Get an independent read on the assumptions carrying the decision.
You are being asked to underwrite a technology, a company or a transaction. The management team is fluent, the data room is organized, and the scientific case is compelling. What adds most is an independent read from someone who has run programs like this one and has no stake in the answer.
The distance between compelling biology and a viable program often sits in CMC, comparability, scale or delivery.
Novel modalities carry little settled precedent, so the evidence plan has to fit the review division that will actually assess it.
Enrollment assumptions, site footprint, CRO structure, and the manufacturing and supply plan can each make a stated timeline arithmetically impossible.
Experience with filings, scale-up and portfolio decisions can be assessed directly, along with what it would take to add what is missing.
By separating what the platform has demonstrated from what it promises: whether the biology is ready to become a program, whether CMC and delivery hold up at scale, and whether the regulatory and timeline assumptions are sound. I give boards and investors an independent read on each.
The science, the regulatory path, the timeline and burn, including manufacturing and supply, and whether the team has what the plan requires. I have run programs like these, so the read draws on direct operating experience.
Yes. Many engagements center on one decision: a pivotal commitment, a partnership, or whether to continue a program. The Load-Bearing Diagnostic is a fixed-fee answer to the decision in front of you, typically in one to three weeks.
A finished brief is not needed. I read every message myself and reply with the two questions I would ask first. If I am not the right person, I will tell you who is.
Roberta Duncan, Founder and Principal