AI operating system for emerging biotech

The operating system
for drug development.

Our mission is to empower every emerging biotech to bring their drugs to market faster and more efficiently. Gauge Labs is the AI coordination layer for emerging biotech, connecting the evidence, plans, decisions and partners behind every drug program.

Built for the decisions
that define your
program's future.

Indication selection, trial design, submission planning, trial execution, commercial case — each decision compounds on the last. Emerging biotech teams make these calls with a fraction of the analytical depth that large pharma brings to bear.

Gauge Labs gives your leadership, clinical, and strategy teams a connected view of the evidence at every stage — so every call is made with the full picture, and every conclusion is traceable to its source.

Indication Strategy & Expansion

Prioritize indications and patient segments through a connected clinical and economic view.

  • Compare biological rationale and clinical precedent
  • Assess unmet need, competition, and patient access
  • Rank opportunities against a shared target product profile
Indication prioritisationUpdated today
OpportunityEvidenceFit
NSCLCStrong84
CRCModerate71
PDACEmerging63
01

Clinical Development Strategy & Trial Design

Pressure-test the development plan before assumptions become expensive commitments.

  • Benchmark populations, endpoints, and comparators
  • Test scenarios against relevant trial precedent
  • Connect each design choice to the evidence it must produce
Phase 2 design scenarios3 compared
Population fit
82
Endpoint precedent
73
Signal sensitivity
64
Operational burden
55
Scenario B creates the clearest proof-of-concept readout
02

Competitive Intelligence & R&D Strategy

See where the landscape is moving and what your program must prove to stay differentiated.

  • Track programs, readouts, and changes in strategy
  • Compare assets across mechanism, design, and evidence
  • Identify whitespace, threats, and decision-relevant signals
Competitive landscape28 active programs
DifferentiationClinical maturity
Your program
03

Submission Critical Path & Milestone Mapping

Map the path from today to filing, so the activities that gate submission are sequenced, owned, and visible.

  • Build an integrated plan across clinical, CMC, nonclinical, and regulatory workstreams
  • Identify critical-path dependencies and the activities that can move the filing date
  • Re-forecast the submission timeline as data, decisions, and agency feedback change
Submission critical pathTarget filing Q3
✓Nonclinical packageOn track
✓CMC comparabilityOn critical path
✓Pivotal data lockOn track
!Agency meeting briefingAt risk
04

Clinical Execution & Trial Oversight

Work alongside your CRO and sponsor team to keep trials on track, with the same rigor large pharma applies.

  • Site selection and feasibility grounded in enrollment performance
  • Site start-up and activation tracked against the critical path
  • Milestone mapping, reminders, and early warning when timelines slip
Site activation tracker24 sites
Selected
24
Contracts executed
19
IRB / EC approved
16
Activated
12
4 sites behind plan: reminders sent to CRO
05

Commercial Forecasting & Investment Case

Keep the economic case aligned with the latest development choices and external evidence.

  • Model probability, timing, cost, and market potential
  • Compare scenarios and expose value-driving assumptions
  • Update the case as clinical and competitive signals arrive
Program value scenariosBase case
Risk-adjusted value$418m+12% vs prior view
202620302034
06

The operating power
of big pharma.