The CMC Function: Best Practices and Optimization

Description

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
  • 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
  • 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

ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

For additional questions about any of ISR’s reports or custom research services, please contact us at info@ISRreports.com.

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