DIA 2026 Global Annual Meeting: Full Schedule

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8:00am EDT

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision

Thursday June 18, 2026 8:00am - 9:00am EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-644-L04-P; CME 1.00; RN 1.00

As pharma companies set increasingly bold ambitions for productivity, technology is more crucial than ever. This session presents a vision for how productivity can be boosted end-to-end with Agentic AI, with humans working alongside agents.

Learning Objectives

Describe recent trends in regulatory submission preparation acceleration, including role of technology; Discuss a vision for how Agentic AI can underpin each step of submission dossier preparation.

Chair

Anton Mihic, MSC

Speaker

Agentic AI for statistical programming and rapid biostatistical analysis
Ralf Raschke

Panel discussion: Learnings from AI-enabled clinical and regulatory decision making
Jennings Xu

Panel discussion: Learnings from AI-enabled regulatory submissions
Cassie Gregson

Panel discussion: Learnings from AI-enabled end-to-end dossier generation
Andrea Doyle

Speakers

Andrea Doyle

Global Regulatory Affairs NA Head, Sanofi, United States

Andrea Doyle is Global Regulatory Affairs Head of Region North America (NA) and Global Advertising and Promotion at Sanofi. She provides oversight and regulatory expertise to optimize development programs and leads Global Advertising and promotion to deliver dynamic solutions to support... Read More →

Cassie Gregson

VP Head of AI Enterprise Process & Innovation Center, AstraZeneca, United States

Anton Mihic

Partner, McKinsey & Company, United States

Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →

Ralf Raschke

Senior Expert, McKinsey & Company, United States

Jennings Xu

Senior Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine, United States

Jennings Xu is Senior Director of Data Science at Johnson & Johnson, where he leads R&D Generative AI strategy, partners with Global Regulatory Affairs on end-to-end AI-enabled acceleration, and heads Asia-Pacific R&D Data Science. He oversees multidisciplinary teams across discovery... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 04: MedAffairs-SciComm, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
Feature Topics Artificial Intelligence
Tags Session

8:00am EDT

#703: How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization

Thursday June 18, 2026 8:00am - 9:00am EDT

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-645-L04-P; CME 1.00; RN 1.00

AI adoption in RA/QA is currently fragmented and uncertain, mirroring earlier technology booms like those of the early 2000s. This session explains why AI will inevitably organize into structured categories and how that shift will reshape decision-making and the marketplace. Executives will gain a clear framework for making confident, risk-aware AI decisions now and as the landscape matures.

Learning Objectives

Analyze the current AI landscape in RA/QA and explain why AI maturity and market structure are inevitable; Differentiate near-term AI actions, deferred investments, and avoidable risks using a category-driven lens; Apply a practical framework to guide compliant, defensible AI decisions across quality and regulatory functions.

Chair

Nicholas Capman, MBA

Speaker

Considerations for AI tool validation and implementation
Benjamin C Eloff, PHD

Pragmatic AI Deployment in RA/QA: Maximizing ROI While Maintaining Human Control
Fatima Sabar, MSC

AI and the Path to Submission Ready RWE: Enabling Compliance and Data Quality
Carrie Nielson, MPH

Speakers

Nicholas Capman

President & CEO, The FDA Group, United States

Nicholas Capman is CEO of The FDA Group, where since 2007 he has led the company’s evolution from a specialized services firm into a service + software organization integrating AI-driven capabilities to strengthen FDA compliance. He is passionate about advancing innovation responsibly... Read More →

Benjamin Eloff

Vice President, Healthcare Innovation Catalysts, United States

Ben Eloff brings nearly 20 years of federal leadership in advancing medical innovation and regulatory science. At FDA, he pioneered the first Bayesian device trial and co-authored the agency’s real-world evidence guidance. He led the launch of public-private initiatives including... Read More →

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States

Carrie Nielson is a Director of Epidemiology at Gilead Sciences, where she focuses on regulatory policy for RWE and on rigorous observational research methods that support reliable evidence generation. She collaborates with industry, academic, and regulatory colleagues, including... Read More →

Fatima Sabar

CEO, Bluenote Health, United States

Fatima Sabar is the CEO & Founder of Bluenote. Bluenote’s AI Agents Platform for Life Sciences is driving 50-75% efficiency gains for scientists and engineers at the world’s leading biopharma, medical devices and diagnostics companies. The platform focuses on regulatory workflows... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 09: RD-Quality-Compliance, Session

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Regulatory
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

8:00am EDT

#706: AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis

Thursday June 18, 2026 8:00am - 9:00am EDT

118C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-648-L04-P; CME 1.00; RN 1.00

The session will show CMC data from an internal system can be transferred to a cloud environment. The session will include a demonstration of structured CMC submissions and show how AI-assisted tools can facilitate review and collaboration.

Learning Objectives

Illustrate a future state in which CMC data from internal systems can be seamlessly transferred to a cloud environment; Demonstrate a structured CMC submission and show how AI-assisted tools can facilitate review and collaboration between industry and regulators.

Chair

Ciby Joseph Abraham, PHD

Speaker

Panelist
Vada Perkins, MS

Panelist
Omar Serang

Speakers

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States

Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →

Omar Serang

Chief Cloud Officer, DNAnexus, United States

General Manager and Lead Architect for DNAnexus' Regulatory Solutions. Expertise working at the intersection of cloud technology, genomic science, and regulatory science. Leading the vision and formation of Trusted Regulatory Spaces (TRS) in the cloud for global regulatory stakeholder... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Session | 03: Data-Tech-AI, Session

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Data Management & Data Standards
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

11:00am EDT

#713: No More Incremental Change: The Radical Future of Healthcare

Thursday June 18, 2026 11:00am - 12:30pm EDT

114

Component Type: Session
Level: Intermediate

This closing session brings together pioneering voices at the intersection of AI, advanced computing, and biopharma to explore how a new intelligence layer is rewiring the entire life sciences value chain—from discovery to delivery. The discussion will examine how foundational AI, cloud-scale infrastructure, and digital platforms are reshaping R&D, clinical development, manufacturing, and patient engagement. The conversation will highlight not only breakthrough opportunities—smarter target discovery, more adaptive trials, real-world evidence at scale, and hyper-personalized care—but also the governance, ethics, workforce, and partnership models needed to harness these technologies responsibly in a highly regulated environment.

Learning Objectives

Describe key ways AI and other advanced digital technologies are reshaping the life sciences value chain; Discuss concrete examples of how leading pharma and tech companies are using digital platforms, cloud infrastructure, and AI to accelerate R&D and improve patient outcomes; Evaluate key risks and governance challenges associated with deploying powerful AI and data technologies in regulated life sciences settings, including bias, transparency, and accountability.

Chair

Eli Weinberg, PHD, MS

Speaker

Panelist
Susan Furth, MD, PHD

Panelist
Carlos Garner, PHD, MSC

Panelist
Dhruv Jayanth

Panelist
Shweta Maniar

Speakers

Susan Furth

Executive Vice President and Chief Scientific Officer, Children's Hospital of Philadelphia, United States

Carlos Garner

Senior Vice-President Global Regulatory Affairs and Head, Lilly Regenerative Med, Eli Lilly and Company, United States

Dr. Garner is executive leader for Global Regulatory Affairs for Eli Lilly and Company. The organization is responsible for the regulatory leadership, strategic and operational support for human drugs, medical devices, and global manufacturing for Eli Lilly and Company. Additionally... Read More →

Dhruv Jayanth

Business Lead, Life Sciences, OpenAI, United States

Shweta Maniar

Global Director, Strategic Industries - Life Sciences, Google, United States

Shweta leads Healthcare & Life Sciences Strategic Industries at Google Cloud, where she bridges the gap between cutting-edge technology and patient outcomes. A PharmaVoice 100 trailblazer, she is a seasoned innovator known for turning complex data ecosystems into collaborative engines... Read More →

Eli Weinberg

Partner, Bain & Co., United States

Eli Weinberg is a leader in Bain's Life Sciences and Private Equity practices. He is an advisor and thought partner to life science innovators in biopharma, diagnostics, and medtech, as well as investors active in those areas. He is keenly interested in commercialization, value creation... Read More →

Thursday June 18, 2026 11:00am - 12:30pm EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 00: Plenary, Session