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In Sickness and in Health: The CDMO/Pharma Relationship

There are two inflection points where a pharma or biotech company looks to a CDMO. In one instance, it’s a technology transfer to create regional or incremental capacity, helping reduce the risk of a single-source manufacturing process. While this isn’t risk-free, it’s relatively straightforward.

In recent years, though, we’ve seen an increase in companies seeking out a CDMO partner much earlier on in the life of a new drug. This means it’s critical to get that relationship right as you’ll be going through a lot more together – this might bring you closer, but it will also probably mean a few rough patches as you go.

How can two would-be partners make sure they’re a good match? Before a CDMO and pharma company say “I do” and commit to a life(cycle) together, there are a few things it’s worth being very clear about through the dating process. I think there are three questions that a pharma company needs to consider – and that a CDMO needs to be ready and able to answer honestly.

1. Do they have the capabilities to meet all your needs? If a relationship is starting in the earlier stages of drug development, phase 1 or even pre-clinical, there is a much longer path to navigate together. The “M” of CDMO is a long way down the line, so you need to focus on the “D”. Can your prospective partner help you to cover all your development needs? Do they have the full range of services you need? Can they accommodate your timelines? Do they have what it takes to help you pass needed regulatory milestones? You don’t want to find yourself in the middle of a messy divorce and seeking out a second marriage, so make sure you’re taking a long-term view of the relationship.

2. Do they have the right experts to help drive success? Facilities are vital, but for many companies the challenge is finding people with the right skills – particularly when you’re dealing with complex processes in areas like cell and gene therapies. In many of the biopharma hotspots (Boston, Dublin), there’s huge demand for highly skilled team members which is driving competition and high prices. Interestingly, we’re starting to see places like Austin, Texas and parts of the Adriatic making a play for CDMO locations as they have skilled graduates. However, the cost of standing up a facility is huge, so there is a balance to be found and questions to be asked.

3. Are they experienced in working through challenges together? There are few certainties in drug development but it’s guaranteed that the path to approval will not be linear. Can you work with a partner to overcome hurdles and rely on them to do more than follow orders? Expecting a CDMO to meet key milestones is important in any relationship. However, can they do it when things don’t go to plan? If something unexpected happens and it’s beyond their capabilities, do they have additional partners they can bring in to help address new challenges? Do they have a proven track record in finding innovative new approaches?
When it comes to really understanding a healthy pharma/CDMO relationship, we at Pfizer CentreOne have something of an advantage. Being embedded within Pfizer means that we can help meet your needs by tapping into a wealth of expertise and experience when the going gets tough. While providing digital and IP protection for your product and business. In addition, it’s often the case that challenges we come across are things that Pfizer has faced themselves so in that respect, we’ve been around the block a few times and aim to find solutions to your needs!

My colleague, Jenny Gattari, will be part of the panel covering all this and more in Evaluate’s upcoming webinar. If you’re able to, do join the session to find out more about the challenges facing CDMOs and their clients as they work to build longer-term, closer relationships to help ensure that life-saving therapies reach patients when they need them.
Tom P Wilson is VP, Global Contract Manufacturing Leader at Pfizer CentreOne.

Evaluate-Author-Thomas-Wilson

Tom P. Wilson

VP, Contract Manufacturing Business Leader, Pfizer CentreOne

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