Panel · Use case · Medical Affairs

Indication Expansion Board.

LiveGo / No-Go Board

Should we invest in a new indication for this marketed product, and what evidence must exist first?

DecisionInvest in a new indication, stage the investment, or stop

LensesMedical, real-world evidence, regulatory, access

ReaderLifecycle leadership

Not askedA study design

DepthStandard, four seats

Indication Expansion Board is a ready-made use case for Medical Affairs. It ships under the Go / No-Go Board template.

For medical affairs leads. You get a recommendation, the score matrix and vote tally, the conditions of approval and the dissent record. Claims are cited or marked as gaps.

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 we invest in a new indication for this marketed product, and what evidence must exist first?

Who scores

A new indication starts from a marketed product with known safety, but needs new efficacy evidence. Agencies publish what they expect of real-world evidence, and the board scores against that.

Seat	What it scores	What it works from
Global Medical Affairs Director	Whether the unmet need is real and the clinical rationale holds.	Guidelines and clinical evidence.
Global Real-World Evidence Lead	Whether real-world evidence can support part of the case.^{1U.S. Food and Drug Administration. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products. August 2023.,2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}	FDA and EMA expectations for real-world data.
VP Global Regulatory Strategy	Whether the path to a label change is credible.	Agency practice.
Global Market Access Director	Whether payers will reimburse the new use.	Payer methods.

What the board does

Evidence first, then money. The board states the evidence that must exist before the investment is released, and makes it a condition.^{1U.S. Food and Drug Administration. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products. August 2023.}

Real-world evidence has a burden. EMA’s reflection paper asks the applicant to justify that the data are appropriate. The board scores whether that case can be made.^{2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}

Staging. The options include a smaller first step, for example a feasibility analysis, with a gate before the larger spend.

Recommended length

Standard

Four lenses bear on this decision. Standard depth gives each a seat, with the criteria, the matrix and the conditions in about four pages.

You can pick another length on the form. The other two stay available.

Assumptions the board scores against

The board states the assumptions behind its criteria and says what each gap limits. Examples for this decision:

The new population is reachable through existing channels.
Real-world data can capture the outcome.
The label change will not require a new development program.

Standards, guidance and sources

Frame

FDA, real-world data and real-world evidence guidance, 2023.^{1U.S. Food and Drug Administration. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products. August 2023.}
EMA, reflection paper on real-world data in non-interventional studies, 2025.^{2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any criterion scored without a basis, any evidence condition with no owner, and any spend release not tied to a gate.

What arrives

The proposal and the decision sought
Board recommendation
Criteria and scoring basis
Seat assessments
Score matrix and vote tally
Conditions of approval
Pre-mortem and rebuttal outcome
Dissent and what would reverse the call

What it will not do

The decision belongs to the named decider and the seats are AI specialists. The thresholds are set by the proposer or the decider, and the board does not invent them.

It does not design the evidence program.

It does not decide. The decision belongs to the named human decider, and the seats are AI specialists.

It does not set thresholds or weights for you. The proposer or the decider sets them.

It does not average away a failed must-meet criterion.

References

[1] U.S. Food and Drug Administration. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products. August 2023. Title and date as known; not read in full.
[2] European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025. Status as given in EMA’s listing; not read in full.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

About the Panel service

Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.

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