Drug development is a risky business both financially and from a patient safety point of view. CDMOs try to minimize that risk by spending a great deal of time developing APIs that are safe enough to be given to humans, remaining ever vigilant for potentially harmful toxins or impurities. A drug candidate’s safety is first tested in small Phase 1
trials, usually with 20-100 volunteers, or a smaller number of patients if the drug is aimed at a rare disease.
According to the FDA, approximately 70% of drug candidates move from Phase 1 to Phase 2. Much of the effort in developing APIs occurs when the CDMO prepares material for the larger Phase 2 trials. It’s then that any scale up issues that surface are resolved, processes tweaked for optimum yield, and analyticals developed in earnest.
Phase 2 trials weed out many more drug candidates due to efficacy or safety issues. Only 33% move on to pivotal Phase 3 clinical trials. This article will focus on the top three considerations in preparing APIs for Phase 3 clinical trials.
In these days of tariff wars and pandemics, securing high quality supplies and safe raw materials has become even more challenging, yet Good manufacturing practices (GMP) guidelines demand it. GMP has always been about paying attention to the details in order to minimize issues that can disrupt or delay project completion. Because the stakes are so high, every CDMO should take extra care in selecting and managing suppliers.
I would suggest that of all supply chain best practices, redundancy is among the most critical. Take Apple for example. One of the biggest U.S. companies, Apple learned the hard way that relying on one country—China—for its iPhone parts and assembly is risky, and the ensuing delays costly. Tesla, whose CEO Elon Musk made all kinds of promises to deliver a certain number of the company’s popular electric cars, was hamstrung by a coronavirus pandemic no one anticipated, which forced closure of factories in both China and the U.S. Until we have a domestic stockpile of raw materials and supplies to draw from when circumstances such as the pandemic warrant, we can’t take the risk of relying on a single foreign supplier.
Finally, when preparing for Phase 3 trials, it’s a good idea to sit down with your customers. The best thing to do is look at everything that’s been done to date. Provide an overview of all the changes that have been made and their impact on the project up to this point. Discuss with sponsors goals for regulatory approval, post-approval volumes, delivery, timelines, etc. Based on that conversation, discuss what justifies additional investment in the asset.
Although they’ve made it to Phase 3 and already invested quite a bit to get to this point, it’s still risky. Going forward at this stage still requires a consideration of investment vs. risk, and it’s important that we CDMOs are sensitive to that. Our extensive experience allows us to give solid advice on the appropriate investment. This is not the time to be penny wise and pound foolish. We still should be doing things that are needed, particularly analyticals that may have been missed, but not making any process changes.
As projects enter Phase 3 trials, it’s our job as CDMOs to work with our customers, sharing best practices and our expertise to help minimize risk and speed safe, effective products to market.
If you have questions about Phase 3, please call us at (978) 462-5555 or email us at email@example.com.