Biopharma commercialization guide: the Stairway to Commercialization

The 5 stages: an overview

The Stairway to Commercialization is Archer Insights' ERP commercialization roadmap for the biopharma lifecycle, dividing it into 5 distinct operating stages separated by a clear pre-revenue and post-revenue boundary. The pre-revenue stages, Establish, Evaluate, and Expand, cover the period from initial funding through the PDUFA date and commercial launch readiness. The post-revenue stages, Enhance and Excelerate, cover commercial operations and full sales generation. Each stage of this biotech ERP implementation framework builds directly on the previous one.

Each step is only solid if the one below it was built correctly. A company that tries to activate commercial operations without the Expand-stage SOX controls and contract management in place does not have a launch problem. It has a foundation problem, and fixing foundations while the house is being built above them is the most expensive and disruptive kind of remediation in biopharma operations.

The pre-revenue and post-revenue boundary marks the point where the nature of the business changes fundamentally. Pre-revenue, the finance team manages costs, accruals, and compliance obligations. Post-revenue, it also manages revenue recognition, gross-to-net calculations, distribution economics, and payer relationships. Commercialization planning that treats ERP readiness as an afterthought at either stage consistently produces the same result: the system is not ready when the business needs it to be, and fixing it under operational pressure costs far more than building it correctly ahead of time.

Establish

Series A and Discovery: build for where you are going

The Establish stage covers the period from company formation through the first significant funding event. The finance team is typically 1 to 3 people. The primary financial activities are payroll, vendor payments, grant accounting if applicable, and basic investor reporting. The operational volume does not seem to justify a serious system. For a clinical-stage biotech, ERP decisions made here, or deferred here, set the conditions for every stage that follows. That reasoning is the source of most of the expensive remediation Archer encounters later.

The decisions made at Establish determine how much the company will spend to undo them at Evaluate and Expand. The chart of accounts structure, the entity setup, the purchase order workflow, and the reporting framework that are built at Series A are either an asset or a liability at Series B and beyond. A chart of accounts organized around a single clinical program requires a complete redesign when a second program is added or a collaboration agreement creates accounting by indication. Entity structures that are set up without intercompany consolidation in mind turn quarterly close into a manual exercise that grows more painful every time the team grows.

What Establish builds in NetSuite

Evaluate

Emerging and IPO-stage: clinical accruals, vendor management, and audit readiness

The Evaluate stage begins when business complexity outgrows what a basic accounting setup can handle. This typically happens at Series B or C: multiple CROs are running trials, clinical site costs are accruing monthly rather than billing on predictable schedules, the procurement function is handling enough volume to require structured vendor management, and the company is either public or actively preparing to be. This is also the stage where life sciences ERP implementation work that was deferred at Establish becomes urgent, often alongside an IPO process that leaves no margin for distraction.

Accrual accounting for clinical costs is the defining operational challenge at this stage. CROs bill on milestone and time-and-materials schedules that rarely align with accounting periods or with actual work performed. The Controller's office is left estimating, each month, how much of a contracted CRO budget has been incurred but not yet invoiced. That estimate needs to be supported by documentation, reviewed by the VP of Finance or CFO, and recorded with an approval that can be shown to auditors. On a basic accounting system, this process runs through spreadsheets and email. On NetSuite configured correctly for Evaluate, it runs through a journal entry workflow with attached budget schedules and a required sign-off inside the system before posting.

A clinical-stage biotech that cannot show its auditors how it calculated the Q3 CRO accrual, with the supporting schedule, the reviewer name, and the basis for the estimate, does not have an accounting problem. It has a controls problem, and that problem does not stay contained to the audit.

What Evaluate adds to the system

Expand

Launch readiness around PDUFA date: SOX, contracts, and commercial infrastructure

The Expand stage is the most operationally compressed in the biopharma lifecycle. The PDUFA date is a fixed deadline. Everything required for commercial launch readiness has to be built, tested, and running before that date. For pharmaceutical companies, ERP readiness at this stage is not optional infrastructure. It is the operational foundation that commercial launch either stands on or falls through. The companies that struggle most are the ones that underestimate how much of the commercial infrastructure sits inside the finance and operations system, not in the commercial team's tools.

SOX controls that should have been fully operational for a full fiscal year before the first public company audit need to be complete. Distribution, specialty pharmacy, and GPO contracts that will govern how the product gets to market need to be tracked in the system before they generate revenue. The multi-book and multi-currency configuration that will support international operations needs to be tested before the first cross-border transaction. And the SEC reporting infrastructure that will support the 10-Q filed after the first commercial quarter needs to be in place before that quarter opens. None of this can be built in parallel with managing a product launch.

What Expand adds to the system

Enhance

Commercial operations: supply chain, inventory, and analytics

Enhance is the first post-revenue stage. The product is approved, the commercial team is in the field, and the finance team is managing something it has never managed before: revenue. Specifically, the gap between the gross invoice price and the net revenue the company actually reports, which for a specialty product with hub services, co-pay assistance programs, and Medicaid obligations can be 40 to 60 percent of the invoice amount.

The supply chain complexity at this stage is also new. A clinical-stage company managed a handful of CRO and CDMO relationships. A commercial company manages finished goods inventory, a third-party logistics partner handling warehousing and distribution, serialization and track-and-trace requirements under DSCSA, and a demand signal from the commercial team that has to be translated into manufacturing purchase orders at the CDMO. None of this was in scope at any of the pre-revenue stages. All of it needs to connect to the same NetSuite instance that the finance team uses for the general ledger.

What Enhance adds to the system

Excelerate

Full commercial sales generation: CRM, GTN, 340B, and FDA compliance at scale

Excelerate is the fully realized commercial operating model. The company has product revenue, a functioning commercial team, and the full range of obligations that come with selling a regulated pharmaceutical product in the United States. The finance function at this stage is managing not just accounting but the commercial economics of the business: gross-to-net waterfall by payer category, 340B program compliance and reporting, Sunshine Act filing, demand forecasting, and the financial controls required for an FDA-regulated commercial enterprise.

The companies that reach Excelerate with a clean operating model are the ones that followed the Stairway. Their NetSuite environment already has the entity structure, the chart of accounts, the approval workflows, the SOX controls, the contract management, the 3PL integration, and the supply chain visibility built at the earlier stages. Excelerate adds the commercial-facing layer on top of a system that already works. The companies that arrive at Excelerate with a system that was patched together stage by stage without a coherent architecture spend the first several commercial years doing remediation instead of scaling.

What Excelerate adds to the system

A company that reaches full Excelerate capability has built something that generalist NetSuite partners consistently struggle to deliver: a single connected system that handles finance, supply chain, commercial operations, compliance, and quality management for a regulated pharmaceutical company. NetSuite for biotech, implemented correctly and sequenced through the Stairway, produces that operating model without the accumulated technical debt that comes from building stage by stage without a coherent architecture. The commercial readiness assessment Archer conducts with new clients at any stage of the Stairway identifies exactly where the current system sits relative to where the business is heading, and what it will take to close the gap before the next inflection point arrives.

Frequently asked questions