Genoskin invited at FDA to present ex vivo human skin models validation data
On November 14th, 2019, Pascal Descargues (Chief Executive Officer) and Eric Merle (Chief Commercial Officer) were invited by the FDA Immunotoxicology Interest group of the US Food and Drug Administration in Silver Spring, MD to present at the FDA Toxicology Seminar Series on HypoSkin® and NativeSkin® validation data. Genoskin provided a scientific presentation introducing their ex vivo skin assay platform and its potential use for an accelerated & standardized prediction of drug & device effects in human skin.
Genoskin prepares ready-to-use living human skin explants to investigate the local safety and efficacy of pharmaceutical candidates administered topically, transdermally or injected into the skin. The format and easy assay protocols ensure easier reproducibility and cross-studies comparison. As skin assays can be produced from explants sourced from a diverse donor population, studies can mimic the diversity found in clinical trial patients.
The presentation was well attended by reviewers from different centers within the FDA. Attendees now have a better familiarity with the Genoskin platform, assay methodology, and validation results.
Genoskin continues to further develop the platform and characterization of their models so that to continue to provide the industry with tools to generate relevant data in human skin. Visit www.genoskin.com for more information about these technologies and the latest developments
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