Drug shortage early warning, weeks before stock runs out — every driver cited, every decision signed
Every supply signal read as it lands, and a ranked, cited shortage alert raised weeks before stock runs out.
See one case, screen by screen ↓A shortage rarely starts in the planning system. It starts as a deviation that puts a lot on QA hold, an email from a CMO about a syringe barrel shortage at its sub-supplier, a temperature excursion at a border stop, a tender award that lifts demand by 18 %. Each lands in a different system, read by a different team, and none of them says which market pack it will empty, or when.
By the time the projected inventory shows the gap, the cheap options are gone. Stock can no longer move from a market with spare cover, QA cannot bring a release forward, the alternate site has no slot left. What is left is air freight, allocation, and an authority notice — with five business days to file it in the US.
Estimated split for one product-market with several supply events at once, by hand and with the solution.
Six specialist agents watch stock, quality, suppliers and shipments, score the risk and draft the plan; the continuity lead confirms and approves.
Three supply events and a tender land on the same six weeks for Veltrimab 40 mg pens in Germany, a Tier 1 cold-chain biologic. Here is what happens, screen by screen, in the working solution.
Lena opens the early-warning screen: 48 critical product-markets watched, 6 open alerts, 2 high, 3 that need her decision. The earliest projected stock-out is Nov 30 — Veltrimab pen in Germany, in 54 days. Of 41 signals read in the last 24 hours, 6 matched a product-market and 3 changed a risk. On the radar, distance from the centre is weeks until the stock-out.
“New alert: Veltrimab 40 mg pen · Germany — projected stock-out Nov 30 · 05:42”
Over three days the watchers read deviation DEV-26-0418 opening on lot VLT-P-2611, a consensus demand update for a German tender, a delay notice from Halvorsen Fill-Finish on lot 2614, and a temperature excursion on shipment SH-77421. Each is linked to A-2611. Other mail in the same feed — a monthly capacity letter, a stopper price list — is read too, and marked “No supply impact” and “Not a supply signal”.
The cover horizon shows each alert’s projected stock for the next 16 weeks against the amber safety-stock line. For Veltrimab pen in Germany, if nothing is done, lowest cover is −0.5 weeks and stock runs out Nov 30. Italy, Brazil, France, the US and Japan sit on the same view, each with or without its approved plan.
A-2611, risk 86, raised by the Risk scorer at 05:42. 18,600 pens short against plan, 5.3 weeks of cover lost: lot VLT-P-2611 on QA hold for visible particles at AQL inspection (−1.7 wk), lot 2614 moved three weeks by the CMO (−1.7 wk), 3,800 pens quarantined after a 9.4 °C excursion (−1.1 wk), and the tender adding 560 pens a week (−0.8 wk). First week under safety stock: Nov 16.
“Three supply events and a tender land on the same six weeks.”
Every driver opens its record. Lena clicks the CMO delay and the supplier’s email opens on the right, the passage marked: the fill of lot 2614 moves from October 26 to November 16, the ship date from November 20 to December 14. A second passage says Halvorsen can ship December 4 if air freight is acceptable. Six records stand behind this alert, from the planning export to the 2026 critical product list.
“Read-only copy · cited, never changed”
Reallocate 4,200 pens from the Netherlands and Austria (€14,800 freight; the Netherlands keeps 6.9 weeks of cover, Austria 7.1). QA priority on DEV-26-0418, so 5,400 pens release Nov 16 instead of Dec 7. Air-freight lot 2614 for €22,500. With all three, the projected stock-out goes from Nov 30 to none, lowest cover from −0.5 to 1.8 weeks, and cover never drops under safety stock.
Also on the list: disposition the quarantined shipment, an extra run on the registered alternate line, phasing the tender deliveries.
Lena confirms the alert and approves the plan with her password and the meaning of her signature — “I confirm this supply risk and approve the plan” — recorded in the decision log. The Austria move takes 24 % of that market’s buffer, so the second approval goes out with her signature.
“Moves 24% of Austria’s buffer — Omar Haddad approves.”
The decision is recorded, and tasks go to Priya Raman for the reallocation, Dana Okafor for the QA priority and Sam Patel for the air freight. The second approval waits with Omar Haddad. No stock-out is projected now, so no authority notice is needed — the rationale is recorded. The alert moves to Mitigating, and stays there until cover holds above safety stock for 4 weeks.
Talmirex vials in the US are another story: an API supplier’s reactor shutdown on Oct 2 delays three API lots by about six weeks, and US stock runs out Dec 21 if nothing is done. The FDA 506C notice is drafted on the alert — drug, date of interruption, reason, expected duration, each cited to the supplier’s notice — with 2 business days left. Regulatory affairs files it.
The notice writer drafts; regulatory affairs files.
The continuity dashboard shows the last 4 weeks: 14 alerts raised, 82 % confirmed by planners, a median warning of 7.4 weeks against a target of 6, and 3 stock-outs avoided. Alerts by driver, a heat map of lowest projected cover by product and market, and what was decided — confirmed, dismissed with a reason, or still open.
The same shortage, seen by the five people who carry it — what their week looked like, and what it looks like now.
Six specialist agents watch stock, quality, suppliers and shipments, score the risk and draft the plan; the continuity lead confirms and approves.
Reads the daily planning export — projected inventory, receipts and demand for 48 product-markets over 16 weeks — and notices when cover drops below plan.
Watches the quality system for batch holds, deviations, OOS results and certification queues, and maps each to the market packs it blocks.
Reads the supply mailbox — delay notices, force majeure letters, capacity letters — and pulls the lot, the new date and the quantity, each with its passage.
Reads the shipment exception feed — temperature excursions, customs holds, missed pick-ups — and finds the stock that is in doubt, checking excursions against the product’s stability budget.
Projects each product-market 16 weeks ahead with at-risk receipts removed or delayed and demand changes applied, then ranks by risk and explains the weeks lost per driver.
Drafts mitigation options from the network — reallocation, QA priority, freight, alternate site, demand phasing — with their effect on cover, and drafts the FDA 506C notice or EU shortage report when a shortage remains likely.
Confirms and approves. The agents propose; a named person decides.
Planners ask in plain words — or tell it what to watch. Answers come from the planning export, the quality system, the supply mailbox, the shipment exceptions and the decision log, with the record behind every number.
Why is Veltrimab in Germany at risk?
Veltrimab 40 mg pens in Germany are projected to run out on Nov 30 — 54 days from now. Four things land on the same six weeks: lot VLT-P-2611 on QA hold (6,000 pens), the CMO delay on lot 2614 (6,000), shipment SH-77421 quarantined (3,800) and the regional tender (2,800). The recommended plan — reallocate 4,200 pens from the Netherlands and Austria, QA priority on the deviation, air-freight lot 2614 — keeps cover above safety stock.
Which Tier 1 products could run out before January?
Three Tier 1 product-markets are projected to break safety stock or run out before January: Veltrimab pen in Germany (stock-out Nov 30, risk 86), Talmirex in the United States (stock-out Dec 21, risk 78) and Veltrimab vial in Italy (under safety stock Nov 9, risk 52).
Draft the FDA notice for Talmirex in the US
Talmirex in the US needs a decision on the FDA 506C notice by Oct 9 — five business days after the API supplier’s reactor shutdown on Oct 2. If nothing is done, US stock runs out Dec 21, which counts as a likely meaningful disruption. I am drafting the notice on the alert now; regulatory affairs files it.
Alert me when a Tier 1 product drops under 6 weeks of cover
Done. New rule: alert when any Tier 1 product-market is projected under 6 weeks of cover, in addition to the safety-stock rule. Running it on today’s export adds no new alerts. The rule is live in Settings and recorded in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
When an alert is raised, what the agents watch and who decides are settings, not a project.
| Setting | Default | Choose from |
|---|---|---|
| Tier 1 — alert when cover will break safety stock within | 16 weeks | 6 to 26 weeks, in steps of 2 |
| Tier 2 — alert when cover will break safety stock within | 10 weeks | 4 to 20 weeks, in steps of 2 |
| Minimum risk score to raise an alert | 40 | 20 to 80, in steps of 5; lower scores are kept as watch notes |
| Safety stock for Tier 1 products | 2 weeks | 1 to 6 weeks of forward demand |
| Confirm alerts — Europe and International | Lena Ortiz | Lena Ortiz · Priya Raman |
| Confirm alerts — Americas | Sam Patel | Sam Patel · Lena Ortiz |
| Reallocation of more than 20% of a market’s buffer | Omar Haddad | Omar Haddad · Lena Ortiz |
| Authority notices (FDA 506C, EU shortage reports) | Hannah Weiss | Hannah Weiss · Priya Raman |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample data (Northwind Bio, a fictional company) · “target” = the design goal, measured in the live solution · “estimated” = our estimate · FDA section 506C and EU shortage reporting are named as context. People and products named on this page are characters in the working solution.
Software that watches the signals a shortage starts from — projected inventory, quality holds, supplier and CMO delay notices, shipment exceptions — and tells you which product-market will run short, when, and why, while there is still time to act. This one projects cover 16 weeks ahead, ranks every alert by risk and cites the record behind every driver.
The risk scorer rebuilds the 16-week projection with the at-risk receipts moved to their new dates and demand changes applied. It reports the lowest cover, the first week under safety stock and the stock-out week, attributes the shortfall to each driver in units and weeks, and scores 0–100 from depth, timing and the product’s criticality tier.
Yes. The supplier and CMO notice reader reads the supply mailbox, decides whether each email or attachment changes supply, and pulls the supplier, the lot, the old and new dates and the quantity, quoting the sender’s words. Price lists and routine letters are marked as not a supply signal; unclear notices go to a person.
It drafts them when the chosen plan still leaves a shortage likely — drug, reason, date of interruption, expected duration and actions, each cited to its record — and shows the days left to file. Regulatory affairs reviews and files; the agent never files.
Yes. Agents raise alerts and draft options; a named continuity lead confirms or dismisses each alert and approves the plan with a signature that records the meaning. Moves over 20 % of a market’s buffer need a second approval, and dismissals need a reason.
No. The coverage monitor never edits the plan, the quality hold watcher has read-only access to the quality system, and quarantined stock counts as lost until QA releases it. Approved actions go to their owners as tasks.
Yes. The alert window for each criticality tier, the minimum risk score, Tier 1 safety stock, the sources watched and the approvers by region are all settings. New rules can be described in plain words.
The Agentic Solution Engine builds and deploys it from your requirements — your critical product list, planning export, quality system and supply mailbox — and it goes live once every quality gate has passed. We will walk you through it on your own product-markets first.
Ask any supply question in plain words and get a traced answer in seconds.
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