The use of consultants by pharmaceutical sponsors to serve as a liaison between themselves and Contract Development & Manufacturing Organizations (CDMOs) is growing thanks to a reduction in in-house resources, as well as a need to have access to specialized skills and experience that may not be available in-house. Further, hiring a consultant can be more cost effective than retaining a full-time employee, especially when there may not be an ongoing need for the specific expertise required during drug development, discovery and manufacturing projects.
Pharmaceutical consultants can play a useful role identifying the right CDMO for your API manufacturing project, helping to set and agree upon contract terms, managing costs and delivery timelines and coordinating with the CDMO on the project. In addition, as the guidance for meeting current Good Manufacturing Practices (cGMP) continues to change, along with regulatory requirements, most sponsors would find it impossible to stay up-to-date on changing and ever-more-complex rules. It’s often also the consultant’s job to conduct due diligence audits on the CDMO.
While consultants can play an important role, it can be difficult to select the right one for your organization. Below are a few considerations:
Once you’ve hired the right consultant to oversee your critical API manufacturing project, it’s easy to become complacent and assume your job is complete. It’s more important than ever, however, that you remain involved in the project without waiting for second-hand information from the consultant. You should be regularly involved in meetings with the CDMO team, project manager and consultant to understand progress on the project, as well as any issues that are arising so you can be part of the solution. If projects are going over budget, it’s you, not the consultant who will have to explain it to the board or funders.
While it must remain a collaborative effort, it’s also important to put your trust in the advice and recommendation of the CDMO. Typically, a CDMO may do many more diverse projects than a consultant, and garner a breadth of best practices and experiences. You should leverage that experience and all the lessons learned to improve the outcome of your project.
Another benefit of staying involved is that you have the opportunity to see where time is being spent in order to avoid cost over-runs. It might not be necessary for a consultant to review every single Quality Assurance (QA) document from the CDMO, or question Standard Operating Procedures (SOPs) that have been time-tested. The time it takes to conduct full reviews and extra documentation not only takes time away from critical stages in the API project, but it also often adds unnecessary costs because of over-vigilance. Before selecting a CDMO, you should have complete trust in its abilities so that you can avoid this extra layer.
Consultants can play a valuable role in helping pharmaceutical companies reach critical milestones on the road to drug delivery. But, true success requires a collaborative effort between sponsor, consultant and a trusted CDMO to be most effective.
For additional insights and observations, please check out: API Manufacturing Technology Transfer; Shattering 5 Myths About CDMOS; or Best Ways to Keep GMP Polymer Projects on Schedule.