Based on the Tech Nation interview with Dr. Eric Merle, our Chief Bussiness Innovation Officer by Moira Gunn, in February 2022. The entire Tech Nation Radio Podcast is available here. Eric’s interview starts at 44:00 mins.

Just before the COVID pandemic, the US Environmental Protection Agency (EPA) declared that 2035 would mark the end of the agency’s funding for testing on mammals for research. The EPA has been awarding millions of dollars to seek out alternatives. Similarly, the US Department of Veterans Affairs will restrict funding for experiments on dogs and “end or reduce” experiments on dogs, cats and primates by 2025. Even the US Department of Agriculture has banned research using cats since 2019. The trend is clear: the goal is for animal testing to be retired. It’s what the general public wants. It’s a growing request from regulatory bodies. The pharmaceutical and biotech industry need to do better than animal testing. It doesn’t sufficiently demonstrate whether a drug will work nor how well it will work when it moves into the clinical phases.

Human skin provides a solution. Having the ability to obtain human data, before testing in humans during clinical trials, not only makes the drug development process less risky, it may improve the number of drugs that will be developed and our understanding of disease pathways to tackle the problem.

Clinical trials need to reflect population diversity and include different genders, ages, ethnic groups and sometimes even different medical conditions. The FDA recently stressed the importance of heterogeneity and clinical trials should include a representative sample of the final patient population. Luckily, surgeries, such as tummy-tucks, that require the removal of human skin tissue, are very common for a diverse group of individuals. Using real human skin therefore offers an excellent opportunity to start studying the diversity sought in clinical trials at the preclinical stage.

Since skin is readily available through donations, this functional organ can be obtained in large amounts. This makes it possible to broaden the scope of preclinical R&D in order to compare different options and pick the best solution. It’s possible to test multiple doses in the same donor because the skin is prepared in small units. The units are about an inch in size and allow research on different conditions. With Genoskin’s skin models, a typical surgery yields roughly 50 units from one individual. This approach allows studying multiple conditions and doing replicate studies in the same individual to make sure that, from a scientific perspective, everything is sound. It therefore becomes possible to document how – sometimes – minute changes can have very large influences in the body, and adjust the development process accordingly.

Genoskin’s ex vivo human skin platforms allow for the immune profiling of drugs, vaccines and compounds that are administered via topical, systemical, intradermal and subcutaneous routes. We provide the only testing platform worldwide to test subcutaneously injected products outside of animals and humans, to not only predict immune response to drugs in the skin but also in other human organs that share a similar immune ecosystem. Our expertise includes unbiased data analysis via artificial intelligence, spatial biology and data comparison to real-world evidence and drug data for extra relevance. Don’t hesitate to get in touch for more detailed information.