Have contingency plans

Supply issues are often entirely unforeseen, it's important to have contingency plans to avoid delays in critical studies, as these can have a significant effect on patients and could make the difference between success and failure for a small biotech company.

One approach is to manage stocks of drugs for clinical trials very carefully, such as using electronic inventory solutions, and control recruitment. As a last resort, drug supplies can also be transferred between clinical trial centers.

CMOs can play a role in managing supply issues and will have tools in place, such as comparator sourcing, detailed project management, lean manufacturing processes, streamlined packaging and labeling operations, logistics services, and enabling technology for supply-chain and inventory management.

The safest approach is probably to have a back-up supplier. Maintaining a portfolio of potential partners--from high-cost top-tier partners to lower tier, as well as spot suppliers--allows drug developers to choose partners according to the importance of a project, or its level of risk, as well as for in emergencies to maintain supply. For companies taking this approach, it's a good idea to sustain good connections with all the partners, keeping projects going with as many as possible to keep the relationships strong and active.

Have contingency plans

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