Unveiling the Power of Animal Models: Melior's Commitment to Quality in Drug Discovery

In the long and complex journey of a drug discovery program, the most important value inflection point, apart from the first proof-of-concept of efficacy in humans (Phase 2a), is the completion of the first in vivo proof-of-concept. This is the mission that Melior Discovery has dedicated itself to since its inception in 2005. Moreover, unlike some other, more routine or commodity-like services, the generation of quality in vivo data has a large component of trust. Unlike contract manufacturing of a small molecule, that at the end of the process comes with a certificate of analysis that provides a client with an objective description of the level of purity of the manufactured substance, the generation of in vivo data has no such equivalent. If a CRO running an animal model to assess the therapeutic potential of a candidate for an indication of interest does not conduct that study with requisite skill and full knowledge of a model’s nuances, then the outcome of that study is likely to be flawed.

Coupling the tremendous importance of animal models in drug discovery, and the imperative for quality within this discipline, is what creates Melior Discovery’s mission statement.

Melior strives towards the highest levels of quality with its in vivo studies by remaining dedicated to in vivo studies as its business model. As a pre-clinical in vivo CRO, we do not let ourselves become distracted with juxtaposed service offerings such as cell-based assays, molecular biology, or, in vitro screening. We “eat, sleep, and breath” animal models for drug discovery. All of our corporate energies and resources are directed towards this important mission.

Simultaneously, Melior balances this degree of focus with a wide scope of animal models and therapeutic areas, including over 150 models ranging from those for CNS diseases, to inflammation, oncology, dermatitis, and many others. There are a couple of reasons for this diversification. One reason relates to Melior’s founding, and ongoing, mission of phenotypic screening, as exemplified by our theraTRACE® platform. Inherent in, and core to the philosophy of, a non-hypothesis-based phenotypic screen is the notion of interrogating compound potential across broad therapeutic space. In hundreds of anecdotes that Melior has collected over nearly twenty years of screening therapeutic candidates in theraTRACE®, if it were not for testing a compound in models that no one predicted it should have activity in, we would not have made the surprising findings about unanticipated compound activity that we did. We have shown that there is power and value creation that comes from being able to look broadly across therapeutic area space when building a drug profile. This is true whether one’s aim is to find a new therapeutic opportunity from a drug repositioning point of view, or to building a differentiated product profile for a candidate in a therapeutic area with established standards of care.
Another reason for broad therapeutic area coverage relates to the notion that capabilities and command of the finer aspects of animal models in one therapeutic area has reinforcing quality benefits for conducting animal models in another therapeutic area. For example, our capability in a host of metabolic disease models is benefited by our command of models in psychotherapeutics and animal models of behavior. The nuances of skill that are honed with running quality behavior models make for better outcomes in models of metabolic disease or inflammation that are not likely incorporated into the assays of those who just specialize in those areas, for example.

While one’s therapeutic area of interest may be quite focused, Melior has shown from our collective years of in vivo phenotypic screening, that the targets our drugs modulate are not nearly as therapeutic-area focused as the investigators developing those drugs. There is a sort of synergistic value to be able to work across this in vivo space and it has proven useful to fully capture the therapeutic qualities of one’s drug candidate.