Publications

In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

In 2009, the passing of the Family Smoking Prevention and Tobacco Control Act facilitated the establishment of the FDA Center for Tobacco Products (CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed ‘modified risk’. On April 4-6, 2016, IIVS convened a workshop conference entitled, In Vitro Exposure Systems and Dosimetry Assessment Tools for Inhaled Tobacco Products, to bring together stakeholders representing regulatory agencies, academia and industry to address the research priorities articulated by the FDA CTP. This report includes the proceedings, recommendations, and outcome of the April 2016 technical workshop, including paths forward for developing and validating non-animal test methods for tobacco product smoke and next generation tobacco product aerosol/vapor exposures. Full article available to full and paid subscribers of ATLA.  

Advances in Science: Next Generation of Lab Tools, Models and Testing Platforms Used in Predictive Toxicology

Toxicology testing platforms represent the basis of the human health risk assessment process that determines whether a material or product may induce harm to humans upon exposure. Historically, safety assessment of raw ingredients or finished formulations has been performed using animal-based test methods (in vivo) that provide whole organism responses to toxicants. Due to the large number of products launched by industry continuously, modern toxicology shifted in recent years towards the use of novel, fast and reliable alternative methods, ranging from in silico to in chemico or in vitro, of which some are validated for regulatory purposes. The manuscript also addresses emerging technologies in the form of “organ/body-on-a-chip” platforms which announce to be instrumental in allowing alternative systems to in vivo models to assess systemic toxic effects induced by chemicals. Read the full article.

Navigating the Claim Substantiation Maze in Cosmetics Industry

Read this article by IIVS study director Dr. Gertrude-Emilia Costin and biologist Asha Shravanthi Pidathala in the June 2017 issue of Eurocosmetics.  The article examines modern, relevant, and reliable in vitro testing strategies using pigmented tissue models that assess the capacity of ingredients and formulations that impact skin tone.    

Assessment of In Vitro COPD Models for Tobacco Regulatory Science: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

On 8-10 December 2014, IIVS organised a workshop conference, entitled Assessment of In Vitro COPD Models for Tobacco Regulatory Science, to bring together stakeholders representing regulatory agencies, academia, industry and animal protection, to address the research priorities articulated by the FDA-CTP. Specific topics were covered to assess the status of current Assessment of In Vitro COPD Models for Tobacco Regulatory Science technologies as they are applied to understanding the adverse pulmonary events resulting from tobacco product exposure, and in particular, the progression of chronic obstructive pulmonary disease (COPD). The four topics covered were: a) Inflammation and Oxidative Stress; b) Ciliary Dysfunction and Ion Transport; c) Goblet Cell Hyperplasia and Mucus Production; and d) Parenchymal/Bronchial Tissue Destruction and Remodelling.

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Multiparametric Image Analysis of Rat Dorsal Root Ganglion Cultures to Evaluate Peripheral Neuropathy-Inducing Chemotherapeutics

Chemotherapy-induced peripheral neuropathy (CIPN) is a major, dose-limiting adverse effect experienced by cancer patients. Advancements in mechanism-based risk mitigation and effective treatments for CIPN can be aided by suitable in vitro assays.  To this end, we developed a multiparametric morphology-centered rat dorsal root ganglion (DRG) assay.

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In Vitro Assessment of Skin Irritation Potential of Surfactant-based Formulations by Using a 3-D Skin Reconstructed Tissue Model and Cytokine Response

The personal care industry is focused on developing safe, more efficacious, and increasingly milder products, that are routinely undergoing preclinical and clinical testing before becoming available for consumer use on skin. In vitro systems based on skin reconstructed equivalents are now established for the preclinical assessment of product irritation potential and as alternative testing methods to the classic Draize rabbit skin irritation test. We have used the 3-D EpiDerm™ model system to evaluate tissue viability and primary cytokine interleukin-1α release as a way to evaluate the potential dermal irritation of 224 non-ionic, amphoteric and/or anionic surfactant-containing formulations, or individual raw materials. Full article available to full and paid subscribers of ATLA.

The Use of Human 3D Reconstructed Airway Cultures for Tobacco Product Evaluation: Precision Low-Volume Exposures at the Apical Site

With a mandate to evaluate the dynamics of pulmonary exposure to inhaled materials such as tobacco-based products, researchers are employing complex, human, three-dimensional pulmonary models. Human reconstructed airway (RHuA) tissues present a platform that more closely resembles airways in vivo. Grown at the air–liquid interface (ALI), RHuA tissues offer apical and basal compartments that allow flexibility in modeling physiologically relevant exposures and provide sampling location-specific results. Read the full article.

Trends in Regenerative Medicine: Repigmentation in Vitiligo Through Melanocyte Stem Cell Mobilization

Vitiligo is the most frequent human pigmentary disorder, characterized by progressive autoimmune destruction of mature epidermal melanocytes. Of the current treatments offering partial and temporary relief, ultraviolet (UV) light is the most effective, coordinating an intricate network of keratinocyte and melanocyte factors that control numerous cellular and molecular signaling pathways. Read the full article.

Decoding and Modulating the Color of Human Skin

The constitutive color of human skin varies widely across the globe, from the very pale as in Celtic skin to the very dark present in regions such as sub-Saharan Africa. There is a biologic player “hard at work” producing the pigments that generate great variations in human skin color and is the protagonist of this article. It is the melanocyte. Read the full article.  

International Harmonization and Cooperation in the Validation of Alternative Methods

The development and validation of scientific alternatives to animal testing is important not only from an ethical perspective (implementation of 3Rs), but also to improve safety assessment decision making with the use of mechanistic information of higher relevance to humans. To be effective in these efforts, it is however imperative that validation centres, industry, regulatory bodies, academia and other interested parties ensure a strong international cooperation, cross-sector collaboration and intense communication in the design, execution, and peer review of validation studies. Read chapter.