Investors expect pharmaceutical companies to meet commercialization timelines, and failure to do so can have significant financial consequences. Contract development and manufacturing organizations (CDMOs) that have a track record of adhering to project timelines and delivering product on time and in full, regardless of the project’s complexity, have a competitive advantage.
Foundation of Collaboration
CDMOs cannot provide effective support to clients unless they establish truly collaborative relationships with them. Collaboration must be integrated into the culture of the CDMO and permeate all of the interactions that each team member has with client representatives.
This high level of collaboration must be established at the outset of a project, with both parties fully sharing all information needed to achieve the best possible outcome — successful process development, implementation, and achievement of all milestones. The project team should be all-encompassing and inclusive of experts from both the CDMO and the customer.
A face-to-face kickoff meeting is important to help make connections and establish a strong relationship between the CDMO and customer teams. It also provides the opportunity to establish direct lines of communication between the program manager and different groups involved in the program. Establishing a strong relationship and foundation of trust leads to greater success in managing the program as it moves forward. Collaboration also ensures that everyone contributes to the decision-making process, leading to the best possible outcomes.
Understanding Customer Needs
The kickoff meeting also provides an opportunity for the CDMO and customer teams to get to know one another. Projects cannot be completed successfully unless the CDMO truly understands the short- and long-term goals of the customer. Only with the understanding of the customer’s primary concerns and essential factors for success can the CDMO establish the deliverables and determine what is needed to achieve those goals.
It is essential to be as flexible as possible so that important customer milestones can be achieved without issue, and so that robust, commercial-ready processes and methods can be established. It is also critical that, by the end of the kickoff meeting, all team members — from both the CDMO and customer — are very clear on what the deliverables are within the scope of the project and the timeline for those deliverables.
Multiple Lines of Communication
True collaboration requires frequent communication from the start of the project through to its completion. Without clear communication, it is too easy to lose trust and create untenable situations with negative consequences. On the other hand, real-time communication helps alleviate customer anxiety and ensures that the best decisions are made.
Communication should occur on an agreed upon regular basis, generally weekly during the busy phases of the program, with all team members involved. During conference calls, it is critical that everyone on the team verbally expresses their thoughts and ideas. In addition to these weekly meetings, multiple lines of communication are important. Program teams can be structured with a project manager who is responsible for ensuring that milestones are achieved on time, not only by making sure that the internal CDMO team stays on track, but also helping to manage customer activities that impact the CDMO’s ability to meet the timeline requirements.
While the project manager is the main point of communication for the project, an exchange of ideas between the technical experts from the project teams — R&D, quality assurance, analytical and engineering — should also take place. The involvement of all of these groups, even for early-stage projects, ensures that everyone is in the loop and can contribute as projects advance, which enables smooth transitions as the project moves through different development phases and is implemented in the plant.
Using multiple lines of communication gives the customer confidence in the CDMO to properly manage the project. In addition to regular meetings, the plan should include additional avenues for communicating with the customer during off-hours (evenings, weekends) to ensure that the customer always has input.
Planning for Change
Unfortunately, no project will progress exactly according to the initial plan laid out at the kickoff meeting. Effective CDMOs are mindful of aspects of uncertainty and work to determine and plan for potential changes. Asking the right questions about being prepared for factors that can change the timeline is essential.
The results of a clinical trial may determine whether a project goes down path A or path B. If an FDA meeting is scheduled, changes to the milestones and timeline could follow. A candidate may receive an accelerated approval designation, compressing the timeline. Knowing when the designation may be awarded can help the CDMO better prepare.
Managing the Unexpected
Even with planning for uncertainties, unexpected issues will still arise. CDMOs that have systems in place that ensure rapid response to these situations will be best positioned to still meet milestones and timelines. One key to success is communicating early and often with the customer. The problem should be laid out, and the full program teams brainstorm ideas for what can be done to keep the project on track. Experience and flexibility are crucial under these circumstances.
Building Customer Confidence
The best way to build customer confidence is to have an established track record of completed projects. Such a track record reflects the flexibility, experience and expertise of the project teams at the CDMO. These teams have demonstrated their ability to identify paths forward for the production of customer material without impacting timelines, even if significant changes occur, including those beyond the control of the CDMO.
For customers that are transferring projects from another CDMO because something went wrong, it is even more important to provide frequent, ongoing communication, including regular face-to-face meetings. It is key to make sure these customers are aware that their knowledge and understanding of the project are essential to resolving issues and ensuring success.
Creating Solutions for Shortened Timelines
At Albemarle Fine Chemistry Services, our flexibility and experience make it possible to develop creative solutions in collaboration with our customers. For these situations, we have successfully devised plans that have enabled us to meet revised goals — including projects for which the timeline was cut in half — and deliver high-quality, on-spec material in agreement with the established timelines.