Pharmaceutical Science Exellence

Cmc Activities, Resources, and Performance

Publication Date	September 2008
Publisher	Best Practices
Product Type	Report
Pages	113
ISBN Number	not applicable
Product Code	BPC00048

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Summary

Study Overview

Best Practices, LLC conducted this study 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

Methodology

This research was conducted on behalf of one of Best Practices, LLC's clients and based on survey results from 18 participants from 18 companies. The participants represent a look at how Top Pharma Companies staff, structure, utilize and measure their CMC functions.

Industries Profiled

Pharmaceutical; Health Care; Biotech; Consumer Products

Companies Profiled

Johnson & Johnson; Daiichi Sankyo; Pfizer; Gilead Sciences; GlaxoSmithKline; Novartis; Sanofi-Aventis; Merck; Abbott Laboratories; Boehringer Ingelheim; Baxter Healthcare; Takeda Pharmaceuticals; Astellas; Eisai; Alcon Laboratories; Solvay Pharmaceuticals; Biogen Idec; Bausch & Lomb

Content

Study Overview
- Research Objective and Methodology
- Data Visualization and Interpretation
- Benchmark Class
- Participant Qualification
- Data Views and Benchmark Class Segmentation
Benchmark Data
- Scope of CMC Operations
  - Company Revenues (2007)
  - Percent of CMC Activities Outsourced
- CMC Activities
  - Percent of Companies Performing API Chemical
  - Percent of Companies Performing API Biologics
  - Percent of Companies Performing DP Activities
  - Percent of Companies Performing Packaging
  - Percent of Companies Performing Analytics
  - Percent of Companies Performing Other Activities
- CMC Facilities
  - Number of Labs/Plants for CMC Development
  - Mean Geographic Breakdown of Facilities
  - Facility Type Breakdown by Geographic Area
- CMC Resources & Education Levels
  - CMC FTEs
  - Percent of Total Global CMC FTEs
  - Percent of FTEs in Each Function
  - Percentage of FTEs with Advanced Degrees
- CMC Outputs and Development Timeframes
  - Number of Drug Development Projects (2007)
  - Number of CMC Batches
  - Percent of CTM Work Completed by CMOs
  - Number of CMOs Used
  - CMC Development Timeframes (in months)
  - API Chemical Timeframes (in months)
  - API Biologic Timeframes (in months)
  - CTM Timeframes (in months)
- CMC Capabilities
- CMC Performance and Measures
- CMC Efficiency Ratios
  - 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 DP FTE
  - Batches per CMC FTE
  - Batches per DP, Packaging and Clinical FTE
  - Lab Error Ratio
  - out-of-Standard Ratio
  - DP, Packaging, Clinical Supply FTE
  - Percent of Outsourced Work
Lessons Learned
- Improving CMC Operations
- Appendix
- Survey Instrument
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