CMC Activities, Resources and Performance Benchmarks in Pharmaceutical Science

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

Pharmaceutical Science Excellence: CMC Activities, Resources, and Performance

ID: POP-225

Features:

Pages: 113

Published: Pre-2019

Delivery Format: Shipped

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