Sponsor–CMO Relationships: Critical Issues

Eric Langer assesses the results of a recent survey of what biopharm companies want from CMOs.

Contract manufacturing organizations (CMOs) should have the technical expertise to be considered by clients for partnerships. It’s no longer enough for them to lay claim to technology, regulatory compliance, and IP protection expertise, as these increasingly become non-negotiable issues, according to results from BioPlan Associates’ 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

Of the 238 industry decision-makers surveyed about the critical issues they consider when selecting a CMO, 71% said it was ‘very important’ that they be able to establish a good working relationship. The next-most recognized factor was sticking to a schedule, deemed at least important by almost 95% of survey respondents. While this would seem intuitively obvious, the fact that this issue continues to appear year-after-year, suggests little is being done within the industry to address the problems.

Clearly, customer service and establishing good client-vendor relationships are perceived as more important attributes. But there are multiple factors that can jeopardize them. CMOs are juggling multiple projects at the same time, and when clients select the lowest bidder, it’s not hard to understand that some CMO projects may not keep to schedule, despite everyone’s careful projections and planning. Add to this the uncertain nature of process development and problems that invariably arise, and it is easy to see how scheduling can be challenging.

CMO perspective
CMOs themselves have something to say about all this as well. In past years, BioPlan has found widespread complaints from CMOs regarding excessive client demands such as

• “Clients don’t build in sufficient time for the project (unrealistic timeframes)”;

• “Clients want to contain cost by doing limited development runs, but still expect successful full-scale manufacturing”;

• “Clients expect us to resolve the most difficult scientific or technical problems.”

Last year, each of those complaints was cited by at least 9 in 10 CMOs as being a “very” or “somewhat common problem.” Each problem had also been cited by a larger share of respondents than in previous years.

The ideal CMO
Results from the study show that clients continue to seek better relationships with CMOs, and that reliability is a key trait they look for in their partners. Technical considerations obviously are paramount, too - there should not be a big difference between results at small scale and large scale when a CMO has been engaged, and clients will always demand expertise and quality.

But the trends in the data suggest that as the CMO market becomes more competitive and globalized, these sorts of qualities are being seen as prerequisites, and that questions of efficiency, timeliness, and reliability are coming to the fore. In essence, the technical expertise gets the CMO a seat at the table, but nowadays it’s the relationship that will seal the deal.

Eric Langer is president of BioPlan Associates. The full version of this article can be found here.