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Using Flow Cytometry Toward Investigational New Drug (IND) Applications and First-in-Human (FIH) Clinical Trials

Posted on: May 02, 2018

Data is the cornerstone of the drug development and clinical trial processes and is critical to determining which candidates move forward. Currently, many drugs and biologics under development, operate by altering the immune system, and flow cytometry is a widely used technique for gathering a wide range of data about the immune response. Flow cytometry can be performed in full compliance with Good Laboratory Practice (GLP) standards, which make it an ideal tool for pre-clinical and clinical studies.

First-in-Human (FIH) clinical trials underway.

The FDA’s Investigational New Drug (IND) program enables drug developers to apply for permission to use experimental drugs in clinical trials and requires evidence to show that a patient will not be subjected to an unreasonable risk. Flow cytometry analysis can provide critical data for IND applications, particularly through customized mechanism-of-action (MOA) and functional assays that measure specific cell actions such as proliferation, drug uptake, calcium flux, and oxidative metabolism. Toxicology and genetic toxicology screenings for IND applications can also be done by flow cytometry, including evaluating how drugs affect cellular viability or induce mutations in the genome that can alter cell function.

After an IND application is approved, clinical trials can be initiated to evaluate the safety and efficacy of an experimental drug. Flow cytometry-based assays are ideal for monitoring clinical trials at all phases through evaluating changes in immune cell populations in the blood with immunophenotyping. Pharmacodynamic and pharmacokinetic assays can also be done using flow cytometry, including receptor occupancy assays, and these assays are critical to determining the correct drug dose, route of administration, potential for drug interactions, and potential use in unique patient populations (e.g., pediatrics, geriatrics).

Flow cytometry-based assays are powerful and flexible for use throughout the drug development process. Large clinical trials may entail large-scale flow cytometry analysis, so consider working with an experienced contract research organization to design a flow cytometry strategy for both pre-clinical and clinical analysis.

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