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Pharmaceutical Science Excellence: CMC Activities, Resources, and Performance

ID: POP-225


Features:

80 Data Graphics

113 Metrics

18 Best Practices


Pages: 113


Published: Pre-2019


Delivery Format: Shipped


 

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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • VIEW TOC AND LIST OF EXHIBITS
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.


Industries Profiled:
Pharmaceutical; Health Care; Medical Device; Biotech; Consumer Products


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

Study Snapshot

This research was conducted on behalf of one of Best Practices, LLC's clients and was 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.

Key topics include:

  • Scope of Operations
  • Activities
  • Facilities
  • Resources and Education Levels
  • Outputs and Development Timeframes
  • Capabilities & Expertise
  • Performance and Measures
  • Efficiency Ratios
  • Lessons Learned


Sample List of Charts & Exhibits

Percent of Activities Outsourced
  • Number of Labs/Plants
  • Type of Labs/Plants
  • Location 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