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#419 IT: AlphaLife Sciences Innovation Theater: AI-Powered eCTD Authoring - Faster Draft-to-Submission with AI Tool Demos
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2
Component Type: Session

This session explores practical, systematic approaches to AI-orchestrated authoring and quality control across the end-to-end R&D document lifecycle. We examine high-value use cases spanning clinical (Protocol, CSR, M2.5, M2.7), CMC, and nonclinical documentation to demonstrate how AI can drastically accelerate IND, NDA, and BLA filing timelines by shortening the draft-to-submission window. Attendees will see AI tool demonstrations showing how regulatory writing teams leverage AI within familiar environments, specifically a Microsoft Word add-in integrated with Veeva RIM. This approach ensures evidence-anchored content generation and orchestration across eCTD documents, utilizing content linkage for change intelligence. Finally, we introduce a document-network model that identifies propagation paths for automated updates across a tightly linked network of documents. This framework enables cross-document consistency and scalable QC for both initial submissions and subsequent amendments, empowering professionals to produce high-quality, compliant filings with greater efficiency and confidence.

Chair

AlphaLife Sciences

Speaker

Speaker
William Chen

Speaker
Sharon Chen


Speakers
avatar for Sharon Chen

Sharon Chen

Founder and CEO, AlphaLife Sciences, United States
Sharon Chen founded AlphaLife Sciences to bring enterprise-grade AI to drug development—specifically to the complex, compliance-driven world of regulatory and clinical authoring. She brings over 30 years of software engineering leadership experience, including roles as Asia Pacific... Read More →
avatar for William Chen

William Chen

Principal Business Solution Architect, AlphaLife Sciences, United States
Will Chen is Head of Solutions at AlphaLife Sciences, where he leads the design and deployment of AI-driven solutions to transform clinical development and life sciences workflows. He specializes in translating complex scientific and regulatory challenges into scalable, commercially... Read More →
avatar for AlphaLife Sciences
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

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