As molecules make their way towards the clinic, they must integrate the totality of evidence to tell a concise and clear story about its potential in patients. Preclinical models can include in vitro systems, in vivo mouse/rat/monkey models of disease or health. While some useful conclusions can be made from animal experiments, there is significant difference in Human systems, e.g., antigen expression levels, binding affinity for human.

The questions of translatability to human from animal model that do not sufficiently capture the human system still remain.

M&S takes calculated risks and assumptions to translate the findings to human data, while using experimental data and results from animal experiments.

The modeling at this stage is focused on the drug’s mechanism of action (MoA):

  • Select Lead Molecule with Optimal Characteristics
  • Use totality of evidence for IND and Human trials
  • How prevalent is the target?
  • How well does this molecule bind the target (affinity, avidity, dynamics, competition)?
  • What downstream events/biomarkers are triggered and how might we connect them to clinical readouts?

Keys Questions M&S can address

  • What should be the recommended First-in-Human dose?
  • How will PD look in human dynamics?
  • Can we predict the range at which toxicity may be triggered?

Case Studies

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