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Pharmaceutical Science Exellence: CMC Activities, Resources, and Performance
Best Practices LLC, Sep 2008, Pages: 113
This study was conducted to better understand resource and investment levels, expertise, and activities in global (pre-launch) Chemistry, Manufacturing and Control (CMC) operations in top pharmaceutical companies. This data-rich study provides numerous operational benchmarks around CMC facilities in terms of number/geographic locations, types of CMC activity performed, and FTEs by function and advanced degrees. The research also delivers benchmarks around number of projects, batches processed and timeframes for CMC activities. Other topic areas include capabilities & expertise and performance & measures. This study is intended to provide executives with data to assess the effectiveness and efficiency of their CMC operations and provide insights to improve drug development programs.
Note: Data for this study is presented in two segments – A Total Benchmark Class containing all participants and a Top 30 Segment, containing those companies that are among the Top 30 by revenue
KEY TOPICS:
- Scope of Operations
- Activities
- Facilities
- Resources and Education Levels
- Outputs and Development Timeframes
- Capabilities & Expertise
- Performance and Measures
- Efficiency Ratios
- Lessons Learned
KEY METRICS:
- Percent of Activities Outsourced
- Number of Labs/Plants
- Type of Labs/Plants
- CMC FTE Data
- Percent of FTEs Located at Central R&D Location
- Percentage of FTEs in Each CMC Function
- Percentage of FTEs with Advanced Degrees
- Number of Drug Development Projects
- Number of CMC Batches
- Percentage of Work Completed by CMOs
- Number of CMOs Used
- CMC Development Timeframes
- Organizational Capabilities
- CMC Performance Measures
Additionally, a number of valuable Efficiency Ratios are included:
- CMC FTEs per $100 Million Revenue
- Number of Projects per $100 Million Revenue
- Number of FTEs per Project
- Number of Batches per $100 Million Revenue
- Batches per Drug Product FTE
- Batches per CMC FTE
- Batches per Drug Product, Clinical and Packaging FTE
- Lab Error Ratio
- Out of Standard Ratio
- Total DP, Clinical and Packaging FTE
- Percent of Outsourced Work per CMO
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