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DIA Webinar 2026

Sep 17, 2026
Online (Live Webinar)

Event: DIA Webinar 2026

Date: Sep 17, 2026

Time: 12:00 PM - 1:00 PM EST

Location: Online (Live Webinar)

Presented by AlphaLife Sciences, this webinar shows how purpose-built AI transforms R&D documentation from a disconnected, document-by-document process into a connected, enterprise-grade lifecycle—from study design through eCTD submission.
Part 1 — AI Product Demo: AI-Powered Authoring and QC Across the eCTD Document Network
The demo begins at study startup, where AI supports study design and protocol authoring with document-specific depth, context, and regulatory-grade quality—creating a stronger foundation for downstream deliverables. It then moves downstream, unifying authoring, evidence, reasoning, quality control, and review across Clinical Summaries, CMC, and Labeling to accelerate NDA readiness while maintaining dossier-wide consistency. It closes with connected eCTD intelligence: identifying cross-document relationships, propagating upstream changes in context, and keeping documents, content, and evidence aligned with a complete audit trail. This is not a collection of point tools; it is one connected, enterprise-grade platform.
Part 2 — Panel Discussion with Industry Leaders: Making AI Work in Practice, From First Use Case to Full eCTD Coverage
A cross-functional panel of clinical data, CMC, and labeling leaders joins AlphaLife’s CEO to discuss where AI creates the greatest opportunity in each domain, how to choose where to start, which metrics demonstrate real impact, and what it takes to scale from a single document type to full eCTD coverage. The discussion closes with a three-year outlook: how the daily work of regulatory, CMC, and clinical data professionals will change—and what companies should do this year to prepare.


Webinar Information：

Topic：AI-Powered R&D Document Lifecycle: From Study Design to eCTD Submission — AI Tools Demo


FEATURED TOPICS:

1. See a live demo across eCTD documents: from study design to AI-orchestrated authoring and QC.

From study design onward, AI supports design decisions and generates a synchronized protocol and downstream documents, compressing upstream timelines while preserving every rationale. It identifies cross-document relationships and propagates content across Clinical Summaries, CMC, and Labeling, enabling teams to author once and remain consistent throughout the submission.

2. See connected eCTD intelligence and integrated workflows: 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. AuroraPrime unifies authoring, evidence, reasoning, quality control, and review in one workflow—giving enterprise teams a consistent operating model across the R&D document lifecycle rather than disconnected point solutions.

3. Learn practical best practices from industry leaders: where to start, how to measure impact, and how to scale.

Hear from leaders who have adopted AI in global pharma and managed CMC and labeling deliverables at scale: how to select the right first use case, which metrics prove real-world value, what makes AI ready for CMC, how connected authoring eases the labeling-change burden across markets, and what it takes to reach full eCTD coverage.


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 is Founder and CEO of AlphaLife Sciences, where she leads AI development for regulatory and medical authoring. With more than 30 years of engineering leadership, she has built reliable systems for rigorous, highly regulated enterprise environments. Her experience includes Asia Pacific General Manager at Verily Life Sciences (Alphabet) and Engineering Director at Google, where she received the Founder’s Award and Outstanding Leadership Award. Sharon combines engineering rigor with life sciences knowledge to build AI designed for accuracy, traceability, and control. More than half of the world’s top 20 pharmaceutical companies trust AlphaLife.


Alastair Clewlow

Vice President, Clinical Data Management, Statistical Programming & Digital Solutions, Lundbeck A/S
Alastair Clewlow is Vice President of Clinical Data Management, Statistical Programming & Digital Solutions at Lundbeck. He holds a BSc (Hons) in Molecular Biology from the University of Portsmouth and brings nearly 30 years of experience across the pharmaceutical and technology sectors. Throughout his career, Alastair has held senior leadership roles spanning clinical data management, statistical and biometric programming, bioinformatics, digital health technologies, operations and life sciences software development. He is passionate about applying data, technology and digital innovation to advance clinical research and improve healthcare outcomes.


Jean-Marie Geoffroy, PhD, RPh, MBA

Principal & Founder, Cachet Pharma Consulting; Former VP, Sterile Injectables Design, Pfizer; Former Director & Senior Fellow, Takeda
Dr. Jean-Marie Geoffroy, PhD, RPh, MBA, is Founder and Principal Consultant of Cachet Pharma Consulting, LLC, bringing over 35 years of pharmaceutical leadership across the full drug development lifecycle. As former Vice President of Sterile Injectable Design at Pfizer, he directed global CMC strategy for parenteral and combination products, managing significant R&D budgets and teams of 240+ scientists. His career spans R&D, manufacturing, Quality, and Regulatory leadership at Abbott, Takeda, Hospira, and Pfizer, with deep expertise in Quality by Design, Process Analytical Technology, and digital enablement. An internationally recognized speaker and FDA collaborator, he now provides fractional CMC leadership and digital strategy to growing biotech and pharmaceutical companies.


Judy Kannenberg, MBA, ACC

Head, Kannenberg Coaching & Consulting; Former VP and Regulatory Affairs Head, BioPharma, CCDS & Labeling, Astellas
Judy Kannenberg brings 37 years of experience in the global Pharma industry as an expert in Regulatory Affairs, with extensive experience in product development and health authority approvals. Currently serving as an Executive Coach and Regulatory Strategic Consultant, Judy shares her experience leading global teams in the development of a diverse portfolio of pharmaceutical, biological, cell & gene therapy products. Additionally, she brings 20+ years of mentoring and coaching colleagues of all levels and geographies.
Judy is the former VP, RA Head for BioPharma, CCDS & Labeling at Astellas, and prior roles also include RA Therapeutic Area Head supporting Frontier Disease.


Will Chen, PhD

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 drug development workflows for life sciences. 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.


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