Decision catalogueModality pressure-test
When potency and comparability decide the cell therapy raise
Decision problem
Is the next round buying a clinical claim, or an unresolved potency and comparability project?
Thesis
If potency is not tied to the clinical claim and comparability after process change is narrative, CMC risk will consume the raise before the readout.
In cell therapy, product identity and release strategy are often the must-be-true claims under a live deal deadline — not operational footnotes.
A claim map asks which assay defines potency for the proposed next study, what would invalidate it, and which process changes are already priced into use of proceeds. Platform-plus-pipeline structures get an extra cut: the platform cannot underwrite an asset check without asset-level exposure.
Comparator and failed-analogue programs belong in the memo. Differentiation that ignores vein-to-vein constraints, allogeneic control strategy, or known toxicity failure modes is incomplete decision support.
Claim map
Must-be-true cuts a Decision Sprint memo would force
- Potency and product identity are decision-grade for the proposed next study
- CMC / process control risk will not consume the raise before a claim-resolving readout
- Comparator and failed-analogue programs support the differentiation story
Decision triggers
Outputs from the claim test that should change the conversation
- Potency or release strategy not tied to the clinical claim
- Comparability after process change left as narrative rather than a plan
- Use of proceeds not mapped to must-be-true manufacturing gates
Sources
Related in the catalogue
- Prior work · Cell therapy
Anonymized account of decision pressure in this modality class.
- Method · graph-backed claim testing
How claims are decomposed, tested against the evidence graph, and turned into decision outputs.
- Platform story, asset check: separate them before you commit
Is this raise underwriting a product path or an unresolved platform science project?
- Identity before mechanism in extracellular vesicle packages
What must be true about vesicle identity and controls before mechanism claims can carry a check?
- Claim maps beat generic diligence checklists for seed decisions
How should a lean team pressure-test science under a 5–20 day deal deadline?
Facing this cut on a live $1–10M package?
Scope a Decision Sprint for one opportunity under your deal deadline—claim map, risk register, management questions, and partner briefing.