Brief · Use case · Corporate Development
Asset Go/No-Go.
LiveDecision MemoDecide whether to advance, pause or license out an asset, scored on probability of success, expected value, cost to the next gate and strategic fit, with the gates laid out.
Asset Go/No-Go is a ready-made use case for Corporate Development. It ships under the Decision Memo template.
For portfolio and R&D leaders at a stage gate. The memo states the decision and who decides, scores the options, shows the gate criteria and names the assumptions that carry the recommendation. Probabilities are cited base rates or labelled analyst estimates.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
Should the company advance a phase 2 asset into phase 3, pause it pending a biomarker readout, or license it out?
The three options at the gate
A gate asks for a decision, not a discussion. The memo scores the three options on the same five criteria and states the rule the committee would apply.
| Route | What it asks of you | It fits when | What the committee will want to see |
|---|---|---|---|
| Advance into phase 3 | Commit to a phase 3 program at this gate. The commitment is the largest of the three, and the risk of failure does not end with a good phase 2.1,2 | The phase 2 evidence meets the gate criteria, and the risk-adjusted value exceeds the cost to the next gate. | Probability of success, expected value, cost to the next gate |
| Pause pending the biomarker readout | Hold investment until the biomarker result arrives, with the readout date and the decision rule set now. The memo names what kind of biomarker it is, because that decides what the result can change.5 | The readout could change the decision, and waiting costs less than the information is worth. | What the readout must show, by when, and what it would change |
| License the asset out | Transfer the asset to a partner for an upfront payment and milestones, and keep or give up the rights you specify. | The asset fits the portfolio poorly, or a partner can value or develop it better than you can. | Strategic fit, partner interest, value retained |
What the memo does with them
Risk-adjusted value, not the upside. Net present value with a single discount rate cannot show risk falling stage by stage. The memo uses risk-adjusted net present value, which weights cash flows by the probability of reaching each stage, so the value of waiting and the value of advancing can be compared fairly.1
Base rates, with their range. Published success rates depend on method and sample. One analysis of industry-sponsored programs estimated that about 13.8 percent reach approval, higher than the 9.6 percent that an earlier analysis it compared itself with had found, and it reports the lowest rates in oncology. A later BIO, Informa and QLS report covers 2011 to 2020. The memo shows the range, uses the figure for your phase and therapeutic area, and labels any probability you supply as an analyst estimate.2,3
The gate as a decision rule. Stage-gate practice separates stages of work from gates where the deliverables are judged against stated criteria and the outcome is go, kill, hold or recycle. The memo states the criteria and the rule for each of the three options before it scores them.4
What the biomarker would change. A biomarker can be diagnostic, prognostic, predictive or a response measure, and each answers a different question. The memo says which it is, what result would move the decision, and who owns the threshold, so the pause has an exit.5
Five criteria, scored the same way. Probability of technical and regulatory success, expected value, cost to the next gate, time to the next readout and strategic fit. The scores are analyst judgment, labeled as such.
How it could fail. The pre-mortem probes the failures this decision invites: a phase 3 that fails for a reason the phase 2 could have shown, a readout that is ambiguous, a licensee who values the asset below your risk-adjusted value, or a pause that drifts with no decision date. Each gets an early warning and an owner.
Recommended length
Comprehensive
A stage gate commits a large budget on probabilities and assumptions. Comprehensive adds the table that tests each assumption and the longer section on what would change the answer.
You can pick another length on the form. The other two stay available.
Assumptions the memo tests
A Comprehensive memo lists the assumptions that carry the answer, each with a test and a date. A Standard memo carries the main ones in its section on what would change the answer. Examples for this decision:
- The probability of success is a cited base rate for this phase and therapeutic area, or is labeled as your estimate.
- The biomarker readout can change the decision, and its threshold is set before the data arrive.
- The phase 3 cost and timeline reflect the current design, not the one used for the budget last year.
- A licensee would value the asset above its risk-adjusted value to you.
Standards, guidance and sources
Valuation and probability
- Risk-adjusted net present value in pharmaceutical asset valuation, and how it differs from net present value.1
- Estimates of clinical trial success rates by phase, disease area and sponsor, from Wong, Siah and Lo, 2019. A corrigendum corrected two tables; the memo uses the corrected figures.2
- BIO, Informa Pharma Intelligence and QLS Advisors, Clinical Development Success Rates and Contributing Factors 2011–2020.3
Gate discipline
- Stage-gate systems for managing new products: stages of work separated by gates with explicit criteria and a go, kill, hold or recycle decision.4
Biomarker terms
- The FDA-NIH BEST glossary of biomarker categories and definitions.5
The decision practice behind the memo itself is on the template page.
What gets flagged
Every probability that is an analyst estimate and not a cited base rate, the assumption that carries the value, what the biomarker readout would change, and any deal comparable that has no source.
What arrives
- Decision requested
- Recommendation
- Context and framing
- Options considered
- Why this option wins
- What must be true
- What would change the answer
- Risks and the pre-mortem
- Path and what we do not know
What it will not do
It does not value the asset for a transaction, and it does not replace a data-room review or a fairness opinion.
It does not predict the biomarker result or the outcome of phase 3. It states the probabilities it uses and where they come from.
It does not make the decision. The named decider does.
Scores and weights are analyst judgment from an AI specialist, not measurements. They show how the options compare on the criteria you chose; change the weights and the ranking can change.
It is one specialist’s answer. When you need several specialists to disagree in the open, run a Panel.
Facts the specialist could not source appear as gaps. Regulatory fees, review goals, reference prices and probabilities are cited to their sources or left open. Check any figure you will act on against its primary source.
References
- [1] Alacrita. Valuing Pharmaceutical Assets: When to Use NPV vs rNPV. White paper. A consultancy white paper.
- [2] Wong, C. H., Siah, K. W. and Lo, A. W. Estimation of clinical trial success rates and related parameters. Biostatistics, 2019;20(2):273–286. Corrigendum published 2018. Data cover 1 January 2000 to 31 October 2015.
- [3] BIO, Informa Pharma Intelligence and QLS Advisors. Clinical Development Success Rates and Contributing Factors 2011–2020. 2021. Only the report’s landing page was read; read the report for its figures.
- [4] Cooper, R. G. Stage-gate systems: a new tool for managing new products. Business Horizons, 1990;33(3):44–54. DOI 10.1016/0007-6813(90)90040-I. Catalog record; the description of gates is from secondary summaries and the article was not read.
- [5] FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource: glossary. Bethesda (MD): FDA and NIH. The page could not be opened from our tools; the category list is from search excerpts. Check the current version.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
To edit a saved template, open New → Brief → From template, or the library rail on the service form.