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Prior to passage, the FDA already considered data from replacement technologies and in vitro data on a case-by-case basis. Microphysiological Systems (MPS) data had already been included in more than 5 IND applications and solely MPS data was used for label expansion of a previously approved drug. The FDA also already had an Alternative Methods Working Group that specifically is focused on this data.
Therefore, the passage of FDA Modernization Act is not expected to cause any immediate drastic changes in the regulatory environment. The FDA and biomedical research field are still gaining confidence with technologies related to MPS & Artificial Intelligence. However, the passage of this act does indicate more general support for replacement technologies and a movement towards more regulatory acceptance of these models.
MPS are miniaturized systems that mimic the physiology of tissues, organs, or organ systems. They contain major organ specific cell types arranged as in human organs to allow for cell-cell interactions. They can model healthy or diseased tissues for up to 3 months. MPS have been designed for 17 major organ systems and sometimes linked together to form multi-organ systems. MPS are an incredible technology that allow scientists to ask and answer important research questions.
MPS cannot fully recapitulate & replace all important features of a single organ system or full body experiment. Neither the larger biomedical research community nor regulators have full confidence in MPS as a core model system – this will take time, more data, and further development to ensure the models validity and reliability. MPS are not appropriate for all paradigms such as behavior, mental health, large fractures, or cardiac output. They are not shaped by external stimuli/environmental factors. Currently interactions between organs is limited. Additionally, these systems are not always highly scalable, affordable, or validated.
For example, potential drug candidates can first be tested with human MPS to eliminate compounds that may ultimately fail in clinical trials due to human-specific toxicity. They can be used for internal portfolio decision making. Several institutions already use MPS in this manner. MPS can also be used during clinical trials or for precision-medicine using cells from particular patients to determine what compounds may be most effective for a particular patient or type of patient.
Animal models have the benefit of giving scientists the complexity of a whole, living animals. MPS can give scientists data from the correct species and a particular disease model. Therefore, in the present day, MPS show promise for answering particular questions and as a “second species”. MPS may also be most useful for simple mechanisms or where animal models are known to not be predictive (such as drug-induced liver injury). Science still has a lot to discover and in cases where there are many mechanisms are involved that scientists are still learning about, animal screens may still be necessary.
If you want to look at some of the exact statutory wording related to the FDA Modernization Act 2.0, we recommend this FDA Law Blog Post.