A successful contract manufacturing partnership pays dividends over many years. As the divide between the two organizations begins to fade, you should be able to work in lockstep, with open dialogue and a shared commitment to the patients you serve. That’s the dream, but how do you find it when there are so many contenders to choose from?
Each relationship is unique, but the challenges often come down to alignment. Equipment can be bought and new skills can be acquired. But if you’re not on the same page culturally, then cracks will soon appear when project deadlines loom and hard discussions are needed. When you don't spend enough time on the front-end aligning on expectations and establishing open channels of communication, the relationship is bound to fall apart quickly when the pressure inevitably builds.
Start with culture. Know who you’ll be working with
When companies hit a certain stage in their drug development program, the economics of outsourcing manufacturing almost always make sense. The only hesitation is the trust factor. Can you trust another group to nurture your program as if it were theirs?
Start by asking your potential partner to articulate their culture. What does it mean to them, how do they build it internally, and how does their organization’s culture impact the customer experience? Get a sense for their overall vision and then continue to evaluate whether that pulls through as you meet different teams and sites.
Request for proposal negotiations typically involve business development, procurement, and leadership teams, but the success of a CDMO relationship usually hinges on the individual contributors. Create time and space for your project teams to engage with the people who would be running your operations, establishing your protocols, and signing off on your batch reports. Ideally, at least some of the discussions should occur at the site that would handle the bulk of the manufacturing.
Encourage the teams to have honest and transparent conversations about their strengths and weaknesses, and where shared gaps may exist (and how they can be bridged). Capture all this raw information early so it can inform the master services agreement (MSA) and other key documents that serve as the foundation of the partnership.
Gather clues during negotiations
It usually takes 6–9 months to move from the first engagement to the signing of the foundational documents. A lot can be learned during this window. As a potential customer, I always took note when a CDMO was slow to return information and responses. If it’s a pattern, it can indicate misalignment and a lack of commitment and prioritization of your business. Or there may be a lot of bureaucracy at play. Either way, it’s an important omen. A truly empowered project team should be able to make decisions without having to consult myriad internal stakeholders. In turn, the streamlined process allows them to be more aggressive with timelines. Never forget that in the CDMO world, agility in negotiations usually predicts agility in execution.
Along with broad communication, I like to see clear and actionable feedback on the MSA and core documents. A lot of CDMOs will limit the scope to up to two rounds of amendments to make sure it’s prescriptive and consolidated. That’s a good thing, by the way. If you’re on round nine of revisions then too many people are weighing in!
If you see signs of excessive bureaucracy during the MSA negotiations, it’s not a dealbreaker, but you need to be honest with yourselves to make sure the governance is set up appropriately. Align on the right touch points for a steering committee and build those into the timeline.
Align on the ultimate goal
There’s a legendary tale that emerged from President John F. Kennedy's visit to a NASA space center in 1962. The President crossed paths with a janitor sweeping the hallways and asked him what he was doing. The janitor replied, “I’m helping put a man on the moon.”
Sixty years later, the details may be disputed, but it remains a powerful anecdote about embracing a shared purpose and mission. Every role, every level, and every step in the life cycle matters. This resonates deeply with me. As a contract manufacturer, our purpose and reason for existing is to deliver safe, high-quality therapies to the patients who need them most. We fully embrace this mission, in partnership with the drug's sponsors, and it remains our absolute north star.
Why is this mindset important? A CDMO that fully embraces this shared goal will make decisions with your patients’ best interests in mind. They will work with urgency and will understand the importance of advancing your life-changing drugs. At the same time, they won’t compromise on safety or bypass their own quality protocols. And because they know their boundaries, they won’t overpromise upfront.
Focusing on the patient also reinforces the importance of the client-CDMO partnership. In drug development, curveballs and setbacks always arise. In these instances, your CDMO shouldn’t step away from the relationship or trigger penalties and fines. They should go to you, as a partner, to help get the program back on track. It’s not a business favor or a financial calculation; it’s just the right thing to do
I’ve worked in biotech organizations that led the way with their commitment to patients. I’ve also worked in roles that were purely transactional (I didn’t stay long). Now, as the President of a CDMO, I don’t allow any level of our organization to lose sight of this responsibility and opportunity to make a meaningful difference in patients’ lives.
Developing and manufacturing therapies is incredibly meaningful and rewarding work. It’s not always easy, but when times are hard, remind yourself why you chose that CDMO partner (or a CDMO altogether). You did the due diligence and picked them because they were trustworthy and capable. It's easy for skepticism to creep in, especially if there isn’t an open and honest conversation about expectations and needs. My final advice: don’t go quiet when you encounter financial or regulatory hurdles or delays. If you’ve chosen the right CDMO partner, they’re on your team and they want to be part of the solution. Use the full extent of their expertise. And of course, it’s a two-way street: CDMOs also need to be transparent when critical supplies are delayed, or cells don’t replicate as planned. For the good of patients, communicate!
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