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Monday, June 20
 

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

12:35pm 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 #110: Adaptive Designs Save Time and Money: Regulatory Agencies Accept Them - Why Aren’t They Used More? Room 178 #112: ICH Q2 (R2) and Q14: Can We Realize the Vision for Risk-Based Approvals of Analytical Procedures and Changes? Room 180

1:30pm CDT

#114: Data Integrity Across the Product Lifecycle Room 183 B #117: The Translational Value of Animal Models in Rare Diseases Room 183 C #120: Practical Applications of the Estimand Framework in Novel, Complex Settings Room 185 AB

2:30pm CDT

#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

3:20pm 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 #137: Successful Virtual Partnering Room 186 #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 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
 
Tuesday, June 21
 

9:00am CDT

#202: Innovations in Risk Minimization: Methods, Tools, and Design Approaches Room 176 #201: Transforming PV at the MHRA Room 175 #206: The Future of Content Authoring and Web Portal Technology, Publishing Stability Calculators: Challenges for Pushing Automation Room 470 B #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

10:20am 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

#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

11:15am CDT

#227: Approaching the Assessment of Clinical Protocol Complexity Room 183 C #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

12:00pm CDT

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

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 #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 #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

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

3:50pm 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 #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 #277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry Room 185 AB

5:00pm CDT

DIA Publications Meet and Greet: Overview and Opportunities Room 471 A
 
Wednesday, June 22
 

9:00am CDT

#301: Uses of Artificial Intelligence for PV in the Context of COVID 19 Room 178 #304: Transformation of the Data Manager to the Data Scientist Room 470 B #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

9:15am CDT

#309: Pharmacovigilance Quality: Key Considerations Room 187 #312: COVID-19 360°: Embedding Global Best Practices in Routine Regulatory Action and Preparing for the Next Pandemic Room 184

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

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

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

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 #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 #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 #351: Health Canada Town Hall Room 183 A #353: Planning for the Worst: Approaches for Drug Shortage Avoidance Room 183 B

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

3:50pm 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 #369: Approaches to Addressing Diversity and Inclusion in Clinical Research Room 185 CD #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
 
Thursday, June 23
 

9:00am CDT

#402 RT: Round Table Discussion: Reimbursement, Compensation, and Incentives: Best Practices for Payments to Research Participants Room 375 A Zone 1

10:00am CDT

#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 #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
 
Monday, June 26
 

10:45am CDT

Artificial Intelligence: Delivering on the Promise TBD New Alternative Methods-Only IND Application: Distant Dream or Immediate Possibility? 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

1:30pm CDT

Enhancing the Quality of Safety Data Collection TBD Patient-Reported Outcome Measures to Support Oncology Clinical Development and Labeling: Responding to FDA’s Draft Guidance 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 WHO Town Hall: The New Era of WHO Listed Authorities (WLAs), Reliance in Action, and Country and Regional Focus for Regulatory Systems Strengthening 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

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 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 Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence TBD
 
Tuesday, June 27
 

8:30am CDT

Illuminating Risk Minimization Effectiveness Measurement 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

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 Medical Storytelling Inserted Into All Aspects of Medical Affairs 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 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 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 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 Demystifying the Common Legal Agreements, Key Terms, and Pitfalls for Non-Legal Professionals TBD

4:00pm CDT

Smarter Approaches to Pharmacovigilance Challenges 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 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
 
Wednesday, June 28
 

8:30am CDT

Advancing PV in Africa TBD Using Real-World Data to Evaluate Safety Signals TBD Writing Summary Documents for Rare Disease Submissions: Unique Challenges TBD Leveraging Project Management Skills for Significant Drug Development Deliverables TBD

10:30am CDT

Opportunities to Improve Risk Minimization Outcomes with Behavioral Science 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 Reliance in Action: How to Ensure Product Sameness When Using Global Supply Chains TBD Patient-Focused Drug Development in Rare Disease Endpoint Selections 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 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 Real-World Data: Maximizing Value and Quality Through End-to-End Patient Centricity 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 Regulatory Reliance: Addressing Gaps to Harmonize and Enhance Uptake Globally TBD From 1000's of Tables to Summarizing Clinical Trials Graphically TBD
 
Thursday, June 29
 

8:30am CDT

Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open Sourced Tool 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

9:45am CDT

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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TBD
Virtual
  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
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  • Innovative Trial Design
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