Alira Health

Mitch Sanders

Preclinical 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 this straightforward 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 or patients.  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 in multiomic (proteomics, genomics, epigenomics, transcriptomics, and metabolomics) profiling of single cells and tissues for preclinical has 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.  These multiomic preclinical 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).

The data generated from the multiomic preclinical study can also be used to supplement or extend the life of your patents to make your intellectual property (IP) portfolio more novel, proprietary, and sustainable which will give you stronger freedom to operate (FTO) position to prevent competitors from encroaching on your intellectual property. Often IP is developed well before the company has a clear product indication for use. As such, it is very worthwhile to have a professional check your patent portfolio yearly to make certain that your R&D objectives align with the business and exit strategy.

A well-defined preclinical MOA also demonstrates the clinical value proposition for a drug or device over the competitive landscape which ensures the marketability of the product.

Head-to-head preclinical studies with the leading product on the market often give you competitive market intelligence on how to improve product design to ensure best-in-class advantage vs. just developing a me-too product, which is unlikely to capture significant market share.  If your drug product or device is only marginally better than the standard of care (SOC) it is unlikely to get interested by a strategic partner or adoption in the marketplace.  For a marginal product, the value proposition is unlikely to withstand the test of time with real-world evidence (RWE) and will capture only modest revenue.

Having a competitive product advantage from a well-designed market-focused preclinical study can assist in marketing the product to stakeholders including clinicians, patients, and payers. It is not sufficient to have a great product innovation without a succinct Go-to-Market Strategy which includes marketing, sales, pricing, and reimbursement.

With a compelling MOA and value proposition you will be much more likely to improve your chances of market penetration that will drive potential partnership collaborations, investments, licensing opportunities, distribution agreements, and ultimately a successful exit. Multiomic preclinical studies are often overlooked because of the cost-cutting measures of lean startups, but ultimately these studies generate very compelling data sets to drive future investments and growth opportunities.