Translational Strength Self-Check

Dimension 1. Positioning check: Product profile clarity

Q1. If your target product profile were handed to three potential partners today, would all three come away with the same understanding of what the product is for?

Yes ‚ it's written down and we've tested it externally

Probably, but it isn't documented, or we haven't tested it

We haven't looked at it that way, we're keeping our options open

Q2. Can you state, in one sentence, the clinical problem your science solves better than the current standard of care, and name what "better" means in a number?

Yes, and the number is one a clinician or payer would care about

Yes on the problem, but "better" is still qualitative

Not yet, it will depend on data we don't have

Dimension 2. Functional alignment check: Working from the same playbook

Are preclinical, clinical, CMC, regulatory, and business working off the same page?

Q3. If you asked your preclinical, clinical, and business (finance and BD) leads to describe the therapy's eventual label, how close would their answers be?

Close, they've had that conversation in joint management meetings

Generally aligned, but they've never actually discussed or compared specifics

Honestly, they'd differ or haven't weighed in on what is the best application and first indication, or one of those roles is still unfilled

Q4. At what level is your manufacturing plan built around the product you intend to commercialize?

Around a commercially feasible process including scale considerations; we've worked backward from market requirements

Around production of cGMP material for the early clinical studies, but we've mapped what process changes will be needed for the commercial product

Around acceptable material (GLP (preclinical) or GMP (clinical) that can be produced in small batches using bench-level SOPs; it's too early to refine or define the process; we'll deal with that once we have more data and money

Dimension 3. Execution check: Evidence-to-decision fit

Are you generating the data the decision-makers actually need?

Q5. Think about the data package you'll have at the end of your current phase. How is it prioritized? Was it designed around what you think your next stakeholder (partner, investor, regulator) will want to see, around stress testing your program's objectives, or around producing support for your hypothesis and strategy?

Mostly what we feel we need to learn to meet the program's long-term objectives, with short-term attention to the next data requirement

Prioritized to what think the next stakeholder will likely want to see in support of our technology and strategy

We haven't framed it that way. We are focused on data generation tasks to show evidence of productivity.

Q6. Are there results you're likely to generate that would be scientifically interesting but wouldn't change anyone's decision, strategy, or work plan?

We've identified those and cut or deprioritized them

Probably yes, but we've kept them because they'll be of use for a manuscript that could highlight our science

Not sure, we haven't audited our planning that way. We'll collect data and determine how to use the information once we have it.

Dimension 4. Naîveté check: Sources of expertise

Where is the expertise coming from?

Q7. How many people on your leadership team have personally taken a program through the specific transition you're about to make?

Two or more, at this stage and in a comparable setting. They can include fractional and senior advisors as senior management, but not "statement of work" consultants. They must be involved as true team members.

One or none. We'll hire consultants for things like regulatory, CMC, and clinical when we get to that stage. The work product is gated and managed by the CEO or the relevant functional management.

None. No one knows our technology like we do or we rely on the know-how of our board and lead investors.

Q8. When your team hits a translational question or potential pivot point where there are differences of opinion as to a solution, what usually happens?

We discuss our concerns and debate possible solutions together until we reach alignment and a compromise if needed. We may seek help from independent senior advisors for added clarity when we feel there is internal bias preventing alignment.

We voice our differences internally but the CEO prioritizes the opinion of the "most-relevant" functional expert and makes decision with our board.

We tend to focus on executing a plan and realize we should have questioned something in the plan after the fact.

Dimension 5. Pressure check: Decision discipline

Do your go/no go decisions have real criteria, or are negative results seen as either problems to work around or outliers? Are you clear on how to tell if a roadblock is resonably surmountable or should be a program killer?

Q9. Can you name a specific result that would cause you to stop your program?

Yes. it's defined, written, and communicated to the board.

We haven't defined any, but we'd know one if we saw it.

Not really, stopping isn't an option right now or our program only fails when we quit.

Q10. In the last twelve months, how often has a problem surfaced that, in hindsight, someone on the team could have flagged six months earlier?

Rarely, we tend to see things coming.

More than that, and it's become a pattern with certain functions.