In vitro diagnostics (IVDs) are medical devices used to analyse biological specimen to help inform diagnosis and therapeutic decision-making IVDs used in combination with other therapeutics drugs and devices are collective referred to as companion diagnostics (Cdx) [1]
As stated on the U.S. Food and Drug Administration website, the key purposes of CDx are to:
Identify patients most likely to benefit from a therapeutic drug
Identify patients most likely to suffer serious adverse effects
Monitor patient treatment responses [2]
IVDs can improve patient outcomes and reduce healthcare costs. The pertinence of Cdx to clinical settings raises the potential risks associated with using unregulated IVDs, thus stringent requirements have and are being introduced to ensure performance and conduct post-market surveillance.
Precision medicine (PM) is the tailoring of prevention, diagnosis, and treatment to each individual in order to eliminate drawbacks associated with blanket medication designed for all patients [1]. Precision medicine seeks to maximize treatment effectiveness, minimize side effects, and improve patient outcomes by customizing healthcare plans to the individual’s unique profile by incorporating genetics, environmental and lifestyle factors [1, 2]. Predictive biomarkers are often key to drawing PM regimens, thus CDx which play a significant role in their identification and characterisation are subject to revolutionising regulations during their development, validation, manufacturing, and distribution [1].
PeploBio can assist in navigating the everchanging regulatory landscape associated with every stage of the CDx product lifecycle.
First-In-Human (FIH) trials are typically Phase I clinical trials that test a promising therapeutic drug candidates in humans for the first time. FIH trials are conducted after preclinical testing and are used to assess safety, dosage, and adverse events for further clinical development [3].. FIH trials are usually facilitated by CDx and principles of PM to ensure that the right patients are included and monitored in these initial safety assessments. Regulatory bodies such as the U.S. FDA and European Medicines Agency (EMA) provide the framework to approach FIH studies [3].
PeploBio supports a range of service levels in FIH trials, spanning from consultation, trial design, and regulatory documentation to patient recruitment and comprehensive clinical trial service.