Cases
Cases · Pharma — flagship Illustrative application

Find the responders before the trial does.

Many trials fail because the effect is real but diluted — a minority respond, and the average washes them out. From a screening-panel cohort, the engine derives a responder signature with explicit N-of-M logic, so an enriched arm can reach significance at a lower n.

Screeningpanel cohort, pre-enrollment
Respondersignature · who is likely
N-of-Minterpretable rule
Lower nsignificance, enriched arm

The problem

A real effect can still read as noise. When only a subgroup responds, the trial average dilutes them — and a drug that works for the right patients misses its endpoint. Enrichment changes the arithmetic before the first dose.

The dilution

Responders washed out

A heterogeneous cohort averages responders and non-responders together — a true effect shrinks toward the mean.

effect · masked

The cost

Brute-forcing power

Chasing significance with a bigger n costs patients, sites, time and money — and still may not rescue a diluted signal.

n · expensive

The fix

Enrichment changes the math

Stratify to the patients likely to respond and the same effect reaches significance in a smaller, enriched arm.

enriched · powered

How the engine applies

Screening panels in, a responder signature out. The engine reads a candidate cohort's screening panels, derives the marker combination that separates likely responders, and expresses it as an interpretable N-of-M rule you can apply at enrollment.

Input · screening Engine Output Candidate cohort Screening panels Zenlo engine deterministic + AI · auditable Separate responders Build N-of-M rule Enrich & power OUTPUT · RESPONDER SIGNATURE Enriched responder arm all-comers enriched e.g. significance at ~40% n (illustrative) N-of-M rule · effect size · drivers interpretable, reproducible Example figure shown for illustration — the real signature comes from your cohort, not from us.

The logic

A rule a statistician and a reviewer can both read. The responder signature isn't a black box — it's an explicit N-of-M rule over a handful of markers, auditable end to end.

Input

Screening panel

The candidate cohort's pre-enrollment panels — the raw material the signature is learned from.

labs · multi-marker

Signature

Responder signature

The marker combination that separates likely responders from non-responders in the cohort.

marker set · directionality

Rule

N-of-M rule

A patient qualifies when N of M signature criteria are met — interpretable, not a black-box score.

N of M · thresholded

Payoff

Power at lower n

Concentrating the effect in an enriched arm lets the same signal reach significance with fewer patients.

effect ↑ · n ↓

Who this is for

Anyone designing a trial that can't afford to miss. Where the asset is promising but the signal is heterogeneous, a responder signature is the difference between a readout and a rescue.

Biotech & emerging sponsors

«One asset, one shot»

Moderna Moderna BioNTech BioNTech Alnylam Alnylam Beam Therapeutics Beam Therapeutics Relay Therapeutics Relay Therapeutics

Moderna, BioNTech, Alnylam, Beam, Relay

Large-pharma translational

«Stratification strategy»

Pfizer Pfizer Roche Roche Novartis Novartis AstraZeneca AstraZeneca Merck Merck

Pfizer, Roche, Novartis, AstraZeneca, Merck

CROs & trial-design partners

«An enrichment layer to bring»

IQVIA IQVIA ICON ICON Parexel Parexel Labcorp Labcorp Medpace Medpace

IQVIA, ICON, Parexel, Labcorp, Medpace

Logos shown are market examples of each segment, to illustrate who the application fits — not Zenlo clients or partners, and no endorsement is implied. This is trial-design support, not a regulatory submission.

What this is — and isn't

Enrichment support, not a companion diagnostic

We derive and document a responder signature from your cohort. We don't run the trial, we don't guarantee its outcome, and we don't issue a regulated diagnostic.

Illustrative application

This page shows how the engine would apply to trial enrichment.

  • No named sponsor or asset
  • Figures shown are example endpoints
  • The real signature comes from your data

The cohort owns the result

The signature is whatever separates responders in your data — or nothing, if nothing does.

  • Held-out validation, with significance
  • Drivers named; nothing cherry-picked
  • Reproducible from the same inputs

Not a companion diagnostic

An N-of-M responder rule is design-stage evidence, not a regulated test or a treatment claim.

  • For trial design & stratification
  • Regulatory strategy stays the sponsor's
  • Zero data retention on model calls
Illustrative application, not a client result or regulatory endorsement. Any figures here are example endpoints to show the shape of the output. We derive a responder signature from a sponsor's own screening cohort; the signature, its performance, and any trial design remain the sponsor's responsibility.

Design your enrichment arm.

Send a screening-panel cohort and we return a responder signature: an interpretable N-of-M rule with held-out performance and an evidence trail your biostatisticians can check.