Development vs Commercial Outsourced Manufacturing Practices: Small Molecule

Description

CMOs continue to expand their service offerings to include specialized development capabilities, especially contract manufacturers with strengths in formulating poorly soluble compounds. Formulation development, analytical development and characterization, clinical trial manufacturing and commercial manufacturing for drug substance and drug product may be obtained from a single provider with end-to-end services. Knowing whether this is the best approach for your organization is challenging. This report dives into how the decision-making process differs among drug innovators outsourcing development activities from those outsourcing commercial manufacturing when it comes to CMO/CDMO selection criteria, use patterns, preferences and perceived leadership. Readers will gain insight into four different outsourcing scenarios for small molecule drugs enabling them to make more educated purchases of CMO services based on their unique needs. CMOs will gain a better understanding of customers’ requirements and how they change as a compound moves through the development to commercialization process.

Development vs Commercial Outsourced Manufacturing Practices: Small Molecule

Drug Developers

  • Differences in CMO engagement and usage patterns based on outsourcing stage and internal capabilities and/or capacity
  • Key differences in CMO selection drivers based on four different outsourcing scenarios: development-stage API manufacturing, commercial API manufacturing, development-stage drug product manufacturing and commercial drug product manufacturing
  • Learn which CMO attributes are becoming more important to different types of outsourcing peers in order to gain advantages from their experiences

Contract Manufacturers

  • Ways to improve your company’s sales and marketing strategies to specifically address the needs of different customer bases, as identified in CMO selection criteria, during specific decision-making scenarios
  • Outsourcing propensity of the different buyers of outsourced services for both drug substance and drug product manufacturing
  • How CMO awareness, familiarity, leadership, proposal volume, use and preference vary between outsourcers of development-stage or commercial-scale manufacturing in order to target specific audiences with the precise information they need
  • Outsourcing Philosophies and Practices
  • CMO Perceptions and Interactions
  • CMO Selection Drivers
  • Study Data

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Development vs Commercial Outsourced Manufacturing Practices: Small Molecule CMO Selection Attributes

Outsourcing Philosophies and Practices

Primary Section Takeaways
Outsourcing Drivers—Small Molecule API
Outsourcing Drivers—Small Molecule Drug Product
Use of Preferred Providers—Small Molecule API
Number of Preferred Providers—Small Molecule API
Use of Preferred Providers—Small Molecule Drug Product
Number of Preferred Providers—Small Molecule Drug Product
Outsourcing Models—Small Molecule API
Outsourcing Models—Small Molecule Drug Product
Outsourced Manufacturing Activities—Small Molecule API
Outsourced Manufacturing Activities—Small Molecule Drug Product

CMO Perceptions and Interactions

Primary Section Takeaways
CMO Familiarity—Small Molecule API
CMO Familiarity—Small Molecule Drug Product
CMO Leaders—Small Molecule API
CMO Leaders—Small Molecule Drug Product
Received Proposals—Small Molecule API
Received Proposals—Small Molecule Drug Product
CMO Use—Small Molecule API
CMO Use—Small Molecule Drug Product
CMO Preference—Small Molecule API
CMO Preference—Small Molecule Drug Product
Summary Table—Small Molecule API
Summary Table—Small Molecule Drug Product

CMO Selection Drivers

Primary Section Takeaways
CMO Selection Attributes
CMO Selection Attributes Gaining Importance

Study Data

Outsourcing Drivers—Small Molecule API
Outsourcing Drivers—Small Molecule Drug Product
Outsourced Manufacturing Activities—Small Molecule API
Outsourced Manufacturing Activities—Small Molecule Drug Product
Outsourcing Models—Small Molecule API
Outsourcing Models—Small Molecule Drug Product
Use of Preferred Providers—Small Molecule API
Number of Preferred Providers—Small Molecule API
Use of Preferred Providers—Small Molecule Drug Product
Number of Preferred Providers—Small Molecule Drug Product
Top 5 CMO Selection Attributes—Small Molecule API
#1 CMO Selection Attributes—Small Molecule API
Top 5 CMO Selection Attributes—Small Molecule Drug Product
#1 CMO Selection Attributes—Small Molecule Drug Product
CMO Selection Attributes Gaining Importance—Small Molecule API
CMO Selection Attributes Gaining Importance—Small Molecule Drug Product
CMO Familiarity Among Development Outsourcers—Small Molecule API
CMO Familiarity Among Commercial Outsourcers—Small Molecule API
CMO Familiarity Among Development Outsourcers—Small Molecule Drug Product
CMO Familiarity Among Commercial Outsourcers—Small Molecule Drug Product
CMO Leaders—Small Molecule API
CMO Leaders—Small Molecule Drug Product
Received Proposals—Small Molecule API
Received Proposals—Small Molecule Drug Product
CMO Use Among Development Outsourcers—Small Molecule API
CMO Use Among Commercial Outsourcers—Small Molecule API
CMO Use Among Development Outsourcers—Small Molecule Drug Product
CMO Use Among Commercial Outsourcers—Small Molecule Drug Product
CMO Preference—Small Molecule API
CMO Preference—Small Molecule Drug Product

Demographics

Company Type
Headquarters Location
Office Location
Job Title
Decision-making Responsibility
Contract Manufacturing Responsibilities
Involvement in Outsourced Manufacturing
Years of Industry Experience

Additional information

License

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