Development-path track
Is the proposed path defensible?
When the answer rests on whether a proposed path is defensible — endpoint, population, indication, trial design, regulatory posture — before it is committed.
OncAdios LLC
Senior oncology-development judgment for the decision your program turns on next — before the capital and the calendar are committed.
For founders, CMOs, boards and investors who need to know whether a development and regulatory story will hold up in a board, a financing, or a health authority room — and what it would take to make it hold. The work is done by one accountable senior operator: Jesús Gómez-Navarro, M.D., thirty years in oncology drug development, seven anticancer approvals.
Deciding with colleagues? OncAdios at a Glance sets out the practice on two pages (PDF).
At a Glance
Where the practice works, and how it engages.
- Discovery
- Pre-IND
- First-in-human
- Phase I expansion
- Phase IIselectively
- Late stagedeclined
Calibration Sprint Ten business days · fixed fee
Development-path track Is the proposed path defensible? First-in-human evidence track What do the human data already support?Where the work continues Fractional CMO · Board director or scientific advisor
The fit call decides the track with one question: what evidence has to carry the answer?
The Record
Thirty years across Pfizer, Millennium and Takeda.
Currently advising an early-stage oncology program: clinical development plan for a first-in-class asset, trial design, endpoints and translational plan
Board-certified medical oncologist. As Immuno-oncology Clinical Lead, Pfizer Oncology, he contributed to advancing the anti-CTLA-4 antibody tremelimumab from first-in-human through Phase 3 (later approved as IMJUDO). As VP, Head of Clinical R&D at Takeda Oncology (2011–2020) and Takeda's inaugural Distinguished R&D Fellow (2020–2022), he oversaw seven anticancer approvals worldwide, including by the FDA, EMA, PMDA and NMPA. He founded OncAdios LLC in 2022 and is its sole principal.
Approvals
NINLARO · ADCETRIS · ALUNBRIG · ICLUSIG · ZEJULA · CABOMETYX · EXKIVITY
Selected Engagement
Fundación INIBIC
Regulatory strategy and evidence synthesis for a therapeutic innovation programme in oncology.
Where to Start
The Calibration Sprint: one decision, ten business days, a fixed fee.
Senior clinical-regulatory judgment on the single decision in front of your program, before the capital and the calendar are committed. It produces four written artifacts and closes with a live, adversarial readout. An independent no is as valuable as a yes; where the evidence does not support a recommendation, refusal is part of the output.
One question decides the track: what evidence has to carry your answer?
First-in-human evidence track
What do the human data already support?
When the answer rests on what human data already collected actually support, and those data are mature enough to answer the question. Scoped typically to one asset and one decision, so an investor can commission it for each asset as it comes up.
A Phase I program can sit in either track. Where both matter, the fit call names the dominant one and says plainly what is left out.
Where the Work Continues
Two ongoing roles, for a small number of companies a year.
Primary
Fractional CMO
Embedded with a small number of companies a year, typically for six to eighteen months across a pre-IND or Phase I decision arc. For a funded early-stage oncology company, AI-originated or conventional, that has not yet hired its full-time CMO. Reserved capacity and accountability: cash-based, with equity added selectively.
A fractional role retires near-term decision risk. It does not build a long-term clinical-regulatory function.
Selective
Board director or scientific advisor
Where the contribution is judgment and governance rather than execution: go/no-go decisions, indication selection, trial-design oversight, and oncology-development judgment at the table for portfolio decisions. Cash or cash-plus-equity, matched to the role.
Not seeking a full-time executive seat. Declined: late-stage execution, day-to-day medical monitoring, open-ended retainers.
How the Work Is Done
An accountable operator, with AI as the leverage layer.
OncAdios is independent of the asset-acquisition thesis, the model vendor and the capital already committed. Its role is to adjudicate the oncology decision, including a disciplined no, and to stay accountable for the reasoning in the room where that decision is made.
- The patient is the reason for the work. The people who enroll in an early oncology trial are not at the table where these decisions are made. Every read asks whether the program is designed to answer the question they were asked to accept the risk for.
- The outcome that matters. Meeting an endpoint, obtaining approval, achieving adoption and delivering meaningful patient benefit are different claims, and each is stated separately.
- AI under explicit governance. Every claim of consequence is sourced; refusal is a valid output; client data is handled under a written data-handling regime.
- Transportability. Evidence from one tumor type, modality, population or setting is not assumed to carry into another.
Who It Serves
Three kinds of client, one kind of question.
- Oncology biotechs — pre-IND to Phase I, with a real decision due in the next 90 to 180 days.
- AI-oncology and platform companies — whose models will inform a regulatory decision, and AI-native developers that acquire, license or sponsor their own assets.
- Boards, investors and family offices — weighing someone else's early oncology program before the next commitment.
How to Start a Conversation
A small number of engagements per year.
If the decision in front of you in the next 90 to 180 days is real — and your program turns on it — the conversation is worth twenty minutes. If the decision is specific enough to read in two weeks, you get a scope and a fixed fee. If it is not, you will hear that too.