Dr. Katharina Schwarz heads the Department of Inhalation and Aerosol Sciences at Fraunhofer ITEM in Hannover. She oversees the aerosol/inhalation and dosimetry-related aspects in drug development programs and toxicological or inhalation exposure studies including GLP/GCP-compliance.
She plays a leading role in advancing preclinical inhalation science by developing integrative, non-animal methodologies—combining ex vivo systems, in silico modeling, particle dosimetry, and aerosol pharmacokinetics—to enable early proof-of-concept predictions and inform decision-making in respiratory drug development and regulatory toxicology.
Her team has developed innovative translational tools—including an inhalation-specific PBPK model and QIVIVE strategies that integrate ex vivo data—which support predictive assessments of respiratory safety and efficacy in preclinical and regulatory contexts.
Dr. Schwarz has led high-impact national and international R&D projects on regulatory inhalation exposure, —including pioneering work in evaluating biocidal and cosmetic spray products.
She currently serves on the ISAM board, co-chairs the ISAM working group on Environmental and Occupational Health/Toxicology, and contributes to the German Society of Toxicology and the scientific community through journal and DFG (German Research Foundation) reviews.
