How Leading Global Pharma Embraces AI to Automate Regulatory and Medical Documents with Quality Control
November 12, 2025 | 12:00PM-1:00PM EST
Webinar Overview
This webinar offers a rare, high-value opportunity for audiences to hear directly from top-10 global pharma, AlphaLife Sciences as the solution enabler, and Microsoft on the future of AI in regulatory and medical authoring. The session features Microsoft’s perspective on harnessing AI to reclaim time for scientific thinking, enable knowledge mining, and accelerate discovery. Attendees will experience enterprise-grade, agentic AI solutions, including auto-templating and scalable workflows that cover the full spectrum of document types such as ICF, Protocol, SAP, CSR, DSUR/PBRER, and CTD Module 2.7.x. A live demo will showcase end-to-end document automation with built-in QC in Microsoft Word and Veeva RIM, complemented by agent-based platforms for enterprise customization. The panel discussion brings together pharma experts to share practical insights on business value, adoption challenges, solution requirements, and change-management practices for AI at scale, — giving you direct insight into what’s working and how to accelerate your own roadmap confidently.
Join top-10 global pharma, AlphaLife Sciences, and Microsoft for exclusive insights and live demos on AI-powered document authoring—reserve your spot now!
Speakers:
Sharon Chen, Founder and CEO, AlphaLife Sciences
Sharon Chen is a visionary leader at the intersection of computer science and life sciences, boasting over 25 years of pioneering software development experience. As the Founder and CEO of AlphaLife Sciences, she drives innovation in generative AI-powered clinical development solutions, transforming the way the industry approaches drug development. Previously, Sharon served as the APAC General Manager at Verily Life Sciences, an Alphabet company, where she led groundbreaking initiatives integrating advanced technology with life sciences. Sharon's visionary leadership and innovative spirit continue to profoundly impact AlphaLife Sciences and the broader life sciences sector.
John Jenkins, Former Director of Office of New Drugs at FDA. Former Principal of Drug and Biological Products at Greenleaf Health, JKJ Advisors, LLC
John K. Jenkins is currently an active advisor to AlphaLife Sciences as the Regulatory advisor. He holds a Master’s degree from the University of Tennessee College of Medicine. He is the former Director of the Office of New Drugs in the U.S. Food and Drug Administration (FDA) and previously served as Principal of Drug and Biological Products at Greenleaf Health.
Darren Weston, Head, Integrated Data Analytics & Reporting, Johnson & Johnson
Darren leads the IDAR organization at Johnson & Johnson, focusing on the delivery of high-quality programs while driving continuous improvement and innovation. With a globally distributed workforce of over 2,000 professionals, IDAR is responsible for managing all Phase I-IV studies across various therapeutic areas and geographical regions. The organization comprises several key functions, including Data Management & Central Monitoring, Clinical & Statistical Programming, Regulatory Medical Writing, Clinical Data Standards & Transparency, IDAR Business Operations, and Enabling Analytics & System Excellence. Before joining J&J in 2017, Darren served as Vice President of Data Sciences & Scientific Operations at Novartis, where he gained extensive leadership experience over 16 years. Additionally, he has contributed as an external advisor for various technology companies and has engaged with key industry groups such as Vulcan/HL7, PhUSE and PSI. He holds a 1(st) class BSc in Chemistry from Brighton University and an MSc with distinction in Applied Statistics from Sheffield Hallam University.
Neil Garrett, Head, Regulatory Medical Writing, Johnson & Johnson
Neil Garrett is the Head of Regulatory Medical Writing at Johnson & Johnson Innovative Medicine and has over 25 years’ experience in medical writing in the pharmaceutical and CRO industry. Neil has held medical writing leadership positions in a number of organizations and been a lead writer on multiple filing submissions across a range of therapeutic areas. In his current role at J&J, Neil has accountability for the efficient production of high quality clinical and regulatory documents supporting the J&J Innovative Medicine portfolio. Neil is interested in how AI can assist and enhance the authoring process in regulatory medical writing. Neil has a PhD in Pharmacology and is based in the UK.
Eunice Youhanna, Industry Advisor, Health & Life Sciences, Microsoft
Eunice Youhanna is a strategic leader and Industry Advisor with deep expertise in pharmaceutical innovation, particularly at the intersection of AI and commercial, medical, regulatory, and R&D functions. She partners with global life sciences organizations to drive transformation across the pharma value chain through emerging technologies. Eunice is known for translating complex scientific and technological trends into actionable strategies that accelerate innovation and deliver measurable impact.