Inhalation Toxicology
Administration of therapeutic agents by the inhaled route provides many advantages including bypassing first-pass metabolism, minimizing the risk for drug-drug interactions and rapid delivery directly to the lungs. However, this route of administration involves various challenges and complexities. Whether the test item is being formulated as a nebulizer liquid, a dry powder, or via a metered dose inhaler (MDI), the generation system and exposure parameters need to be established to maintain a stable aerosol, yielding the required aerosol concentration. Another important aspect is maintaining a respirable aerosol particle size based on the pulmonary deposition region of interest and the species being evaluated. Knowledge of acceptable formulation excipients is also crucial for inhaled projects.
Guiding you through the crucial steps
Our experts can guide you in the crucial steps to ensure appropriate CRO selection, study design and monitoring throughout the development phase. With their hands on experience, our team is also able to troubleshoot and assist with the critical prestudy aerosol characterization phase to ensure appropriate drug delivery during the dosing phase. Assessment of pulmonary findings can also be made and differentiated from historical background findings that are unique to this route of administration.
Supporting all stages of development
Our team of inhalation toxicology experts have experience of designing packages to support all stages of development from support for First in Human trials through to registration for small molecules and biologics. For inhalation delivery, we have experience of disease indications including asthma, COPD, cystic fibrosis and IPF either for individual active ingredients, or combinations (dual or triple). Increasingly, we also provide advice on program design for drugs administered via the intranasal route. We are also able to advise and assist with preparations for interactions with regulatory authorities and authoring and review of regulatory submission documents including IND, IMPD and eCAC and PIP submissions.
Our Inhalation Toxicologists
Susan Tantawi
DABT
Based in Montreal in Canada, Susan has over fifteen years’ experience working in CROs, consultancies and biotechnology companies. With broad toxicology expertise, Susan also has specialist knowledge of inhalation toxicity. Always keen to support the progress of a compound to the next stage, she particularly enjoys the structured organisation involved in timelines and gap analysis. Susan is a board certified toxicologist.
Paul Carter
Paul has 30+ years’ experience in both CRO and pharmaceutical industries (AstraZeneca) as a study director/study monitor on a range of studies, including all delivery routes and species but specialising as an inhalation toxicologist. For the last 10 years at AstraZeneca, Paul led the global strategic implementation of nonclinical outsourcing of inhalation toxicology studies. A recognised international expert in the field of inhalation toxicology/aerosol science, Paul has been an active committee member of the Association of Inhalation Toxicologists since 1987. Paul is a versatile toxicologist within the pharmaceutical arena and has all round knowledge of all processes involved in drug research and development.
Dr Jo Kilgour
PhD
Jo is an expert inhalation toxicologist, having worked in the field for 30 years, initially working in the agrochemicals and chemicals sector at Central Toxicology Laboratory as a Study Director and Project Toxicologist, and for the last 20 years working almost exclusively in inhaled drug development, formerly at AstraZeneca.
Jo works with small and large Pharma companies worldwide to deliver toxicology programs for small molecules and biologics to support First in Human studies (Phase 1) through to Phase 3 clinical trials and registration. She has represented clients in interactions with Regulators in Europe and the US, and worked on drugs (small and large molecule) targeting many therapeutic areas including COPD, asthma, cystic fibrosis, idiopathic pulmonary fibrosis and antivirals.
Jo has been an active member of the British Toxicology Society and the Association of Inhalation Toxicologists, Chairing the latter since 2011. She has co-authored a number of pivotal papers under the banner of the AIT and Industry Consortia, and has been an invited expert speaker at a number institutions and events including the US FDA, the European Chemicals Agency (EChA) and the University of Birmingham.
