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DIA 2018 Global Annual Meeting
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00: Plenary
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01: ClinSafety-PV
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02: ClinTrials -ClinOps
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Workshop
03: Data-Data Standards
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Workshop
04: MedAffairs-SciComm
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05: Patient Engagement
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06: PreClin Dev-EarlyPhaseCR
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07: ProjMgt-StrategicPlanning
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Workshop
08: R and D Quality-Compliance
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Workshop
09: Regulatory
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10: RegCMC-Product Quality
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Session
Workshop
11: Statistics
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Workshop
12: Value-Access
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13: DIAmond
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14: InnovTheater
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15: Engage-Exchange
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16: Content Hubs
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17: Community Rounds
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18: ProfDevelopment
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19: Posters
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Poster Presentation
Networking-CommunityEvents
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Social Event
Short Course
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Featured Topics
Biomarkers - Diagnostics
Biosimilars
Career Development
Devices and Combination Products
ExUS Regulatory
Gene Therapy
Generics
Mobile Technology
Outsourcing
Pediatrics
Rare Diseases
Real World Evidence
Regulatory Agency Presenters
Translational Science and Medicine
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Sunday
, June 24
Commonwealth Room Westin
10:30am •
#000: Emerging Professionals and Student Forum
North Lobby
8:00am •
Registration for Full Day and Morning Preconference Short Courses
8:00am •
Exhibitor Registration
12:30pm •
Registration for Afternoon Preconference Short Courses, Conference Attendees, and Speakers
Room 157C
8:30am •
#20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?
Room 158
8:30am •
#21: The IDMP Challenge: Points to Consider for Pharmacovigilance Departments
Room 159
8:30am •
#22: Protocol Co-Design with Patients and Advocates
1:00pm •
#34: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
Room 160A
8:30am •
#23: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
1:00pm •
#30: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Room 160B
8:30am •
#24: Preparing for a US FDA Advisory Committee Meeting
1:00pm •
#31: Machine Learning in Pharmacovigilance
Room 160C
8:30am •
#25: Precedent: A Driver of Regulatory Strategy
1:00pm •
#37: Data Visualization in the Life Sciences
Room 161
8:30am •
#27: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment
1:00pm •
#33: Quality Tolerance Limits/Issue Management: Taming the Beast of Clinical Development Risk
Room 162A
8:30am •
#28: Preparing Documents for Disclosure and Public Sharing
1:00pm •
#35: FDA Advisory Committee Purpose and Noninferiority Case Study: Rivaroxaban
Room 162B
8:30am •
#29: Leadership: How to Organize and Lead People in a Work Group
1:00pm •
#36: Value Pricing Bootcamp: A Crash Course in How to Use Real World Evidence to Better Measure Outcomes and Evaluate New Innovative Therapies
Room 252AB
3:00pm •
#001: Effective Use of Social Media
4:15pm •
#002: The Power of Networking
Room 253C
9:00am •
#40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm
Room 256
9:00am •
#42: Back to the Future: Combination Products in the 21st Century
Monday
, June 25
Ballroom
8:30am •
#100: Opening Plenary Session and Keynote Speaker
Community Zone NE Lobby
1:45pm •
#133: DIA Good Clinical Practices and QA Community Round Table Discussion: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity
1:45pm •
#134: DIA Medical Writing Community Round Table Discussion: Scientific Communication Key Message Development, Management, and Dissemination
Content Hub NE Lobby
10:30am •
#104: LinkedIn Review
12:30pm •
#126: EU Global Data Protection Regulation and Impact on US Companies
1:15pm •
#129: Using Quality-Inspired Dashboards to Track Patient Engagement
2:00pm •
#136: Drug Safety: A Continuum Approach Linking Pre-Market and Post-Market Safety Assessment
E and E Exhibit Hall
10:15am •
#103: Networking Do's and Don'ts
12:30pm •
#125: Organizational Change and Knowledge Management for Cybersecurity Threats
1:45pm •
#132: New Approaches, Novel Endpoints, and Next-Generation Trials
Exhibit Hall
10:00am •
Exhibit Hall Open
10:00am •
Coffee Break
12:00pm •
Luncheon Service
4:30pm •
Opening Reception
4:30pm •
Opening Reception
North Lobby
7:00am •
Attendee, Speaker, and Exhibitor Registration
7:30am •
Coffee and Light Refreshments
Posters Exhibit Hall
10:00am •
Student Poster Session
Room 151AB
11:00am •
#113: Patient-Focused Medicines Development: Where It has Led Us to Today, What Challenges Remain, and What Do We Still Need to Do to Achieve Success?
3:00pm •
#147: Facilitating Nonclinical Data-Sharing and Access Across the Industry
Room 153ABC
11:00am •
#114: A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases
3:00pm •
#145: A New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors
Room 156ABC
11:00am •
#115: Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval
3:00pm •
#146: Development of Microbiome-Derived Therapeutics
Room 157AB
11:00am •
#123: Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge
2:00pm •
#135: On the Soapbox: Right to Try
Room 204AB
11:00am •
#119: ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017
3:00pm •
#153: New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges
Room 205AB
11:00am •
#118: How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making?
3:00pm •
#151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future
Room 205C
11:00am •
#117: Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D
3:00pm •
#149: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
Room 206AB
11:00am •
#120: FDA Innovation in Pharmaceutical Quality Assessment and Inspection
3:00pm •
#152: FDA Expectations for Demonstration of Interchangeability
Room 208
11:00am •
#110: Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research
3:00pm •
#150: TFDA Town Hall
Room 209
11:00am •
#111: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity
3:00pm •
#143: Applying Artificial Intelligence, Machine Language, Natural Language Processing, and Predictive Models in Clinical Trials to Deliver Value to Stakeholders
Room 210AB
11:00am •
#124: Analyzing Innovations Progress in the Gottlieb Era
3:00pm •
#156: International Regulatory Convergence
Room 210C
11:00am •
#112: Scientific Communication Key Message Development, Management, and Dissemination
3:00pm •
#144: The Evolving Biosimilars Landscape: A Medical Affairs Perspective
Room 252AB
7:30am •
Annual Meeting Orientation
11:00am •
#122: Contracting for Value: From Outcomes-Based Contracts to Bundled Payment Programs: What’s Working and Why
3:00pm •
#155: Real World Evidence for Value and Access
Room 253AB
11:00am •
#105: Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model
3:00pm •
#140: How Inspection-Ready is Your Organization?
Room 253C
11:00am •
#106: Signal Management: Separating Needles From Haystacks
3:00pm •
#139: Novel Approaches to Pharmacovigilance Collaboration
Room 254AB
11:00am •
#116: Culture: The Link Between Team Culture and Productivity - An Interactive Workshop
3:00pm •
#157: Courageous Leadership
Room 256
11:00am •
#121: Use of Historical Information in Clinical Trial Design
3:00pm •
#154: Bayesian Application in Small-Sized Clinical Trials
Room 257AB
11:00am •
#107: The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials
3:00pm •
#141: eSource: The Road to Real World Evidence – Are We There Yet?
Room 258AB
11:00am •
#108: From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design
3:00pm •
#142: Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes
Room 258C
11:00am •
#109: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials
3:00pm •
#148: Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific
Theater 1 Exhibit Hall
10:15am •
#101: PAREXEL International Innovation Theater: Innovation’s Greater Purpose - How Technology Can Increase Commercial Success
12:45pm •
#127: IQVIA Innovation Theater: Re-imagine Clinical Development with Human Data Science
1:30pm •
#130: PAREXEL International Innovation Theater: The Innovation Imperative: The Future of Drug Development
2:15pm •
#137: DiagnoSearch Life Sciences Innovation Theater: Disruptive Innovation - ‘Wide-Angle-Data’ - Intuitive Algorithms and Artificial Intelligence for Real-time Safety and Risk Management
4:45pm •
#158: Advanced Clinical Innovation Theater: Preparing for the Next Generation of Clinical Research
5:30pm •
#160: Cognizant Innovation Theater - Powering New Possibilities for Site-Sponsor Collaboration with the Shared Investigator Platform in partnership with TransCelerate
Theater 2 Exhibit Hall
10:15am •
#102: Deloitte Innovation Theater: Engage. Innovate. Execute. - How Digital Technologies are Transforming Clinical Development
12:45pm •
#128: PPD Innovation Theater: Reimagining Study Planning and Feasibility to Create More Efficient Clinical Trials
1:30pm •
#131: Covance Innovation Theater: Evidence-Based Approaches to Accelerating Patient Recruitment and Improving Patient Retention
2:15pm •
#138: SAS Institute Innovation Theater: Real World Evidence - Better, Faster, More!
4:45pm •
#159: ArisGlobal Innovation Theater: A Clinical Perspective - How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma - Introducing LifeSphere from Clinical to Regulatory
5:30pm •
#161: Appian Innovation Theater: Moving beyond Cloud with Digital Transformation to Unify Process, Connect Data, and Turbocharge Innovation
Tuesday
, June 26
Ballroom Lobby 3
12:00pm •
DIA Community Luncheon
Community Zone NE Lobby
9:30am •
#221: DIA Regulatory Community Round Table Discussion: Artificial Intelligence: The Future of Regulatory Affairs
9:30am •
#222: DIA Patient Engagement Community Round Table Discussion: New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors
2:00pm •
#269A: DIA Regulatory Community Round Table Discussion: Global Regulatory Strategies for Biosimilars
3:15pm •
#270: DIA Medical Writing Community Round Table Discussion: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications
3:15pm •
#271: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management - New Directions
4:30pm •
#295: DIA Devices and Diagnostics Community Round Table Discussion: Navigating the Regulatory Landscape of Drug-Device Combination Products
4:30pm •
#296: DIA Medical Writing Community Round Table Discussion: CTD Regulatory Defense Strategies - How Best to Prepare Your Response to Health Authority Queries
Content Hub NE Lobby
9:15am •
#219: FDA Warning Letters on Data Integrity
10:00am •
#225: Building a Dynamic Presentation: Rethinking Audience Engagement
1:30pm •
#250: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials
3:30pm •
#273: DIA Insights: Latest Global Healthcare Coverage and How to Get Published
DIA Booth #1519 Exh Hall
3:30pm •
Annual Meeting of Members
E and E Exhibit Hall
9:30am •
#220: Brexit: Practical Real-World Solution Planning
12:00pm •
#244: Yes, No, Maybe: Sharing Health and Other Data for Research - Enthusiasm and Concern from the Patient Community
1:15pm •
#249: Global Evolution in Regulatory Science and Medicine: Novel Modalities and Intersection with Rare Disease Development
2:15pm •
#269B: Avoiding Rejection on your "First Date" with EMA Policy 0070
3:30pm •
#272: LinkedIn Profile Exchange Review
Exhibit Hall
9:00am •
Exhibit Hall Open
9:00am •
Coffee Break
11:30am •
Luncheon Service
3:00pm •
Refreshment Break
North Lobby
7:00am •
Attendee, Speaker, and Exhibitor Registration
7:00am •
Coffee and Light Refreshments
Posters Exhibit Hall
9:00am •
Professional Poster Session 1
Room 151AB
8:00am •
#206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making
10:30am •
#233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives
2:00pm •
#258: Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels
4:15pm •
#284: Using Advocacy Partnerships to Improve Real World Evidence in Clinical Trials
Room 153ABC
8:00am •
#208: Effective Management of Internal Stakeholders and External Strategic Partners from Multiple Perspectives: Non-Profit, CRO, and Pharmaceutical Industry
10:30am •
#242: Unmet Medical Need: Can the Stakeholders Align? Progress to Date
2:00pm •
#261: Project Management Throwdown: How Not to Get Chopped
4:15pm •
#279: Redefining the Site Investigator's Experience
Room 156ABC
8:00am •
#207: Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges
10:30am •
#234: Personalized Medicine Approaches During Early-Phase Clinical Research
2:00pm •
#260: Optimizing Clinical Development With Adaptive Trial Designs
4:15pm •
#285: Gene Therapy: Advances in Translating Technology
Room 157AB
9:45am •
#223A: On the Soapbox: Blockchain and Genomics
4:15pm •
#286: Which Regulatory Project Management Staff at FDA Should You Engage With? When and How?
Room 204AB
8:00am •
#212: Global Regulatory Strategies for Biosimilars
10:30am •
#238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer?
2:00pm •
#263: Navigating the Regulatory Landscape of Drug-Device Combination Products
4:15pm •
#289: Electronic Submissions Demystified
Room 205AB
8:00am •
#213: 2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry
10:30am •
#239: Generic Drug Town Hall
4:15pm •
#288: Is It Time to Change the Content and Format of Labeling?
Room 205C
8:00am •
#209: Oversight in the Era of E6 (R2)
10:30am •
#236: Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat?
2:00pm •
#262: The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan
4:15pm •
#287: The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team
Room 206AB
8:00am •
#210: Artificial Intelligence: The Future of Regulatory Affairs
10:30am •
#237: Expanded Access: Where Are We Now?
2:00pm •
#264: Global Development Using Expedited Pathways in Established and Emerging Markets
4:15pm •
#290: Priority Review Vouchers: Here to Stay and Worth the Effort?
Room 208
8:00am •
#211: Update on Collaboration and Trends in Global Companion Diagnostics
10:30am •
#230: Common Data Model Harmonization for Evidence Generation
2:00pm •
#255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations
4:15pm •
#291: ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes?
Room 209
8:00am •
#204: FDA Data Standards Update
10:30am •
#231: Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation
2:00pm •
#257: Globalizing and Regionalizing Medical Information Contact Centers
4:15pm •
#282: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials
Room 210AB
8:00am •
#217: Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence
10:30am •
#243: Global Perspectives on Patient Engagement
2:00pm •
#268: Future of PharmaTech
Room 210C
8:00am •
#205: Best Practices for Implementing Lay Summaries and Communicating Results to Patients
10:30am •
#232: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications
2:00pm •
#256: CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries
4:15pm •
#283: Evolving Roles and Responsibilities for Medical Affairs Professionals
Room 252AB
10:30am •
#235: The Adventures of Patient Experience in Drug Development
2:00pm •
#267: Developing and Partnering on Evidence for Outcomes and Value Assessment: Standardizing Measurement for Patient-Centered Care
4:15pm •
#278: Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring
Room 253AB
8:00am •
#201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin
10:30am •
#226: Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities
2:00pm •
#251: Risk Management: New Directions
4:15pm •
#276: Patient Engagement in Pharmacovigilance
Room 253C
8:00am •
#214: CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs
10:30am •
#240: Biosimilars: Demonstrating Structural and Functional Similarity
2:00pm •
#265: ICH M9 BCS-Based Biowaivers
4:15pm •
#277: Pharmacovigilance: No Longer Going it Alone
Room 254AB
8:00am •
#218: Building Your Brand
2:00pm •
#259: Measuring the Impact of Patient Engagement: What to Ask Depends on Who You Ask
4:15pm •
#280: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers
Room 256
8:00am •
#215: Pediatric and Rare Disease Drug Development
10:30am •
#241: Time-to-Event Analysis in Clinical Trials
2:00pm •
#266: User-Friendly Tools for Study Planning and Analysis
4:15pm •
#292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs
Room 257AB
8:00am •
#202: Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality
10:30am •
#227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible
2:00pm •
#252: Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection
4:15pm •
#293: Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management
Room 258AB
8:00am •
#203: Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials
10:30am •
#228: Global Clinical Trials: Lessons in Effective Execution
2:00pm •
#253: Digitizing a Patient-Focused Clinical Trial Experience
4:15pm •
#294: Sustainable Healthcare Funding
Room 258C
8:00am •
#216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome?
10:30am •
#229: Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments
2:00pm •
#254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go
4:15pm •
#281: Future of Endpoints
Theater 1 Exhibit Hall
9:45am •
#223B: Covance Innovation Theater: Case Study - Driving Clinical Transformation Through a Next-Generation of Data Integration and Analytic Technologies with a GlaxoSmithKline-Covance Partnership
12:10pm •
#245: IQVIA Innovation Theater: Real World Evidence to Enhance Drug Development
1:10pm •
#247: BioClinica Innovation Theater: Transformational Trends in Investigator Site Payments 2018
3:40pm •
#274: WIRB-Copernicus IRB Group Innovation Theater: Clinical Research Sites: Your Competitive Battleground for Study Success
Theater 2 Exhibit Hall
9:45am •
#224: Veeva Systems Innovation Theater: Global Industry Report - New Findings from the 2018 Unified Clinical Operations Survey
12:10pm •
#246: AMPLEXOR Innovation Theater: How Regulatory Information Will Become Part of Your Company Big Data Architecture
1:10pm •
#248: Veeva Systems Innovation Theater: Tufts Research - Strategies from Data Management Leaders to Speed Clinical Trials
3:40pm •
#275: Veeva Systems Innovation Theater: Simplifying Variation Management
Wednesday
, June 27
Community Zone NE Lobby
8:00am •
#319: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance: No Longer Going It Alone
8:00am •
#320: DIA Patient Engagement Community Round Table Discussion: Reaching the Underserved - Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels
9:30am •
#324: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Patient Engagement in Pharmacovigilance
9:30am •
#325: DIA Clinical Data Management Community Round Table Discussion: The Letter and Spirit of Risk-Based Monitoring - How to Creatively Implement the RBM and Unlock the Potential of the Team
1:00pm •
#352: DIA Clinical Pharmacology Community Round Table Discussion: Evolution and Harmonization of First-in-Human Guidelines
1:00pm •
#353: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Automation in Pharmacovigilance - Doing More With Less
3:00pm •
#378: DIA Devices and Diagnostics Community Round Table Discussion: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products
3:00pm •
#379: DIA Clinical Trial Disclosure and DIA Medical Communication Communities' Round Table Discussion: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program
Content Hub NE Lobby
9:15am •
#322: New Resource from the DIA Interdisciplinary Disclosure Working Group
10:00am •
#328: Getting the Questions Right
12:00pm •
#348: Making Better Portfolio Prioritization Decisions
12:45pm •
#351: Moving Forward with the EU Vigil: The Patient Contact in Pharmacovigilance
1:30pm •
#357: Difficult Conversations
2:15pm •
#377: First-In-Human Studies: An Examination of the Evolving Regulatory and Clinical Practices to Ensure Subject Safety
3:30pm •
#381: Project Management’s Role in Developing and Securing Governance Approval of a Drug Development Program Strategy
E and E Exhibit Hall
9:30am •
#323: Good Things Come in Small Packages: Product Development Strategies for Small Companies
12:00pm •
#347: Just the Right Tool: ICH E6 (R2) Compliance Tools for Small to Mid-Size Companies
1:15pm •
#356: The Worst Co-Worker on the Block
3:15pm •
#380: Use of New Data Sources and Evidence Types for Regulatory Decision Making in Drug Development
Exhibit Hall
9:00am •
Exhibit Hall Open
9:00am •
Coffee Break
11:30am •
Luncheon Service
3:00pm •
Refreshment Break
North Lobby
7:00am •
Attendee, Speaker, and Exhibitor Registration
7:00am •
Coffee and Light Refreshments
Posters Exhibit Hall
9:00am •
Professional Poster Session 2
Room 151AB
8:00am •
#308: How Do Patients and Other Multi-Disciplinary Stakeholders Collaborate to Develop Patient Registries which Accelerate Research?
2:00pm •
#365: Engaging the Rare Disease Community to Design Clinical Trials
4:00pm •
#389: Patient Observation Versus Patient Engagement: Optimizing Development
Room 153ABC
8:00am •
#307: Maintaining Patient Engagement in the Development of Patient-Reported Outcome (PRO) Measures
10:30am •
#336: Addressing the Elephant in the Room: A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement
2:00pm •
#368: Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling
4:00pm •
#392: FUNdamentals of Project Management
Room 156ABC
8:00am •
#309: Evolution and Harmonization of First-in-Human Guidelines
10:30am •
#337: Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally
2:00pm •
#366: Gene Therapy Clinical Trials: Current Challenges
4:00pm •
#390: Special Population Study Challenges
Room 157AB
8:00am •
#321: PowerUp: Career Transforming Moments
10:30am •
#338: You've Got Data #now what?
2:00pm •
#363: Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions
Room 204AB
8:00am •
#314: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products
10:30am •
#341: New FDA Draft Guidance on Part 11 in Clinical Investigations
2:00pm •
#370: Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials
4:00pm •
#398: The Impact of Cell and Gene Therapy on the Payer System
Room 205AB
8:00am •
#313: Global Rare Disease Town Hall
10:30am •
#344: Biosimilar Interchangeability: A Global Perspective
2:00pm •
#373: PMDA Town Hall
4:00pm •
#394: Update on BREXIT
Room 205C
8:00am •
#311: Harnessing the Power of Data and Analytics to Enhance Quality
10:30am •
#342: Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How
2:00pm •
#371: What's New in Health Canada: Updates and New Endeavors
4:00pm •
#395: PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities
Room 206AB
8:00am •
#312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH)
10:30am •
#340: Harmonization Beyond ICH
2:00pm •
#372: AdPromo: Assessing Risk in the Current Regulatory Environment
Room 208
8:00am •
#315: Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes
10:30am •
#332: Clinical Data: Let’s Get to the Source and Streamline it to the End
2:00pm •
#374: Modernization and Harmonization of Inspectional Approaches
4:00pm •
#387: Evolving CDISC Standards and Technologies
Room 209
10:30am •
#333: Streamlining Vendor Reconciliation
2:00pm •
#362: Do the Evolution: The Future Role of Clinical Data Management
4:00pm •
#391: How to De-Risk Alliances for Success
Room 210AB
8:00am •
#318: Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice?
10:30am •
#346: Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical Care
Room 210C
8:00am •
#306: phactMI: A Collaborative Approach to Advancing the Practice of Medical Information and Enabling Innovative Customer Solutions
10:30am •
#334: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program
2:00pm •
#364: Achieving Customer Centricity to Advance Patient Care Through Innovative Communication Channels
4:00pm •
#388: Using Patient-Centric Outcomes to Engage Patients in Shared Treatment Decision Making
Room 252AB
8:00am •
#310: Becoming Highly Self-Aware: Leading in the Midst of Ambiguity
10:30am •
#345: Unmet Medical Need: Path Forward – Creating a Commonly Agreed Criteria Globally
2:00pm •
#367: Real Life Strategies for Collaborative Stakeholder Management
4:00pm •
#393: Think Like a Regulator: Evaluating Trial Integrity
Room 253AB
8:00am •
#302: Risk Communication and Patient Safety: Recent Learnings and New Approaches
10:30am •
#329: Reducing the Burden of Drug Safety Risk Minimization Programs on the Healthcare System: How Do We Do So and What Has Been Learned to Date?
2:00pm •
#358: Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations?
4:00pm •
#382: Artificial Intelligence: A Disruptive Journey for Pharmacovigilance
Room 253C
8:00am •
#301: Automation in Pharmacovigilance: Doing More With Less
10:30am •
#330: Artificial Intelligence: Robots Taking Over Clinical Research
2:00pm •
#359: IMEDS: A Collaboration Based on the FDA's Sentinel Initiative
4:00pm •
#383: Safe Use and Prescribing of Opioid Medications: An In-Depth Look at the Strategies and Their Evaluation
Room 254AB
8:00am •
#305: Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders
10:30am •
#331: Rebuilding or Building a Research Site in the Year 2020
2:00pm •
#376: Courageous Hiring
4:00pm •
#396: Current and Future Perspective on Mutual Recognition, Work Sharing, and Global Regulatory Convergence
Room 256
8:00am •
#316: Opportunities for Efficient and Innovative Study Designs
10:30am •
#343: Innovative Visualization Approaches
2:00pm •
#375: Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints
4:00pm •
#397: Design and Statistical Considerations for Real World Evidence to Support Regulatory Decision Making
Room 257AB
8:00am •
#317: Operationalizing Real World Evidence and Value
10:30am •
#335: Collaboration Across the Medical Affairs Ecosystem to Advance Patient Care
2:00pm •
#369: Virtual Audits: Do They Achieve the Objective?
4:00pm •
#386: Bring Your Own Device ePRO: Hold the Relish, or No Holds Barred?
Room 258AB
8:00am •
#304: Data and Quality Approaches to Informing Global Investigative Site Selection
10:30am •
#339: Determining Data Integrity: Decoding the Impact of Inspectional Observations
2:00pm •
#360: Implementation of eConsent and Other Digital Clinical Trial Innovations
4:00pm •
#384: Innovations in Managing Global Clinical Supplies
Room 258C
8:00am •
#303: Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial
2:00pm •
#361: A New Way of Authoring and Reviewing Documents for Clinical Development
4:00pm •
#385: Does Sourcing Strategy Matter? Executives Debate the Influence of Outsourcing Model on Clinical Trial Execution
Theater 1 Exhibit Hall
9:45am •
#326: ArisGlobal Innovation Theater: A Regulatory Perspective - How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma - Introducing LifeSphere from Clinical to Regulatory
12:10pm •
#349: ZS Associates Innovation Theater: Building an RWE Bridge from Population Health to Personalized Medicine
1:10pm •
#354: IQVIA Innovation Theater: The Digital Future is Now
Theater 2 Exhibit Hall
9:45am •
#327: SAS Institute, JMP Division Innovation Theater: RECIST Criteria and Their Impact on Safety and Efficacy Reporting in Oncology Studies
12:10pm •
#350: Salesforce Innovation Theater: Accelerate R&D Innovation with Salesforce for Life Sciences
1:10pm •
#355: PAREXEL International Innovation Theater: The Application of Mobile Health Across the Clinical Development Spectrum: 5 Critical Insights
3:25pm •
#380B: Tata Consulting Services Innovation Theater: TCS' Life Sciences Platforms: Disrupt Clinical Research in a Digital World!
Thursday
, June 28
Community Zone NE Lobby
8:00am •
#401: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management: Artificial Intelligence - A Disruptive Journey for Pharmacovigilance
8:00am •
#402: DIA Patient Engagement Community Round Table Discussion: Addressing the Elephant in the Room - A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement
Content Hub NE Lobby
8:30am •
#403: General Data Protection Regulation (GDPR): Impact, Self-Assessment, and Practical Solutions for Compliance
North Lobby
8:00am •
Attendee and Speaker Registration
8:00am •
Coffee and Light Refreshments
10:30am •
Coffee Break
Room 204AB
9:00am •
#404: Biologics and Biosimilars: Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance
Room 205AB
9:00am •
#405: Putting Patient Experience First
Room 205C
9:00am •
#406: Improving Efficiency and Effectiveness in Data Management of Pediatric, Rare Disease, and Oncology Trials
Room 206AB
9:00am •
#408: Innovative Funding Models for Novel Therapeutics
Room 208
9:00am •
#414: Unmet Medical Need: What Did We Create Together and Where to Take It?
Room 209
9:00am •
#407: Beyond Adult Patients, Untapped Advisors in Clinical Development: Adolescents, Parents, Siblings, and Spouses
Room 210AB
9:00am •
#415: EMA/FDA Question Time
10:45am •
#416: FDA Town Hall
Room 252AB
9:00am •
#410: Assessing Your Clinical Quality Management System: An In-Depth Look at TransCelerate’s Assessment Tool
Room 253C
9:00am •
#411: Regulatory and Industry Perspectives on the Common Protocol Template
Room 254AB
9:00am •
#413: The Correlation Between Patient-Reported Outcomes and Clinician-Reported Outcomes
Room 256
9:00am •
#409: Emerging Best Practices and Challenges in Strategic Drug Development and Design Decision Making
Room 257AB
9:00am •
#412: Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability
Timezone
DIA 2018 Global Annual Meeting
America/New York
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DIA 2018 Global Annual Meeting
Jun 24
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28, 2018
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Sunday
, June 24
Monday
, June 25
Tuesday
, June 26
Wednesday
, June 27
Thursday
, June 28
Types
00: Plenary
All
Session
01: ClinSafety-PV
All
Forum
Session
02: ClinTrials -ClinOps
All
Forum
Session
Workshop
03: Data-Data Standards
All
Session
Workshop
04: MedAffairs-SciComm
All
Forum
Session
05: Patient Engagement
All
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Session
06: PreClin Dev-EarlyPhaseCR
All
Forum
Session
07: ProjMgt-StrategicPlanning
All
Forum
Session
Workshop
08: R and D Quality-Compliance
All
Forum
Session
Workshop
09: Regulatory
All
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Session
10: RegCMC-Product Quality
All
Forum
Session
Workshop
11: Statistics
All
Session
Workshop
12: Value-Access
All
Forum
Session
Workshop
13: DIAmond
All
Forum
14: InnovTheater
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15: Engage-Exchange
All
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16: Content Hubs
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17: Community Rounds
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18: ProfDevelopment
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Forum
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19: Posters
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Poster Presentation
Networking-CommunityEvents
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Venues
Ballroom
Ballroom Lobby 3
Commonwealth Room Westin
Community Zone NE Lobby
Content Hub NE Lobby
DIA Booth #1519 Exh Hall
E and E Exhibit Hall
Exhibit Hall
North Lobby
Posters Exhibit Hall
Room 151AB
Room 153ABC
Room 156ABC
Room 157AB
Room 157C
Room 158
Room 159
Room 160A
Room 160B
Room 160C
Room 161
Room 162A
Room 162B
Room 204AB
Room 205AB
Room 205C
Room 206AB
Room 208
Room 209
Room 210AB
Room 210C
Room 252AB
Room 253AB
Room 253C
Room 254AB
Room 256
Room 257AB
Room 258AB
Room 258C
Theater 1 Exhibit Hall
Theater 2 Exhibit Hall
