Summer Entrepreneurial Experiences

EncepHeal Therapeutic’s Drug Development Model

Sunday, August 6, 2017 1:35 pm

Traditional drug development models describe the process of taking a drug from the drug discovery phase to FDA approval in 8-15 years (Figure 1). In addition, it costs about $1 billion for the entire process. This daunting pipeline is partly due to the fact that pharmaceutical companies oversee the entire process, which requires the need for in-house chemists to develop the compounds, to clinical research teams that carry out the early- and late-phase clinical trials.

Drug Development Gap

Figure 1. Drug Development Gap

To lessen the cost and time, larger companies are now moving towards developing at the later stages of research, by conducting clinical trials. In this way, they can bypass the early stages that require laboratories to do the pre-clinical animal research, as well as all of the personnel required for those tasks. The approach of EncepHeal Therapeutics is to bridge the gap, as shown in Figure 2, between early research discovery and commercialization/mitigating risk. One of my tasks has been to look into the drug development model that other pharmaceutical companies follow and compare/contrast with the model of EncepHeal. Understanding what works with these new and upcoming alternative models will provide greater insight into how EncepHeal can modify and expand on their own model and be even more efficient.

By in-licensing modafinil analogues from NIDA, EncepHeal can skip straight to carrying out the pre-clinical assays and early clinical trials. Once proof of concept has been established, they can out-source their lead compound(s) to a larger pharmaceutical company that’s specialized in the later clinical phase stages. In this way, EncepHeal Therapeutics can use their scientific team that has expertise in those particular experiments, and leave the other tasks to better equipped external experts.

Bridging the Drug Development Gap

Figure 2. Bridging the Drug Development Gap

Stay tuned to learn more about EncepHeal Therapeutic’s drug development model, which can potentially cut the time and cost associated with the typical 8-15 year drug development pipeline, by half.

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