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  • Report details
  • 36 Figures
  • 4 Tables
  • Introduction
    • Copyright and Usage Guidelines
  • Study Overview
    • Background
    • Research Objectives
  • Glossary
    • Best Practice
    • Respondent Categories
    • Company Sizes
      • Established company
      • Small company
      • Virtual company
    • Department Names
      • Operations
      • Regulatory Affairs
      • Research and Development
  • Methodology and Demographics
    • Participant Geographies
    • Respondent Categories
    • Potential Best Practices
    • Interviewee Job Titles
    • Interviewee Responsibilities
  • CMC Employees
    • Educational and Professional Background
      • Job Training
    • Attributes of Successful Employees
    • Responsibilities and Workload
    • Years of Experience in CMC
    • Key Takeaways
  • The Product Development Process
    • CMC Involvement
      • Approach A
      • Approach B
      • Approach C
    • Factors That Change the Level of Involvement
    • Key Takeaways
  • Best Practices for Managing CMC Strategy Across Regions
    • Pandemic Impacts
    • Key Takeaways
  • CMC Department Size & Structure
    • Size of CMC Departments
    • CMC Department Structures
      • CMC Structure Models
    • Organizational Alignment
    • Alignment Advantages and Disadvantages
    • Key Takeaways
  • Measuring CMC’s Success / KPIs
  • Outsourced Manufacturing
    • Degree of Outsourcing
    • Vendor Preferences
    • Vendor Attribute Importance
    • The Future of Outsourcing
    • Key Takeaways
  • Main CMC Challenges & Potential Solutions
    • Regulatory Challenges
      • Challenge: Addressing all complexities of clinical trials in filing paperwork
      • Challenge: Regulatory requirements are increasing
    • Budgetary Challenges
      • Challenge: Limited budgets with expectations for same/increased output
    • Capacity and Supply Chain Challenges
      • Challenge: CDMOs are overextended and lack capacity to meet needs
      • Challenge: Supply chain challenges/shortage of resources
    • Timeline Challenges
      • Challenge: Timeline delays
    • Organizational Challenges
      • Challenge: Organizational changes seem constant and disruptive
      • Challenge: High turnover at the company
      • Challenge: Ensuring high quality
    • Process Development Challenges
      • Challenge: Indication-specific complexities require quick adaptation
    • Key Takeaways
  • CMC Budgets & Funding
    • Sources of Funding for CMC
    • CMC Budget for 2023
    • Key Takeaways
  • Moving Forward: CMC Over the Next Five Years
  • CMC Best Practices & Recommendations
    • CMC Employee Attributes
    • Drug Development Involvement Timeline
    • Collaboration—Intern​al and External
    • CMC Success
    • Outsourcing
    • Overcoming CMC Challenges
  • About Industry Standard Research
Attachments
The CMC Function at Emerging Pharma
9 Aug 2023

Single-user License: $5,650.00
Site-wide License: $8,475.00
Enterprise-wide License: $11,300.00

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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
 
Table of Contents
  • Introduction
    • Copyright and Usage Guidelines
  • Study Overview
    • Background
    • Research Objectives
  • Glossary
    • Best Practice
    • Respondent Categories
    • Company Sizes
      • Established company
      • Small company
      • Virtual company
    • Department Names
      • Operations
      • Regulatory Affairs
      • Research and Development
  • Methodology and Demographics
    • Participant Geographies
    • Respondent Categories
    • Potential Best Practices
    • Interviewee Job Titles
    • Interviewee Responsibilities
  • CMC Employees
    • Educational and Professional Background
      • Job Training
    • Attributes of Successful Employees
    • Responsibilities and Workload
    • Years of Experience in CMC
    • Key Takeaways
  • The Product Development Process
    • CMC Involvement
      • Approach A
      • Approach B
      • Approach C
    • Factors That Change the Level of Involvement
    • Key Takeaways
  • Best Practices for Managing CMC Strategy Across Regions
    • Pandemic Impacts
    • Key Takeaways
  • CMC Department Size & Structure
    • Size of CMC Departments
    • CMC Department Structures
      • CMC Structure Models
    • Organizational Alignment
    • Alignment Advantages and Disadvantages
    • Key Takeaways
  • Measuring CMC’s Success / KPIs
  • Outsourced Manufacturing
    • Degree of Outsourcing
    • Vendor Preferences
    • Vendor Attribute Importance
    • The Future of Outsourcing
    • Key Takeaways
  • Main CMC Challenges & Potential Solutions
    • Regulatory Challenges
      • Challenge: Addressing all complexities of clinical trials in filing paperwork
      • Challenge: Regulatory requirements are increasing
    • Budgetary Challenges
      • Challenge: Limited budgets with expectations for same/increased output
    • Capacity and Supply Chain Challenges
      • Challenge: CDMOs are overextended and lack capacity to meet needs
      • Challenge: Supply chain challenges/shortage of resources
    • Timeline Challenges
      • Challenge: Timeline delays
    • Organizational Challenges
      • Challenge: Organizational changes seem constant and disruptive
      • Challenge: High turnover at the company
      • Challenge: Ensuring high quality
    • Process Development Challenges
      • Challenge: Indication-specific complexities require quick adaptation
    • Key Takeaways
  • CMC Budgets & Funding
    • Sources of Funding for CMC
    • CMC Budget for 2023
    • Key Takeaways
  • Moving Forward: CMC Over the Next Five Years
  • CMC Best Practices & Recommendations
    • CMC Employee Attributes
    • Drug Development Involvement Timeline
    • Collaboration—Internal and External
    • CMC Success
    • Outsourcing
    • Overcoming CMC Challenges
  • About Industry Standard Research
Categories
Tags
CMC, Manufacturing
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