This specialized case study explores Kymanox’s expert program management support for a high-value Contract Development Management Organization (CDMO) client, accelerating drug product development and CGMP manufacturing. Our team of SMEs collaborated across functions to implement measurable improvements in clinical supply coordination, compliance adherence, and project acceleration, resulting in significant commercial agreements and strengthened client relationships.
CHALLENGE
SOLUTION
RESULTS
- Provide comprehensive program management support for a CDMO overseeing drug product development and CGMP manufacturing across all clinical phases.
- Manage client Statements of Work (SOWs) and Change Orders (COs) to ensure contractual clarity and project continuity.
- Coordinate end-to-end program activities, including clinical material shipments, site visits, and milestone tracking, while adhering to compliance and high customer service standards.
- Seamlessly integrated with the CDMO’s operations, maintaining full adherence to internal processes and regulatory compliance.
- Compressed project timelines to meet Process Performance Qualification (PPQ) start date expectations without compromising quality.
- Implemented a structured communication and escalation framework to enable efficient decision-making and rapid issue resolution at all organizational levels.
- Developed a process improvement flowchart facilitating standardized impact analysis, supporting informed decision-making within accelerated timelines.
- Successfully led 12+ clinical supply manufacturing runs incorporating process improvements.
- Created over $30 million in SOWs and COs, ensuring full contract execution and uninterrupted project progress.
- Initiated PPQ run schedules with all critical pre-PPQ requirements met, ensuring readiness.
- Coordinated international clinical material shipments, fulfilling all drug development and pre-PPQ deliverables on schedule.
- Secured a $107 million, five-year commercial supply agreement, solidifying the client-CDMO partnership.