Survey Examines Trends in the Outsourcing Relationship - The BioPlan Associates 8th annual survey identifies key outsourcing concerns of sponsor companies and contractors. - BioPharm International


Survey Examines Trends in the Outsourcing Relationship
The BioPlan Associates 8th annual survey identifies key outsourcing concerns of sponsor companies and contractors.

BioPharm International
Volume 24, Issue 10, pp. 26-33


Figure 3: Most common mistakes (ranked as "very common" or "somewhat common" problems) made by biopharmaceutical sponsors according to CMOs.
Our survey also analyzed the client–CMO relationship from the perspective of CMOs. We identified 11 critical issues that CMOs claim to be the most common mistakes their clients make. The data offers insight into gaps that exist—and that can be improved—in the client–CMO relationship. We asked respondents to rate client-driven problems as "very common" or "common" (see Figure 3).

Unsurprisingly, CMOs identified the top problem as "clients don't build in sufficient time for the project (unrealistic timeframes)." This year, 92% of CMO respondents indicated this attribute as a problem. The factor grew significantly from last year when it also topped the list at 80%. Indeed, timelines are now a critical factor for 60% of CMOs who responded to the survey, as compared with less than half of 2010 respondents.

Clearly, the issue of timeliness is a stress point on both sides of the client–contractor relationship. According to Noe, this problem is "often the case in client–CMO collaborations.... In one scenario, an inexperienced small company [had very] unrealistic ideas about how to achieve high-performance processes, then move into clinical manufacturing, release clinical grade material, move into IND-submission, and have patients recruited for early clinical studies."

The most widespread critical problem, identified by 92% of CMOs as either "very common" (74%) or "somewhat common" (18%), was that "clients want to contain cost by doing development runs, but still expect successful full-scale manufacturing." Resolving this problem may require better management of expectations, improved project management, and more controlled exchanges of information.

Interestingly, although further down the list of critical factors affecting the client–CMO relationship (at 84%), the concern among CMOs that "clients don't recognize the variability in process development" suggests that the majority of biomanufacturers, who are under increasing cost and time pressures, are pushing that stress onto their suppliers and contractors.

Other pain points on the part of CMOs include: "clients don't appreciate the difference between small-scale and full-scale manufacturing" and "clients don't understand their [i.e., the CMO's] role in regulatory submissions." Both concerns involve the need for effective time- and project-management; in a high-stress environment, these factors may be in short supply.

As predicted, virtually all of the problem areas evaluated in the client–CMO relationship from the CMO perspective went up in level of importance compared with the 2010 survey results.

The largest jump was seen in how CMOs find they are expected to resolve the most difficult technical problems (90%). This increase over last year (from 68%) may represent a change in how bio/pharmaceutical clients are allocating their internal staff resources, largely expecting CMOs to work harder on challenging technical issues. Some representative comments offered by study respondents include:

  • "Client expectations are too high (e.g., want the best service for the least price and completed in an unrealistic timeframe)."
  • "Clients are often their own biggest problem [regarding delays] because they do not provide deliverables or timely document review."
  • "The biggest problem by far is that clients want to limit or eliminate development and engineering runs to save costs; this ends up hurting their production runs with unforeseen problems."
  • "Clients sometimes don't provide enough information in their raw materials, cell lines, etc."

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