We all know that the decision to outsource to a CRO or CMO partner is an important one. Whether you need drug substance from an API manufacturer for an upcoming project or help with chemical synthesis, there is much that needs to be done.
In the second of our three-part blog series, aimed at helping to take the pain out of chemistry research or small-scale GMP API manufacturing projects, we look at the importance of establishing your key drivers from the outset of a project.
1. Strike the right balance
There are generally three drivers to consider: quality, time and cost. It goes without saying that quality is of paramount importance and should not be compromised, especially in GMP manufacture. The ability to speed up the drug development process is also key if we are to bring vital new drug products to market quicker and more efficiently.
However, it’s perhaps unrealistic to expect your CRO to turnaround complex chemical synthesis projects very quickly and very cheaply. Consider what is most important to you so your contract service partner can strike the right balance.
2. Think through your priorities
We speak to our clients regularly for feedback on what qualities they require in a CRO/ CMO partner. Scientific capability, dependency, flexibility, adaptability and reputation all come up. It’s important to think through your priorities and which of these qualities you value more highly than others. This will not only help in the selection of a suitable partner, but also in managing your expectations for the relationship.
3. Why outsource?
One thing we do know is that pharmaceutical outsourcing is on the rise. In Contract Pharma’s 2016 Outsourcing Survey [include link], 73 per cent of contract service providers revealed they are experiencing increased demand for their services already this year.
Before making the leap to outsource, it’s important to consider your reason for doing so. Are you deciding to outsource to a CRO or CMO as you lack the internal expertise and capabilities? Or are you suffering from a temporary lack of capacity?
Outsourcing may help you to focus on your own core competencies, while accessing the specialist skills of others. It may also help to keep costs down by eliminating the need for capital investment. Establish a clear rationale and objectives at the start of a project and you will be in a better position to reflect on the results.
4. Communicate your expectations
Make it clear from the outset of your relationship with the CRO or CMO what your key drivers are. Some CROs are better equipped to deal with rapid delivery so if that’s what you need make sure the CRO can deal with your requirements. In reality, most clients will have a combination of needs. Whatever these are, ensure your CRO or CMO has the capability and flexibility to deal with the combination of speed and economy you need.
Now that we’ve helped you to identify the CRO or CMO for you, in the third instalment of our three-part series, we’ll cover the importance of utilising your contract service provider’s expertise.
By Denise Bowser, commercial director at Onyx Scientific and Chris Wallis, independent consultant for development projects.[addtoany]