Courtney Tindle, MS., Program Manager and Director, HUMANOIDTM Center of Research Excellence (CoRE).
| "On Thursday, September 29, 2022 Senate Bill 5002, “FDA Modernization Act 2.0” was passed by unanimous and bipartisan consent. This bill changes the requisite for animal testing and allows for market approval for a new drug to use alternative methods to establish the drug's safety and effectiveness, such as organoids. Naturally, those already engaged in organoid research has been jubilant (and so are we), but we also feel the pressure to get it right because precision in disease modeling is a prerequisite before findings can be translated.
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Pradipta Ghosh, M.D., Faculty Director, HUMANOIDTM Center of Research Excellence (CoRE).
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"Each time a drug program that was successful in pre-clinical animals' models fails to reproduce efficacy in Phase III clinical trials on real-world patients, the society bears a tab of ~$ 2.4B as patients continue to suffer. HUMANOID's stem cell-based multi-dimensional disease models, reverse-engineered using co-cultures of 'all-human' patient-derived organoids, primary cells and even microbes and vetted by omics approaches for accurately recapitulating the human condition is expected to introduce an additional step in drug discovery, i.e., Phase '0' trials, which allows the testing of efficacy and toxicity of drugs so that ineffective candidates can be rejected early. We also decided that we will *not* do something; to know more, click here."
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