What Should You Look for In a Consultant to Manage Your Prized API Project?

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:

1. Make sure there’s a long-term commitment.  Major pharma firms can go through lots of transition, as drugs come off-patent or R&D costs and regulatory hurdles force reductions in staff as a way to rein in costs.  For this reason, often experts will seek temporary employment as a consultant in between jobs.  Make sure your candidates are committed to making a career out of consultancy – or at the very least, they should be committed to staying on for the duration of your project.

2. Inquire about any relationships with specific CDMOs. When seeking a consultant to help you choose a CDMO, it’s important that he/she can share the names of specific CDMOs he/she has worked with in the past, but you want to make sure that there’s no affiliation or arrangement with any specific ones that could bias any objective advice about which one would be the best fit for you.

3. Sometimes close proximity is best.  While today it may seem impossible that we will actually be working face-to-face, on-site with co-workers again, there will be a return to normalcy post-COVID-19. It’s important that the consultant you hire is willing and able to visit the CDMO site regularly and participate in regular face-to-face meetings. In addition, if you are selecting a supplier in a far-off country, the consultant should be willing to travel, and maybe also experienced with the workstyles, culture and the language of the CDMO.

4. Value experience over all other factors.  It’s always good to feel comfortable with your consultants and find them agreeable, but what’s far more important is their experience. They should have a proven track record of managing projects similar to your own. Ask them to provide examples and references for projects that were challenging or that went sideways and hear how they handled it.  Anyone can give an example of the perfect project, but it’s how they address adversity that can be most telling.

5. Don’t be swayed by big pharma experience. It’s tempting to be impressed with consultants with resumes packed full with big pharma experience, but don’t be.  Big pharma experience is not always a good thing or even relevant if your company is a smaller, boutique firm. The big firms operate very differently. They’re often too large to be nimble and swift to get things done quickly, and each employee is often pigeonholed into one very specific task without lots of opportunity to gain broad experience across different areas. 

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.

About the Author

Ed is President & CEO of SEQENS North America (formerly PCI Synthesis). He serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA)...

Do you have questions? Talk to Ed.