dia-lp-header-logo-only-1024x200-2

 

 

AI-Augmented Lifecycle: From Study Design to eCTD Submission — AI Tools Demo


September 17  | 12:00 PM - 1:00 PM

 

Webinar Overview

This webinar presented by AlphaLife Sciences demonstrates AI across two stages of drug development, turning a traditionally document-by-document process into one connected lifecycle. In Part 1, AI-augmented Study Startup, AI accelerates upstream design and authoring, moving from Study Design to Protocol writing and the documents downstream. In Part 2, AI-orchestrated Authoring and QC across the eCTD document network, AI works from M2.7.3 and M2.7.4 Clinical Summaries to Labeling, and from CMC Module 3 to Labeling, to accelerate NDA submission. Through live demos, you'll see AI discover cross-document relationships, propagate upstream changes semantically, and deliver submission-ready coherence with a complete audit trail. This is the same platform approach top-20 pharma companies are deploying today.

 

See AI run the full lifecycle—from Study Design to an eCTD-ready submission — linking documents and propagating changes live. Register now

 

 
 
 
 

Featured Topics:
 

AI-Augmented Study Startup: From study design onward, AI assists with design and generates a synchronized protocol and downstream documents with one click, compressing upstream timelines while capturing every rationale.

AI-Orchestrated Authoring & QC Across the eCTD Network: AI discovers cross-document relationships and propagates content across M2.7.3, M2.7.4, CMC Module 3, and labeling, so you author once and maintain consistency. 

The Document Network Effect: Change intelligence and complete audit trails keep every change traceable and submission-ready, turning connected documents into a faster, regulatory-ready NDA.

 

 

 
 
 
Who Should Attend
 
  • 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

 

Register Now

Speakers:

 

Sharon Chen, M.S. 
Founder and CEO, AlphaLife Sciences

Sharon_Chen
Sharon Chen is a visionary leader at the intersection of computer science and life sciences with more than 25 years of experience building innovative software solutions. As Founder and CEO of AlphaLife Sciences, she leads the development of AI-powered platforms that transform clinical development, regulatory authoring, and submission processes. Prior to founding AlphaLife Sciences, Sharon served as APAC General Manager at Verily Life Sciences, an Alphabet company, where she led initiatives that combined advanced technology with life sciences innovation. Her work continues to help pharmaceutical and biotech organizations realize the value of generative and agentic AI across the drug development lifecycle.

Will Chen, Ph.D.
Head of Solutions,  AlphaLife Sciences

image-3

Will Chen leads solution strategy and implementation at AlphaLife Sciences, working closely with pharmaceutical and biotech organizations to apply AI across regulatory, clinical, and submission workflows. With deep expertise in life sciences technology, document automation, and AI-driven authoring platforms, he helps organizations streamline complex document ecosystems while maintaining quality, compliance, and traceability. His work focuses on enabling scalable AI adoption through connected document networks, intelligent content reuse, and submission-ready workflows that accelerate regulatory operations and business outcomes. .