Setting regulatory submissions milestones and timelines is a team effort. And, with patients, the market, and investors in mind, pharmaceutical and biotech companies are looking for every viable way to speed up those timelines.
Here’s how chemistry, manufacturing, and controls (CMC) can do their part to accelerate development timelines and investigational new drug applications (IND), new drug applications (NDA), biologic license applications (BLA), and other submissions.
- Split up large batches into smaller batches to initiate a study sooner. For instance, Integrated Project Management led an IND submission for a biotech startup. They decided they could begin studies sooner if they commissioned just 150g of the 400g drug substance needed for in vivo studies, then follow up with a second batch. Doing two batches cost more, but it reduced risk (if the initial study failed, they could have canceled the second). So they were able to justify the investment to management.
- Consider religious and cultural holidays. And don’t ignore vendors’ vacation policies, especially when relying on overseas contract manufacturing organizations (CMOs). Overlooking such time off when scheduling significant milestones could cause delays.
- Hire multiple or redundant manufacturers. Another IPM client chose to spend more by contracting two manufacturers in two different countries. The better manufacturer was in Europe, but there were import delays, so they chose to derisk the problem by using a U.S. manufacturer as well.
- Manufacture product at risk. Some companies will produce material before key data results are complete that indicate whether the potential compound is a viable drug candidate. Again, this practice increases costs; confer with leadership and the cross-functional team (regulatory, R&D, clinical, data management, etc.) to align on risk and reward.
- Reserve CMO timeslots early. Count on the cross-functional team to help provide a reasonable timing estimate. Missing a scheduled time slot and having to wait for the next available slot may mean an extra cost, but the risk may be worth it, especially if you need special equipment.
- Use a relevant stand-in or safe substitute where possible. IPM worked with a global biopharma company that did their GLP toxicity studies using a pool of clones instead of waiting for a specific clone selection. This allowed them to begin getting animal data while they finished the top clone analysis and to move into manufacturing earlier. Be sure to check with the FDA or other regulatory agency to make sure they approve of this strategy first.
The complexity of manufacturing the product, such as the type of drug substance, the number of dosages, the number of vendors involved, etc., will influence the development timeline. Recognize where you can accelerate and where you can’t, the associated risks, and the value that strategy and planning can bring.
For ways that other regulatory roles can work faster, as well as real-world examples of how they did so, download Working Together to Accelerate Regulatory Submissions.
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