Oncology Drug Development Consulting
Independent, senior oncology drug development consulting.
Senior clinical and regulatory judgment on the decisions that determine whether an oncology molecule advances — endpoint strategy, trial design, indication choice, and the FDA interactions that gate the next phase. One accountable operator, thirty years of oncology drug development, seven approvals across FDA, EMA, PMDA, and NMPA.
What the Consulting Covers
Four kinds of decision, one discipline.
- Endpoint and indication strategy the FDA can actually review. Translating AI-discovered targets and prioritized candidates into endpoint structures, trial designs, and pre-IND positions the agency has precedent to accept — and recognizing when the science warrants a reasoned departure the evidence can defend.
- Clinical trial design that enrolls. Pressure-testing inclusion/exclusion logic, referral patterns, line-of-therapy windows, and combination-regimen practicality against what community oncologists will actually prescribe, before the protocol is locked.
- Regulatory translation. Putting the science into the language and documentation tier a CDER review division will accept — the failure is rarely missing engineering, it is engineering that has not been translated for the reviewer.
- Independent adjudication for boards and investors. An independent read on whether a third party's oncology development story is calibrated — before a round, a partnership, or a disciplined no.
How It's Different
Calibrated judgment from one accountable operator — not a staffed firm, a CRO, or a tool.
Calibration is the accuracy of confidence, not the volume of opinion. In an oncology program it is the ability to look at a model's prediction, an analyst's deck, or an enthusiastic founder slide and tell — with reasons — what is true, what is conditionally true, and what will not survive a pre-IND meeting. Every claim of consequence in a deliverable is retrieved, source-tiered, and externally cited; every recommendation surfaces the reasoning trail, the strongest counterevidence, and the conditions under which it would change. When the evidence does not support a recommendation, refusal is part of the output.
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 remain accountable for the reasoning in the room where that decision is made. It is an AI-augmented practice: AI is the internal leverage layer under senior clinical-regulatory judgment and explicit governance. You are paying for the judgment, not the tool. The operating standard →
Engagement Shapes
From a two-week Sprint to a co-founder seat.
- Calibration Sprint — the fixed-scope, two-week front door: senior judgment on the single decision in front of your program, for a fixed fee.
- Fractional CMO — the primary ongoing structure: embedded with one company for six to eighteen months across a pre-IND or Phase I decision arc.
- Board or scientific advisor — oncology-specific FDA judgment at the board layer, for go/no-go, indication, and trial-design oversight.
- Co-founder — rare, typically one engagement per year, for a founding team that recognizes clinical-regulatory judgment as a co-founder seat.
Full detail on the engagement structures and the person in the seat, Jesús Gómez-Navarro, M.D.
Common Questions
Oncology drug development consulting, answered.
What does an oncology drug development consultant do?
Provides senior clinical and regulatory judgment on the decisions that determine whether a cancer therapy advances — endpoint strategy, trial design, indication and population choice, and how the program is positioned for the FDA and other regulators, such as at a pre-IND meeting. At OncAdios the work is done by one accountable senior operator, not a staffed team.
How is this different from a large consulting firm or CRO?
OncAdios is a single-operator advisory practice — not a staffed firm, a CRO, or a software product. One senior medical oncologist with 30+ years in oncology drug development stays accountable for the recommendation, and the practice is independent of any acquisition thesis, model vendor, or committed capital, which is what makes a disciplined no possible.
Do you work with early-stage and AI-oncology biotech companies?
Yes — the typical fit is a Series A or B AI-oncology or biotech company that is pre-IND or in Phase I with a real decision the program turns on in the next 90 to 180 days. The practice also advises boards, investors, and family offices evaluating someone else's oncology program.
How does an engagement start?
Most begin with a fixed-scope, two-week Calibration Sprint on a single decision, scoped after a short fit call. Where the work warrants, it converts into a deeper structure such as a fractional CMO or board-advisor role.
What does this look like before an FDA pre-IND meeting?
The pre-IND meeting is where much of this judgment gets tested. The package is due 30 calendar days beforehand and does most of the substantive work, so the decisions that matter are settled well before anyone is in the room. See what an oncology pre-IND meeting actually decides — the sequence, how to spend a limited number of questions, and why the agency's advice is not permission to dose patients.
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