SOLUTIONS
target product profile

Build a Target Product Profile every function can act on

A TPP asks clinical, commercial, regulatory, and medical affairs to work from one evidence base. Causaly automates that evidence base so your team spends its time on the judgment calls it informs.

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Why Use Causaly

Causaly turns TPP evidence generation from a months-long, hand-assembled reconciliation exercise into a source-cited, continuously current evidence base every function can act on directly.

  • One evidence base, multiple functions: Clinical, commercial, regulatory, and medical affairs work from the same version, not a reconciled patchwork.
  • Evidence that doesn't go stale: The TPP can be rapidly updated when a competitor reads out or a regulatory precedent shifts.
  • Built on your context: Internal documents, decision rubrics, and prior outputs, not literature alone.
  • Decision support, not templates: Organization-specific judgment, encoded and made repeatable.

What a Causaly TPP actually contains

A biomarker-enriched profile for a late-stage immunology asset, generated and refreshed inside Causaly's TPP Workspace  

  • Strategic positioning: Synthesized from the evidence and tagged for differentiation, with every claim linked back to its sources.
  • Asset, indication & population: Mechanism, regimen, and companion diagnostic requirements, structured in one place.
  • Efficacy vs. benchmarks: Your program's own signal plotted directly against the competitor classes it has to beat.
  • Safety & tolerability: Your target profile set against the safety bar each competitor class has already established.
  • Trial design timeline: Every readout plotted against today, so the profile always shows where the program actually stands.
TPP Workspace — Product X
01

Strategic positioning

SynthesisedSources

Product X is positioned for a defined patient population within a target therapeutic area. The profile evaluates potential differentiation across clinical benefit, safety, convenience, and evidence generation. Final positioning will be informed by the totality of the development evidence.

Clinical benefitPatient segmentationSafety profileEvidence strategy
02

Asset, indication & target population

Mechanism of action
Mechanism placeholder
Indication
Target indication
Target population
Defined patient population
Adjacent opportunity
Potential future indication
Regimen (proposed)
Administration approach under evaluation
Diagnostic strategy
Patient selection approach to be defined
03

Efficacy targets vs benchmarks

Causaly Pipeline Graph + Agentic synthesisSources
Primary clinical outcome — Assessment timepoint
Primary endpoint

Target outcome measure for the defined population; detailed endpoint criteria to be established.

Aspirational target
≥ X%
Minimum viable threshold
≥ X%
External benchmark A
Range
External benchmark B
Range
Product X — initial signal
X%
Product X — selected subgroup
X%
Key observation: Early evidence will inform target population selection and the pivotal evidence-generation strategy.
Long-term clinical outcome — Follow-up timepoint
Durability measure

Sustained outcome among eligible participants.

Aspirational target
≥ X%
External benchmark
Range
Secondary outcome targets
Patient-reported outcome
Target ≥ X%
Symptom-domain measure
Clinical assessment
Target ≥ X%
Objective outcome measure
Biomarker outcome
Target ≥ X%
Supportive evidence measure
04

Safety & tolerability target

Sources
Target safety profile
  • Acceptable benefit-risk profile
  • Safety outcomes aligned with target product profile
  • Administration tolerability assessed
  • Routine safety monitoring approach
Competitive safety context
  • Comparator safety considerations to be evaluated
  • Class-specific risks to be characterised
  • External safety benchmark to be defined
Note: The evolving safety database will inform future labelling and evidence strategy.
05

Study timeline

CompletedPivotalFollow-up
Year 1Year 2Year 3Year 4Year 5+
CompletedCompleted study
Evidence generation complete
Year 1 → Year 2 · Completed
PivotalPivotal study
Clinical evidence programme
Year 2 → Year 5 · Primary outcome assessment
Follow-upFollow-up study
Long-term evidence collection
Year 2 → ongoing · Long-term follow-up
Additional sections — full TPP
06

Competitive landscape

07

Differentiation strategy

+ lifecycle management · real-world evidence · clinical operations · stakeholder landscape

Make smarter decisions

Meeting the conditions decision-support work demands takes more than any single capability. Three core layers generate the evidence; two delivery layers get it into your organization's hands.

Scientific Workflows

Turn a TPP into the same five sections every time: positioning, population, efficacy, safety, timeline.

Agentic Research

Sources the evidence behind every benchmark comparison.

Data Integration

Uses your own trial data, not public literature alone.

Professional Services

Configures which cohorts and cut points matter for your

A2A Ecosystem Integration

Keeps the workspace refreshed inside your own systems.

Get started with Causaly

Ready to transform the way your R&D teams discover and deliver? Take the first step - see Causaly for yourself.

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