CMC Department Structures

Report Overview

ISR interviewed 15 CMC professionals at 14 Top 50 pharmaceutical and biotechnology companies, as well as one company outside the Top 50 to better understand the Chemistry Manufacturing and Controls function throughout the preclinical, clinical, and commercialization phases of the product development process. This report also details how CMC departments are modeled, the challenges faced by CMC professionals along with best practices and forward-thinking perspectives about how the role may evolve over time.

• Identify how your company’s approach to CMC may be different from other organizations in the industry, and the benefits and drawbacks that may result
• Gather information on CMC personnel best practices used by other organizations, which may be used to improve or streamline the function
• Benchmark your company’s CMC department size, structure, resources, and approach to those of other companies

What you will learn:

• CMC personnel role, operations and structure, including:
  • How different CMC departments are structured and funded, the benefits and drawbacks of various reporting structures and best practices for your organization
  • Roles and responsibilities of CMC personnel including educational and professional paths that lead to a successful CMC career
  • Outsourcing behavior—reasons for outsourcing and desired vendor attributes
  • Future predictions for the department
• Challenges faced by CMC personnel, such as global complexity, lack of harmonization across regulatory authorities, and changing requirements
• Best practices for new hires, involvement timelines, work challenges and proposed solutions

Major Topics:

• Study Overview
• Methodology
• CMC Employees
• The Product Development Process
• Best Practices for Managing CMC Strategy Execution across Regions
• CMC Department Size and Structure
• Measuring CMC’s Success
• CMC Outsourcing
• Main Challenges & Potential Solutions
• CMC Budgets & Funding
• Moving Forward: CMC Over the Next 5 Years
• CMC Best Practices and Recommendations