2023 US Interchange Presentation Archive
Session 1: Opening Plenary
Chair: Dave Evans, CDISC President and CEO
Salons 1-4 (Lobby Level)
Welcome Address and State of the CDISC Union
Dave Evans, President and CEO
Presentation Files (Media)
Welcome from the CDISC Board of Directors
Chris Decker, CDISC Board Member
Transforming Drug Development and Regulatory Assessments: Is it Possible?
Dr. Lilliam Rosario, Director, Office of Computational Science, FDA-CDER
Presentation Files (Media)
Document
State of the CDISC Standards
Christine Connolly, CDISC
Presentation Files (Media)
Session 2: Second Opening Plenary
Chair: Harivardhan Jampala, Fortrea
Salons 1-4 (Lobby Level)
ICH M11 Initiative
Dr. Ron Fitzmartin, FDA-CDER
Digital Data Flow, Phase 3: The USDM meets M11
Dave Iberson-Hurst, data4knowledge
Presentation Files (Media)
Document
Dataset-JSON as Alternative Transport Format for Regulatory Submissions
Sam Hume, CDISC; Jesse Anderson, FDA-CDER
Presentation Files (Media)
Session 3A: Digitization and AI
Chair: Srinivasa Rao Mandava, Merck
Salons 1-3 (Lobby Level)
The Digital Blueprint: Automating End-to-End Workflows using Standards
Nathan Johnson, eClinical Solutions
Presentation Files (Media)
Leveraging Data Standards and Machine Learning for Efficient Imaging Data Management in Oncology Clinical Trials
Kim Nguyen, Clario
Digital Transformation – Will AI Be Our New Best Friend in Creating CDISC Compliant Workflows?
Michelle Lumicao, Syneos Health
Presentation Files (Media)
Session 3B: Business Optimization
Chair: Terek Peterson, YPrime
Salon 4 (Lobby Level)
Trial Master File Reference Model – TMF Index Zone 11-Statistics – Implementation Lessons Learned from a Statistical Programmer
Salma Ameen, AstraZeneca
Presentation Files (Media)
Your Guide to Successfully Up-Versioning CDISC Standards
Kapila Patel, Soumya Rajesh; IQVIA
Presentation Files (Media)
Getting More Efficiency from your instruments using CDISC
Frank Menius, YPrime
Presentation Files (Media)
Session 3C: ARS Hands-On Workshop
Chair: Bess LeRoy, CDISC
Junior Ballroom (Lower Level)
Presentation Files (Media)
Session 4A: Real World Data + Implementation
Chair: Srinivasa Rao Mandava, Merck
Salons 1-3 (Lobby Level)
Digital Health Technologies (DHTs): Data Standardization and Where We Go from Here
Christine Connolly, CDISC; Jessie Bakker, Digital Medicine Society
Presentation Files (Media)
Decentralized Clinical Trials - Umbrella Trials
Srinivasa Rao Mandava, Merck
Presentation Files (Media)
Adapting Real World Data (RWD) into CDISC Submission Standards: Challenges and Potential Solutions
Lauren Green, Adrienne Boyance, Amgen
Presentation Files (Media)
Transforming RWD for Regulatory Submissions: How to Use SDTM for RWD
Tasha Nagamine, Mayur Saxena; Droice Labs
Presentation Files (Media)
Session 4B: CDISC Foundational, Part I
Chair: Rhonda Facile, CDISC
Salon 4 (Lobby Level)
Challenges and Solutions in Chromosome Aberration Data Mapping to Genomics Findings (GF) Domain for Oncology Studies
Shanshan Ma, Agenus
Presentation Files (Media)
Document
IS Domain Scope Update for the SDTMIG v3.4 and Its Impact on the MB and LB Domains
Jordan Li, NCI-EVS
Presentation Files (Media)
Non-Standard Variables in Standards Development - The Ultimate Oxymoron
Rebecca Baker, CDISC; Erin Muhlbradt, NCI-EVS
Presentation Files (Media)
Plain Language as a new CDISC Standard: The MRCT Center Clinical Research Glossary
Sylvia Baedorf Kassis, Harvard MRCT Center
Presentation Files (Media)
Session 4C: COSA Session - 360 & End-to-End
Chair: Charles Shadle, CDISC
Junior Ballroom (Lower Level)
From Proof-of-Concept to Reality: The Transformative Evolution of CDISC 360
Charles Shadle, CDISC
Presentation Files (Media)
OpenStudyBuilder: Â An Open-Source DDF and COSMoS Compatible Solution
Mikkel Traun, Novo Nordisk A/S
Presentation Files (Media)
Oak-SDTM Automation: Â Enabling industry-level automation of SDTM
Rammprasad Ganapathy, Roche; Yogesh Gupta, Pfizer
Presentation Files (Media)
Admiral: An Open-Source R Package for Creating ADaM Datasets with Modularized Functions in a Readable and Easily-Constructable Manner
Zelos Zhu, Atorus Research
Presentation Files (Media)
Document
Integrating TFL Designer with CDISC 360: Advancing Automation and Concept-Based Standards in Clinical Trial Analysis & Reporting
Bhavin Busa, Clymb Clinical
Presentation Files (Media)
Session 5A: CDISC Strategic Updates- Biomedical Concepts & CORE
Chair: Dr. Sam Hume, CDISC
Salons 1-3 (Lobby Level)
Biomedical Concepts Presentation
Linda Lander, Lex Jansen & Jon Neville, CDISC
Presentation Files (Media)
CDISC CORE Presentation
Peter Van Reusel & Amy Palmer, CDISC
Presentation Files (Media)
CDISC CORE and Real-Time Validation - The Perfect Match
Bremer Luow, Bioforum
Presentation Files (Media)
Session 5B: Updates Towards Regulatory
Chair: Sandra Minjoe, ICON
Salon 4 (Lobby Level)
Meta-Metadata: Management of CDISC ADaM Metadata in Light of New Industry Documents - FDA Standard Safety Tables and Figures IG
Amanda Johnson, Merck
Presentation Files (Media)
FDA-CTP and CDISC Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Chrissie Cai, FDA-CTP and Chris Connolly, CDISC
Presentation Files (Media)
Panel Discussion - SOGI Patient Journey: Data Collection Lessons Learned and Future Road Map
Donna Sattler, BMS
Presentation Files (Media)
Session 5C: Workshop - Evaluating Safety, Quality and Traceability of Regulatory Submission Data
Chairs: Rhonda Facile, CDISC; Wenjun Bao, JMP Clinical
Junior Ballroom (Lower Level)
Welcome, CDISC Overview, Regulatory Environment
Rhonda Facile, CDISC
Presentation Files (Media)
CDISC SDTM Models Overview and Practical Implementation Examples
Bess LeRoy, CDISC
Analysis Results Metadata and Practical Implementation Examples
Richard Marshall, CDISC
JMP Clinical Background and Use by Global Regulatory Agencies
Wenjun Bao, JMP Clinical
JMP Clinical Demo
Wenjun Bao, Dr. Geoffrey Mann, JMP Clinical
Q&A
Session 6A: Digital Data Flow
Chair: Bron Kisler, Nurocor
Salons 1-3 (Lobby Level)
Digital Data Flow: Breaking the Document Paradigm with Digital Data Flow from Protocol Design to Electronic Data Capture
Sumesh Kalappurakal, Janssen R&D; William Illis, Novartis
Presentation Files (Media)
Document
Automating Study Set-up through Digitalized Protocol
Frederik Malfait, Nurocor
Presentation Files (Media)
From Medical Writing to Data Management: Key Considerations for Successfully Adopting the Unified Study Definitions Model (USDM) and Enabling Digital Data Flow (DDF)
Akash Trivedi, Accenture
Presentation Files (Media)
Document
Session 6B: CDISC Foundational, Part II
Chair: Kent Letourneau, ICON
Salon 4 (Lobby Level)
ADaM implementation of Anti-drug Antibody (ADA) Analysis Dataset
Jiannan (Jane) Kang, Merck
Presentation Files (Media)
ADaM Discussion Topics: PARQUAL, ADPL, and NADIR
Sandra Minjoe, ICON
Presentation Files (Media)
Document
Current and Forthcoming ADaM Publications
Cindy Stroupe, UCB
Presentation Files (Media)
Session 6C: CORE Workshop
Chair: Amy Palmer, CDISC
Junior Ballroom (Lower Level)
CORE Workshop
Amy Palmer, CDISC
Presentation Files (Media)
Document
Session 7: Third Plenary - Regulatory Presentations
Chair: Peter Van Reusel, CDISC
Salons 1-4 (Lobby Level)
FDA Presentation on Technical Conformance Guide (TCG)
Helena Sviglin, FDA-CDER
Presentation Files (Media)
PMDA Presentation
Dr. Yuki Ando, PMDA
Presentation Files (Media)
EMA Presentation
Eftychia-Eirini Psarelli, EMA
Panel Discussion
Session 8: Closing Plenary
Chair: Dave Evans, CDISC President & CEO
Salons 1-4 (Lobby Level)
Charting a Course to Standardization: The Future of the TMF Reference Model
Karen Roy, CDISC
Presentation Files (Media)
Closing Remarks
Peter Van Reusel, CDISC
Presentation Files (Media)