SSPLAXClinical Supply Coverage
A clinical-stage program supplies an active Phase 2 trial. Drug substance comes from a primary CDMO plus a higher-cost backup slot, then moves through drug product, fill/finish, and QC release / QA disposition. Released kits enter an inventory buffer before they are allocated to sites. Enrollment changes month by month, so early released supply can cover later demand only if the buffer stays ahead of the ramp.
Across the trial timeline, does QC-released supply stay ahead of ramping enrollment — and if it breaks, what is the smallest modeled change that restores coverage?
The model treats QC-released kits as a queue that can carry inventory across trial months. A predefined enrollment schedule sets the monthly coverage floor, while CDMO, fill/finish, QC-release, budget, and inventory-carryover constraints define what can be supplied. The solve minimizes supply cost while meeting coverage, then reports the month where coverage first becomes infeasible and the smallest modeled capacity change that restores it.
- QC release throughput below cumulative demand
- Released inventory drains by Month 9
Coverage holds early because surplus released kits bank as inventory. The buffer drains as enrollment rises, then cumulative demand overtakes the 340 kits/month QC-release ceiling in Month 9. Drug-substance capacity is not the ceiling at this point; the smallest modeled relief is QC release.