It's easy to get caught up in moving drug development forward, focusing on the clinical questions, but this could mean losing sight of the formulation and manufacturing issues.
It's vital to start thinking about manufacturing early on in the drug development process, initially making the decisions about whether to outsource manufacturing or not, and then finding the right partner and starting discussions about what is needed and when.
If the decisions are not made and the manufacturing is not put in place in time, it could cause delays to clinical trials that are as limiting as those caused by manufacturing problems. But when is the right time? Companies that are going to outsource need to start finding a CMO as soon as they have selected their lead candidate, potentially even a couple of years before the product goes into clinical trials.
However, it's important to remain flexible too. Setting up partnering or licensing agreements can change any decisions made about manufacturing, particularly for small pharma or biotech companies signing agreements with large pharmaceutical companies with in-house capabilities or established relationships with CMOs.