Global MNC BioPharma · Governed Preclinical Discovery & China Compliance Cockpit

Page 1 · Pillar 1 · Embedded Engineering Phase

1. Drug Discovery Embedded in PM (embeds: nlc)

5 Drug Discovery phases & stage gates run inside the 3. Project Controlling management period.

Page 2 · Pillar 2 · Agent Containment by Method Gates

2. Quality & Compliance Gates Contain Agents

Agents cannot push tainted IC50s or restricted China HGRAC sequences past Gate L→PC or Gate PC→IND.

Page 3 · Pillar 3 · Agents as Work Package Owners

3. Multi-Avatar Agent WPOs & Human Interface

Each Agent WPO owns a WBS package under bilateral contract and hands off to Human Sponsor/PI Dr. Lin Chen.

Page 4 · Pillar 4 · Governance as Built-In Kernel

4. G1–G4 Kernel Guarantees Built In

SHA-256 Witnessed Log (G1), Provenance Lineage (G2), Role Gate Separation (G3), Custom Bake & Conformance (G4).

Page 1 of 4

Pillar 1 · Embedded Engineering Lifecycle

Drug Discovery Lifecycle Embedded inside `nlc` Project Management

Method: az_china_preclinical_target_triage · embeds: nlc

Track 1 · Outer PM Layer

nlc Management Periods

Charter · WBS · 4-Week Controlling

Track 2 · Embedded Engineering

Drug Discovery Phases & Gates

Embedded inside 3. Controlling

Pillar 2 · Containing Agents via Method Gates

`WoW` Work Package Board (`Planned` → `Specified` → `In Progress` → `Delivered`)

Click 🤖 Try Agent WPO Deliver on any active WBS card to see how the Method Gate contains the agent, then use the Human Resolution button to advance it.

🛡️ Method Gate Containment & Human-Agent Handover Monitor

Ready. Select an active Work Package in "In Progress" or click "🤖 Try Agent WPO Deliver" to test gate containment.

Pillar 3 · Agents as Work Package Owners (WPOs)

Human Sponsor, Digital PM & Autonomous Agent WPO Team Roster

Bilateral contract hierarchy: Sponsor (Dr. Lin Chen) ⇄ Digital PM (Dr. Evelyn Carter) ⇄ Agent WPOs (WBS 2.1, 2.2, 2.3)

Pillar 4 · Governance Built-In as Kernel

`src/governance/` Kernel Guarantees (G1 Witness · G2 Provenance · G3 Authority · G4 Method as Data)

Every WPO report, gate refusal, custom threshold bake, and human sign-off executes through the non-bypassable Governance Kernel.

24/7 Autonomous Governance Watchdog & Non-Drift Conformance Center Continuous Monitoring Active

Translates high-level enterprise policies (GxP · 21 CFR Part 11 · China PIPL/DSL · HGRAC · Pharmacovigilance) into Control as Code predicates outside the LLM reasoning loop.

Not yet verified in this session.

Control as Code · Enterprise Regulatory Translation Matrix

Framework	Paper Policy Requirement	Compiled Deterministic Code Gate	Status
21 CFR Part 11	Tamper-Evident Audit Trail & Attributed Writes	`WriteGate(actor, justification) + SHA-256`	ENFORCED
GxP Scientific Truth	Quarantine Unverified LLM Preprints / Hallucinations	`TraceableValue(origin=inferred, taint=True)`	ENFORCED
China PIPL & DSL	Block Cross-Border Patient Data Transmission	`gate_china_pipl_hgrac_boundary()`	ENFORCED
China HGRAC	Human Genetic Resources Sequence Shield	`CodeGate(contains_hgrac_restricted=True)`	ENFORCED
Pharmacovigilance (GVP)	24/7 Safety Signal & Adverse Event Invariant	`AutonomousWatchdog.scan_invariants()`	24/7 ACTIVE

Live Autonomous Watchdog Stream & Non-Drift Verification

Awaiting verification

G4 · Method as Tested, Versioned Data ("Custom Bake")

verifying…

Tighten the declarative method pack thresholds below (e.g. set Max IC50 to 1.0 nM) and click Re-bake Method: Gate L→PC immediately re-evaluates all WBS packages and contains WBS 2.1 (1.8 nM)!

Max Potency IC50 (nM)

Max hERG Liability

Min Wet-Lab Assays

G2 · Quality Register & 3-Origin Provenance Lineage

Selected: WBS 2.2 (MNC-ONC-207)

G3 · External CodeGates & Role Authority Matrix

Zero Agent Self-Approval

Role / Avatar	Assigned WBS	Propose	Authorize (RED Gate)

G1 · Dual-Witnessed SQLite Action Log & SHA-256 Chain

Chain Verified ✓

Drug Discovery Lifecycle Embedded inside nlc Project Management

WoW Work Package Board (Planned → Specified → In Progress → Delivered)