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San Diego Convention Center

Jun 16, 2024 7:00 AM - Jun 20, 2024 3:00 PM

111 W Harbor Drive, , San Diego, CA 92101 , USA

DIA 2024 Global Annual Meeting

Join us at the premier life sciences conference, celebrating our 60th anniversary! Discover 180+ sessions on Cell and Gene Therapy, Decentralized Clinical Trials, AI, ICH, and more. Get ready to tackle challenges, improve skills, network, and drive change for healthcare at DIA2024.

Agenda

7:00 AM — 8:00 AM

DIA Annual Meeting Orientation

8:00 AM — 10:00 AM

Opening Plenary and Keynote Address

10:00 AM — 11:00 AM

Student Case Competition

10:00 AM — 10:58 AM

Student Case Competition

10:15 AM — 10:45 AM

Appian Innovation Theater: AI in Life Sciences - Promise or Peril?

10:15 AM — 10:45 AM

Mendel AI Innovation Theater: Supercharge Your Clinical Data Workflows

10:15 AM — 10:45 AM

Taimei Technology Innovation Theater: Transforming Data Management - The Power of AI-Driven Automation

11:00 AM — 12:00 PM

Breaking Boundaries: Overcoming Policy Crosstalk and Globalization Barriers to Foster Innovation

11:00 AM — 12:00 PM

China Town Hall

11:00 AM — 12:00 PM

Cloud-Driven Transformation: Empowering Pharma Industry and Regulators

11:00 AM — 12:00 PM

From Intention to Action: Building Diversity, Equity, and Inclusion Initiatives to Create a Culture of Belonging

11:00 AM — 12:00 PM

GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US?

11:00 AM — 12:00 PM

Machine Learning and Simulations to Facilitate Clinical Trials

11:00 AM — 12:00 PM

Master Protocols: Integrating and Debating Clinical Trial Designs

11:00 AM — 12:00 PM

Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update

11:00 AM — 12:00 PM

Navigating the Trusted, Responsible, and Ethical Horizon of Artificial Intelligence: Uniting Healthcare Perspectives

11:00 AM — 12:00 PM

Regulatory Convergence for CMC Requirements: The Challenges and Benefits of a Single Global Dossier

11:00 AM — 12:00 PM

Reporting of Pre-Market and Post-Market Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards

11:00 AM — 12:00 PM

Risk Management in Advanced Device Technology Development

11:00 AM — 12:00 PM

The Intersection of Science, Ethics, and Participant Collaboration in Pediatric Rare Disease Product Development

12:00 PM — 12:30 PM

Rare Diseases Multistakeholder Collaboration Towards Regulatory Endorsed Innovative Clinical Development Approach

12:15 PM — 12:45 PM

Castor Innovation Theater: Practical AI - Creating a Future Without Manual Data Re-Entry

12:15 PM — 12:45 PM

Datacubed Health Innovation Theater: The Impact of Digital Tools on Pediatric and Elderly Clinical Trials

12:15 PM — 2:15 PM

Professional and Student Poster Session 1

12:15 PM — 1:15 PM

Roundtable Discussion: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development

12:15 PM — 12:45 PM

RWS Innovation Theater: Accelerate Time-to-Market with Smart, Structured Content, Reuse, and AI

12:45 PM — 1:15 PM

Digital Transformation: More Than Just Technology - Understanding How to Make it a Reality

12:55 PM — 1:25 PM

Box Innovation Theater: From Data Chaos to Digital Clarity - Defining the Next Generation of Life Sciences with AI and eSignatures

12:55 PM — 1:25 PM

IQVIA Innovation Theater: Evolving Clinical Development Approach Amidst a Digital Transformation Wave

12:55 PM — 1:25 PM

PPD, part of Thermo Fisher Scientific Innovation Theater: Accelerating Drug Development Through the Convergence of Real-World Data (RWD) and Technology

1:30 PM — 2:00 PM

AI Enhanced Contact Center: Risks to Consider for Medical and Patient Information Exchange

1:35 PM — 2:05 PM

Deloitte Innovation Theater: Turning Vision into Reality - Realizing the Promise of Next-Gen Regulatory Intelligence

1:35 PM — 2:05 PM

Evernorth Health Services Innovation Theater: Analyzing Online Survey Responsiveness by Demographics and SDOH Metrics

1:35 PM — 2:05 PM

H1 Innovation Theater: Beyond the Numbers - Humanizing Data in Clinical Trials for Inclusive Healthcare Solutions

2:15 PM — 3:15 PM

Causal Inference Methodology in Drug Development

2:15 PM — 3:15 PM

Comparative Perspectives on Regulating AI in Drug Development: US Versus EU

2:15 PM — 3:15 PM

Enhancing the Science of Patient Engagement and Patient Input: What's in the Future?

2:15 PM — 3:15 PM

Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective

2:15 PM — 3:15 PM

ICH M11 Protocol Template: A Global Solution for Global Drug Development

2:15 PM — 3:15 PM

In Vitro Diagnostic/Companion Diagnostics Developments in the US and Impact on Global Programs

2:15 PM — 3:15 PM

Innovation in Manufacturing Globally

2:15 PM — 3:15 PM

Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation

2:15 PM — 3:15 PM

Interactive Safety Graphics in the Regulatory Decision-Making Process

2:15 PM — 3:15 PM

Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines

2:15 PM — 3:15 PM

Shifting Medical Writing Value Propositions with the Use of Technology Tools

2:15 PM — 3:15 PM

The Cost of Moving the Needle on Clinical Trial Representation: Strategies for Diversity Budget Planning and Resourcing

2:15 PM — 3:15 PM

The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA

2:15 PM — 3:15 PM

Unveiling the Secrets of Success: An Executive Panel with Insights to Navigating your Career Journey

3:30 PM — 4:30 PM

Be Creative and Innovative: Top 5 Secrets from Decision Science for You and Your Team

3:30 PM — 4:30 PM

Building Trust in New Alternative Methods in Investigational New Drug Applications

3:30 PM — 4:30 PM

Data and Technology Influence on ICH Initiatives: M4Q(r2)/Q12 and Global Harmonization

3:30 PM — 4:30 PM

Data Insight Generation: Leveraging Data Visualization in Study Planning, Monitoring, Exploration, Reporting, and Submission

3:30 PM — 4:30 PM

Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking

3:30 PM — 4:30 PM

Effective Patient / Industry Collaboration: Valuing Patient Lived Experience To Inform Trial Design

3:30 PM — 4:30 PM

Elevate Leadership: Harnessing the Five Superpowers

3:30 PM — 4:30 PM

Health Canada Town Hall

3:30 PM — 4:30 PM

Impact of Accelerated Pathways on Patients in Five Countries/Regions

3:30 PM — 4:30 PM

Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond

3:30 PM — 4:30 PM

Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents

3:30 PM — 4:30 PM

Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward

3:30 PM — 4:30 PM

Past, Present, and Future: How Industry and FDA are Handling the Evolving Clinical Trial Diversity Regulatory Landscape

3:30 PM — 4:30 PM

Selective Safety Data Collection: As a Tool to Advance Clinical Trial Designs

4:45 PM — 5:15 PM

Certara Innovation Theater: Technology-Enabled Writing - Use CoAuthor™ as your Fully Integrated GenAI Medical Writing Platform

4:45 PM — 5:15 PM

Infosys Innovation Theater: Gen AI Led Innovations for Clinical and Regulatory Landscape

4:45 PM — 5:15 PM

InSilicoTrials Technologies Innovation Theater: Are Human Patients Needed for Clinical Trials, Tomorrow?

8:00 AM — 9:00 AM

Behavioral and Educational Strategies for Avoiding Falsified Medicine Exposure (BE SAFE)

8:00 AM — 9:00 AM

Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications

8:00 AM — 9:00 AM

Considerations for Identification of Drug-Induced Liver Injury

8:00 AM — 9:00 AM

Data Standards SOS: Reducing Burnout and Navigating Through Fatigue - Part 1

8:00 AM — 9:00 AM

Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability

8:00 AM — 9:00 AM

Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making

8:00 AM — 9:00 AM

Feasible Site Feasibility Assessments: Rethinking Business as Usual to Reduce Burden, Timelines, and Costs for Sustainability

8:00 AM — 9:00 AM

Good Data Governance Practices: Regulatory and Industry Perspectives

8:00 AM — 9:00 AM

Leveraging New Meeting Opportunities in PDUFA VII: Experiences with Type D and INTERACT

8:00 AM — 9:00 AM

PMDA Town Hall

8:00 AM — 9:00 AM

Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability

8:00 AM — 9:00 AM

Unlocking Artificial Intelligence's Latest Development: Chat GPT for Beginners

8:00 AM — 9:00 AM

Wearable Sensors and Digital Health Technologies for Tracking Neurological and Neuromuscular Disorders

9:15 AM — 9:45 AM

Clario Innovation Theater: Responsibly Advancing the Use of Artificial Intelligence (AI) in Clinical Trials - Current Landscape, Common Misconceptions, and Future Opportunities

9:15 AM — 9:45 AM

Lokavant Innovation Theater: Prescriptive Study Planning: Optimizing Clinical Trials for Time Efficiency, Cost Savings, and Quality

9:15 AM — 9:45 AM

Zelta by Merative Innovation Theater: Revolutionizing Research - The Impact of Machine Learning and Automation in eClinical Platforms

10:00 AM — 11:00 AM

Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement

10:00 AM — 11:00 AM

Challenges in Exceeding the Quality of Existing Endpoints and Approaches Using Digital Tools

10:00 AM — 11:00 AM

Clinical Trial Enrollment Diversity: Why and How to Engage Community Health Centers

10:00 AM — 11:00 AM

Data Standards SOS: Reducing Burnout and Navigating through Fatigue - Part 2

10:00 AM — 11:00 AM

Effective Patient Engagement in Patient Experience Data: Practical Insights from Case Studies in Hard-to-Reach Populations

10:00 AM — 11:00 AM

External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms

10:00 AM — 11:00 AM

How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics

10:00 AM — 11:00 AM

How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective

10:00 AM — 11:00 AM

Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology

10:00 AM — 11:00 AM

International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation

10:00 AM — 11:00 AM

Long-Term Safety of Approved Medicines: Approaches for Identifying, Characterizing, and Quantifying Delayed Adverse Events

10:00 AM — 11:00 AM

Regulatory Guidance and Papers on Technology Innovations

10:00 AM — 11:00 AM

Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases

11:00 AM — 11:30 AM

Quality in Focus: Diethylene and Ethylene Glycol Challenges

11:00 AM — 12:00 PM

Roundtable Discussion: Innovation in Manufacturing Globally

11:00 AM — 12:00 PM

Roundtable Discussion: Interactive Safety Graphics in the Regulatory Decision-Making Process

11:00 AM — 12:00 PM

Roundtable Discussion: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA

11:15 AM — 11:45 AM

Deloitte Innovation Theater: Drug Safety Unfiltered - Why Isn’t the Needle Moving?

11:15 AM — 1:15 PM

Professional Poster Session 2

11:15 AM — 11:45 AM

Snowflake Innovation Theater: Secure and Efficient Gen-AI to Accelerate Research and Development

11:15 AM — 11:45 AM

UiPath Innovation Theater: AI Powered Automation - Reducing Time to Market for Life Sciences

11:55 AM — 12:25 PM

Fortrea Innovation Theater: Teamwork Makes the Dream Work - How Partnering to Develop Practical Solutions that Address Site and Patient Challenges is Changing the Clinical Trial Landscape

11:55 AM — 12:25 PM

IQVIA Innovation Theater: An Ecosystem Approach to Site Tech Overload

11:55 AM — 12:25 PM

UBC Innovation Theater: RWD Enrichment Studies - Linking Pre and Post-Trial Data to Inform Product Strategy

12:30 PM — 1:00 PM

Practical (and Real) AI and Advanced Automation in New Product Planning and Clinical Development

12:35 PM — 1:05 PM

Flatiron Health Innovation Theater: The Time is Now - Pragmatic Approaches to Prospective Evidence Generation

12:35 PM — 1:05 PM

PCM Trials Innovation Theater: Mastering the Logistics of Mobile Visits in Global Decentralized Trials

12:35 PM — 1:05 PM

ProductLife Group Innovation Theater: Navigating the AI “boom” - A Methodological Framework to Create New Value Streams in your Specific Regulatory Affairs Context

1:15 PM — 2:15 PM

Bridging Randomized Clinical Trials and Real-World Data Utilizing Data Linkage and Tokenization

1:15 PM — 2:15 PM

Enabling Patient Access Worldwide Including Japan or Other Countries to Innovative Drugs Through Global Development Strategy

1:15 PM — 2:15 PM

Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features

1:15 PM — 2:15 PM

Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time

1:15 PM — 2:15 PM

FDA Rare Disease Town Hall

1:15 PM — 2:15 PM

Implementable Approaches to Fully Integrating Patient Engagement Across an Entire Company: Including all Clinical Trials

1:15 PM — 2:15 PM

International Harmonization to Support Pharmaceutical Quality and Lifecycle Management

1:15 PM — 2:15 PM

Platform Technology Designation: Opportunities and Challenges for Implementation

1:15 PM — 2:15 PM

Successful Strategies for Leading and Influencing Without Authority in an Evolving Digital Landscape

1:15 PM — 2:15 PM

The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On

1:15 PM — 2:15 PM

The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle

1:15 PM — 2:15 PM

The State of Clinical Trials in 2024: Are We Making the Grade?

1:15 PM — 2:15 PM

Topics Related to the Oncology Real-Time Oncology Review Process

2:15 PM — 3:15 PM

Roundtable Discussion: Be Creative and Innovative: Top 5 Secrets from Decision Science for You and Your Team

2:15 PM — 3:15 PM

Roundtable Discussion: Good Data Governance Practices - Regulatory and Industry Perspectives

2:15 PM — 3:15 PM

Roundtable Discussion: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability

2:30 PM — 3:00 PM

Arnold Venture Innovation Session: Better Drug Information for Payers, Physicians, and Patients

2:30 PM — 3:00 PM

Milliman IntelliScript Innovation Theater: Pre-Screening for Clinical Trials - The Revolution Starts in 3, 2, 1…

2:30 PM — 3:00 PM

Parexel Innovation Theater: FSP Partnership - A Foundation for Innovation and Patient-Guided Development

2:30 PM — 3:00 PM

Weave Innovation Theater: Minutes, Not Months - How to Draft an Efficient IND

3:15 PM — 4:15 PM

Enhancing Adoption of Innovative Approaches in Clinical Trials

3:15 PM — 4:15 PM

Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare

3:15 PM — 4:15 PM

Exploiting Real-World Data From Social Media in Patient-Focused Drug Development

3:15 PM — 4:15 PM

For Whom the Cell Tolls: Ethics in the Era of Precision Medicine

3:15 PM — 4:15 PM

How to Provide Necessary Medicinal Products to Children?

3:15 PM — 4:15 PM

How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections?

3:15 PM — 4:15 PM

Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium

3:15 PM — 4:15 PM

Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines

3:15 PM — 4:15 PM

Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward

3:15 PM — 4:15 PM

Security the Chain: US Legislative Reforms, Regulatory Actions, and Recommendations to Mitigate Drug Shortages

3:15 PM — 4:15 PM

Something Borrowed Something New for Effective Project Management: Adopting Different Thinking Approaches and New Technologies in Life Science Project Management

3:15 PM — 4:15 PM

Strategies to Make your Clinical Trials More Inclusive for Patients with Disabilities

3:15 PM — 4:15 PM

The Promise of Disease Progression Modeling to Bring Treatments to Patients Sooner

3:15 PM — 4:15 PM

This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice

4:30 PM — 5:30 PM

Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials

4:30 PM — 5:30 PM

ANVISA Town Hall

4:30 PM — 5:30 PM

Charting the Biosimilars Beat Drop: The Latest Updates in the Biosimilars Landscape, Coverage, and Adoption in the US

4:30 PM — 5:30 PM

Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance

4:30 PM — 5:30 PM

FDA's Approach in Harmonized Surveillance for Drugs and Biologics Safety and Quality Data

4:30 PM — 5:30 PM

Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU

4:30 PM — 5:30 PM

Innovation, Agility, and Accessibility in Trial Execution: Collaboration Among Labs, Pharmacies, and Research Enablers

4:30 PM — 5:30 PM

Post-COVID cGMP Inspections by Global Regulatory Authorities

4:30 PM — 5:30 PM

Recent Evolution of the Accelerated Approval Pathway: Impacts on Use and Implementation

4:30 PM — 5:30 PM

Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy

4:30 PM — 5:30 PM

Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox

4:30 PM — 5:30 PM

Shame and Blame: Our Words are a Barrier to Clinical Research are a Care Option

4:30 PM — 5:30 PM

The Value of Project Management in Driving Drug Discovery Success: A Comparison Between Small Versus Large Pharmaceutical Companies

8:00 AM — 9:00 AM

All the Ways Medical Affairs Supports Product Development: From Clinical Trials to Product Launch

8:00 AM — 9:00 AM

Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration

8:00 AM — 9:00 AM

FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”

8:00 AM — 9:00 AM

Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics

8:00 AM — 9:00 AM

How Common Data Models Can Address the Challenges in the Use of Clinical Trial and Real-World Data for Evidence Generation

8:00 AM — 9:00 AM

Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products

8:00 AM — 9:00 AM

Revolutionizing Regulatory CMC and Advanced Manufacturing with the Power of AI: Unleashing Innovation and Efficiency

8:00 AM — 9:00 AM

Risk Minimization in the EU: New Guidance, New Collaborations

8:00 AM — 9:00 AM

Synergizing Large Language Models and Digital Health Technology for Healthcare Transformation

8:00 AM — 9:00 AM

The Future of Women’s Health: Do We Really Want Innovation? Policy Ideas To Advance Innovation, Access, and Novel Approaches

8:00 AM — 9:00 AM

Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge

8:00 AM — 9:00 AM

Which Clinical Outcome Assessment to Choose: Questionnaire or Sensor? Time to Align an Endpoint Selection Framework

8:00 AM — 9:00 AM

WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence

9:15 AM — 9:45 AM

ArisGlobal Innovation Theater: Unleashing the Power of Automation and Understanding the Promise of GenAI in Pharmacovigilance and Regulatory Affairs

9:15 AM — 9:45 AM

HCL Innovation Theater: HCLTech Supercharging Digital Evolution

9:15 AM — 9:45 AM

IQVIA Innovation Theater: Pre-Approval Access - Strategies for Providing Investigational Product to Patients Beyond Clinical Trials

10:00 AM — 11:00 AM

A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived?

10:00 AM — 11:00 AM

AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases

10:00 AM — 11:00 AM

Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products

10:00 AM — 11:00 AM

Defining an Inclusive Clinical Trials Approach in Europe

10:00 AM — 11:00 AM

Driving Capacity Building, Equity, and Geographic Expansion in Clinical Trials

10:00 AM — 11:00 AM

Enabling Innovation and Regulatory Agility to Address Sustainability, Environment, and Climate Goals

10:00 AM — 11:00 AM

Leveraging Testing Results Generated Within Treating Hospitals for Trials Across the Globe

10:00 AM — 11:00 AM

Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products

10:00 AM — 11:00 AM

The ChatBot Will See You Now: Ethical Considerations in Incorporating AI into Informed Consent

10:00 AM — 11:00 AM

Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data

10:00 AM — 11:00 AM

Unlocking the Potential of Pharmacogenomics for Reducing the Burden of Adverse Drug Reactions

10:00 AM — 11:00 AM

Using Data Analytics for Good Pharmacovigilance Practices

11:00 AM — 12:00 PM

Roundtable Discussion: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases

11:00 AM — 12:00 PM

Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation

11:00 AM — 12:00 PM

Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle

11:15 AM — 11:45 AM

Emerging Standards for Novel Excipients

11:15 AM — 11:45 AM

N-Power Medicine Innovation Theater: A Unifying Platform to Unlock the Value of Cancer Patient Data for Both Clinical Trials and Routine Care

11:15 AM — 11:45 AM

OM1 Innovation Theater: Revolutionizing Prospective Studies and Registries with Automation and AI

11:15 AM — 11:45 AM

Syneos Health Innovation Theater: From Formula One to Fortnite - Clinical Trials Fast-Track to Innovation

11:45 AM — 12:15 PM

Informing Clinical Trials with Patient Feedback Through Simulations: An Innovative Methodology

11:55 AM — 12:25 PM

Advisory Board Innovation Theater: What Pharma Marketing and Commercial Teams Need to Do to Build Successful IDN Relationships in 2024

11:55 AM — 12:25 PM

Wipro Innovation Theater: Transforming Literature Management using smart Digital Automation

12:30 PM — 1:00 PM

Real-World Evidence (RWE) for Regulatory and Health Technology Assessment (HTA) Decision Making – Where are we?

12:35 PM — 1:05 PM

Synterex Innovation Theater: AgileWriter - The Adaptive AI Solution for Clinical Documentation

1:15 PM — 2:15 PM

A Clinical Research Workforce in Crisis: Imperatives for a Sustainable Staffing Model

1:15 PM — 2:15 PM

Applying Machine Learning and Artificial intelligence for Predicting Product Profile Approvability (PoPPA)

1:15 PM — 2:15 PM

Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations

1:15 PM — 2:15 PM

Challenges and Solutions to Building the Right Patient-Centered Evidence to Support Fit-For-Purpose Sensor-Based Outcomes

1:15 PM — 2:15 PM

ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development

1:15 PM — 2:15 PM

ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance

1:15 PM — 2:15 PM

ICMRA Post-Pandemic: Regulators Looking into the Future

1:15 PM — 2:15 PM

Leveraging Point of Care Technologies for Near Real Time, Interactive Safety Surveillance: Opportunities and Challenges

1:15 PM — 2:15 PM

Regulatory Considerations in Trial Design for Cell and Gene Therapies

1:15 PM — 2:15 PM

Revolutionizing Quality Management: Harnessing the Power of AI for Enhanced Decision Making and Continuous Improvement

1:15 PM — 2:15 PM

Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates

1:15 PM — 2:15 PM

Unlocking the Puzzle of Borrowing Adult Data for Designing Innovative Hybrid Pediatric Trials

2:15 PM — 3:15 PM

Roundtable Discussion: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience

2:15 PM — 3:15 PM

Roundtable Discussion: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent

2:30 PM — 3:00 PM

DIA Innovation Theater: The 2024 DIA Science Priorities - Inspired by the Original Olympic Games Motto "Faster, Higher, Stronger"

2:30 PM — 3:00 PM

RBQM (Risk-Based Quality Management): What Topics Should be Discussed with Whom in the Room?

3:15 PM — 4:15 PM

A Safety Surveillance Plan for Serious Anticipated Events

3:15 PM — 4:15 PM

EMA Town Hall

3:15 PM — 4:15 PM

Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going?

3:15 PM — 4:15 PM

Harnessing the Power of Artificial Intelligence (AI) in Clinical Research From Knowledge Graphs to Generative AI

3:15 PM — 4:15 PM

Implementing Changes To Drug-Device Combination Products Globally

3:15 PM — 4:15 PM

Improving Communication Across Differences in Drug Development Teams

3:15 PM — 4:15 PM

More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color

3:15 PM — 4:15 PM

Recruitment Optimization in Clinical Trials: Looking Towards an Adaptive Future

3:15 PM — 4:15 PM

Streamlining Processes and Data Exchange Across R&D Functions to Improve Performance and Facilitate Automation

3:15 PM — 4:15 PM

The Intersection of Patient-Experience Data and Benefit-Risk Analysis

3:15 PM — 4:15 PM

Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey

4:30 PM — 5:30 PM

Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices

4:30 PM — 5:30 PM

Critical Appraisal of Artificial Intelligence Solutions for Pharmacovigilance

4:30 PM — 5:30 PM

From X to Z: Unleashing the Power of Multigenerational Collaboration in Life Sciences – The Basics for All

4:30 PM — 5:30 PM

Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework

4:30 PM — 5:30 PM

Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence: An Industry and Regulatory Agency Experience

4:30 PM — 5:30 PM

Middle East and Africa: Emerging Opportunities

4:30 PM — 5:30 PM

Patient-Centric Approaches in Summaries and Data Return

4:30 PM — 5:30 PM

Sustainability of Rare Disease Drug Development

4:30 PM — 5:30 PM

Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation

4:30 PM — 5:30 PM

Using Influencers to Recruit Hard-to-Engage Populations

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