Investors expect pharmaceutical companies to meet commercialization timelines, and failure may carry significant financial consequences. CDMOs with a track record of adhering to project timelines and delivering products in full, regardless of project complexity, have a competitive advantage. This is best achieved through a cooperative culture, driven by open dialogue with clients.
Foundation of Collaboration
CDMOs cannot effectively support clients without establishing truly collaborative relationships. High-level collaboration must be integrated into the culture of the CDMO. It must be established at the outset of a project and permeate every interaction between team members and client representatives.
True collaboration requires frequent communication from start to finish. Real-time communication alleviates – and even prevents – anxiety by ensuring that project teams make the best possible decisions.
A foundation of trust facilitates successful management over the life of the project. A project team operates best when it includes experts from both the CDMO and client, who openly share all the information necessary for successful process development and implementation and achievement of all milestones.
Setting the Standard for Meaningful Communication
A detailed kickoff meeting is important for establishing a strong relationship between the CDMO and customer teams. It establishes direct lines of communication between the program manager and different groups involved in the program.
Client and CDMO should agree to a regular communication schedule, generally weekly during the busy phases of the program, with all team members involved. During conference calls or virtual meetings, it is critical that everyone on the team expresses their thoughts and ideas.
Establishing multiple lines of communication builds customer confidence in the CDMO’s ability to manage the project. Program teams often include a project manager who is responsible for ensuring deadlines are met by keeping the CDMO team on track and managing customer activities that impact the CDMO’s ability to execute its responsibilities. While the project manager is the main contact point for the project, technical experts from the R&D, quality assurance, analytical, and engineering teams also should maintain open communication. Involving these groups even for early-stage projects enables smooth transitions through different development phases, and all the way through project implementation at the plant. The communication plan also should include a means of contacting the client during off-hours.
Planning for Change
No project, of course, progresses exactly according to the initial plan. Effective CDMOs are mindful of uncertainty and plan for potential changes by asking the right questions about factors that can change the timeline.
For example, the results of a clinical trial may determine whether a project goes down path A or path B. Changes to the milestones and timeline also could follow meetings with regulatory agencies; a candidate may receive an accelerated approval designation, compressing the timeline. Knowing when the designation may be awarded can help the CDMO better prepare.
Even with planning for uncertainties, unexpected issues will still arise. The best CDMOs have rapid-response systems in place for just these situations, which keeps them well-positioned to maintain timelines and meet milestones. When challenges arise, the project manager should communicate early and often with the client. While the full project should brainstorm solutions for keeping the project on track, this is where the CDMO’s experience and flexibility are most crucial.
Building Customer Confidence
The best way to build customer confidence is to establish a track record of completed projects, which reflects the flexibility, experience, and expertise of the CDMO’s project teams. It is important to demonstrate to prospective clients the teams’ abilities to identify production paths for sponsor projects and meet timelines regardless of significant changes, even those beyond the CDMOs control.
For clients transferring projects from another CDMO because something went wrong, it is even more important to maintain constant communication, including regular meetings. The CDMO must reassure the client that their knowledge and understanding of the project is essential to resolving issues and ensuring success.
At Grace Fine Chemical Manufacturing Services (FCMS) flexibility and experience help us collaborate effectively with our clients to develop creative solutions for even the most challenging projects and circumstances. Again, and again in these situations — including projects for which the timeline was cut in half — we have successfully devised plans to meet revised goals and deliver high-quality products on-spec and on time.