Dr. Chris Bode, the vice president of business development at Absorption Systems LP, recently published an article titled “Using In Vitro Testing to Address the Critical Path†on Bioworld, a well-known U.S. online publication. The article highlights the growing importance of in vitro testing in drug development and its promising future. His insights are particularly relevant for researchers and professionals in China’s pharmaceutical industry, where efficiency is declining, risks and costs are rising, and regulatory standards are becoming more stringent.
In this challenging environment, leveraging well-established in vitro systems can offer a faster and more cost-effective way to address key technical challenges during drug evaluation. This approach not only helps accelerate the development of new drugs but also supports the advancement of generic medications. By identifying potential issues early, it can help reduce the failure rate in later stages, avoid unnecessary financial investments, and prevent resource wastage from late-stage clinical failures.
If more advanced and innovative in vitro models become widely adopted in the future, they could significantly reduce the need for traditional animal experiments. This shift could also help alleviate concerns raised by animal rights activists, leading to a more balanced and ethical research landscape.
In the early stages of drug development, in vitro research should be a priority. However, many companies still underinvest in this area. Fortunately, the U.S. FDA allows applicants to use in vitro data to potentially skip certain clinical trials. Why not take full advantage of this efficient and cost-effective method?
The FDA's Critical Path Initiative aims to speed up drug development by reducing reliance on empirical approaches and promoting more scientifically grounded methods. While the initial focus was on clinical trials—such as validating biomarkers and surrogate endpoints—in vitro model studies have had a significant impact on these trials and must not be overlooked.
The value of in vitro models has been increasingly recognized over the years. In the early 1990s, about 40% of drug candidates failed in clinical trials due to poor ADME properties. After 15 years, that number dropped to around 10%, largely because in vitro tests now identify potential issues before clinical trials begin. Some in vitro tests have even become mandatory for the FDA.
Today, poor toxicity and efficacy remain the main causes of clinical trial failures. This is often due to the difficulty of predicting clinical outcomes based on preclinical or in vivo models. As a result, the reliability and predictive power of in vitro models have never been more important.
In 1997, when the FDA first required the use of in vitro models to predict drug interactions, it was already somewhat behind the pharmaceutical industry's practices. The guidelines issued by the FDA in 1999 regarding in vivo drug metabolism and interactions, and the revised draft in 2006, clearly emphasized the importance of in vitro results in clinical research. A positive outcome in clinical trials may require additional interaction tests, while a negative result alone can often lead to a conclusive decision.
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