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Acute airway toxicity is an important consideration during the development of pharmaceuticals, chemicals, cosmetics and agrochemicals. Currently validated methods require the use of animals, yet it is widely acknowledged that these methods may not be appropriate for accurate prediction of human risk. To combat this, as part of our integrated toxicology and 3Rs (Replace, Reduce and Refine) program, we have been evaluating and using 3D tissue models of the upper and lower airway tract to screen our potentially toxic chemicals to the respiratory tract. These same methods are being used to identify the mechanisms of action or adverse outcome pathway via histopathology or biomarker analysis. In addition, these models can also be used to identify new chemical entities for respiratory medicines by assessing toxicity and efficacy of the drugs in the human lung. Examples of the use of these tests and how these are being evaluated by regulatory authorities will also be discussed.
Dr Roper has been Head, In Vitro Sciences at Charles River since 2010 having joined the company in 1996 after his degree, PhD and postdoc in Newcastle University. Dr Roper’s acknoeldged speciality area is dermal absorption where he has papers quoted by the OECD in the current guideline (OECD TG 428/ OECD GD 28). He has advised many companies and industry bodies as well as regulatory authorities. He has since become more well known in in vitro toxicology where his papers have also been quoted by OECD (OECD TG 437) for in vitro ocular toxicology. His department is now leading in in vitro respiratory toxicology having defended a New Approach Methodology (NAM) at the US EPA in December 2018. Dr Roper has authored and continues to write peer review papers as well as regularly acting as a peer reviewer for toxicology journals. He has organised scientific meetings including Skin Forum, Nail Forum, Skin Metabolism Meeting as WC9. He has presented at many scientific meetings most recently as an invited speaker at the US ICCVAM SACATM conference (NIH) in September 2018 and Occupational Toxicology Roundtable (October 2018) and Association of Inhalation Toxicologists (October 2018).