Dr. Gizelle Baker, PhD in Epidemiology and Biostatistics, Director Global Scientific Engagement:
How is [pre-clinical research] done to best give the information that people need to understand the risk potential of your product?
Dr. Davide Sciuscio, PhD in Toxicology, Manager Pre-Clinical Toxicology Evaluation:
So, in our pre-clinical assessment strategy, we have performed several kinds of studies. The first study is a study that occurs in silico. Basically, we look at the structures of different molecules present in the aerosol, for instance, of smoke-free alternatives. And based on the structure, we can predict the toxicity of these chemicals.
Then we move to in vitro, where we use isolated cells of tissues that are exposed to the aerosol, and there we get information about the toxicity of the aerosol. Then we move to in vivo studies, so more complex system - an entire organism. And then we move to clinical study.
Why do we do this? First of all, it’s the most effective way to test chemicals in terms of cost and time. But of course, the predictiveness of these [in vitro] methods is low, because you’re just working on cells. Then you move to a more complex system – an animal study – but the study becomes at the same time more expensive and more time-consuming, but also more relevant for human exposure. Then you move to humans.
So you have to go through this path because it’s more cost effective, it’s more time effective, but also because it ensures the safety of people enrolling in clinical trials. You cannot go straight into a clinical trial with a molecule that you don’t know anything about. If you need to understand the toxicity, you need to understand the mechanism of action of these molecules before exposing people.
So that’s why we go through this stepwise approach. We need to go through all these steps, but toxicology is extremely important because it’s a kind of proactive science to limit as much as possible the adverse events in humans.
Smoke-free products are for adult smokers who would otherwise continue smoking. They are not risk-free and contain nicotine, which is addictive. The best choice any smoker can make is to quit cigarettes and nicotine altogether.