials managed by the firm. The firm now has a proven track record of advancing multiple drugs in discovery and moving those discoveries into successful clinical trials.