Ranked against your program
Models are ranked against your specific program context, drawing on a curated knowledgebase of 2,000 organ-on-chip, MPS and organoid systems from academic and industry sources.
SolutionsPreclinical model alignment
Solutions · Preclinical model alignment
Does the model recapitulate patient biology?
It is the question a program is least able to answer and least able to afford getting wrong. Pluto answers it twice: when you choose the model, and when you defend it.
01 · Model selection
Turning preclinical model selection from expert intuition into a queryable, evidence-backed decision.
Alternatives, with the reasoning
If the best available model doesn't clear the bar, you get better-fitting alternatives ranked with the reasoning behind each.
Never a dead end
If nothing clears it, Pluto tells you what experiment would close the gap.
Where the depth is
A program can be right about the disease, right about the target, and still fail — because the model was never the patient.
Model translatability is the least structured judgment in discovery and the most expensive one to get wrong. It's usually made from experience, in a meeting, and recorded nowhere. It's why we built a second framework just for it: the Biological Fidelity Framework, alongside TAF, purpose-built to score model translatability.
What you get
A fidelity readout for every candidate model.
Each of the four dimensions comes back with a status, the evidence behind it and, where there's a gap, the experiment that would close it. It's the page you take into the stage-gate review instead of a slide defended from memory.
Tumour organoid panel · 6 donorsBiological Fidelity Framework
Biological Representation
Are the right cells there, doing the right things?Tumour epithelium and fibroblast states match patient single-cell data. No immune compartment.
NextAdd an autologous immune co-culture arm.
Molecular Fidelity
Does the biology match the disease at the molecular level?Disease signature and key pathway activity track the human reference, not a generic one.
Functional Fidelity
Does it behave like the tissue, under stress and over time?Standard-of-care dose response reproduced across three batches.
Translational Confidence
Will this hold up once it reaches a patient?No benchmark compound tested against known patient response yet.
NextRun two clinical benchmark compounds with known outcomes.
Biological Fidelity Framework
Built for where the field is going, not where it has been.
New approach methodologies are moving from talking points to expectations. Organoids, organ-on-chip, and human-derived systems are changing what counts as a defensible model, and current FDA guidance is moving with them.
The Biological Fidelity Framework assesses model systems on the terms regulators actually use, so evidence generated today still counts when the expectations tighten.
Human relevance
How closely the system reflects human biology, not species-adjacent biology.
Context fidelity
Whether disease context, subtype and stage are represented, not just cell identity.
Functional readout
Whether the system produces measurable, mechanism-linked responses.
Reproducibility
Whether the result holds across donors, batches and assays.
Run the Biological Fidelity Framework against a live program.
Bring the model package you already have. We will assess it against the framework and show you what is evidenced and what is assumed.