APRIL 2023LIFE SCIENCES REVIEW8IN MY OPINIONMULTIOMIC PRECLINICAL MODELS TO DEFINE THE MECHANISM OF ACTIONBy Mitch Sanders, Chief Scientific Officer and EVP of the ProDevLab, Alira Healthreclinical models are often used to ensure the safety and primary efficacy of a drug or device as a requirement for regulatory filings (FDA, EMA). Although thisstraightforward biocompatibility and preclinical efficacy trials are required for drug and device approvals, they are not sufficient to delineate the mechanism of action (MOA) or value proposition to clinicians orpatients. Potential strategic partners and investors want more than just an approved product. They want a product that has a compelling unmet need, a value proposition, and a clear path to market to ensure revenue adoption and scalability. The innovations in the past few years inmultiomic (proteomics, genomics, epigenomics, transcriptomics,and metabolomics) profiling of single cells and tissues for preclinicalhas been a game changer for researchers to better understand the biochemical pathways underlying disease and offers new paradigms for targeted cell-based therapies and novel active pharmaceutical ingredients. Thesemultiomicpreclinical studies often define the MOA that is critical to honing the primary and secondary endpoints for clinical trials. A deeper understanding of pathways involved in the therapeutic indication or device also leads to better Phase II/III outcomes and reduces adverse events (AEs). pMitch Sanders
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