DIA 2025 Global Annual Meeting

DIA 2025 Global Annual Meeting

1:00pm EDT

12P: Real-World Evidence: Navigating the Evolving Landscape of Regulation, Data, and Integration Virtual

9:30am EDT

21A: Risk-Based Quality Management in Action: Hands-On with a Real Study Protocol Virtual

1:00pm EDT

22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development Virtual

9:30am EDT

31A: Cell and Gene Therapies 101: Specific Regulatory, CMC, Non-Clinical, and Clinical Requirements and Considerations Virtual

1:00pm EDT

32P: Introduction to Artificial intelligence (AI) Ethics, Regulations and Governance for Life Sciences Virtual

9:30am EDT

41A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials Virtual

1:00pm EDT

42P: Regulatory Strategy Development for Complex Devices and Combination Products Virtual

6:00pm EDT

Inspire Awards Planet Word

7:00pm EDT

DIA Annual Meeting Welcoming Reception - Planet Word Planet Word

7:00am EDT

Coffee and Light Refreshments Ballroom Foyer 3rd Floor

8:00am EDT

#100: Opening Plenary and Keynote Address: From Personal Journeys to Global Solutions – Collaborating for Innovation and Patient Impact Ballroom

10:00am EDT

Coffee Break EH

10:15am EDT

#101 IT: IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI Innovation Theater 1 #102 IT: Lokavant, Inc Innovation Theater: Uncertainty Drives Innovation - Four Use Cases of AI-Powered Study Forecasting Innovation Theater 3 #103 IT: OM1 Innovation Theater: Real-World Evidence Generation in a Demanding Era Innovation Theater 2

11:00am EDT

#104: A Regulator's View on the Future Vision for Pharmacovigilance 207A #105: Advancing Clinical Outcomes through Digital Health Technology Innovation 209ABC #106: Real-World Evidence: First Choice or Last Resort? 207B #107: From Approval to Access: Integrating Patient Insights into Coverage Decisions 202A #109: Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized 152AB #110: Moving Toward Pragmatism in Clinical Trials 151B #111: Project Orbis: Six Years Later 147AB #112: Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation 201 #113: Accelerating Global Access to Drugs for Chronic Diseases Salon B #108: Advancing Innovation Through Essential Drug Delivery Outputs 204ABC #114: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives 146BC

12:00pm EDT

#POS 1: Student Poster Session I EH Luncheon Service Exhibit Hall Lunch

12:10pm EDT

#115 CH: Leading Teams Through Organizational Change and Layoffs: Best Practices for Change Management L Street Bridge

12:15pm EDT

#115.1 IT: Salesforce Innovation Theater: Personalized Patient Engagement from Recruitment to Enrollment and Beyond with Life Sciences Cloud Innovation Theater 2

12:55pm EDT

#118 IT: PCM Trials Innovation Theater: Insights from Across the Care Continuum - How Community-Based Research Supports Trial Success Innovation Theater 3 #117 IT: AlphaLife Science Innovation Theater: AI in Action - End-to-End Automation and Quality Control in Regulatory Document Authoring with AI and Veeva Integration Innovation Theater 1

1:30pm EDT

#119 CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products L Street Bridge

1:35pm EDT

#120 IT: Evernorth Health Services Innovation Theater: Empowering Case Managers - Bridging Patient Education and Oncology Clinical Trial Enrollment Innovation Theater 3 #121 IT: Taimei Technology Innovation Theater: Transforming eClinical Platform - The New Era of Agentic AI in Data and TMF Management Innovation Theater 1 #122 IT: Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce Innovation Theater 2

2:15pm EDT

#124: Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases 209ABC #123: A Masterclass: Patient Recruitment Campaign Management 207A #127: Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion 202A #128: Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine 204ABC #129: Models of Collaborations to Advance Regulatory Science: Lessons Learned 151B #130: Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management 152AB #131: International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here 150AB #132: FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding? 147AB #133: Health Canada Town Hall 145AB #125: Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence 207B #126: Best Practices for Navigating Divergent Regulatory Feedback 151A #134: Building a Regulatory Landscape to Support CMC Innovation 143ABC #135: Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights 144ABC #136.1: Ushering in a New Era of Africa Healthcare TBD #136: Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge 201

3:45pm EDT

#137: Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting 207A #138: Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials 209ABC #139: Efficient Data Exchange: Drivers for End-to-End Standards Adoption 207B #141: How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development 202A #142: Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience 144ABC #143: Ethics in the Era of Precision Medicine and Advancing Technologies 204ABC #145: Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How 152AB #146: FDA Accelerated Approval Program: Putting Withdrawals in Context 147AB #147: Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation 146BC #148: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease 145AB #149: WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation 150AB #140: Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders 151A #144: Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management 151B #150: Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C 143ABC #151: Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication 206 #152: AI in Patient Care: Aspirations and Considerations 201

4:45pm EDT

DIA Annual Meeting Opening Reception

5:30pm EDT

FDA Appreciation Event

6:45pm EDT

DIA at the Nationals Park Nationals Park

6:30am EDT

CISCRP's Annual 2025 Medical Heroes Appreciation 5K Run & Walk

8:00am EDT

Coffee and Light Refreshments Room 145-147 Lobby

8:30am EDT

#201: Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates 207A #202: From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age 206 #203: Realizing Value Through Responsible AI in Clinical Development 207B #205: Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem 151A #206: Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective 152AB #207: Japan Town Hall 147AB #208: International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers 144ABC #209: A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge 145AB #210: MHRA Town Hall 151B #204: Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence 143ABC #211: Redesigning Research and Development with Women in Mind: Turning Ambition to Impact 146BC

9:30am EDT

Coffee Break EH

9:45am EDT

#212 IT: IQVIA Innovation Theater: The Future is Now - Transforming Regulatory Processes through AI, ML, NLP, and RPAs Innovation Theater 1 #213 IT: Clario Innovation Theater: Striking the Balance - Integrating Patient-Friendly Solutions Without Compromising Quality Science Innovation Theater 2 #214 IT: Aris Global Innovation Theater: Successful Implementation of Gen AI in Pharma - Strategy, ROI, and Cultural Transformation Innovation Theater 3

10:30am EDT

#215: The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What? 150AB #216: The Globalization of Risk Management 207A #217: Case Studies of Application of AI in Risk-Based Quality Management 209ABC #219: Resilient Leadership: Overcoming Isolation and Adversity 151A #220: Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation 202A #221: Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities 201 #222: Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers 204ABC #223: Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects 151B #224: FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct 152AB #225: Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development 147AB #226: US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases 146BC #227: ANVISA Town Hall 145AB #218: Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence 207B #228: Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management 143ABC #229: Bayesian Benefit-Risk Analysis: A Framework for Quantitative Evidence-Based Decision Making in Medical Product Development 144ABC #230: Banishing Burnout: A Practice of Mindfulness Tools to Reduce Stress and Improve Well-Being 206

11:00am EDT

DIA Global Annual Meeting Blood Drive Exhibit Hall Lunch

11:30am EDT

#POS 2: Professional Poster Session II EH Luncheon Service EH

11:40am EDT

#231 CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials TBD

11:45am EDT

#232: Arnold Ventures Innovation Theater: Biosimilars Today - Who is Winning the Global Race? Innovation Theater 1 #233 IT: Yseop Innovation Theater: Scaling Regulatory Automation - The One-Click Vision Innovation Theater 2

12:00pm EDT

#234 RT: Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease Exhibit Hall / Zone A #235.1 RT: Roundtable Discussion: Clinical Care vs Research - Walking the Ethical Tightrope Between Advocacy and Coercion and Updating Ethics What's New in Declaration of Helsinki Exhibit Hall / Zone C #235 RT: Roundtable Discussion: Building a Regulatory Landscape to Support CMC Innovation Exhibit Hall / Zone B

12:25pm EDT

#236.1 IT: Whatfix Innovation Theater: Closing the Digital Execution Gap in Life Science - A Practical Path to Compliance, Efficiency, and Speed Innovation Theater 1 #237 IT: Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies Innovation Theater 3 #237.1 IT: Salesforce Innovation Theater: Life Sciences Cloud - An Intelligent Clinical Engagement Platform Innovation Theater 2

1:00pm EDT

#238 CH: Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts L Street Bridge

1:05pm EDT

#239 IT: Syneos Health Innovation Theater: From Pilot to Powerhouse - Scaling AI for Life Sciences Innovation Theater 1 #239.1 IT: Faro Health, Inc Innovation Theater: Real World Applications of AI to Clinical Development Innovation Theater 3

1:45pm EDT

#240: Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology 207A #241: Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision 204ABC #242: Not all AI is Equal: Ensuring Reliable, Responsible AI to Accelerate Adoption, Innovation, and Impact 150AB #244: How Medical Writing and Regulatory Strategy Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot 151A #243: The Adoption of Artificial Intelligence and Machine Learning in Clinical Research 207B #245: Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact 202A #246: US Executive Orders: Impact on Precision Medicine and Diagnostic Development 146BC #247: Guerrilla Strategic Delivery 151B #248: Embracing ICH E6(R3) with Risk-Based Quality Management 152AB #249: Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives 147AB #250: Pediatric Cluster Town Hall 209ABC #251: China Town Hall 145AB #252: Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency 143ABC #253: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint 144ABC #254: Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development 206

2:45pm EDT

Refreshment Break EH

2:55pm EDT

#256 RT: Roundtable Discussion: Alphabet Soup - Utilization of Quality by Design and Risk Based Quality Management in Clinical Trials Data Goverernance Exhibit Hall / Zone B #256.1 RT: Roundtable Discussion: Participant Compensation in Clinical Trials and Using Generative AI to Explore our Track Record on Paying Participants Exhibit Hall / Zone C #255 RT: Roundtable Discussion: International Regulatory Harmonization for Development of Medicines - A Look at How far We’ve Come and Where We Go From Here Exhibit Hall / Zone A

3:00pm EDT

#257 CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development L Street Bridge #258 IT: Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier Innovation Theater 2 #259 IT: Milliman IntelliScript Innovation Theater: What are you Missing in Recruitment and Enrollment? Innovation Theater 3 #260 IT: Weave Bio Innovation Theater: Advancing the Regulatory Lifecycle - Evolution of the Weave Platform Innovation Theater 1

4:00pm EDT

#261: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships 207A #262: Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration 202A #263: Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation 209ABC #264: How Do We Get from Here to There: Putting Real-World Data Quality Assessments into Practice 207B #265: Breaking Barriers: Making Health Information Accessible to All 151A #270: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance 146BC #266: Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics 204ABC #267: Delivering Effective Business Transformations and How to Apply them to Drug Development 151B #268: New Data and Insights on the Vendor Qualification Process in Drug Development 150AB #269: Pharmacovigilance Inspections Fireside Chat 152AB #271: Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products 147AB #272: Towards Instantaneous Regulatory Decisions and Better Predictability 145AB #273: Regulatory Cooperation Between US and Japan Salon B #274: Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk 143ABC #275: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies 144ABC #276: Exploring Regulator Career Paths: How Breadth of Experience Informs Decision Making and Medicines Development? 206 #277: Getting the Work of Medicines Development and Manufacturing Done by Hook or by Crook: Attracting, Retaining and Developing Key Talent in the New World of Work 201

6:45pm EDT

DIA at the Nationals Park Nationals Park

8:30am EDT

#301: Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report 204ABC #302: From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care 202A #303: Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime? 207A #304: Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities 209ABC #305: Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Automation and Regulatory Review 207B #306: Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives 152AB #307: Regulators and Communication in a Changing World: The ICMRA Role Room 151A #308: The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways 147AB #309: Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum 150AB #310: Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards 145AB #311: How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance 143ABC #312: Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges 146BC

9:30am EDT

Coffee Break EH

9:45am EDT

#313 IT: IQVIA Innovation Theater: Harnessing the Power of Artificial Intelligence in Medical Affairs - Driving Efficiencies and Preserving Trustworthiness Innovation Theater 1 #313.1 IT: Synterex, Inc Innovation Theater: AgileWriter.ai™ - Your All-in-One Solution for Authoring and Managing Clinical Trial Documentation Innovation Theater 2

10:30am EDT

#314: From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14 145AB #315: Data and Methods for Signal Detection: Where are we Today and What is the Current State of the Art 207A #316: Research in Participants with Progressive Cognitive Impairment: Best Practices for Ensuring Continuing Informed Consent 150AB #317: Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa 209ABC #318: Patient Referral: Is It Hope or Hype? 201 #319: Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development 207B #320: Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing 151A #321: Why Patient/Site Collaboration is a Must Have to Ensure Accessibility of Digital Health Technologies and Development of Patient Relevant Clinical Endpoints 202A #323: Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development 151B #324: Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality 152AB #325: Practical Implementation of MRCTs Based on ICH E17 Guidelines 144ABC #326: Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance 147AB #322: Navigating the Challenges of Drug Delivery Using a Novel Device 204ABC #327: Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval 143ABC #328: Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health 146BC #329: Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance 206

11:30am EDT

#POS 3: Professional Poster Session III EH Luncheon Service Exhibit Hall Lunch

11:40am EDT

#330 CH: Pharmacoequity: The Route to Representative Clinical Trials in the Current Political Environment L Street Bridge

12:00pm EDT

#332 RT: Roundtable Discussion: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint Exhibit Hall / Zone B #333 RT: Roundtable Discussion: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships Exhibit Hall / Zone C #331 RT: Roundtable Discussion: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects Exhibit Hall / Zone A

12:20pm EDT

#334 CH: Addressing Key Challenges in Global Biosimilar Development and Regulation L Street Bridge

1:00pm EDT

#335 CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases? L Street Bridge

1:45pm EDT

#336: Addressing Challenges in Devices Safety Monitoring 202A #337: AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research 207A #338: Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan 204ABC #340: Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe 201 #341: Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research 207B #343: Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations 151B #344: Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go? 152AB #345: Africa's Evolving Regulatory Landscape 145AB #347: EMA Town Hall 146BC #348: Indonesia Town Hall 150AB #342: Evolving Regulatory Considerations for Medical Affairs Communications 151A #346: Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success 147AB #349: Potency Measurements for Cellular and Gene Therapy Products 143ABC #339: Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation 209ABC #350: Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Drug Development 144ABC #351: Transforming Industry through Mentorship 206

2:45pm EDT

Refreshment Break EH

2:55pm EDT

#353 RT: Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma Exhibit Hall / Zone B #352 RT: Roundtable Discussion: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products Exhibit Hall / Zone A #354 RT: Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability Exhibit Hall / Zone C

3:00pm EDT

#355 CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out L Street Bridge

4:00pm EDT

#356: Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels 207A #357: Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders 151B #358: Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges 207B #359: Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now? 209ABC #360: Maximizing the Voice of the Patient in Healthcare Decision-Making: Integrating Patient Experience Data into Regulatory, Value Assessment, and Payer Decision-Making 204ABC #362: Collaborating for Equity: Reaching Communities Through Partnerships with Federally Qualified Health Centers and Community Health Workers 201 #361: Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability 202A #363: Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders 152AB #365: International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs 150AB #366: FDA Rare Disease Town Hall 146BC #367: Beyond Weight Loss: Pioneering the Future of Obesity Drug Development 147AB #368: Perspectives on the Adoption of Advanced Manufacturing Technologies 143ABC #370: Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development 145AB #369: Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20 144ABC #364: Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators 151A #371: Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations 206

8:00am EDT

Coffee and Light Refreshments Room 145-147 Lobby

9:00am EDT

#401: Implementing the Aggregate Safety Assessment Planning and Aggregate Safety Review with an Interactive Application: Learnings and Enhancements 151A #402: Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders 145AB #403: How AI is Transforming the Area of Data Standards and Access to Source Data 207B #404: Embedding and Leveraging AI for Quality and Compliance in Pharma 152AB #405: EMA - FDA Question Time 146BC #406: Beyond the Frequentist Approach in Hard to Recruit Populations: Acceptance of Bayesian Methods for Registration/Pivotal Trial 144ABC #407: Bridging Science and Business: A Roadmap from Pharmaceutical Research to Successful Entrepreneurship 151B

10:00am EDT

Coffee Break Room 145-147 Lobby

10:30am EDT

#408: FDA Town Hall 146ABC

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