DIA 2022 Global Annual Meeting has ended

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DIA 2022 Global Annual Meeting

10:00am CDT

11A: “Has it Happened Already?” Questions of Precedent from Which Regulatory Intelligence Can Save You Virtual

2:00pm CDT

12P: Defining the Clinical Questions of Interest: Why Everyone Developing a Protocol Should Understand Estimands! Virtual

10:00am CDT

21A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved in Clinical Trials Virtual

2:00pm CDT

22P: Machine Learning in Pharmacovigilance Virtual 23P: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use Virtual

10:00am CDT

32A: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks throughout the Drug Development Lifecycle Virtual 31A: Global AdPromo: Considerations for Compliance and Success Virtual

2:00pm CDT

33P: Presentation of Safety Risks Throughout the Product Lifecycle Framework: Key Findings and Practical Uses Virtual

8:00am CDT

41A: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development Virtual

2:00pm CDT

42P: Become a DCT Master: Understanding the Lifecycle of Decentralized Clinical Trials Virtual

8:00am CDT

Coffee Service Skyline Ballroom Foyer

9:00am CDT

Annual Meeting Orientation Room 470 A

10:00am CDT

#100: Opening Plenary: The Future of Healthcare Room Skyline 375 CDE

11:30am CDT

Luncheon Service Exhibit Hall

11:50am CDT

#101 IT: Advanced Clinical Innovation Theater: Implementing Innovative Patient and Site Engagement Strategies for More Predictable Outcomes Exhibit Hall Theater #2 #102 IT: Syneos Health Innovation Theater: Leveraging the Power of Medical Affairs - Overcoming Obstacles to Optimize Product Development Exhibit Hall Theater #1 #103 IT: Microsoft Innovation Theater: Accelerating Clinical Research - How a New Collaboration is Driving Digital Data Flow Solutions from Protocol Design to Electronic Data Capture Exhibit Hall Theater #3

12:00pm CDT

#01 POS : Poster Session I Level 3 F2 Entrance

12:15pm CDT

#104 CH: What Do Patients Want From Digital Solutions? Considerations for Access, Self Determination of Their Data and Portability Room 470 B

12:35pm CDT

#105 IT: CRIO Innovation Theater: Creating an EMR to EDC Pipeline Through eSource Exhibit Hall Theater #2 #106 IT: IQVIA Innovation Theater: Redefining Patient Centricity in a Post-Pandemic Era Exhibit Hall Theater #1 #107 IT: SAS Innovation Theater: Level Up! Advancing Clinical Trial Operations with Novel Methods and Richer Data Exhibit Hall Theater #3

1:15pm CDT

#108: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP) Room 175 #109: Risk-Based Monitoring in Clinical Trials: An Evolution of Practices During the COVID Pandemic Room 176 #110: Adaptive Designs Save Time and Money: Regulatory Agencies Accept Them - Why Aren’t They Used More? Room 178 #111: The Role of Sensors in Clinical Research: Integrating Sensor Generated Data into Data Platforms to Power Clinical Research and Patient Care Room 179 #112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Based Approvals of Analytical Procedures and Changes? Room 180 #113: Fostering Innovation and Psychological Safety Room 470 A

1:30pm CDT

#114: Data Integrity Across the Product Lifecycle Room 183 B #115: Scientific Communication During a Pandemic: The Ethics of Ensuring Accuracy and Combatting Misinformation Room 186 #116: Incorporating Patient Experience Data in Global R&D Room 183 A #117: The Translational Value of Animal Models in Rare Diseases Room 183 C #118: Real-World Evidence Frameworks Across the World: Three International Perspectives Room 184 #119: Is it Time to Change the Accelerated Approval Pathway? Room 187 #120: Practical Applications of the Estimand Framework in Novel, Complex Settings Room 185 AB #121: Identifying Value and Driving Access to Drug-Based Products Evaluated Using Digital Endpoints Room 185 CD

2:15pm CDT

Refreshment Break Exhibit Hall

2:30pm CDT

#122 CH: Transgender and Non-Binary Patients’ Inclusivity in Clinical Research: How Far Have We Come and Where Are We Going Next? Room 470 A #123 CH: Mastering the Science of Medical Writing Communications Room 470 B Annual Meeting of Members Exhibit Hall Booth #1719 #124 RT: Round Table Discussion: Support of IND Safety Reporting by the Aggregate Safety Assessment Plan (ASAP) Room 375 A Zone 1

2:40pm CDT

#125 IT: PPD, part of Thermo Fisher Scientific Innovation Theater: Patients as Influencers - How Today’s Patients are Shaping Tomorrow’s Clinical Trial Designs Exhibit Hall Theater #1 #126 IT: Medable Innovation Theater: The Real R&D Accelerator Exhibit Hall Theater #2 #127 IT: RWS Innovation Theater: Advancement Through Adversity - How COVID-Driven Innovations are Becoming Best Practices for Pharmacovigilance Exhibit Hall Theater #3

3:00pm CDT

#002 STU: Collective Connections: Networking with Leaders Room 471 A

3:20pm CDT

#128 IT: Castor Innovation Theater: A New Paradigm in CDMS Exhibit Hall Theater #3 #129 IT: Precision for Medicine Innovation Theater: Solving the Unique Central Lab Services Challenges of Precision, Biomarker-Driven Trials Exhibit Hall Theater #1 #130 IT: Deloitte Innovation Theater: Sanofi’s Approach to Automating Adverse Event Case Processing Through Machine Learning and Innovation Exhibit Hall Theater #2

4:00pm CDT

#131: Innovations for Implementing REMS Room 185 CD #132: ICH E2D Update: Innovations in Collecting Safety Data from Disparate Sources Room 175 #133: New Tools for Creating Flexible and Sustainable Master Protocols Room 176 #134: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment Room 178 #135: Demystifying the Delivery of Healthcare Economic Information (HCEI) by Medical Affairs and Market Access Personnel Room 470 B #136: Developing and Implementing a Strategic Framework to Guide Patient Engagement Room 179 #137: Successful Virtual Partnering Room 186 #138: ICH E8(R1): Regulators' Perspectives on Quality-by-Design of Clinical Studies Room 185 AB #140: ICMRA: COVID-19 Response and International Collaboration Room 184 #139: FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences? Room 187 #142: The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management Room 180 #143: A Targeted Learning Framework for Causal Effect Estimation Using Real-World Data Room 183 B #144: Value of Patient Experience Data in Healthcare Decision-Making Room 183 C #145: Design Thinking: The Empathy Map Room 470 A DIA Student Case Competition Presentation Room 471 A

5:00pm CDT

DIA Welcome Reception supported by Change Healthcare Exhibit Hall

5:15pm CDT

#146 IT: Labcorp Innovation Theater: How AI Modeling of Diagnostic Data is Providing Actionable Insights for Difficult to Diagnose Conditions Exhibit Hall Theater #3 #147 IT: Care Access Innovation Theater: The DRO Model for Global Clinical Trials: A Demonstrated Transformation that Delivers Game-Changing Speed, Quality, and Access Exhibit Hall Theater #1 #148 IT: Parexel Innovation Theater: An Ethical Framework to Guide the Development of AI in Clinical Research Exhibit Hall Theater #2

8:00am CDT

Coffee Service Meeting Rm Lobby Level 1

9:00am CDT

#202: Innovations in Risk Minimization: Methods, Tools, and Design Approaches Room 176 #201: Transforming PV at the MHRA Room 175 #203: The Site Landscape: Data and Discussion of the State of the Clinical Research Site Room 178 #204: Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity Room 179 #205: Optimizing Evidence Supporting Fit-for-Purpose Digital Clinical Measures Across the Drug Development Life Cycle Room 180 #206: The Future of Content Authoring and Web Portal Technology, Publishing Stability Calculators: Challenges for Pushing Automation Room 470 B #207: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities Room 183 C #208: Keeping Passion for Project Management Alive Room 470 A

9:15am CDT

#209: New EU Clinical Trial Regulation: Experience So Far Room 184 #210: Challenges of Translational and Early-Phase ASO Development Room 183 B #211: Shifting the Audit Paradigm for a More Effective Outcome Room 186 #212: Where Are We with Antimicrobial Resistance (AMR) in the Regulatory Space? Room 185 AB #213: Reflections on PDUFA: A Look Back at PDUFA VI and A Preview of PDUFA VII Room 187 #214: New Policy Developments in Combination Products Room 185 CD #215: Efforts Toward Global Convergence of CMC and GMP Expectations Room 183 A

10:00am CDT

Coffee Break Exhibit Hall

10:20am CDT

#216 IT: Clario Innovation Theater: Decentralized Clinical Trials - Real Solutions in Real-Time Exhibit Hall Theater #2 #217 IT: Flatiron Health Innovation Theater: Leveraging Access at the Point of Care and Next-Generation Electronic Source (eSource) Technology to Accelerate Clinical Research Exhibit Hall Theater #1 #218 IT: Twilio for Life Sciences Innovation Theater: Delivering Personalized Experiences through Omnichannel Engagement Exhibit Hall Theater #3

11:00am CDT

#219: Post-Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy Room 176 #220: Collection of Quality Endpoint Data in a Decentralized Trial in Complex Indications: The Practical and Logistical Challenges Room 180 #221: Complying with the EU-CTR Disclosure Standards in the Era of GDPR Room 470 B #222: Patient-Focused Drug Development: Reflecting on a Decade of Insights Room 183 A #224: ICMRA Update: Convergence and Collaboration on COVID-19 - Learning from the Present for the Future Room 179 #223: Meeting Regulatory Expectations: What Needs to be Considered When Using Digital Technologies to Generate Clinical Evidence? Room 175 #225: Solving for ‘Shared Value’ of Cell and Gene Therapy with Real-World Evidence in the Post-Pandemic Healthcare Ecosystem Room 178

11:15am CDT

#227: Approaching the Assessment of Clinical Protocol Complexity Room 183 C #226: Simulating Trial Activities with Patients: Our Experiences Room 185 CD #228: Individualized Therapeutics: Walking the Line Between Research and Treatment Room 183 B #230: Asia Town Hall Room 186 #229: Accelerating Cell and Gene Therapy Development Through International Regulator Collaboration Room 185 AB #231: Leveraging Real-World Evidence for Regulatory Purposes Room 187 #232: Preparing for the Future of Research and Development:10-Years of Multistakeholder Innovation, Collaboration, and Transformation Room 184

12:00pm CDT

#02 POS: Poster Session II Level 3 F2 Entrance Luncheon Service Exhibit Hall Community Networking Lunch Exh Hall Community Area

12:25pm CDT

#233 IT: JMP Statistical Discovery Innovation Theater: Interactive Safety Assessment Reports to Aggregate, Filter, and Subgroup Clinical Trial Data Exhibit Hall Theater #2 #234 IT: Labcorp Innovation Theater: The Labcorp Patient Recruitment Ecosystem - Designing a Better Clinical Trial Experience Exhibit Hall Theater #3 #235 IT: Veeva Innovation Theater: Clinical Trials Prepare for a Digital, Connected Future Exhibit Hall Theater #1

12:30pm CDT

#237 RT : Round Table Discussion: Individualized Therapeutics: Walking the Line Between Research and Treatment Room 375 A Zone 2 #236 RT: Round Table Discussion: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment Room 375 A Zone 1

12:45pm CDT

#237.2 CH: Location, Location, Location: Building the Next Generation of Community-Based Clinical Trial Site Networks Room 470 A #237.1 CH: Emerging Editorial Policies, Researcher, and Author Standards in Promoting Diversity, Inclusion, and Equity in Cancer Research Room 470 B #003 STU: Career Ladder or Career Lattice? Strategies for Career Development Room 471 A

1:05pm CDT

#238 IT: Precision for Medicine Innovation Theater: Bridging Clinical Operations and Translational Science to Meet Critical Endpoints in Precision Medicine Trials Exhibit Hall Theater #1 #239 IT: IQVIA Innovation Theater: Delivering Better Outcomes with Connected Intelligence Exhibit Hall Theater #2 #240 IT: Microsoft Innovation Theater: The New Reality of Work in Pharma - How Mixed Reality is Modernizing Operations, Accelerating Research and Improving Patient Engagement Exhibit Hall Theater #3

1:45pm CDT

#241: Drug Safety in Africa: New PV Horizons Room 178 #242: Risk Minimization for Health Products: What are we Learning for an Improved Path Forward Room 175 #244: Planning and Conducting Efficient, High-Quality Decentralized Trials: A Multi-Stakeholder Initiative Room 179 #243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations Room 176 #245: Understanding the Consumer's Journey for Information From Searching for Information to Using Information Room 180 #246: Project Management Across the Healthcare Continuum Room 470 B #247: Paying for Digital Health: What Evidence is Needed? Room 185 CD

2:00pm CDT

#248: Healthcare Datasets as Assets: Secure and Compliant Valuation and Transaction Methods Room 186 #249: Regulatory-Grade Real-World Evidence: Distilling to Practice Room 183 A #250: Patients as Central Partners in COA Design Room 183 C #251: Data Science, Text Analytics, and Machine Learning to Derive Insights from Clinical Quality, Compliance, and Real-World Data Room 183 B #252: International Collaborations: What’s New in Oncology? Room 184 #254: Overcoming Challenges in Pediatric Product Development Room 187 #253: Efforts to Improve Diversity of Clinical Trial Participants Room 185 AB #255: Demystifying Statistical Concepts for Non-Statisticians Involved with Clinical Trials Room 470 A

2:45pm CDT

Refreshment Break Exhibit Hall

3:00pm CDT

#256 RT: Round Table Discussion: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations Room 375 A Zone 1 #257 RT: Round Table Discussion: Enhancing Interactions Among Stakeholders to Advance Patient-Focused Drug Development: Landscape of Current Activities Room 375 A Zone 2

3:10pm CDT

#258 IT: IBM Watson Health Innovation Theater: User Centricity in Clinical Data Management - The Next Revolution for eClinical Solutions Exhibit Hall Theater #2 #259 IT: UBC Innovation Theater: Modernizing Observational Research and Decentralized Studies with Patient Mediated Electronic Medical Record Release Exhibit Hall Theater #1 #260 IT : Appian Innovation Theater: Shape the clinical trials journey by bringing people, process and data together on a unified platform Exhibit Hall Theater #3

3:30pm CDT

#261 CH: How Drug Development Will Change Post-COVID Room 470 A #262 CH: Mentoring 101 Room 470 B

3:50pm CDT

#263 IT: Certara Innovation Theater: Optimizing Patient Narrative Technology - Automating the Complicated and Creating Efficiency Exhibit Hall Theater #1 #264 IT: Veeva Innovation Theater: Defining Digital Trials to Operationalize Decentralized Trials Exhibit Hall Theater #2 #265 IT: M-Files Innovation Theater: Does your Document Management System Support your Growth Trajectory? A Charles River Labs Story Exhibit Hall Theater #3

4:15pm CDT

Poster Showcase Session Room 471 A #267: Improving Safety Data Through Innovative Use of Technology Room 175 #266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs Room 178 #268: Life Science Research Innovation Powered by Real-World Data Room 183 A #269: Strategic Planning in Selecting the Right Countries and Sites for Clinical Trials Room 183 C #270: Recommendations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies Room 180 #271: Building the First Cloud-Based Submission Review Collaboration Platform Room 184 #272: Fit-for-Purpose Patient Preference Studies: Emerging Recommendations from IMI PREFER Room 186 #273: IMPALA (IntercoMPany quALity Analytics) Industry Group: Data Science Development and Other Collaboration Updates Room 470 B #274: Regulatory Convergence Successes and Opportunities Room 179 #275.1: PMDA Town Hall Room 183 B #275: How to Interact with Regulators to Qualify a Digital Mobility Outcome? Room 185 CD #276: Rethinking Fundamental ICH CMC Guidelines: Analytical Procedures, Stability, Specifications, and Risk Assessment Room 176 #277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry Room 185 AB #278: FDA Real-World Evidence Guidance for Regulatory Approval: Implications for Evidence Needs for Payers and Population-Based Decision Makers and Healthcare Providers Room 187 #279: Decision Making and Decision Science;: Learn to Make Better Business and Life Decisions from Patients that Used Decision Science Room 470 A

5:00pm CDT

DIA Publications Meet and Greet: Overview and Opportunities Room 471 A

8:00am CDT

Coffee Service Meeting Rm Lobby Level 1

9:00am CDT

#301: Uses of Artificial Intelligence for PV in the Context of COVID 19 Room 178 #302: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs Room 176 #303: Grappling with Uncertainty: Pediatric Gene Therapy Trials and Ethics Room 470 A #304: Transformation of the Data Manager to the Data Scientist Room 470 B #305: What’s New at ICH? From the E11A Pediatric Extrapolation Guideline to Model Informed Drug Development (MIDD) Room 175 #306: Leveraging Best Practices and Tools from the Discipline of Project Management to Uphold Quality, Protect Patient Safety, and Optimize Financial Budgets in a World of Complexities Room 183 C #307: Improve the Speed and Cost of Clinical Trials With Bayesian Approaches: Unpacked for Non-Statisticians Room 180

9:15am CDT

#308: Community and Patient Engagement: Putting Research into Context Room 183 B #309: Pharmacovigilance Quality: Key Considerations Room 187 #310: BsUFA III and GDUFA III: Increasing FDA’s Authority to Enhance Competition Room 185 AB #311: Ahead of Analyses: Planning, Designing, and Pre-Specifying Observational Studies Room 185 CD #312: COVID-19 360°: Embedding Global Best Practices in Routine Regulatory Action and Preparing for the Next Pandemic Room 184 #313: China Town Hall Room 186

10:00am CDT

Coffee Break Exhibit Hall

10:20am CDT

#314 IT: Datacubed Health Innovation Theater: How Innovations in ePRO Are Powering Better Patient Engagement Exhibit Hall Theater #1 #315 IT: RxTROSPECT Innovation Theater: Oncology - Expediting Strategy Exhibit Hall Theater #2 #316 IT: ATCOR Medical Innovation Theater: Non-Invasive Central BP Monitoring - Improving Efficiency and Success of Drug Development Exhibit Hall Theater #3

11:00am CDT

#317: Let’s Make a PV Agreement: Four Solutions You Can Use to Enhance Your Entire PVA Process Room 175 #318: Rare Disease Data Sharing: A Value Proposition Room 178 #319: Ensuring Diversity in Clinical Trials Room 179 #321: FHIR in Clinical Research Room 180 #320: De-Risking Decentralized: Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials Room 176 #322: Risky Business – The Sequel: Successfully Manage Program-Level Risk Room 470 A #323: Remote GMP Assessments, Inspections and Audits : Here to Stay? Room 186

11:15am CDT

#324: The Value of Medical Writing: The Regulator's Perspective, Development of Professional Medical Writers as Successful Leaders Room 183 C #325: Assessing and Integrating Patient Preferences into Treatment and Clinical Trial Design Room 183 A #326: China’s Biopharma Innovation Landscape and Trends Room 187 #327: New Approaches to Inspections Room 185 AB #328: Approaches to Health Authority Collaboration: Are They Fit-for-Purpose and How Should They Evolve Post-Pandemic? Room 183 B #329: Complex Innovative Design: What’s in Name? A Global Perspective on the Changing Design Landscape Room 185 CD #330: Leveraging Real-World Evidence to Address Diversity Gaps in Randomized Clinical Trials: Regulatory, Clinical, and Other Considerations Room 184

12:00pm CDT

Luncheon Service Exhibit Hall

12:25pm CDT

#331 IT: IQVIA Innovation Theater: Real World Evidence (RWE) to Enhance Clinical Development Exhibit Hall Theater #1 #332 IT: Deloitte Innovation Theater: Ushering in Next-Gen Regulatory Intelligence Exhibit Hall Theater #2 #333 IT: Curebase Innovation Theater: Learning by Doing - An Analysis of a Curebase DCT Patient Experience Exhibit Hall Theater #3

12:30pm CDT

#334 RT: Round Table Discussion: The Value of Medical Writing: The Regulator's Perspective, Development of Professional Medical Writers as Successful Leaders Room 375 A Zone 1 #335 RT: Round Table Discussion: Value of Patient Experience Data in Healthcare Decision-Making Room 375 A Zone 2

12:45pm CDT

#336 CH: Reviewing FDA's Draft Guidance on PROs in Oncology Trials: How This Affects Future Measurement Strategy and Study Designs Room 470 B #005 STU: Hashtag Your Way to a Job: How to Use Social Media to Promote Yourself and Start Your Career Room 471 A

1:05pm CDT

#337 IT: Yseop Innovation Theater: Automate Medical Writing with Artificial Intelligence (AI) Exhibit Hall Theater #3 #338 IT: Evernorth Innovation Theater: Trends in Behavioral Health - Effects of Telehealth, Medications, and Outpatient Treatment on Total Cost of Care Exhibit Hall Theater #2 #339 IT: Parexel Innovation Theater: FSP Futureview - Building Infrastructure and Talent for a Flexible Future Exhibit Hall Theater #1

1:45pm CDT

#340: Monitoring COVID-19 Vaccine Safety Room 178 #342: Democratizing Data for Cancer Research and Real-World Evidence Generation Room 176 #341: New Approaches to Site Selection in Clinical Trials Room 175 #343: Redefining the Value Proposition for Innovation: Connecting Data, Technology, and Quality to Improve Outcomes Room 179 #344: Managing Up and Managing Down: Developing and Advocating for Your Medical Writing Team Room 470 A #345: Statistical Issues in Master Protocols: Beyond Type I Error and Concurrent Controls Room 180 #346: New Global Team: Building and Leading Remote Teams and Non-Fulltime Equivalents (FTEs) Room 470 B

2:00pm CDT

#347: Enabling Digital Transformation in Health Care and Clinical Trials Room 184 #348: Research and Innovation to Enhance Patient Access to Topical Dermatological Products in the US Room 185 AB #349: The Power and Uncertainty of Data: How it Can be Used to Drive Efficiency While Recognizing its Limitations Room 186 #350: The Transformation of Quality Assurance: The Roadmap Room 185 CD #351: Health Canada Town Hall Room 183 A #352: FDA Rare Disease Town Hall Room 187 #353: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 183 B #354: How Can Population Decisions Makers and Pharmaceutical Companies Engage Collaborative Research? Room 183 C

2:45pm CDT

Refreshment Break Exhibit Hall

3:00pm CDT

#355 RT: Round Table Discussion: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs Room 375 A Zone 1 #356 RT: Round Table Discussion: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 375 A Zone 2

3:10pm CDT

#357 IT: Labcorp Innovation Theater: Transforming the Patient Experience in Decentralized Clinical Trials Exhibit Hall Theater #3 #358 IT: Axiom Innovation Theater: Saving Patient Lives – The Value of Time Exhibit Hall Theater #1 #359 IT: Calyx Innovation Theater: Meeting Regulatory Expectations on IRT Data Ownership Exhibit Hall Theater #2

3:15pm CDT

#360 CH: Considerations for Establishing Meaningful Change for Digital Endpoints Derived From DHT Drug Development Tools Room 470 A #361 CH: Separating the AI Hype From Reality: A Primer on NLP (Natural Language Processing) Room 470 B

3:50pm CDT

#362 IT: PointClickCare Innovation Theater: LTPAC EHR Data - Patients Included! Exhibit Hall Theater #1 #363 IT: ZS Innovation Theater: Shaping the Future of Clinical Development - A Novel Approach for Today’s Siloed Model Exhibit Hall Theater #3 #364 IT: Florence Healthcare Innovation Theater: Design Better Trials with Always-On Connectivity to Sites - A Case Study Exhibit Hall Theater #2

4:15pm CDT

#365: Field of Dreams: If We Build it, Will they Come? Using Implementation Science to Improve Digital Risk-Minimization Tools Room 175 #366: Development of Standard Core Sets of Clinical Outcome Assessments and Related Endpoints Room 178 #367: Local Conduct for Global Clinical Trials: Focus on Japan, Latin America, and Africa Room 176 #368: Sneak Peak: First Share from Initiatives of a Global Collaboration to Address Barriers to Decentralized Trial Scale and Adoption Room 183 A #370: Where Are we Really on Data Interoperability? Room 185 AB #369: Approaches to Addressing Diversity and Inclusion in Clinical Research Room 185 CD #371: Reimbursement, Compensation, and Incentives: Best Practices for Payments to Research Participants Room 180 #372: Accelerating Innovation Through Investing Room 186 #373: Effective Oversight Strategies of CROs and Digital Technology Vendors: How to Comply with Health Authority Expectations Room 183 B #374: Around the World: Regulator Perspectives on Decentralized Clinical Trials Room 184 #375: The Global Impact of ORBIS: Case Studies and Perspectives Room 187 #376: How to Manage Device Design Changes Under EU MDR Room 183 C #377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives? Room 470 B #378: US Health Care System Adoption of a Class of New Technologies for the Treatment of Alzheimer’s Disease: Access Challenges and Opportunities Room 179 #379: Search Within: Maximize your Strengths and Possibilities Room 470 A

8:00am CDT

Coffee Service Meeting Rm Lobby Level 1

9:00am CDT

#007 STU: It’s About the Journey Not the Destination: Lessons Learned in Professional Development Room 471 A #402 RT: Round Table Discussion: Reimbursement, Compensation, and Incentives: Best Practices for Payments to Research Participants Room 375 A Zone 1

9:15am CDT

#403 CH: Who Should Be in the Room to Discuss Risk-Based Quality Management (RBQM) for a Clinical Trial Protocol? Room 470 A

10:00am CDT

#404: Combination Product Safety: A Journey of Organizational Transformation Room 175 #405: How the Heck do I Get this Digital Endpoint to Work in my Clinical Trial? Nuts and Bolts for Trials Teams Room 176 #406: The PCORnet Response to COVID-19: The Importance of Partnerships, Data, and Digital Innovations to Provide Fast Answers Room 178 #407: Methodologies Used to Aggregate Real-World Data and Clinical Trial Data Room 179 #408: Writing at Lightspeed: Optimizing Submission Dossiers in Today’s Environment Through Better Processes, Planning, and Technology Room 180 #409: How to Build and Support a Culture that Values Critical Thinking and Open, Proactive Dialogue About Quality Room 185 AB #410: Addressing Gaps in the Use of Real-World Evidence for Regulatory Decision-Making Room 187 #411: FDA Oncology Center of Excellence’s Real-Time Oncology Review Program: 2022 Update Room 183 A #412: Novel Visualization Tools for Safety Assessment: An Initiative Based on Multidisciplinary Collaboration Room 185 CD #413: Where Next? Targeting Value Assessment and Contracting Optimizing Adoption, Use, and Payment for Technologies and Therapies in Care Room 183 C #414: Optimizing the Pharma Workforce for Trial Success in the Digital Era Room 470 B #415: EMA-FDA Question Time Room 184

11:00am CDT

Coffee Break Meeting Room Lobby

11:30am CDT

#416: FDA Town Hall Room 184

9:30am CDT

11A: Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use TBD

1:00pm CDT

12P: Understanding the Bayesian Approach in Decision Making for Anyone Involved in Clinical Trial Design or Interpretation TBD

9:30am CDT

21A: Signal Management in Pharmacovigilance TBD

1:00pm CDT

22P: Global Labeling: The Basics of Core Datasheet TBD

9:00am CDT

31A: Introduction to Cell and Gene Therapies: Specific Regulatory, CMC, Non-clinical and Clinical Requirements and Considerations TBD

1:00pm CDT

32P: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials TBD

10:45am CDT

Artificial Intelligence: Delivering on the Promise TBD Risk-Based Monitoring in Clinical Trials: A Four Year Analysis TBD Sponsor-CRO Collaborations and the Impact of Decentralized Clinical Trials TBD Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation TBD What’s in the Future for Global Advancements in Patient Engagement and Patient-Focused Medical Product Development? TBD New Alternative Methods-Only IND Application: Distant Dream or Immediate Possibility? TBD ICH E6 R3 Forum: Highlights of What's new and What Changed Regarding Sponsor Responsibilities TBD Cell and Gene Therapies Pulse Check TBD Diversity and Inclusion Implications for Global Regulatory TBD E9(R1) Implementation: Practical Applications of Using Estimands in Protocols, SAPs, Data Standards in Clinical Trials and NDA/BLA Submissions to FDA TBD Applying Implementation Science Methods to Generate Evidence to Improve Access to New Therapeutics: What has Been Learned? TBD Negotiating your Next Offer TBD

1:30pm CDT

Enhancing the Quality of Safety Data Collection TBD Can We Further Innovate Clinical Trial Designs? Lessons Learned and Future Opportunities TBD Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance TBD Building Trust: Data Privacy in Decentralized Clinical Trials TBD Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance TBD Consent is the Oil of Customer Engagement: How to Keep the Omnichannel Engine Running TBD Patient Involvement Optimizes Clinical Protocol Design: Real-World Experiences and Insights TBD Contemporary Challenges in Personalized Medicine and Companion Diagnostics TBD Unleashing the Fearless Quality Professional TBD Combating Misinformation with Authoratative Medical Product Information TBD Novel Biomarkers and Surrogate Endpoints in a Rare Disease TBD WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening TBD International Collaboration for Pharmaceutical Quality and Manufacturing Agility TBD Advances in Real-World Evidence: Randomized Clinical Trials Duplicate, Publication Scandal, and China’s Real-World Evidence Heaven TBD Do Surrogate Endpoints Expedite or Hinder Payer Coverage of Drugs? TBD

4:15pm CDT

Utilizing Wearable Biosensors to Better Manage Patient Safety During Immuno-Oncology Studies TBD Enabling the Use of Randomized Pragmatic Studies to Generate High Quality Real-World Evidence for Regulatory Decisions TBD What Patients and Care Partners are Saying about Hybrid and Decentralized Trials TBD Digital Endpoint Qualifications in Clinical Trials: Collaborations and Applications TBD The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology TBD Best Practices in Effective Gathering of Medical Information Industry Insights TBD How to Assess and Implement Patient Preferences in Decision-Making Along the Medical Product Life Cycle? TBD What's Next in Precision Medicine? Translational Strategies for Dose Optimization in the Age of Project Optimus TBD One Year On: How Quality Briefs are Transforming the Approach to Quality and Driving Innovation to Serve Patients TBD Emerging Therapies and Technologies and Leveraging Opportunities for Engaging with Medicine Regulators to Support Innovation TBD Regulatory Cooperation, Coordination, and Reliance in Times of Crisis: The ICMRA Role TBD The Promise of Vaccine Platforms to Advance Regulatory Science: Where are we Now, Where are we Going, and How do we get There? TBD Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence TBD Supporting Providers in Value-Based Contracts: Machine Learning and Recursive Neural Networks for Outcomes and Treatment Journey Optimization TBD Creating your Career Plan 101: A Practical Workshop TBD

8:30am CDT

Illuminating Risk Minimization Effectiveness Measurement TBD Ethical Considerations for Conducting Research During Times of Disruption TBD Innovating Patient Recruitment Through Pharmacy Channels TBD ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange TBD The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives TBD Innovation Across Medical Affairs Throughout the Global Pandemic TBD Leveraging Analytics, Visualizations, and Decision Science to Drive Strategic Decision Making TBD International Regulatory Convergence and Collaboration TBD Pediatrics and the Paradox of Progress: What’s New, What’s Next, What’s Needed? TBD Office of Generic Drugs/Office of Pharmaceutical Quality Town Hall TBD

10:30am CDT

Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report TBD Good Recruitment Practice Under Regulation (EU) No 536/2014 TBD The Future of Regulatory Submissions: Opportunities and Challenges TBD Medical Storytelling Inserted Into All Aspects of Medical Affairs TBD Disrupting the Status Quo: Best Practices for Bringing Together Patients and Medical Staff to Positively Impact Trial Diversity TBD The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) Collaboratory: Facilitation of Medical Product Development for Rare Diseases TBD IMPALA (IntercoMPany quALity Analytics) Industry Consortium: Quality Analytics Use Cases and Early Health Authority Feedback TBD ANVISA Townhall TBD International Harmonization of Real-World Data/Real-World Evidence Use and Acceptance by Health Authorities: Time to Make it Right! TBD Patient Experience Data in the Label: Closing the Loop TBD Post-Pandemic Regulatory Innovation for Clinical Trials and Opportunities for Global Alignment TBD A Regulatory Pharmaceutical Quality Knowledge Management System to Improve the Availability of Quality Medicines TBD The Full Picture: Innovative Software Tools for Data Insight Generation TBD Is Mark Cuban Really Solving the Drug Pricing Problem? TBD

1:15pm CDT

Novel Methods for Signal Identification for Medicines and Medical Devices TBD Hot off the Press: Site Challenges and Solutions in Workforce and Technology TBD Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape TBD Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives TBD Tech-Enabled Narratives: Technology Meets Process FTW (For the Win!) TBD Measuring Impact of Patient Engagement Across Research and Development TBD Using Artificial Intelligence to Illuminate Predictive Relationships and Discover Biomarkers from Clinical, Molecular, and Digital Data TBD Getting Things Done in Drug Development Using Agile Practices TBD Pharmacovigilance: Regulator's Perspectives on Quality Approaches to Additional Risk-Minimization Measures and Post-Pandemic Inspection Reflections TBD Asia Town Hall TBD Implementing Digital Health Technologies in Clinical Trials: How to Apply New Resources to Address Key Questions TBD One Dossier and One Timeline for a Post Approval Change: The Story of a Regulatory Reliance Pilot! TBD Quality in the Real World: Diagnosing and Addressing Inaccuracies and Gaps in Routinely Collected Patient Data TBD The Inflation Reduction Act Price Setting: What are the Impacts on Biopharmaceutical Innovation from Different Perspectives? TBD Demystifying the Common Legal Agreements, Key Terms, and Pitfalls for Non-Legal Professionals TBD

4:00pm CDT

Negotiating your Way Through the Vigilance Agreement Maze: Is There a Better Way? TBD Smarter Approaches to Pharmacovigilance Challenges TBD Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers and Clinical Care? TBD The Many Faces of In-Trial Interviews: Navigating Operational and Scientific Waters to Optimize Value for Clinical Trials TBD IDMP and Data Harmonization Methods: How Your Company will be Impacted TBD SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data TBD Generating Patient Insights to Inform Health Policy Issues: Policy Patient Engagement Research Councils (PERCs) TBD An Assessment of the Challenges Associated with Cell and Gene Therapies: Are Digital Health Technologies the Way Forward? TBD Data Analytics for Quality Assurance: Shifting the Paradigm from Issue Detection to Quality Evidence Generation TBD Globally Accelerating the Drive to eLabeling for All TBD PMDA Town Hall TBD Quality Aspects of FY23-28 User Fee Agreements TBD Patient-Preferences and Multistate Models to Enhance Patient-Focus of Traditional Endpoints in Oncology TBD Improving Patient Access with Real-World Evidence: A Framework for Coverage and Formulary Decisions TBD

8:30am CDT

Advancing PV in Africa TBD Using Real-World Data to Evaluate Safety Signals TBD Returning Individual Participant Data: A Cultural and Operational Shift Towards Personalized Clinical Trial Options TBD Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making TBD The Rapidly Changing Landscape of Data Collection and its Implications for Clinical Data Management TBD Writing Summary Documents for Rare Disease Submissions: Unique Challenges TBD Leveraging Project Management Skills for Significant Drug Development Deliverables TBD Strategies for Benefit-Risk Analysis in Regulatory Submissions TBD Strategies to Make the Right Virtual Connection: Play and Learn TBD

10:30am CDT

Opportunities to Improve Risk Minimization Outcomes with Behavioral Science TBD Registries Aren’t Always the Answer: Novel Designs for Executing Post-Market Pregnancy Requirements TBD Best Practices for Managing Rare Disease Trials in Latin America as an Emerging Trial TBD Leveraging Data Scientists and Data Managers with Evolving Protocol Designs TBD Operationalizing Real-World Data: Methods, Acceptance, and Future Hopes TBD Is the Hype Real? Real-Life User Experience of Medical Writing Artifcial Intelligence Tools for Clinical Study Reports Production TBD Combining Qualitative and Quantitative Research to Generate Within-Patient Meaningful Changes in Clinical Outcome Assessments TBD What Can ICH Bring to the Future of Model-Informed Drug Development (MIDD)? TBD PI 1572 Responsibility and Oversight in Decentralized Clinical Trials TBD 25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness? TBD Dose Optimization in Oncology: How Do we Tackle the Tricky Topic of Combinations? TBD Health Canada Town Hall TBD Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains TBD Patient-Focused Drug Development in Rare Disease Endpoint Selections TBD How Real-World Data from Wearable Biosensors and Artifical Intelligence (A)I-Based Analytics Is Enabling the Shift from Efficacy to Effectiveness TBD

1:15pm CDT

Operationalizing FDA Medical Queries TBD Regulatory Insights into Decentralized Clinical Trials TBD Today’s Episode of Clinical Research Talk Explores Clinical Adjudication and Practical Applications of Artifical Intelligence and Natural Language Processing TBD Managing BYOD and Wearables in Clinical Trials: Sustainable Data Collection TBD Estimands and Designing of the Clinical Trial and Protocol Structure TBD Capturing the Patient Voice Using Longitudinal Qualitative Research Methods in Medical Product Development TBD Fostering Cross-Functional Team Success with Project Management and Alliance Management Best Practices TBD Industry and Regulators’ Experience with the Implementation and Use of Remote Consent TBD FDA Rare Disease Town Hall TBD The Future of Biosimilar and Interchangeable Biologics: Global Development, Harmonization, and the Inflation Reduction Act TBD Evolving Global Landscape for Addressing Drug Shortages: Innovative Strategies in the Area of Regulatory and Technology TBD Opportunities and Issues with Existing Analytical Technologies for Safety Monitoring of Ongoing Clinical Studies TBD Real-World Data: Maximizing Value and Quality Through End-to-End Patient Centricity TBD Performance, Interrupted: Examining Diversity, Equity, and Inclusion Dynamics that can Impact Team Performance in Drug Development TBD

4:00pm CDT

Assessing Safety in Rare Disease Gene Therapy TBD Modernizing the Clinical Trials Environment in Europe: ACT EU and the New EU Clinical Trial Regulation TBD Patient-Generated Health Data and Real-World Evidence: How Can They Be Used to Accelerate Patient Engagement and Diversity? TBD Leading Cross-Functional Teams Through Mergers, Divestments, and Acquisitions TBD Quality by Design for Real-World Evidence Studies TBD Mobilizing Cooperation with the African Medicines Agency TBD Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally TBD Patient and Quality Impacts of Restrictions on the Use of Titanium Dioxide (TiO2) in Medicines TBD From 1000's of Tables to Summarizing Clinical Trials Graphically TBD Critically Thinking Organization: An Action-Oriented Workshop for Leaders TBD

8:30am CDT

Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open Sourced Tool TBD Effective Use of Intelligent Automation in Clinical and Regulatory TBD A Global Sponsor Perspective on Implementation of the New EU Clinical Trials Regulation TBD The Value of Patient-Centric Communication Strategies TBD Crafting the Message: Driving Drug Development Through Compelling Governance Interactions TBD FDA Sponsor Interaction: Best Practices and New PDUFA Formal Meetings TBD International Medical Device Regulators Forum (IMDRF) and Technological Innovation: How International Medical Device Harmonization is Impacting Drug Strategy TBD Demystifying Statistical Concepts for ANYONE Involved with Clinical Trials TBD

9:45am CDT

Reporting of Pre- and Postmarket Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B Standards TBD The Other Side of the Table: Drug Development Professionals Share Their Experiences Participating as Patients in Trials TBD Process Automation and Artificial Intelligence in the Field: Practical Applications TBD Statistical Applications of Machine Learning (ML) and Artificial Intelligence (AI) in Drug Development and Success Stories of Application TBD

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Exh Hall Community Area
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01 - Clinical Safety and Pharmacovigilance
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