CDMO Relationships: Set Your Oversight Early, But Do Not Dictate All The Rules

As more and more drug sponsors partner with CDMOs to leverage their expertise and efficient manufacturing capabilities, utilizing the right framework to manage an outsourcing partner is crucial to ensure the relationship functions at its optimal level.

Determining a level of oversight which is effective and appropriate, not only for the current stage of the product’s life cycle, but also for the history and the performance that the outsourcing partner you’ve selected is providing you, requires careful consideration and early planning. Focusing on communication, transparency, and leadership and drafting a well-structured framework in the master services agreement — which should handle core functionalities such as dispute resolution — will help to convey from the very first batch, the specifications and expectations for that product or manufacturing step.

However, CDMOs, especially larger, well-established organizations, tend to be very rigid in their expectations and asking an outsourcing partner to significantly change the way it does business can increase risk of delays and inefficiencies. Learn how the right balance of flexibility and oversight can help ensure better results, more consistency, and a better performance out of the relationship.