The CMC Function at Emerging Pharma

Report Overview

Industry Standard Research (ISR) interviewed 15 CMC professionals at pharmaceutical and biotechnology companies, eleven of whom are at small or emerging companies, to better understand the CMC role and function. CMC is integral to drug development, as they ensure the drug is effective, safe, and of the highest quality.

This report details the Chemistry, Manufacturing and Controls (CMC) role and function in preclinical, clinical, and commercialization phases of product development, with a focus on how the CMC function is set up at virtual and small biopharma companies.

In this report, you will:

• Learn best practices specific to CMC roles and responsibilities
• Gain insight into benefits and drawbacks of departments and reporting structures specific to CMC professionals
• Compare and contrast your company’s approach to CMC tasks and measuring success, resource allocation, and CMC involvement by clinical phase

What you will learn:

CMC background, responsibilities, and department structures, including:

• Education background
• Job training and previous experience, with emphasis on what backgrounds lend themselves to the CMC role
• Attributes of successful employees, their responsibilities and workload
• Various approaches to CMC influence throughout the drug development lifecycle

Challenges faced by CMC professionals and proposed solutions:

• How do CMC professionals propose to solve supply chain issues?
• What have CMC professionals proposed to resolve regulatory changes?
• How are CMC professionals adapting to limited budgets and what are they strategizing to implement in the future?

Best practices and future predictions:

• Discussion of effective collaboration between departments and with outside vendors
• Detailed reasons on vendor preferences for outsourcing manufacturing
• Forward-thinking perspectives on: (1) expectations for outsourcing (2) collaboration, and (3) changes to the CMC role and function over the next five years
   

Major Topics:

• Educational background and pathways to a CMC career
• CMC’s role in the drug development cycle
• Structure of CMC departments
• Activities currently outsourced and future predictions
• Main challenges faced by CMC departments and potential solutions
• CMC department funding and budgets
• Anticipated changes in the CMC function over the next five years