Posters & Presentations
Nicotine Characterization of an In Vitro Inhalation Exposure System Using Conventional and Next-Generation Tobacco Products: A US/UK Inter-Laboratory Comparison
March 28, 2018The US-FDA has regulatory authority over tobacco products, including conventional cigarettes and next generation products (NGPs) such as e-cigarettes and tobacco heating products (THPs). There is a desire by the industry, regulator and animal protection organizations to incorporate non-animal test methods for tobacco product and NGP assessment. When assessing respiratory effects in vitro, reliable exposure systems that deliver aerosols to cellular/tissue cultures at the air-liquid interface are needed.
Quality Considerations: Redefining Test Systems from Animals to Tissues and Beyond
August 28, 2017The use of non-whole animal test methods transforms the way regulatory requirements are applied in preclinical testing. Recent global regulatory initiatives emphasize the importance of transitioning to human relevant assays and test systems that do not use animals. When these methods are moved from research into the regulated arena, GLP principles must be followed. The GLPs were originally written in the 1970s, when the vast majority of regulated research was performed using animals as the test system. Current innovative, alternative test systems include ex vivo tissues, manufactured biological systems, three dimensional tissue constructs, and cell cultures maintained in dynamic flow bioreactors. Each type of alternative test system raises new quality and compliance points to consider when used within a regulatory context. Just as the applications of these methods have advanced with regulatory acceptance, the quality control and compliance of these test systems must also progress.
Introducing the 3R Concepts into Pre-College Classrooms
August 28, 2017This poster provides a snapshot of pre-college teachers (46) within the U.S.—gauging their knowledge and familiarity of the 3Rs and non-animal testing methods (i.e. in vitro methods), initiative to address the topic in the classroom, and their students’ level of interest in the topic. While recognizing the ethical considerations related to animal experimentation, the current generation of teachers and students are also eager to understand the relevance, reliability, and reproducibility of in vitro methods as the modern wave of technologies in toxicology, and possible replacement of animal use for testing purposes. Our data indicate an education field eager to learn about new concepts that might impact our daily activities in an ethical way, and to get up to speed with advances in science.
Non-Animal Testing Approach to Address Biocompatibility Testing of Medical Devices Required by the United States Food and Drug Administration (US FDA)
August 28, 2017Presented at the 2017 World Congress on Alternatives and Animals in the Life Sciences (WC10)
E. Hill, R. Curren, and G.-E. Costin Starting in December 2015, personal lubricants must receive pre-market approval from the US FDA Center for Devices and Radiological Health (CDRH) in order to be sold in the US. Part of the testing battery for biocompatibility includes the in vivo Rabbit Vaginal Irritation (RVI) test. We have created an Industry Consortium comprised of personal lubricants manufacturers and are working collaboratively with stakeholders and the US FDA to develop an in vitro testing approach to substitute for the RVI. Our Validation Program will analyze paired in vivo-in vitro data for vaginal irritation utilizing commercially available human reconstructed vaginal tissue models. A Prediction Model will be proposed that can be used for the safety assessment of personal lubricants. Our Validation Program proposal has been accepted in the Incubator Phase of the US FDA Medical Device Development Tool (MDDT) Pilot Program and is currently ongoing.Using In Vitro Assays, the Direct Peptide Reactivity Assay (DPRA), KeratinoSens™ Assay (KS), and Human Cell Line Activation Test (h-CLAT) to Assess Skin Sensitization Potential of Electronic Cigarette Liquids
April 4, 2017Three regulatory accepted in vitro assays were evaluated in a proof-of-concept project to determine skin sensitization potential of electronic cigarette liquids (eliquids). These assays measure molecular initiating events and initial cellular responses prescribed in the OECD Integrated Testing Strategy (ITS) describing key events in the adverse outcome pathway (AOP) leading to skin sensitization.
Precision Digital Dispensing of Patterned Picoliter Quantities of Test Material onto Apical Surfaces of Human 3D-Reconstructed Airway Tissues
March 30, 2017There is an increasing need for researchers to understand the dynamic aspects of inhaled tobacco product exposure. Available 3D human reconstructed airway tissues (RHuA) provide researchers with a more physiological platform that offers apical and basal compartments for flexibility in modelling relevant exposures. We have tested the Tecan D300 digital dispenser as potential technical solution to deliver precise amounts of very small vehicle droplets to coat the apical surface of an available RHuA.
Addressing the Assignment of US EPA Hazard Categories for Dermal Safety by a Revised Prediction Model of the Validated In Vitro Skin Irritation Test (OECD TG 439)
March 30, 2017One of the current goals of the United States Environmental Protection Agency Office of Pesticide Programs (US EPA OPP) is to replace by non-animal testing methods as many of the endpoints of the battery of acute toxicity tests known as the “6-pack” as possible. One of the “6-pack” tests is the Draize rabbit test for dermal irritation. We investigated whether the validated in vitro Skin Irritation Test (SIT, OECD TG 439) can be used to determine US EPA OPP dermal hazard category assignment.
The 3D Human Reconstructed Skin Micronucleus Assay (RSMN) Using the EpiDerm Tissue: Validation and Application to the Safety Assessment of Cosmetics Ingredients
March 30, 2017Regulatory restrictions on animal use have increased the reliance of risk assessors and regulators on in vitro test systems. Ideally, tissue-based assays could replace the animal studies as follow-up tools to verify results from standard in vitro assays. The RSMN assay combines the EpiDerm™ 3D reconstructed skin (RS) model with the micronucleus (MN) assay to provide a more realistic model for evaluating the genotoxic potential of dermally applied chemicals or products, such as cosmetics.
In Vitro Models Available for Testing of ENDS
February 20, 2017Presented at the National Academies of Sciences, Engineering, and Medicine's (NAS) workshop on electronic nicotine delivery systems (ENDS), e-cigarettes.
Case Study: Applying GLPs to New, Non-Animal Methodologies
January 26, 2017Presented at the 2nd Good Laboratory Practice Compliance Summit, January 26-27, 2017, Arlington, VA