Engagement note

What the First 90 Days Look Like

For AI-platform companies selling capabilities into pharma — target discovery, patient stratification, dose optimization, biomarker development. The biotech-shaped variant lives here.

A platform company's FDA exposure is real but indirect. You do not file the IND. Your partners do. The agency does not adjudicate your platform — it adjudicates your partner's submission, in which your platform plays a role at a risk tier the partner must be able to defend. When the partner cannot defend the platform's role to a CDER review division, the partner stops using the platform — and the platform's commercial momentum slows in ways usually attributed to "sales execution" but actually attributable to regulatory friction at the partner interface.

What follows is the 90-day arc I propose with AI-platform companies whose commercial trajectory depends on partners successfully defending the platform's role to the FDA. The structure mirrors the biotech-shaped variant, but the deliverables and the retired decisions are different. Agency-facing work in the biotech-shaped variant becomes partner-facing work in the platform-shaped variant.

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Phase 1 — Weeks 1 to 2: Diagnostic

Artifact produced. A two-part Calibration Map of the platform's regulatory exposure.

Part one is platform-internal: a structured separation of what the platform's published validation actually supports, what is asserted in commercial materials but not yet validated, and which partner-facing claims would survive a partner's regulatory team review — versus which would not.

Part two is platform-portfolio: a view of current partners — which partner programs are approaching FDA inflections (pre-IND, IND, end-of-Phase-II, NDA) in the next 12 to 18 months, which partners have strong internal regulatory capacity for AI components and which do not, and where the platform's commercial revenue is concentrated relative to that regulatory-exposure timing.

Both parts carry four small decision fields, written in plain English: risk track (validation, context of use, regulatory precedent, partner capacity, operational integration, commercial model, or concentration risk); reference class (closest comparable platform use, with a note on where the comparison breaks); next best learning action (the conversation, analysis, or check most likely to change the decision if the current view is wrong); revisit trigger / date (the partner inflection, milestone, or calendar point at which the decision is deliberately reopened).

Decision retired. Scope of the engagement.

By the end of week two, you and I both know which partner programs the engagement should prioritize and which platform capabilities need the most urgent regulatory translation.

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Phase 2 — Weeks 3 to 5: Platform Regulatory Positioning

This phase follows an expansive-then-decisive arc. The three documents at the end of Phase 2 are the output of that arc, not the input to it. The discipline guards against the most common failure mode at this phase — a platform locking in a single regulatory-readiness positioning before alternative commercial-and-regulatory models have been systematically considered.

Weeks 3 to 4: Expansive working sessions

1. Knowledge. What is actually known about the platform's validation status, the current partner portfolio's regulatory-exposure timing, the relevant precedent landscape (FDA/EMA joint principles, sector-specific guidance, recent submissions referencing AI components), and the competitive set among platforms with similar capabilities. Facts surfaced; sources tier-labeled; "facts" challenged for whether they are facts or marketing assertions in disguise.
2. Blue Sky. What regulatory-readiness offering the platform could become, with no commercial constraints applied. Could it become a paid premium service? A co-development partner inside specific partner programs? A platform-validated certification partners can carry into submissions? A regulatory-affairs-as-a-service offering? The point is not to commit. It is to ensure that the regulatory-readiness positioning ultimately chosen has been chosen against alternatives that were actually considered, not by default.
3. Assumptions. What the platform is currently betting on without definitive evidence — that current partners would pay for premium regulatory support (often unverified); that the platform's published validation is sufficient for the risk tiers partners actually deploy it at (often optimistic); that reviewers will accept the platform's documentation in the format it currently exists (rarely tested).

Weeks 4 to 5: Convergence to the three documents

A constraints session narrows the surface area — current commercial trajectory and partner contract structures, technical feasibility of the validation lift implied by each option, sales-team capacity, board appetite for commercial-model change.

Convergence then produces:

1. Platform Regulatory Readiness Memo — how the platform's capabilities map to each phase of the development process, with the FDA/EMA joint principles risk tier for each capability and the documentation tier the platform should be ready to produce for partners.
2. Partner Regulatory Capacity Analysis — which partners need what kind of regulatory support to defend the platform's role in their submissions.
3. Calibrated-Departure Map — where partners are proposing or considering reasoned departures from established regulatory precedent (tumor-agnostic indication studies, external controls, novel surrogates, Project Optimus dose-optimization frameworks), and where the platform's capabilities meaningfully support those departures.

The underlying commercial question. Behind the regulatory positioning work is a commercial decision the platform's leadership team will have to make: whether partner regulatory support is a standard feature of the platform's offering or a paid premium service. The Phase 2 work is structured to support that commercial decision, not to make it on the platform's behalf.

Decision retired. What regulatory positioning the platform adopts publicly, and what it offers partners commercially.

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Phase 3 — Weeks 6 to 9: Partner Regulatory Support Packages

Artifact produced. A partner-facing toolkit and a partner-engagement plan.

The partner-facing toolkit includes:

• Platform Validation Package — a modular documentation artifact partners can include in their pre-IND or IND submissions, supporting the platform's specific role in their program. Partner draws the sections relevant to the submission's risk tier.
• Partner Q&A Library — anticipated reviewer questions partners will face about the platform's role, with model responses keyed to the FDA/EMA joint principles risk tiers and to the relevant precedent classes. The regulatory equivalent of a sales-enablement library.
• Reasoned-Departure Support — for partners proposing departures from established precedent where the platform's capability is part of the proposed package, platform-side evidentiary materials the partner can cite. Not the platform proposing departures on the partner's behalf — the platform providing the evidentiary work the partner needs to defend a departure they have decided to propose.

The partner-engagement plan includes an escalation playbook, pre-meeting prep cadence, and a post-meeting debrief loop that feeds each partner's agency-interaction learning back into the next version of the Validation Package and Q&A Library.

Decision retired. What the platform delivers to partners ahead of their FDA interactions, and whether the delivery is standard or a paid premium service.

What this is not. The platform does not become the partner's regulatory function, and the engagement does not propose that it should.

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Phase 4 — Weeks 10 to 12: Regulatory Translation and Internal Build

The translation package addresses the third failure mode from the Three Ways thesis at the platform layer:

• Platform Context-of-Use Statements — for each of the platform's core capabilities, what role the capability is designed to play in a regulatory decision, at what risk tier, with what documentation tier expected.
• Platform Fitness-for-Purpose Documentation — analytical and operational validation of each capability for its intended role, in the language a CDER review division (and a partner's regulatory team) will accept.
• Platform Drift Monitoring Framework — how the platform's performance is monitored across deployments, what triggers retraining or re-validation, and how partners are notified of material model changes.

In parallel:

• Strategic Theme one-pager — a single page compressing the calibration trail and the chosen positioning into a portable summary. WHERE the platform will play in the regulatory-readiness market / WHY this positioning and not the alternatives / WHAT it will take to win. Forwarded to the board, the commercial leadership, future regulatory and scientific-liaison hires, and (selectively) to key partners.
• Internal Build Recommendation — what next-stage regulatory function the platform should hire, at what time. Typically a VP of Regulatory Affairs or Director of Scientific Liaison.
• Board Documentation Package — the full calibration trail compressed into board-readable format. The Strategic Theme one-pager is the front page; the Board Package is what supports it.

Decision retired. Post-90-day operating model for partner regulatory support.

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What the 90 days do not deliver

• A regulatory function for the platform's pharma partners. That is their work to do.
• A guarantee that any specific partner submission will succeed.
• A replacement for the platform's eventual internal regulatory affairs, scientific-liaison, and field-medical functions.
• A direct FDA relationship for the platform (the platform does not file submissions; the agency relationship runs through partners' regulatory teams).

What it delivers is calibration on the platform's regulatory positioning — what the platform can credibly support partners on, what it cannot yet support, and what regulatory translation work needs to happen before commercial growth runs ahead of regulatory readiness.

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Working logistics: Madrid and Central European Time

I am based in Madrid, Spain — Central European Time (UTC+1 winter, UTC+2 summer). For a platform engagement, time zones also affect partner-facing work: a Validation Package handed off to a partner's regulatory team in Boston, or a partner pre-IND prep call held in San Francisco.

• Working sessions for East Coast clients and partners. Late-Madrid-morning maps to mid-East-Coast-morning. The overlap window is generous — roughly 14:00 to 18:00 Madrid / 08:00 to 12:00 EST.
• Working sessions for West Coast clients and partners. The overlap window is narrower — roughly 17:00 to 19:00 Madrid / 08:00 to 10:00 PST. Workable, with deliberate scheduling.
• Asynchronous work fills the gaps. Platform-engagement deliverables — the Validation Package, the Partner Q&A Library, the Reasoned-Departure Support materials — are designed to travel asynchronously to partner regulatory teams.
• In-person sessions when justified. Pre-IND meetings with key partners, FDA advisory sessions where the platform's capabilities are at issue, board meetings — travel is built into the engagement scope.

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A note on this schema

The platform-shaped 90-day arc described above is a designed schema, not a tested-and-validated process. It draws on three decades of biopharma drug development experience — across Pfizer, Millennium, and Takeda; across seven anticancer approvals at FDA, EMA, PMDA, and NMPA; across pre-IND meetings, advisory committees, and the long quiet work of regulatory translation — and on collaborative work with AI to articulate the calibration discipline that has been implicit in that experience for years.

What this means in practice: specific platform engagements will reorder phases, adjust artifacts, and surface gaps the schema does not yet handle — particularly given that the platform-shaped engagement model is newer and tested against fewer instances than the biotech-shaped variant. When that happens, the schema is updated visibly, in the document's version history, rather than papering over the gap.

The schema is honest about being a starting point. The discipline behind it is not.

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How this differs from the biotech-shaped engagement

The biotech-shaped engagement builds the artifacts a sponsor walks into a pre-IND meeting with. The platform-shaped engagement builds the artifacts a platform delivers to partners so that their sponsors walk into pre-IND meetings able to defend the platform's role.

Both engagements share three structural features: the calibration discipline (citation-required outputs, externalized reasoning, structured refusal); the calibrated-departure disposition (knowing when to fit established precedent and when to support a reasoned departure); and the expansive-then-decisive arc inside Phase 2 (alternatives surfaced systematically — destinations for the asset in the biotech variant, regulatory-readiness offerings for the platform variant — before convergence to the chosen position). What differs is where the work shows up: at the agency–sponsor interface for biotech-shaped companies, at the partner–platform interface for platform-shaped companies.

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