Development and Evaluation of Ex Vivo Human Skin Models to Predict Injection Site Reactions
Marcus Deloney – Senior Scientist, Formulations and Process Development, Gilead Sciences; Dana Levine – Principal Scientist, Formulation and Process Development, Gilead Sciences; Tyler Novak – Director, Drug Delivery Strategy & Innovation, Gilead Sciences
Principal Scientist II Gilead Sciences San Francisco, California, United States
Introduction: Injection site reactions (ISRs) associated with long-acting injectable (LAI) therapeutics can be painful and severe, yet preclinical animal models often fail to predict ISR incidence or severity observed in the clinic1. The observation of ISRs in clinical programs significantly hinders the advancement of novel LAI therapies. Human derived ex vivo skin models may provide improved translational tools to mitigate ISR risk during drug product development. This study evaluates ex vivo human skin tissue models to reproduce inflammatory and histopathological features associated with ISRs observed clinically for multiple antiviral formulations and their corresponding vehicle controls.
Learning Objectives:
1. Understand the limitations of current testing methods for ISRs
2. Explain the strengths and weakness of human ex vivo skin models for ISR prediction
3. Evaluate the consistency of ex vivo skin models to reproduce clinical findings
