The Audacious Goals Initiative (AGI) for regenerative medicine is a program run by the National Eye Institute (NEI), aimed at finding new therapies for eye diseases that remain difficult to treat. Age-related macular degeneration is the leading cause of vision loss in the US, affecting 2.5% of the population, most over the age of 50.

白皮书的这篇文章探讨了2020 regulatory changes in U.S. FDA guidance1 and recommendations, compared to existing EU EMA2 and Japanese PMDA3 guidance for in in vitro drug-drug interaction (DDI) assessments. The Evolving Regulatory Landscape Since 1997 the regulatory agencies, FDA, EMA and PMDA have endorsed the use of in vitro metabolism studies to assess the DDI potential of new chemical entities (NCE). Over the past 10 years, however, scientific progress has been rapid, fueled by sophisticated in vitro models and in silico predictive programs.

The FDA recently approved updated regulatory guidance for drug-drug interactions (DDIs). This webinar will focus on how to follow the FDA guidance, design in vitro studies, interpret the data and assess potential drug-drug interactions, using both static and Physiologically Based Pharmacokinetic (PBPK) models. We will also share our interpretations, as regulatory agencies recommend different approaches for calculation of the DDI potentials including static and PBPK models. Co-administration of multiple drugs may potentially cause a drug-drug interaction (DDI) in which one drug alters the exposure of another, resulting in either therapeutic failure or risk of a patient's life. In vitro studies are key to assessing potential DDIs because they are cost-effective, time-saving and can help to understand the mechanisms of DDI and provide directives to clinical trials (clinical trials should not be used to screen potential DDIs because of high costs, lengthy duration and ethical considerations, but they should be used to confirm potential DDIs recommended from in vitro studies and corresponding modeling).

Cytokine Release Syndrome (CRS), otherwise known as cytokine storm, is a systemic inflammatory response caused by complications due to disease, infection or an adverse effect of biologic therapy. The clinical symptoms of a cytokine storm are massive release of a potent cocktail of pro-inflammatory cytokines into the general circulatory system, leading to severe multi-organ damage, failure or potentially death. This is an extremely unwanted immunotoxicological side effect in drug development.