Building a Business-Led Digital and AI Roadmap for Clinical and Commercial Manufacturing
Clarkston Consulting recently partnered with a biotech on an AI roadmap for clinical and commercial. Read a synopsis of the project below or download the full case study.
Download the AI Roadmap for Clinical and Commercial Case Study Here
As biotechnology companies advance products through clinical development, their manufacturing sites must sustain clinical delivery while preparing for commercial obligations. For one biotechnology company, that transition required its in-house site to support more programs and higher production volumes without disrupting critical operations. As the workforce grew, leadership needed a business-led plan to prioritize technology investments and determine when to make them. The company engaged Clarkston Consulting to develop a site-specific Digital & AI Roadmap aligned with its five-year site vision.
Clarkston began by assessing the site’s digital capabilities against its business goals. A vision workshop established near-term priorities for building the foundation and mid-term priorities to support portfolio growth. Long-term planning focused on sustaining commercial operations. Interviews with more than 25 stakeholders across seven value streams identified recurring constraints in workflows and the technology support model. Manual system handoffs remained common, while ownership of product and process data was unclear. The support model wasn’t yet equipped to scale.
These gaps created significant manual work: bills of materials were reconciled by hand between systems, and a single process change could affect 10–15 documents and systems. Each technology transfer consumed roughly 300 supply chain hours.
Clarkston translated the findings into a capability framework connecting business needs to technology requirements. The team evaluated six initiatives against site milestones and execution readiness, accounting for dependencies and urgency. Manufacturing execution system (MES) expansion and quality management system (QMS) transformation were advanced for the 2027 budget. Governed AI adoption rounded out the priorities, while the remaining initiatives were incorporated into targeted funding and supporting work.
To protect readiness for the FDA’s upcoming pre-license inspection, the roadmap called for production batch records to remain unchanged through the inspection. Major integration and quality system cutovers were scheduled afterward. Clarkston also defined a future-state architecture in which each system would connect once to a shared integration layer, replacing point-to-point workarounds.
The roadmap gave leadership a clear basis for funding and execution. It aligned first-year investments with regulatory milestones and translated priorities into scoped project charters. By defining the capabilities needed to scale, Clarkston gave the site a practical plan for maintaining clinical delivery while preparing for commercial manufacturing.
Download the AI Roadmap for Clinical and Commercial case study, and learn more about our Life Sciences and Supply Chain Consulting Services by contacting us below.
Contributions by Ben South
