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The Pennsylvania Convention Center

Jun 14, 2026 7:00 AM - Jun 18, 2026 3:00 PM

1101 Arch Street, Philadelphia, PA 19107, USA

DIA 2026 Global Annual Meeting

Register

Agenda

8:00 AM — 10:00 AM

Hidden Potential: Turning Today’s Science into Tomorrow’s Cures

11:00 AM — 12:15 PM

A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy

11:00 AM — 12:15 PM

Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts

11:00 AM — 12:15 PM

Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution

11:00 AM — 12:15 PM

Combined Clinical Trials: A Focus on In Vitro Diagnostics

11:00 AM — 12:15 PM

Enhancing Regulatory Collaboration through Cloud Technologies

11:00 AM — 12:15 PM

Evidence-Based Insights Informing Participant Compensation Strategies

11:00 AM — 12:15 PM

Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI

11:00 AM — 12:15 PM

FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis

11:00 AM — 12:15 PM

Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care?

11:00 AM — 12:15 PM

Health Canada Town Hall

11:00 AM — 12:15 PM

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency

11:00 AM — 12:15 PM

Outcome Based Portfolio Management: Aligning Decisions with Strategic Business Value Across R&D and Medical

11:00 AM — 12:15 PM

Regulatory Cooperation Between the United States and Japan

11:00 AM — 12:15 PM

The Great Debate: Using AI in Patient-Facing Materials

11:00 AM — 12:15 PM

Transforming Women’s Health Science: Closing the Innovation Gap and Accelerating Impact

2:30 PM — 3:30 PM

A Conversation about Quality: A Global Regulators Discussion

2:30 PM — 3:30 PM

AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise

2:30 PM — 3:30 PM

Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development

2:30 PM — 3:30 PM

Driving Efficiency in Clinical Development with Master Protocols

2:30 PM — 3:30 PM

Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty

2:30 PM — 3:30 PM

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions

2:30 PM — 3:30 PM

Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines

2:30 PM — 3:30 PM

ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science

2:30 PM — 3:30 PM

Industry Collaboration 2030: Head, Heart and Gut Perspectives

2:30 PM — 3:30 PM

Next-Generation Data Standards for RWD/RWE (FHIR, Dataset-JSON, and the Road Ahead)

2:30 PM — 3:30 PM

Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing

2:30 PM — 3:30 PM

Reimagining Postmarketing Safety: Creating Unified Postmarketing Registries

2:30 PM — 3:30 PM

Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV

2:30 PM — 3:30 PM

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence

2:30 PM — 3:30 PM

The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, PMDA, and CDE

4:00 PM — 5:00 PM

Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children

4:00 PM — 5:00 PM

Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness

4:00 PM — 5:00 PM

Bias and Methodological Challenges in External Control Arms: Time-Related Bias, Endpoint Alignment, Unmeasured Confounding

4:00 PM — 5:00 PM

DIA2026-001: Co-Creating the Patient-Centric Trial Live

4:00 PM — 5:00 PM

Enabling Faster Global Study Start-Up Through Regulatory Reliance and Harmonization

4:00 PM — 5:00 PM

Is There an Urgent need for Global Alignment on External Controls in Clinical Trials?

4:00 PM — 5:00 PM

Japan Town Hall

4:00 PM — 5:00 PM

Medical Writing Ted Experience

4:00 PM — 5:00 PM

Mentorship Myth Busters: Moving Beyond Misconceptions

4:00 PM — 5:00 PM

Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities

4:00 PM — 5:00 PM

Race/Ethnicity, Ancestry, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes

4:00 PM — 5:00 PM

Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations

4:00 PM — 5:00 PM

Study Participants Want to Know When AI is Processing Their Medical Data: Perceptions of AI and operational implications

4:00 PM — 5:00 PM

Tailoring Risk Minimisation Activities to Special Populations Locally: Patient Needs, Digitalisation, Global Learning

4:00 PM — 5:00 PM

Understanding the Misconceptions and Myths around Surrogate Endpoints

8:00 AM — 9:00 AM

Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies

10:15 AM — 11:30 AM

Agility Unlocked: How Hybrid FSP/FSO Models Support Clinical Trials for Complex, Global Studies

10:15 AM — 11:30 AM

AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate

10:15 AM — 11:30 AM

Before You Build: Finding Real Product–Market Fit in Clintech and Biotech

10:15 AM — 11:30 AM

From Barriers to Bridges: Unlocking Research Potential in Primary Care

10:15 AM — 11:30 AM

From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration

10:15 AM — 11:30 AM

Global Regulatory Perspectives on Obesity as a Chronic Disease: Learnings from FDA, EMA, PMDA, CDE, and Beyond

10:15 AM — 11:30 AM

How AI and Protocol Data Standards can enable improved patient-centric study designs

10:15 AM — 11:30 AM

Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients

10:15 AM — 11:30 AM

Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development

10:15 AM — 11:30 AM

Leveraging Federated AI and Open Data to Transform Oncology Research and Development

10:15 AM — 11:30 AM

Modernizing Preclinical Testing: FDA and EMA Roadmaps for New Approach Methodologies

10:15 AM — 11:30 AM

Next Generation Clinical Trial Quality Assurance Using Advanced Analytics

10:15 AM — 11:30 AM

Patient Registries: Basket Trial or Basket Case?

10:15 AM — 11:30 AM

Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation

10:15 AM — 11:30 AM

Workshop 1: Enhanced Analytical Procedure Development – Principles, Prior Knowledge, and Change Management

1:45 PM — 3:00 PM

AI Readiness Beyond Pilots: Building the Data and Content Governance Backbone for Reliable Innovation

1:45 PM — 3:00 PM

Applied Innovation for Patients: Implementing AI, Cloud, and Data in Regulatory Science

1:45 PM — 3:00 PM

Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

1:45 PM — 3:00 PM

From Strategy to Impact: Hands-On Project Management for Biopharma Leaders

1:45 PM — 3:00 PM

Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making

1:45 PM — 3:00 PM

Innovations in Drug Review

1:45 PM — 3:00 PM

Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication

1:45 PM — 3:00 PM

Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability

1:45 PM — 3:00 PM

Pitch Perfect: How to Nail Stage Talks and Product–Market Fit Presentations

1:45 PM — 3:00 PM

Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?

1:45 PM — 3:00 PM

Regulators Approach to Address Drug Shortages

1:45 PM — 3:00 PM

Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention

1:45 PM — 3:00 PM

The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials

1:45 PM — 3:00 PM

Tolerability in Immuno-Oncology: Patient Experience as a Core Element of Clinical Trials

1:45 PM — 3:00 PM

Unlock AI's Full Potential: The Power of FAIR Data

4:15 PM — 5:15 PM

Adapting Regulatory Frameworks to Address Mass Distribution of Unapproved or Unauthorized Medicines

4:15 PM — 5:15 PM

Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation

4:15 PM — 5:15 PM

Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation

4:15 PM — 5:15 PM

China Town Hall

4:15 PM — 5:15 PM

Clinical Research Training for Community Cancer Centers: A Pilot to Extend Clinical Trials into Diverse Catchment Areas

4:15 PM — 5:15 PM

Evolving Artificial Intelligence Regulatory Landscape in Drug Development across US and EU

4:15 PM — 5:15 PM

Increasing Vigilance Transparency: When is the Right Time to Publish Safety Signals?

4:15 PM — 9:15 PM

Latest in Combination Product Industry Trends: Development and Submission Strategies for Success

4:15 PM — 5:15 PM

Leveraging Real-World Evidence and External Controls in Clinical Trials of Rare Outcomes/Small Trials: Statistical Innovation

4:15 PM — 5:15 PM

Myths vs Reality: Generative AI and LLMs in Drug Development and Real-World Evidence Generation

4:15 PM — 5:15 PM

Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment

4:15 PM — 5:15 PM

Oncology Pathways Under Pressure: From CAR-T Access Today to Longevity-Driven Care Tomorrow

4:15 PM — 5:15 PM

Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate

4:15 PM — 5:15 PM

Reimagining Site Source: Optimizing Clinical Trial Execution for Sponsors, Sites, and Patients

4:15 PM — 5:15 PM

Reverse Pitches: How Pharma Actually Buys

4:15 PM — 5:15 PM

Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance

8:00 AM — 9:00 AM

From Breakthrough to Life: Engineered T Cells, Patients, and the Future of Biotech

10:15 AM — 11:30 AM

Bridging the AI Divide: Regulatory Trends, Industry Innovation, and the Future of AI in Pharma & Biotech

10:15 AM — 11:30 AM

Can You Complete Your Submission in 10 weeks?

10:15 AM — 11:30 AM

Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials

10:15 AM — 11:30 AM

Counting the Cost: Translating Participant Burden into Fair Compensation

10:15 AM — 11:30 AM

Decision Under Uncertainty

10:15 AM — 11:30 AM

Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

10:15 AM — 11:30 AM

FDA Rare Disease Town Hall

10:15 AM — 11:30 AM

From Dysfunctions to Dynamics: Mapping Hidden Assumptions to Strengthen Trust, Debate, and Accountability

10:15 AM — 11:30 AM

From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures

10:15 AM — 11:30 AM

How to Accelerate Utilization of Decentralized Clinical Trial: What are issues to perform Decentralized Clinical Trial?

10:15 AM — 11:30 AM

Inside the Biotech Breakthroughs: How Investors and Founders Build Winning Companies

10:15 AM — 11:30 AM

International Regulatory Cooperation with the African Medicines Agency

10:15 AM — 11:30 AM

Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact

10:15 AM — 11:30 AM

Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies

10:15 AM — 11:30 AM

Streamlined Trials Embedded in Pragmatic Settings

10:15 AM — 11:30 AM

Workshop 2: Future of Enhanced Product Development – Enabled through new ICH guidelines

1:45 PM — 2:45 PM

Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes

1:45 PM — 2:45 PM

Beyond the Keyboard: Elevating Regulatory Writing with a Business Mindset

1:45 PM — 2:45 PM

Bold Leadership: Embolden Your Team for Smart Risk-Taking

1:45 PM — 1:45 PM

Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences

1:45 PM — 2:45 PM

Designing the Future: Emulation of Clinical Trials Using Real-World Data

1:45 PM — 2:45 PM

Destigmatizing 483 Observations

1:45 PM — 2:45 PM

Inside the Investor’s Mind: How Today’s Biotech Investors Choose Where to Place Their Bets

1:45 PM — 2:45 PM

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?

1:45 PM — 2:45 PM

Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden

1:45 PM — 2:45 PM

Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22

1:45 PM — 2:45 PM

Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use

1:45 PM — 2:45 PM

Pharmacovigilance to Strengthen Vaccine Confidence and Address Hesitancy: Lessons from Brazil and Beyond

1:45 PM — 2:45 PM

Program Manager: Jack of All Trades, Master of None?

1:45 PM — 2:45 PM

Real-World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples

1:45 PM — 2:45 PM

Streamlining Regulatory Frameworks for Complex Generic Development: Global E&L Harmonization

1:45 PM — 2:45 PM

The Next Frontier: Autoimmune Cell & Gene Therapy, Regulation, and Patient Access

4:00 PM — 5:00 PM

50,000 Participants, Two Countries, One DCT: Oversight That Worked

4:00 PM — 5:00 PM

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing

4:00 PM — 5:00 PM

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle

4:00 PM — 5:00 PM

Clinical Trial Experience Surveys: Results from a Sponsor-Wide Implementation Across Countries and Therapy Areas

4:00 PM — 5:00 PM

India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation

4:00 PM — 5:00 PM

Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare

4:00 PM — 5:00 PM

Navigating the New FDA: Insights from Former FDA Chief of Staffs

4:00 PM — 5:00 PM

Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts

4:00 PM — 5:00 PM

Not Can, but Should: How do we WANT AI/ML to transform Clinical Development?

4:00 PM — 5:00 PM

Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact

4:00 PM — 5:00 PM

Regulatory CMC and Product Quality Hot Topics Discussion

4:00 PM — 5:00 PM

Regulatory Frameworks and Use Cases: Harnessing Generative AI for Compliance and Innovation in Pharma

4:00 PM — 5:00 PM

The New Era for Innovation: Catalysts and Collaborators for Acceleration

4:00 PM — 5:00 PM

Utilizing Signal Detection Methodologies: A Toolkit for Diverse Product Types

4:00 PM — 5:00 PM

Who Owns Long-Term Follow-Up? Addressing Stakeholder Gaps in Gene Therapy Evidence Generation

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