DIA 2025 Global Annual Meeting

DIA 2025 Global Annual Meeting, held at the Walter E. Washington Convention Center, is hosted annually to create solutions that advance therapies and care. We’ll be there from start to finish: see below for more details on where to find us!

Sessions:

• Models of Collaborations to Advance Regulatory Science: Lessons Learned
  • Date and time: June 16 at 2:15 pm (EST)
  • Session chair: Huong Huynh, Critical Path Institute
  • Speakers: Meghana Chalasani, FDA Center for Drug Evaluation and Research; Carla Rodriguez-Watson, Reagan-Udall Foundation for the FDA; Allison Cuff Shimooka, TransCelerate; Liang Zhao, University of California San Francisco

• Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
  • Date and time: June 16 at 3:45 pm (EST)
  • Session chair: Emily Gebbia, FDA Center for Drug Evaluation and Research
  • Speakers: Rob DiCicco, TransCelerate; Grant Huang, VA Cooperative Studies Program; Jason Wakelin-Smith, MHRA

• The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
  • Date and time: June 17 at 10:30 am (EST)
  • Session chair: Mayur A Patel, AstraZeneca
  • Speakers: Andrew Bate, GlaxoSmithKline; Suranjan De, FDA; Phil Tregunno, MHRA

• Embracing ICH E6(R3) with Risk-Based Quality Management and Data Governance
  • Date and time: June 17 at 1:45 pm (EST)
  • Session chair: Madeleine Whitehead, Roche
  • Speakers: Abigail Dirks, Tufts CSDD; Nicole Stansbury, Premier Research

• Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Automation and Regulatory Review
  • Date and time: June 18 at 8:30 am (EST)
  • Session chair: Chris Decker, CDISC
  • Speakers: Rob DiCicco, TransCelerate; William Illis, Novartis

• From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
  • Date and time: June 18 at 8:30 am (EST)
  • Session chair: Allison Cuff Shimooka, TransCelerate
  • Speakers: Jeremy Jokinen, Bristol-Myers Squibb Company; Narayan Nair, FDA; Rebecca Noss, Noss Research Consulting

• From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
  • Date and time: June 18 at 10:30 am (EST)
  • Session chair: William Blumentals, Sanofi
  • Speakers: Alice Hsu, Amgen; Jie Li, FDA; Susan Oliveria, Thermo Fisher Scientific

• How AI is Transforming the Area of Data Standards and Access to Source Data
  • Date and time: June 19 at 9:00 am (EST)
  • Session chair: Jesper Kjær, Novo Nordisk
  • Speakers: Chris Decker, CDISC; Rob DiCicco, TransCelerate; Charles Jaffe, HL7; Patrick Ryan, Janssen