“Working as a toxicologist in the pharmaceutical industry allows me to contribute to ensuring that patients around the world have access to safe medicines.”

What is your job position and how would you define it?

I have been working as a toxicologist for 3 years now at Aixial. Toxicology could be defined as the study of the adverse effects of chemical, physical, or biological agents on humans, animals, and the environment. The role of a toxicologist is to determine how substances may be harmful, what are the potential health effects, and at what levels of exposure and under what conditions these effects are likely to occur.

Why is your job position relevant at Aixial Group? 

Safety issues remain one of the main causes of clinical failure during drug development. So, to optimize time and effort, toxicologists join the drug development team early and conduct a series of studies that play a pivotal role in identifying the right drug candidates. These studies are an essential part of drug development as they can provide information about potential side effects or adverse events and help to identify appropriate dose ranges, then increasing the chances of successful development.

When does your expertise come into the product’s life cycle?

First, toxicology studies are conducted at an early stage of drug development to help minimize the risk of failure during preclinical studies. Then, before entering the clinical phases, mandatory toxicology studies following good laboratory practices are performed to provide detailed information on dosing and toxicity levels.

Depending on the new drug’s clinical application purpose, additional regulatory toxicology studies are conducted in parallel with the clinical phase of development to assess specific toxicity such as reproductive and developmental toxicity.

Finally, the toxicologist is involved after marketing authorization for example in the mandatory reassessment of the benefit/risk balance during the renewal procedure, or in support of industrial purposes such as the qualification of impurities.

“Toxicologists working in the pharmaceutical industry are involved in all stages of drug development, from the discovery and development phases to the marketing authorization.”

Jules Morsch, Toxicologist

What are some current and future challenges or trends impacting your area of expertise?

We are working in a sector that is constantly evolving, it requires a high degree of adaptability and ongoing training to keep up with technical developments, regulatory changes, and therapeutic innovations.