02 · Sandboxes for Serious Grown-Ups

THE FOUR CONSTANTS

The guest body

Martin Heitmann — a mind that reads the regulatory room, and asks not "can we?" but "can we do this together?"

The stance it summoned

The bridge-builder — the stance that puts regulators, pharma, and suppliers in one room and tries to get them to act, not just talk.

The unknown on the table

Can the sandbox idea survive contact with GxP — holding rigour and exploration in one room, without endangering patients or defeating the very purpose of a sandbox?

The residue

A multi-party blueprint — three problems to build inside (the data architecture, the IP geometry, the validation paradigm) — and an open seat: put a shovel to sand.

THE DISCUSSION · WHERE THE ALIVENESS LIVES

Video or podcast · coming

THE RETICLE · THE RESIDUE YOU READ IT THROUGH

THE ARTEFACT

"Sandboxes for Serious Grown-Ups"

The Trust Architecture · Edition #8 · 02 June 2026 · Nuno Valério & Martin Heitmann

What it leaves a stranger: a working prototype of collaboration — the Annex 22 consultation read as the closest thing yet to a GxP sandbox, and three concrete tensions (data, IP, validation) a third party can pick up and build inside.

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REFERENCES · THE GROUND IT STANDS ON

01UK Financial Conduct Authority — the regulatory sandbox (first opened 2016; now run as a continuous, always-open flow rather than cohorts).FCA
02EU AI Act — Article 57, the member-state regulatory-sandbox obligation (originally to be operational by 2 Aug 2026).Regulation (EU) 2024/1689
03Digital Omnibus — political agreement, 7 May 2026: pushed the sandbox deadline to 2 Aug 2027 and added an EU-level sandbox under the AI Office from 2028.Council & Parliament of the EU
04EU GMP Annex 22 (draft, July 2025) — the consultation that drew ~1,300 comments and a pre-competitive, collaborative posture.European Commission · EudraLex Vol. 4
05EMA — Reflection paper on AI in the medicinal product lifecycle; FDA — Jan 2025 draft guidance on AI in regulatory decision-making.EMA · FDA
06MELLODDY — federated learning across institutional firewalls in pharma (10 companies, IMI2).IMI / MELLODDY consortium
07Pre-competitive consortia — TransCelerate, the Pistoia Alliance, the IMI / IHI public-private partnerships.Industry collaboration precedents
08FDA & EMA — joint guiding principles for AI in medicines development (ten principles, Jan 2026).Global regulatory convergence

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Sandboxes for Serious Grown-Ups: Fostering Collaborative Environments for Emerging Technologies in GxP