About the study
The client is a small, clinical-stage oncology company focused on developing novel medicines for metastatic breast cancer patients.
Challenge
Advancing a new registration-ready drug from discovery and phase 1 clinical trials to phase 3 clinical trials is challenging. Managing the manufacturing, quality, and regulatory side of the processes (collectively called CMC – Chemistry, Manufacturing and Controls) takes a unique team with multiple areas of expertise. As a small company, the client did not have in-house team members with the skills necessary to manage all aspects of CMC effectively. Neither did they have the financial resources with which to hire such a highly qualified, specialized team.
Results
The client was impressed with Syner-G’s ability to deliver value from the very first day by building highly effective communication channels across functional teams, including leadership and management. This included hosting regular meetings and maintaining project timelines and Gantt charts. Syner-G also created alignment on goals and set expectations on timing and outputs, ensuring everyone was represented on the Gantt and that they stayed on schedule.
Solution
The client chose to partner with Syner-G BioPharma Group to manage all of its CMC activities. They made the decision based on Syner-G’s expertise in peptide manufacturing and because one of its founders had worked with the FDA to create accelerated guidelines for review and approval. This is a very unique expertise in the marketplace.
Other results included the following:
- Engaged directly with our manufacturing partners to ensure technical success and high-quality deliverables
- Reduced multiple quarters of drug development through improved efficiencies
- Reduced overall spend as a result of a phase-appropriate comprehensive CMC strategy
- Enabled registration-ready drug for late-phase clinical trials