The outsourcing market is growing rapidly due to industry trends such as increasing demand for advanced medicines to address unmet needs, global economic expansion, and the FDA’s growing use of accelerated approval pathways. Drug sponsors now have access to a larger-than-ever pool of contract manufacturing organizations (CDMOs) from which to vet a potential partner. In addition, sponsor companies are no longer outsourcing just noncritical products and services. Key steps of the drug development process, such as clinical processes and product manufacturing, are now being left in the hands of CDMOs that must fulfill promises made during the sales process. With the stakes higher than ever for drug sponsors, choosing a CDMO that is the best strategic fit is not just difficult, but imperative.
In a recent survey, pharmaceutical company sponsors and CDMOs were asked about the biggest challenges of the sponsor-contract services relationship.1 While many CDMOs pointed to insufficient information as the top challenge, nearly half of drug sponsors cited a lack of clarity from CDMOs about what processes can be supported (e.g., lead times, documentation, communication). To avoid this issue, drug sponsors will want to find a CDMO that recognizes these struggles and has established internal strategies to overcome them.
Below are three important factors to consider when weighing your CDMO options. These “Three Cs” can indicate whether a CDMO has the ability to provide a drug sponsor with not only the resources to fulfill a company’s long-term goals but also the confidence that every team member involved is committed to its success.
A CDMO must be able to provide a clear path for project management that indicates open and timely communication can be guaranteed throughout the project timeline.
Any company can create a great marketing campaign and promote itself as the best, but its skills are put to the test when words turn into action. This can occur only if there are processes in place that help eliminate silos and achieve business goals. For example, in an entrepreneurial landscape, startups have their thumb on the pulse of everything going on within the company. Because the company is often small, its few members know they are the brains and the guts behind the organization. Instead of working in silos, the environment is an open forum, and everyone is aware of how each piece will fit together to make a whole. As companies grow in size, this collaboration can get lost. Walls begin to go up, and there is no longer a common knowledge about how the quality agreements and standard operating procedures (SOPs) of each department will come together to deliver on promises made to the customer.
An effective way to determine if the CDMO you are vetting has the resources to drive down silos and sufficiently support your project is to review the company’s organizational chart. This documentation depicts each department’s role in a project as well as the flow of responsibility. It provides a clear picture of communication SOPs and the process for issues that need to be taken upline. With this tool, a drug sponsor can be confident the CDMO has the capabilities and resources to handle large projects and the transparency necessary for open communication and collaboration.
A CDMO must ensure it has not only the facility space available for its clients but also the resources and personnel necessary at each stage of the project.
Defining a CDMO’s capacity extends beyond cleanrooms and technology; it is about the CDMO knowing how much it can handle in the course of a day. By understanding the level of commitment needed from each department within the company, there are no unwelcome surprises along the way. The CDMO has to be aware of what is in its pipeline so when new opportunities arise, it can be sure the capacity, human capital, and machinery needed are available. Collectively, this information provides a CDMO with the tools to provide accurate commitments to customers. If a CDMO knows it has a capacity for X number of projects but commits to more than that, yet has not changed the expectations it sets with clients, business is guaranteed to suffer. Measuring capacity is the only way to successfully manage a project and eliminate customer frustrations. A CDMO that measures results in real time to hold itself accountable to the promises it made is one that has an unequivocal commitment to customer satisfaction.
A CDMO’s culture must align with that of the drug sponsor’s to ensure a working relationship that is productive and profitable.
If you are a drug company seeking a CDMO, you want to be certain you are comfortable with the manner in which they operate. If a company is very rigid and buttoned-down and your company is more casual and open, it may not be possible for the companies to thrive together. A company’s culture is indicative of its values. Those values connect to other key areas of the organization, which is why it is so important to identify and align with a partner’s culture. This drives both the operational and communicational aspects of the relationship and allows a mutual contribution to the overall business goals.
While there are many factors important in the evaluation of a CDMO, the three listed above are especially critical. They offer insight into what a drug sponsor’s long-term expectations can be for the partnership, and drive higher standards for those CDMOs that want to stand out in a competitive field that gets bigger every day.
Contract Pharma, 2015 Annual Outsourcing Survey —http://www.contractpharma.com/contents/view_outsourcing-survey/2015-05-13/2015-annual-outsourcing-survey