According to the latest industry research, about 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. At first glance, one could conclude that the reason is the stringent FDA review process designed to ensure that only products that deliver an acceptable efficacy and safety profile ever reach consumers. But a more detailed analysis of the results of many clinical research programs tells a different story.
Only half of all drugs that are rejected during the process fail due to a lack of efficacy[1]. Instead, many drug development programs are derailed by setbacks that are often unrelated to a drug’s mechanism of action or efficacy. These setbacks can include factors as diverse as a failure to maintain proper manufacturing protocols or even follow the FDA’s feedback precisely and on time. There are examples of trials that were delayed because required forms were filed late or incorrectly. In many cases, the factors that can cause delays in trial progress can be both anticipated and avoided. Given the fact that delays in drug development can cost companies hundreds of thousands or even millions of dollars, understanding the many avoidable risks in clinical research is now considered a significant advantage.
This article highlights the scope for developing therapeutics with new innovative, alternative approaches. The current trillion dollars pharmaceutical industry is in peril where the current drug development pipeline is slow, inefficient and incapable of being extended to multi-combination drug therapies as well as minimally focused on prevention. The complex modeling of diseases and biological functions has been limited because of the inability to integrate large scale molecular pathways.
Watch this Video to understand how recent advances provide breakthrough technology for doing scalable modeling of complex molecular systems to dramatically accelerate drug discovery and development.