2026 CDISC US Interchange Presentation Archive
Thank you for attending the 2026 US Interchange!
Session 1: Opening Plenary & Keynote Presentation
Chairs: Jennifer Duff, NA3C Co-Chair, and Karen Roy, CDISC
Evergreen Ballroom
CDISC Welcome
Jennifer Duff, NA3C Co-Chair, and Karen Roy, CDISC
Keynote Presentation: The Rise of Precision Empathy
Jason Binder, CEO, Ember
Industry Pulse and CDISC's 2030 Vision
Chris Decker, CEO, CDISC
CDISC 360i and the State of the Standards: What Worked, What Didn't, and What Comes Next
Peter Van Reusel, CSO, CDISC
Session 2: CDISC Plenary - 360i Vision & Roadmap
Chair: Julie Smiley, CDISC
Evergreen A, B, C
360i Phase 2: The Journey of an Endpoint
Julie Smiley, CDISC
Endpoint by Design: SOA Workbench and Data Definition Specifications
Darren Moreland, CDISC
From Fragmentation to Interoperability: The Digital DTA Transformation
Valerie Sheft, Merck
Analysis Concepts: A Standard for Executable Clinical Analysis
Edwin van Stein, CDISC
Digital Therapeutic Area User Guides: A Modern Approach to Developing CDISC Standards
Bess LeRoy, CDISC
Session 2: TMF Plenary: The Future of TMF
Chair: Paul Carter, Montrium
Evergreen D, E
From Reference Model to Standard Model: How We Got Here
Donna Dorozinsky, Just in Time GCP; and Paul Carter, Montrium
Understanding the Architecture of the TMF Standard Model
Lisa Mulcahy, Mulcahy Consulting; and Gillian Gittens, TransPerfect
Integrating 4 Reference Models into 1 Standard
Paul Carter, Montrium
Session 3, Track A: Foundational Standards - ADaM
Chair: Harivardhan Jampala, Sumitomo Pharma
Evergreen A
ADaM 3.0 Update Part 1: Consolidation of Documents
Nancy Brucken, IQVIA; and Tatiana Sotingco, Johnson & Johnson
ADaM 3.0 Update Part 2: Curation of ADaM Examples as Part of ADaM 3.0 Update
Brian Harris, AstraZeneca
ADaM 3.0 Update Part 3: New Content
Sandra Minjoe, ICON; Alyssa Wittle, Atorus Research
Session 3, Track B: Digital/AI Foundations
Chair: Srinivasa Rao Mandava, Merck
Evergreen B
NGSI-LD as a Context Management Layer for CDISC 360i: Linking Standards Without Replacing Them
Bo Lora, Independent
Semantic Bridges: Linking Study Design to Analytical Concepts
Bhargav Koduru and Luke Morgan, Medidata Solutions
AI-Driven Study Orchestration and Implementation: Powered by CDISC Biomedical Concepts
Chetan Tamballa and Murugesan Vadivel, Saama Technologies
Session 3, Track C: AI Innovation Challenge
Chair: Julie Smiley, CDISC
Evergreen C
Use Case #1: Winner - Syn2Real
Novartis & AWS
Use Case #1: Runner-Up - Leova Synthetic Data Generator
Shirley Collie and Robert Kieser, BioInformatiCo
Use Case #2: Winner - Smart ClinSAP - AI Driven Generation of Statistical Analysis Plans
Chetan Tamballa and Murugesan Vadivel, Saama Technologies
Use Case #2: Runner-Up - SAP-Genie
Rajprakash Chennamaneni and Sachin Tiwari, Jazz Pharmaceuticals
Use Case #3: Winner - PAIR - AI TFL Generation
Novartis & AWS
Use Case #3: Runner-Up - TLFGenix
Zifo Scientific Informatics
Session 3, Track D: AI in TMF Management
Chair: Steph Viscomi, Kymera Therapeutics
Evergreen D
Same Team, Different Worlds: Building AI Competency Across Every Level
Robert Jones, Arithmos
Human + AI: Driving TMF Excellence Through Culture, Collaboration, and Connected Systems
Hari Gopichandran, Sycamore Informatics
Transforming TMF Oversight: Applying AI to Address Persistent Site Personnel Record Gaps
Niamh Smith, CSL Behring; and Aaron Grant, Just in Time GCP
Session 3, Track E: Site, Sponsor & Service Provider Partnerships
Chair: Sarah Dean, Precision for Medicine
Evergreen E
Elevating the Investigator Site File: Driving Standardization and Data Integrity in Global Clinical Trials
Guillaume Gerard, Agatha
From Transactional Support to Trusted Partnership: Achieving TMF Excellence Together
Jared Brooslin, Intellia Therapeutics; and Seth Pearl, Phlexglobal
From Daily Operations to Audit Spotlight: Standardizing Document Management and Quality Assurance Collaboration
Cristina Iannaccone, SGS
Session 4, Track A: Foundational Standards - SDS
Chair: Erin Muhlbradt, NIH/NCI
Evergreen A
Report from SDS: SDTM 3.0
Michael Wise, Edwards LifeSciences
Report from SDS: SDTMIG 4.0
Maria Sekac, Merck
Report from SDS: Future Directions
Dave Scocca, Rho
Session 4, Track B: Submissions
Chair: Asif Karbhari, AstraZeneca
Evergreen B
Interrupting the Conversation: AI-Assisted Clinical Submission Artifacts as a Model for Targeted AI Adoption
Carlo Radovsky, Immanant
Advancing Global Regulatory Submissions through Next Generation Submission (NGS): A Collaborative Implementation Case Study
Carrie Zhang, ClinChoice; and Asif Karbhari, AstraZeneca
Session 4, Track C: RWD/DCT
Chair: Donna Sattler, Eli Lilly
Evergreen C
Bridging the Gap: A Validated Pipeline for Transforming High-Frequency Sensor Data to SDTM
Aman Thukral and Sanjay Bhardwaj, Abbvie
RWD Lineage: Data Point Traceability for Reliable Real-World Data Using Define-XML
Tasha Nagamine and Anita Umesh, Droice Labs
From Wearables to Regulatory Submissions: The Evolving Role of Digital Health Technologies in Clinical Research
Varun Sethuraman, Hexaware Technologies
Session 4, Track D: AI in TMF Management
Chair: Marion Mays, Jerion Consulting
Evergreen D
Smarter TMFs: Solving Today's Challenges While Preparing for an AI-Enabled Future
Angie Gill, Phlexglobal; and Christina Allen, Daiichi Sankyo
From AI Hype to TMF Reality: Early Lessons from Implementing AI Agents
Pawel Rucki, BASE Life Science; Jamie Toth, BeOne Medicines; & Nisi Nazim, BeOne Medicines
Redefining TMF Strategy with Agentic AI
Jim Horstmann, Veeva Systems
Session 4, Track E: TMF Culture and Engagement
Chair: Laurel-Ann Schrader, Transperfect
Evergreen E
Change Management: From Strategy to Practical Execution
Rhonda Nolan, Regeneron Pharmaceuticals
Japanese TMF Community Update: Recent Highlights Including TMF RM Survey Review
Yuto Kanda, Chugai Clinical Research Co., Ltd.; Mai Nishihara, Chugai Clinical Research Co., Ltd.; and Miyuki Taguchi, inSeption Group
TMF TED Talks - Hot Takes
Rebecca Halbur, Moderna Therapeutics
Session 5, Track A: Foundational Standards - Advanced Standards
Chair: Srinivasa Rao Mandava, Merck
Evergreen A
SUPP to NSV: Transforming Data Representation for Improved Reviewer Utility
Soumya Rajesh, IQVIA
Around the Data DOSE-y Doe: Using DOSExx Variables within ADaM Data Sets
Richann Watson, InkaStat Solutions
Transforming Vendor Biomarker Data into CDISC Compliant SDTM Datasets
Devi Gohimukkula and Saravanan Kandasamy, BeOne Medicines
Session 5, Track B: Digital Data Flow
Chair: Erin Muhlbradt, NIH/NCI
Evergreen B
Closing the Digital Data Flow Gap: AI-Powered Protocol Digitalization with Pluggable EDC Adapters for Automated Study Builds
Uma Maheswari Adiseshan and Sai Sri Sravya Deevi, Zifo Technologies
From Study Intent to USDM-Compliant Protocol: What We Learned Building a Multi-Agent AI Digital Protocol Authoring System Under 21 CFR Part 11
Shekhar Thumake, Ephicacy
From Digital Protocols to Executable Trials: Neuro-Symbolic Intelligence Enabling CDISC Digital Data Flow
Jian Chen and Shakthi Kumar, EDETEK
Session 5, Track C: Innovation/AI
Chair: Asif Karbhari, AstraZeneca
Evergreen C
From Manual Writing to Intelligent Drafting: Leveraging GenAI to Create Data Reviewer's Guides for Regulatory Submissions
Sirisha Davuluri and Valerie Cadorett, Pfizer Inc.
Agentic AI Meets Data Simulation: A Framework for Self-Optimizing Clinical Trial Digital Twins
Ward Line, Clinventive
What Happens When Analysis and Display Are Independently Produced as Analysis Results DataSets (ARDS) and TFLs?
Andrew Miskell, Eli Lilly and Company
Session 5, Track D: Inspection Readiness
Chair: Steph Viscomi, Kymera Therapeutics
Evergreen D
The Clinical Study Data Flow Diagram
Liz Farrell, Agios Pharmaceuticals; and Lisa Mulcahy, Mulcahy Consulting
Leverage AI To Accomplish the Impossible: An Inspection Ready TMF
Marion Mays, Jerion Consulting; and Chad Scribner, Epista
Case Study: The 12-Month TMF Turnaround : Oversight, Alignment, and Inspection Readiness
Suzanne Turner, ICE Consulting
Session 5, Track E: TMF Interoperability
Chair: Karen Roy, CDISC
Evergreen E
Your Clinical Systems Are Connected - Your TMF Governance Isn't
Olga Radyushkina, Epista; and Tiffani Nelson, Gilead
From Repository to Intelligent Platform: Connected Standards and AI for RWE eTMF
Thomas Stonehouse and Chris Huang, Oracle
Panel Discussion: End of Study Quality and Archiving Inspection Findings
Chris Sigley, Arkivum
Session 6, Track A: Foundational Standards - Validation/Quality
Chair: Harivardhan Jampala, Sumitomo Pharma
Evergreen A
Seeking Validation: Verified or Truly Vetted? Challenges on the Path to Regulatory Approval
Julie Ann Hood, Pinnacle 21 by Certara
Architectural Divergence Across Three Hemophilia Studies: Technical Implications for SDTM/ADaM Conformance, Metadata Governance, and CSR‚ Level Consistency
Prasanna Kakade and Achin Wadhwa, Ephicacy Consulting Group
From Framework to Practice: Practical ADaM Implementation
Jie Yang, SGS Pharma – Clinical Research
Session 6, Track B: Study Design/USDM
Chair: Kent Letourneau, ICON
Evergreen B
A Guide to Utilizing USDM from Study Concept to Study Execution
Christopher Damato and Ali Soltani, Evinova AG
What It Actually Takes: Lessons from Production USDM Adoption and the Path to Digital Data Flow
Bill Lynch, HumanTrue
What Breaks First When You Go DDF?
Udiksha Jaiswal and Bill Qubeck, Sycamore Informatics
Session 6, Track C: Integration/Interoperability
Chair: Jim Box, SAS
Evergreen C
The Evolving Landscape of eSouce to Sponsor Integration: Challenges and Opportunities with CDISC Standards
Heather Marino, Axtria Inc.
Operationalizing CDISC Biomedical Concepts as a Semantic Layer for EHR-to-EDC Data Transfer, AI-Grounded Extraction and Metadata-Driven Study Configuration
Miten Mistry and Abhishek Dabral, Paradigm Health
Reimagining Clinical Trials with FHIR-to-CDISC Interoperability
Prasoon Sangwan and Arka Mazumder, TCS
Session 6, Track D: Risk Based Approaches
Chair: Donna Dorozinsky, Just in Time GCP
Evergreen D
Integrating the Risk Based Principles of ICH E6 R3 to Drive TMF Inspection Steadiness
Dawn Niccum, inSeption Group
The Connected TMF Mindset: Embedding Risk-Based Thinking and Engagement at Scale
Christina Mantzioros, Montrium
Strengthening Inspection Readiness Through Proactive Reviews
Carol Radwanski and Jenn Stamper, Just in Time GCP
Session 6, Track E: TMF Validation and Governance
Chair: Lisa Mulcahy, Mulcahy Consulting
Evergreen E
Leveraging Enterprise AI in TMF Management: How Governance Enables Confidence and Compliance
Brittany Walker, USDM
Approaches to AI Validation in Regulated Clinical Systems and the eTMF
Jay Smith, TransPerfect
Proving Your TMF Has Not Changed: A Post-Export, Zero-Custody Verification Model Validated in Blinded Multi-Operator Conditions
Fernando Telles, Cardiovascular Diagnostic Audit & AI
Session 7, Track A: Foundational Standards - SDTM
Chair: Alana St. Clair, CDISC
Evergreen A
From Human-Readable Mappings to Machine-Verifiable SDTM Transformation Specifications with AI-Assisted Authoring
Rostislav Markov, Amazon Web Services
Accelerating SDTM Engine Development and Adoption with a Multi-Agent AI Framework and RAG-Based Assistant
Proma Debnath and Srinivas Malipeddi, Merck & Co.
Governance Powered CDISC Implementation: Driving Standards Reuse at Scale
Minda Quiroz, Alcon
Session 7, Track B: End-to-End Flow
Chair: Kent Letourneau, ICON
Evergreen B
CDISC Open Rules: Progress, Performance, and Foundations for the Future
Tomás Sabat Stöfsel, Verisian
From Protocol to CSR: Reimagining Clinical Trials with AI and Next-Gen CDISC Models
Bhavin Busa, Clymb Clinical
Dataset-JSON Is Coming: What FDA Adoption Could Mean for Standards, Systems, and Submission Readiness
Bill Qubeck, Sycamore Informatics
Session 7, Track C: Special Topics
Chair: Donna Sattler, Eli Lilly
Evergreen C
Beyond XPT: Reimagining the Clinical Submission for 2041
Rajprakash Chennamaneni, Jazz Pharmaceuticals
From Intent to Execution: How Biomedical Concepts Quietly Rewired the Safety Data Pipeline
Chithra Subramaniam and Rohini Goyal, Bristol Myers Squibb
Unlocking eSource Potential: A Call for Ecosystem Alignment on AI/NLP Standards
Jo-Zahn Baxter, Axtria
Session 7, Track D & E: TMF Standard V1
Chair: Jamie Toth, BeOne Medicines
Evergreen D, E
Change Management for TMF SM V1
Steph Viscomi, Kymera Therapeutics
Session 8: CDISC Plenary - Clinical Trials, Reimagined: What the Next Decade Looks Like
Chair: Chris Decker, CDISC President and CEO
Evergreen A, B, C
Panel Discussion: Clinical Trials, Reimagined: What the Next Decade Looks Like
Dr. Ron Fitzmartin, CDISC Board of Directors, Decision Analytics LLC
Closing Remarks
Nicole Harmon, COO, CDISC
Session 8: TMF Closing Plenary
Chair: Jamie Toth, BeOne Medicines
Evergreen D, E
Moving to a Standard and Beyond
Paul Carter, CDISC; and Sydney Stamper, Just in Time GCP
Closing Remarks