Event: DIA Webinar 2026
Date: Sep 17, 2026
Time: 12:00 PM - 1:00 PM EST
Location: Online (Live Webinar)
This webinar, presented by AlphaLife Sciences, demonstrates how purpose-built AI transforms R&D documentation from disconnected, document-by-document processes into a connected, enterprise-grade lifecycle—from study design through eCTD submission.
In Part 1: AI-Augmented Study Startup, see how AI supports upstream study design and protocol authoring with document-specific depth and regulatory-grade quality—creating a stronger foundation for downstream documents and reducing rework across the lifecycle.
In Part 2: AI-Orchestrated Authoring and QC Across the eCTD Document Network, see how AI connects authoring, evidence, logic, quality control, and review across M2.7.3 and M2.7.4 Clinical Summaries, CMC Module 3, and labeling—accelerating NDA readiness while maintaining dossier-wide consistency.
Through live demonstrations, see how AI identifies cross-document relationships, interprets and propagates upstream changes in context, and maintains submission-ready coherence with a complete audit trail. This is not a collection of point tools; it is a connected, enterprise-grade platform built on depth, workflow, and eCTD connectivity
Webinar Information
Topic：AI-Powered R&D Document Lifecycle: From Study Design to eCTD Submission — AI Tools Demo
Register Link：Click Here
Featureed Topics:
1. AI-Powered Study Startup: From Study Design to Protocol Authoring — From study design onward, AI supports design decisions and generates a synchronized protocol and downstream documents with a single click—compressing upstream timelines while preserving every rationale.
2. AI-Orchestrated Authoring and QC Across the eCTD Network — AI identifies cross-document relationships and propagates content across M2.7.3, M2.7.4, CMC Module 3, and labeling—enabling teams to author once and maintain consistency throughout the submission.
3. Change Intelligence Across the Document Lifecycle — Change intelligence and complete audit trails keep every update traceable and submission-ready, turning connected documents into a faster path to a regulatory-ready NDA.
Target Audience:
Regulatory Affairs & Regulatory Operations leaders (submission / eCTD strategy)
Heads of Medical Writing & Regulatory Writing and their teams
Clinical Development & Study Startup leads
Regulatory CMC / CMC documentation professionals
Heads of R&D Digital Transformation / AI & Data Strategy
Biotech, pharma and CRO executives evaluating agentic AI for the submission lifecycle
About the Presenters:
Sharon Chen, Founder and CEO, AlphaLife Sciences
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 General Manager at Verily Life Sciences (Alphabet) and Engineering Director at Google, where she received the Founder’s Award and the Outstanding Leadership Award. Sharon’s rare combination of deep technical expertise and life sciences domain knowledge shapes AlphaLife’s approach to building AI that regulated teams can deploy and trust in real-world environments.
Will Chen, Head of Solution, AlphaLife Sciences
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 viable digital platforms. With more than 15 years of experience at the intersection of healthcare, data, and strategy, Will has held leadership roles at McKinsey & Company, Elsevier, and Syapse, driving growth and operational transformation across the pharmaceutical sector. He holds a Ph.D. in Genetics from Stanford University School of Medicine and a B.S. in Biology from MIT.
To request a meeting, fill out the form provided and a representative will be in contact soon to schedule.