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Session 8, Track 4: Co-Managing a Complete Regulatory Program with AI: A Sponsor–Technology Co-Design Case Study
Session Chair(s)
Kunal Lal, MBA
Consultant - Strategy & Change, Red Nucleus, United Kingdom
This session explores a biotech sponsor’s integration of AI across its regulatory program, from pre-IND planning to submission, to streamline workflows, reduce manual effort, and ensure compliance while managing multiple assets. It describes a co-design approach, where sponsor subject matter experts and technology partners mapped regulatory workflows, leveraging large language models for narrative drafting, automated document management, structured data extraction and metrics managed to achieve significant time savings and improved cross-functional alignment. Attendees will have the opportunity to participate in a live workflow mapping exercise to identify automation opportunities in their own programs and gain a practical framework for AI adoption in regulatory management.
Transforming IND Preparation with AI: A Biotech Perspective on Smarter Regulatory Documentation
Sigrid Selberg, Chemestmed OÜ
Co-Designing AI for Regulatory Teams: Building Trust, Traceability, and Efficiency
Meelis Lootus, Tehistark
The Life Sciences Lens: Unpacking the Need to for Sponsors to Evaluate, Validate, and Govern GenAI for Regulatory Use
Emily Lewis, UCB
Learning Objective :
At the conclusion of this session, participants should be able to:
- Apply co-design principles to integrate AI into sponsor-led regulatory programs
- Map end-to-end submission workflows to identify automation opportunities
- Evaluate metrics for efficiency, compliance, and collaboration in AI-enabled regulatory management
Speaker(s)
Co-Managing a Complete Regulatory Program with AI: A Sponsor–Technology Co-Design Case Study
Meelis Lootus, PhD, MS, MSc
CEO & Founder, Tehistark, United Kingdom
Transforming IND Preparation with AI: A Biotech Perspective on Smarter Regulatory Documentation
Sigrid Selberg, PhD
Chief Scientific Officer, Chemestmed OÜ, Estonia
The Life Sciences Lens: Unpacking the Need to for Sponsors to Evaluate, Validate, and Govern GenAI for Regulatory Use
Emily Lewis, MS
AI and Innovation Lead, UCB, United States
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