CDMO Checklist - Part Three | Trust & Communication

A CDMO’s Checklist For Prospective Clients – Part Three

We have been discussing what a CDMO wants to see in a client, and we are going to wrap it up with this article. Part 1 and Part 2 focused on the key element of transparency. Now, let’s get into some additional topics.

Project Management

Another category that can be problematic is communication, and in this context, that largely falls to Project Management. Theragent, like most CDMOs, knows that a good project manager (PM) is critical to a successful program and client relationship. The PM is responsible for setting timelines and keeping teams on task, facilitating risk and impact assessment, coordinating communication, ensuring organization of the documents, meeting minutes and data, and in general being the conduit for information in and out of the CDMO. However, this works best when there is a reciprocal point person on the sponsor side. Instead, what CDMOs often see is a myriad of voices from the client side converging on the CDMO PM, often with mixed messages. Additionally, any sideline conversations among project team members that don’t align with what the PM is hearing create pockets of confusion within the team and can obfuscate what is thought to be the path ahead. If one of your team members does have an important side conversation with the CDMO, ensure that your point person and the CDMO project manager are informed. Speaking with one voice from the CDMO is expected, but speaking in one voice from the Sponsor is equally important to establish clear communication and consensus on a path forward.

Decision Making

Why are you hiring a CDMO? There can be several reasons. Maybe you don’t have the facilities or equipment to do the work. Perhaps you are short-handed and need to bring in outside hands to get you over a hurdle. Maybe you have a short-term project and don’t want to resource for a one-off discrete project. These are all valid reasons, but it really boils down to this: you hire a CDMO for their expertise. They can do something you cannot do on your own (due to lack of facilities, equipment, people, or know-how). However, some sponsors want to cherry pick that expertise and override it when it doesn’t fit their timeline, budget, or some other reason.

This doesn’t mean there’s no room for negotiation in how the work is done; after all, the end clinical result is the sponsor’s, so it is ultimately your call. But you come to a CDMO because they have experience – perhaps not with your exact process, but with moving similar programs into and through development, clinical manufacturing, and so on. If you selected properly, they have the proper understanding for how a program should move forward, which could mean how many runs it takes to show reproducibility and a robust process, how best to qualify a standard method like flow cytometry immunophenotyping, how to ensure regulatory compliance, and what is required to move from Phase 1 to Phase 2. If that is the case, don’t constantly second guess their decisions and push back on every detail. Trust the CDMO to work with you, not against you. During the process of scoping a project there is always some back and forth to get to a scope of work that is acceptable to both parties. But then, when a snag happens, avoid the classic sponsor knee-jerk reaction – to recover time or money (or both) by reducing the scope of work. “Let’s remove this run, let’s forgo this process etc.”, is a short-sighted approach that tends to lead to bigger (and more costly) issues in the future while solving little in the short term.

You bring on a CDMO as a partner, so avoid the instinct to undermine that partnership when things get difficult. In fact, those challenging times may end up being when you need their insight and expertise the most! Remember, the CDMO also has plenty at stake – their success is your success. Trust that they aren’t advising a certain strategy or tactic just to get a few more bucks from you, but because they want a long-term partnership and long-term success for your product. Utilize their expertise, treat them like the partner they are, and try not to beat them over the head and force your way when they have a valid argument as to why something may not be in your best interest long term.

Master Service Agreement Negotiating Woes

When it comes down to it, the Sponsor and CDMO must engage in contractual agreements not only to ensure an agreed upon scope of work but also to lay out the terms and conditions of the engagement – which, whether we like it or not, are in place to cover potential contingencies and mitigate risk. Master Service Agreements (MSAs) are much like an insurance policy – it doesn’t do much until bad times hit. It covers all those things you don’t want to think about, such as bankruptcy, lawsuits, indemnities, intellectual property, and limits of liability. Lawyers and executives can get very staunch in their stance and negotiating these terms can get testy – it’s understandable – what one side gets is what the other side has to give up and everyone has plenty at stake. Lawyers and executives are paid to consider the ‘what if’s’ and think ahead to make sure risk and exposure are limited on their side. It isn’t enjoyable to think about the possible negative legal or commercial outcomes but discussing them ahead of time gives all parties a clear direction on what to do should those events occur. Why do I mention all of this? Don’t let those negotiations – and especially the emotions generated by them – impact the working relationship beyond the signing of the documents. Once agreements are signed, it’s water under the bridge and the focus shifts to working on the project.

I have seen emotions take over and feelings fester to the point of making the working relationship difficult due to uncommunicated tensions. This is especially true with very small sponsor companies when the person that negotiated the MSA is the same person that is leading the project. This rarely occurs on the CDMO side, because typically Business Development and/or legal are working on the MSA and 0nce finalized, the project shifts to a Project Manager and Operations.

You may feel the negotiations went poorly, that you were taken advantage of, or that even if you got what you wanted, you had to work too hard to get there. However, once the MSA is signed, it should be out of mind while the focus shifts solely to the project work. So my advice is to let any lingering animosity go, move on, and focus on the science and technology. As long as those work out, many of those MSA items will become moot.

Building Trust

This is a way to summarize all the above – we want to build a trusting relationship with our client partners, and we hope they want that as well. We know that some clients have been burned in previous CDMO relationships, but that concern goes both ways. Clients sometimes provide promises they don’t keep, incur bills they don’t pay, and change the plan midstream only to blame the CDMO when things don’t go perfectly to plan. Remember, you should be partners.

At the same time, we attest to the fact that CDMOs don’t always get it right. Just like you, we are often working on very novel therapies with new technologies and are doing so in an ever-changing regulatory environment. However, we want to be able to trust our clients as a partner just like we want our clients to trust in us as a partner.

A CDMO’s success is reliant on their client’s success, but what does that mean? It means we want your program to succeed. We are not putting obstacles in your way or trying to make things harder than they need to be, and we are not providing advice that will put you or your project in peril. CDMOs are using their expertise to advise you along a path that brings your product clinical and commercial success.

CDMOs want to be able to trust our clients as a partner, just like we want our clients to trust in us as a partner. Try to view your relationship like the Musketeers: All for one and one for all.

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