Safer Medical Devices – In Vitro Skin Sensitization Testing with Human Relevance and High Accuracy

Join this webinar to learn how combining genomics and machine learning provides a highly accurate in vitro method for assessment of skin sensitization hazard in medical device extracts, prepared according to ISO 10993-12.

Featured speakers will introduce how the GARD technology and the GARD™skin Medical Device assay were developed, with a focus on the technological origins of the high predictive performance. We will also demonstrate how the results can be used for risk assessment and decision-making in compliance with the principles of the 3Rs.

The GARD™ Technology: Genomics and Machine Learning

Predictive toxicology is a discipline that aims to proactively identify adverse human health and environmental effects in response to chemical exposure. GARD – Genomic Allergen Rapid Detection™ – is a next-generation, animal-free testing framework for assessment and characterization of chemical sensitizers. The GARD platform integrates state-of-the-art technological components, including human immunological cells, specific genomic biomarker signatures and machine learning-assisted classification models.

As a result, the GARD platform provides an accurate, cost-effective and efficient assessment of skin sensitizing capabilities of neat chemicals, complex formulations, mixtures and materials, including finished medical devices. GARD assays are successfully applied throughout the product life cycle of chemical, life science and medical device industries.

Extraction Vehicles According to ISO 10993-12

The GARD™skin Medical Device assay is an adaptation of SenzaGen’s skin sensitization test for chemicals, GARD™skin. The medical device adaptation enables the medical device industry to perform skin sensitization testing of both saline and oil extracts from devices or materials as described in ISO 10993-12, thus mimicking the intended use of the device when in contact with skin. The GARD platform is also compatible with a broad selection of solvents, allowing for further analysis of extracts from chemical characterization studies. GARD™skin is currently being validated for regulatory acceptance (OECD, TGP 4.106).

A Highly Accurate and Ethical Alternative for Customers

GARD™skin Medical Device offers a solution for customers looking for a highly accurate and ethical alternative for skin sensitization testing of materials and medical devices. The webinar will conclude by presenting customer cases where the assay has been successfully utilized for risk assessment as part of the biological evaluation throughout the production life cycle. Both small and large companies have used the assay in product development, monitoring of manufacturing changes, and as a part of the regulatory approval process for finished medical devices.

Speakers

Rose-Marie Jenvert PhD, Product Manager GARD Applications

As a Product Manager at SenzaGen, Dr. Rose-Marie Jenvert is responsible for managing new GARD applications, being the link between the market and the internal organization. She also acts as a medical device expert, contributing with her extensive knowledge from the medical device industry, previously working at Gambro/Baxter as study director for biocompatibility studies and currently as an expert in ISO/TC194 updating the standards for skin sensitization and skin irritation (ISO 10993-10 and -23). She also brings many years of experience working with R&D, method development and QA at AstraZeneca and Johnson & Johnson. Dr. Rose-Marie Jenvert holds a Master of Science in Molecular Biology from Lund University and a Doctor of Philosophy in Cell Biology from Stockholm University.

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Joshua Schmidt PhD, Business Development Director-Americas

In his role as the Business Development Director for the Americas, Joshua is responsible for most aspects of building business for SenzaGen in the USA and Canada. In this role, he leads the efforts to gain recognition and acceptance of the GARD assay.  To this position, he brings a wealth of technical knowledge and experience, having obtained his PhD in Pharmaceutical Sciences from the University of Wisconsin in Madison, and working for companies such as Medtronic and 3M’s Drug Delivery Systems Division. He also has over 10 years of experience in B2B and B2C sales of scientific instrumentation and analytical testing services in the pharma, med device, and other healthcare industries.

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