by Sheri Farsakh on 3/18/15
Why run a Proof of Concept clinical trial? Well, it's just about the best solution to mitigate risk, minimize cost, and still gain solid safety and efficacy data all before late-stage clinical development. Early drug development challenges raise a lot of risk in which many experts in the industry have realized can be alleviated rather strategically. During the early stages of developing a drug, startup biotech companies have both a scientific and financial perspective to seriously consider. A PoC study is considered a fairly simplified study design as it establishes the safety of drug candidates in a small target population and explores the relationship between the dose and desired reaction. As a Phase I-IIa carefully designed study, it is done in the parameters of a controlled and safe environment. Our principals and co-founders, Dr. Joel Neutel and Dr. David Smith work very closely with our clients to assure the appropriate measures are taken in order to reach the strongest biomarkers in the study. Over the past 5 years, running a proof of concept clinical trial has taken precedence over traditional healthy volunteer studies.