Meet the Study Director…

Meet the Study Director…

Dr Fiona Bailey joined the XCellR8 team in October 2017 as Study Director. She looks after most of the non-GLP studies that the company conducts, focusing primarily on in vitro genotoxicity tests using the BlueScreenTM method, adapted to use animal-free reagents. We caught up with her recently to gain an insight into the typical working day of a Study Director.

Tell us what you do in the lab each day?

I’m responsible for overseeing tests on a variety of ingredients and formulations, that end up in cosmetics, industrial products and other personal care items. A lot of my work is in the area of genotoxicity – understanding how a compound can affect the DNA of a cell, in some cases increasing the risk of cancer.

Our process starts when samples arrive from a client. I check the accompanying documentation is correct and schedule the test with the team in the lab. I often double check the safety information that accompanies the samples, so that when it comes to inhalation or exposure, we all know exactly what we’re working with and are appropriately protected.

Sometimes, a client needs results to be turned around urgently and we’ll do our best to accommodate that in the schedule. It’s one of the joys of working for a more flexible CRO rather than having to battle bureaucracy.

The next task is to check that the samples are soluble, and determine the right concentration to use in the assay. We need to be able to work with them, whilst using the highest concentration possible to deliver robust results. It’s a fine balance and can sometimes take a whole day to get right. After that, I write up the protocol for the test.

How do samples actually get tested in the lab?

I make sure the lab scientists are happy with the compound and are clear on what they’re doing. They then conduct the experiment, incubating the cells for 48 hours and testing them to understand the genotoxicity. We check how many cells died and measure the cells’ stress responses to see how much the DNA of the cell been altered or damaged. I’m always on hand to troubleshoot if anything unexpected happens, for instance an unusual deviation.

My job is to then process the raw data from the experiment, check it against control samples, ensure its accuracy and finally write the study report. I’ll create the graphs that show how the compound reacted and draw a conclusion about its safety.

How often do you have to flag that an ingredient might be harmful?

Fewer than 25% of the items that we test are flagged as being genotoxic. However, when this happens, we can re-test ingredients at concentrations akin to those used in the final product formulation or that have been adapted by the client to try and reduce the levels of genotoxicity, and often discover that these are now classified as non-genotoxic.

What do you enjoy most about your job?

I’m currently training to conduct tests to GLP standards and I’m loving learning new techniques and processes. Obviously, XCellR8 is an entirely animal-free lab so whilst I’m happy that our tests are ethical, the quality of the science is what excites me most. Labs that still rely on animal data just don’t produce results that are as representative of what happens to human cells as our studies.

I’ve also enjoyed working with the rest of the XCellR8 team to develop a new assay for airway and inhalation toxicity. It’s satisfying to be able to offer that new assay to clients and take another step forward in protecting human health.

To find out more about XCellR8’s
regulatory and non-GLP safety tests, visit
www.x-cellr8.com