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How to bridge the gap

The Swiss Center for Applied Human Toxicology will have a major presence at OpenTox Euro in Basel November 21-23. SCAHT Director Martin Wilks will chair Session 1: Defined approaches towards regulatory acceptance and SCAHT Regulatory Toxicologist Rex FitzGerald will join him on the panel to present Test guidelines, AOPs and IATA - current and future. Here, Dr. FitzGerald explains why he thinks it’s important for the OpenTox Community to be there. One of the goals (and challenges) of the Swiss Centre for Applied Human Toxicology (SCAHT), Rex FitzGerald says, is “to get people to understand the regulatory guidance that is coming and to pay attention to international activities”.

“Bridging the gap between academic researchers and regulators is the ongoing theme for the decade,” he says. “OpenTox Euro is the place to see what regulators need as well as what scientists are doing. It is a great opportunity to define regulatory  acceptance of different kinds of data.” Dr. FitzGerald calls the new regulations “simply common sense” and urges everyone to take them seriously. “So many things will change over the next decade. We encourage the OpenTox community to participate in this evolving process. They will gain through collaboration.”

Science, he says, is now moving from a data-basis to a knowledge-basis. “One of the challenges is that pathway toxicity is a fundamentally different way of looking at existing data and new data. Technology is no use if you haven’t got the right questions. It’s not about animal testing, not about in vitro, not about organs-on-chips – it’s about using any available technology to measure key events. Are you measuring a key event which is plausibly linked to human adverse health outcome? In other words, are you measuring and demonstrating to regulators the likelihood of human disease? The important question is to thrash out which part of the gigantic data universe we are talking about. You can see the potential for that in the topics that will be discussed at OpenTox Euro.”