Dvir Doron, PhD, ERT
Director, Chemical Toxicology Team Leader
Dvir Doron has been working at Teva Pharmaceutical Industries Ltd. since 2014 in the Nonclinical Safety Department of the Global R&D Division. The Chemical Toxicology team, under his leadership, is responsible for providing risk assessments and qualifications of process-related impurities, degradation products, residual solvents, elemental impurities, as well as extractables and leachables, along with other types of contaminants and foreign materials.
Dvir is a European Registered Toxicologist (ERT) since 2020. He earned a Ph.D. in Computational Chemistry from Bar-Ilan University, Israel (2013), where he studied enzyme-catalyzed hydrogen-transfer reactions using Quantum Mechanics/Molecular Mechanics (QM/MM) simulations and explored the temperature dependence of kinetic isotope effects in these systems. Prior to his doctoral studies, Dvir received a B.Sc. (summa cum laude) in Medicinal Chemistry (2006) and an M.Sc. (summa cum laude) in Medicinal and Organic Chemistry (2008), both from Bar-Ilan University.
DAY 1: February 27th, 2025
SESSION: Risk assessing extractables and leachables in topical ophthalmic drugs: case studies and lessons learnt
◆ E&L originating directly from the LDPE bottle vs. adducts between the active ingredient and LDPE bottle components (secondary leachables): regulatory perspective.
◆ Application of PQRI principles and the FDA draft guidance for industry on quality considerations for topical ophthalmic drug products: key toxicity endpoints and safety thresholds.
◆ Evaluation of dermal and systemic sensitization of E&L based on the ELSIE framework.
◆ Utilization of in silico (Q)SAR methods in the absence of experimental data.
