About Hristos Bilis
I'm Hristos (Evan) Bilis, a Pharma AI Solutions Consultant with 15 years in the pharma industry. I help teams choose the right AI projects, run them well, and use AI effectively, including validating it where GxP applies. I take on consulting projects through Lean Biologix, usually starting with a small, scoped first project.
Background
I have led IT implementations at large pharmaceutical companies, covering maintenance management (CMMS), document management (EDMS), ERP, process analytical technology (PAT) and analytics systems. I have done computer system validation (CSV and CSA) in FDA-regulated environments, including more than 1,000 tests and hundreds of change controls.
For industry clients, I lead AI work from start to finish. I assess which projects are worth funding, consult on vendors and tools, and build AI tools. I set up AI governance and risk assessment, validate GenAI tools in GxP-adjacent settings, and build automated, AI-assisted testing. I also write the documentation that keeps AI systems auditable, and I train teams to use AI well.
What I publish
The Pharma AI Tracker is a sourced record of AI initiatives that the largest pharma companies have disclosed in public. Each entry is quoted, sourced and archived. The method page explains how entries are sourced and checked.
The Pharma AI Tracker covers 49 of the largest pharma companies.
Writing on validating AI in GxP:
- How much validation does your AI actually need? Start with Context of Use
- AI validation in GxP doesn't have a settled playbook yet. Here's where regulators stand as of fall 2026.
- What a CSV validator should look for in an LLM gateway
Zero to Validated, runnable examples with public code:
- An LLM gateway from scratch, code on GitHub
- An ALCOA+ audit trail for LLM calls, code on GitHub
See all of what I write about pharma AI validation.
Work
I consult through Lean Biologix on AI project selection, delivery and GxP validation. To talk about a project, reach me on LinkedIn.
To work together, see Work with me.