At the EMWA Spring Conference 2026 in Barcelona, Matilde Thye Kveiborg joined AlphaLife Sciences CEO Sharon Chen and AI Product Specialist Lucia D'Amado to share Lundbeck’s real-world experience adopting GenAI for regulatory writing.
With more than 15 years of experience across pharma, biotech, CRO, and consulting environments, Matilde presented a practical perspective on how AI is evolving beyond first-draft generation into end-to-end submission support.
From Pilot to Scaled Deployment
Lundbeck conducted a structured pilot comparing manually written Clinical Trial Reports (CTRs) with outputs from two AI vendors. The evaluation focused on:
Output quality
Regulatory robustness
Scalability
Adoption barriers
Vendor support
The pilot demonstrated that GenAI could produce fit-for-purpose CTRs and helped establish internal confidence for broader adoption across:
Clinical submission documents
CMC documents
DSURs
Investigator Brochures
The Bigger Opportunity: Submission Timeline Compression
Rather than focusing only on faster document drafting, Matilde emphasized a larger strategic shift: moving submission work earlier in the development timeline.
By leveraging simulated Phase 3 data, teams can begin drafting CTRs, Clinical Summaries, and related submission content before final data lock. Once actual data become available, AI systems help identify only the areas requiring updates instead of triggering full rewrites.
The result is a meaningful reduction in post-lock submission pressure and a faster path toward regulatory submission.
Technology Is Ready — Capability Building Is the Real Challenge
A key theme of the session was that successful AI adoption depends less on technology availability and more on organizational readiness.
Matilde highlighted Lundbeck’s focus on:
AI upskilling
Prompting best practices
Responsible AI usage
Knowledge-sharing culture
Human-in-the-loop review models
She also shared high-impact AI opportunities across:
Structured document authoring
AI-assisted QC and formatting
Project management support
Agentic AI co-authoring for strategic documents
Key Takeaway
The session reinforced that the real value of GenAI in medical writing is not simply faster drafting — it is enabling a fundamentally different, more scalable approach to end-to-end regulatory submissions.
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