Walk into a room. Hit the switch. Light.
Nobody claps for transformers, substations, or the crew that mapped every feeder line. We take it for granted because infrastructure made it boring and reliable.
That’s the difference I saw at LogiPharma US in Boston: a lot of “AI” switches… and not enough grid. Demos that look slick until the first bad data point, missing SOP, or LSP handoff. Then it’s back to meetings and maybes.
PAXAFE showed the grid and the switch. Push “on,” and it works — every time.
How we actually got here
First was the wiring: rules encoded as SOPs and evidence for release, lanes / packouts / sites actually labeled, and passive + active signals reconciled so each lane has one truth. If you’ve ever connected a lamp to a wall socket without wondering if the house will burn down, that’s the level of boring we wanted. “Do the fundamentals so well you forget they exist.”
Next, the plugs matched across companies — traceability / lineage at handoffs and Logistics Services Provider(LSP) alignment on shared context (packout, dwell, service tier) so power flowed without frying the panel. Two companies, one handoff; zero translation drama. LSPs, carriers, packaging providers, and temperature-device providers were reading the same labels and playing by the same rules. Chain of custody and identity didn’t depend on someone’s memory or a PDF from last quarter.
With the current stable, we extended the circuits that proved themselves: a validated release flow and a waste elimination & savings pattern scaled to look-alike lanes with audit trails Quality signs off on. Translation: stop admiring pilots; copy-paste the winners to five more lanes and harvest real dollars. Launch fewer “experiments,” do more replication.
And finally, is the control tower room: a daily “what changed” brief, pre-approved alternates, and decisions in minutes. Cell & Gene rides a protected circuit where identity + condition + slot protection get the green light every time. You don’t argue your way to release; you prove your way to release. That’s not a demo. That’s reliability.
Bottom line: dashboards are the light switch; foundations are the grid. When weather hits — bad data, missed handoffs, odd dwell — the boring, encoded rules carry the day and the P&L.
“Turn the lights on” progress at a glance
Phase |
What we built |
Why it mattered |
PAXAFE pieces doing the work |
Proof / actions to scale |
Label the wires |
Digitized SOPs + evidence model for release; lane/packout/site MDM; passive + active reconciliation; add dwell & service tier context |
Flip the switch without sparks (clean, consistent inputs) |
SOP Ingestion, Lane Manager (MDM + data overlay) |
% shipments with full context ↑; exception→decision playbooks authored; data QC gates live |
Make the plugs match |
Traceability/lineage at handoffs; LSP alignment on shared context (packout, dwell, service tier) across LSPs, carriers, packaging providers, temperature-device providers |
Power flows across companies; fewer “brownouts” at handoffs |
Lane Manager (standard schemas), RCA trails |
Handoff errors ↓; time-to-verify lineage ↓; partner SLA adherence ↑ |
Run more lines that work |
Validated release (accept/reject/quarantine with audit trail); waste elimination & savings pattern rolled to look-alike lanes |
Savings escape the pilot; Quality trusts speed |
Release (Validated), RCA & Metrics |
Waste $ ↓; audit findings = “no action”; # lanes with the pattern ↑ |
Staff the control room |
Daily change brief; pre-approved alternates; 5-minute decisions; Cell & Gene Therapy (CGT) on protected circuit (identity + condition + slot) |
Readiness > reports; priority shipments get guaranteed green lights |
ATHENA Decision Intelligence, Risk & Alternates, Release (Validated) |
Median “change→decision” time ≤ 5 min; alternates executed with owner + timestamp; CGT on-time with full Chain of Identify(COI)/Chain of Custody(COC)log |
What we heard on stage - Pharma’s needs & issues
Clean, interoperable data (or nothing works)
What it is: Duplicate/spotty device metadata, vendor-by-vendor schemas, missing context (service tier, dwell, packout).
Why it matters: AI can’t fix mismatched labels; bad inputs = coin-flip decisions.
Pilots → Platforms (scale > POCs)
What it is: Wins die as slides unless they’re cloned across like-lanes with SOPs + evidence trails.
Why it matters: Value is a pattern you can replicate, not a pilot you admire.
Decision intelligence (readiness over reports)
What it is: Daily change briefs, pre-cleared alternates, formal cross-company workflows.
Why it matters: The bar is five minutes from change → decision; indecision is the cost center. The logistics control tower either enables the decision or it’s a cost center.
Quality/GxP + Release, digitization & automation (faster and auditable)
What it is: Release as an evidence model: TOR + automation workflow + GxP auditable trail → digitized temperature release
Why it matters: Speed without GxP sin; boring (repeatable) beats heroic. Retire the emails & attachments
Risk playbooks & scenario planning
What it is: Scenario runs, alternates, contingencies — with pre-approval and a named owner.
Why it matters: Playbooks beat heroics; action beats meetings.
Security & integrity are process problems first
What it is: Theft modes + LSP/carrier vetting > gadget arms races; integrity triggers must flow into release logic, not inboxes.
Why it matters: Tech without process hardens nothing.
Advanced therapies raise the bar (Cell & Gene)
What it is: COI/COC, vein-to-vein, cryo; “visibility” = identity + condition + slot protection.
Why it matters: CGT is patient safety; treat it like the protected circuit.
What we heard on the floor - the ecosystem’s real blockers
Tech is changing fast → tech debt & buyer’s remorse
What it is: Teams realizing mid-cycle that non-Life Sciences(LS) platforms don’t fit; debating augment vs rip & replace.
Why it matters: Speed without fit = rework. LS-specific data, workflows, and validation shorten time-to-value (and regret).
Device & packaging providers are becoming software businesses
What it is: Providers racing to integrate/white-label with agnostic platforms; 3–4 years ago many didn’t see the point — now they’re knocking.
Why it matters: Data network effects beat hardware margins; integrated software = stickier, predictable revenue and better outcomes.
What ‘agnostic’ actually means
What it is: You can’t be both player and referee (sell the scale and certify your own weight).
Why it matters: Neutral data models + open interfaces or trust erodes.
Early biotech: start much earlier
What it is: At 1,000 shipments, you already have 1,000 failure modes (excursions, overpaying for packouts/logistics/services).
Why it matters: Cheaper and cleaner to lay the piping early than retrofit at 25k+ shipments and 2k+ lanes.
Simple Day-1 use cases win
What it is: The most-used features are simple, high-friction killers: passive data milestone overlays, shipment doc parsing via email, TOR resolution for false deviations/excursions.
Why it matters: You don’t need “agentic” on Day 1 to delight; nail the basics, layer automation on Day 2.
What we actually showed at Logi (not buzzwords)
“But we already have a control tower…”
Great. Does it tell you what changed today and give you a pre-approved move with an owner in under five minutes — with the audit trail Quality accepts?
If yes, keep going!
If no, you have a very nice wall-mounted nightlight.
But fear not! You don’t need to replace everything overnight. You can start by augmenting your control tower with some of the circuitry and wiring it’s currently lacking (tying SOPs, temperature release, AI-enabled recommendations, etc.) and enhancing the value of your existing solution, rather than going further and further into tech debt.
The fastest possible playbook (Q4-ready)
This isn’t overwhelming — it’s a repeatable pattern. We’ve run it enough times to know the order matters and the drama doesn’t. Do these five, in sequence, and you’ll see money in weeks, not quarters — no heroics, just wiring.
Spicy truths (because it’s me)
What happens next
Send me your three lanes. I’ll show you: