# Navigating Biotech’s First-in-Human Trial in Rare Disease With Jurate Lasiene

Page: https://stenobird.com/podcast/the-cog-review-building-better-clinical-studies-7614513/navigating-biotech-s-first-in-human-trial-in-rare-disease-with-jurate-lasiene
Text version: https://stenobird.com/podcast/the-cog-review-building-better-clinical-studies-7614513/navigating-biotech-s-first-in-human-trial-in-rare-disease-with-jurate-lasiene.md
Podcast: [The COG Review: Building Better Clinical Studies](https://stenobird.com/podcast/the-cog-review-building-better-clinical-studies-7614513)
Published: 2026-02-19T04:00:00+00:00
Episode link: https://the-cog-review.captivate.fm/episode/navigating-biotechs-first-in-human-trial-in-rare-disease-with-jurate-lasiene
Audio file: https://episodes.captivate.fm/episode/791d8e2f-f919-4027-85f5-5c07baf0fb69.mp3
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Duration seconds: 1586

## Resource

Learn how small biotech’s can streamline clinical trial outsourcing, optimize CRO selection, and establish truly patient-centered operations for rare disease studies—while maintaining high data quality and speed. Guest Jurate Lasiene, VP Clinical Operations, North Sea Therapeutics LinkedIn: Jurate Lasiene Episode Overview This episode of The COG Review: Building Better Clinical Studies is recorded live at COG Europe in Amsterdam. Jurate Lasiene, VP Clinical Operations at North Sea Therapeutics, shares firsthand insights from managing a first-in-human, early-phase rare disease trial with a small, agile biotech team. The session explores critical decision points and real-world solutions in clinical trial outsourcing, CRO selection, and effective sponsor–vendor collaboration. Key topics include designing adaptive, patient-first protocols for challenging rare disease populations, the shift from traditional full outsourcing models to targeted FSP (Functional Service Provider) or hybrid approaches, and optimizing budget, speed, and quality by retaining operational control in-house where it matters most. Jurate Lasiene offers a practical breakdown of site and partner selection, early regulatory and KOL engagement, and hands-on clinical operations best practices. This episode equips clinical research professionals in biotech, pharma, and CROs with actionable frameworks for clinical study optimization—especially useful for those navigating complex trials with lean teams and limited resources. Listeners gain concrete guidance on the sponsor-side leadership choices and process refinements that reduce common failure points and accelerate study timelines. Key Moments 00:01:40 – The unique operational challenges of rare disease trials: small, dispersed patient populations and high r…

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