CDISC US Interchange 2026

Other · Conifer Ballroom Foyer

Early Registration / Check-In

Networking · Networking · M Club Lounge

Platinum Member Mixer - MUST be registered to attend

Other · Rocky Mountain Events Center

Registration / Check-In

Break · Networking · Rocky Mountain Event Center

Breakfast

Other · Plenary · Evergreen Ballroom

CDISC Welcome

Jennifer Duff · Karen Roy, CDISC

Keynote · Plenary · Evergreen Ballroom

Keynote Presentation: The Rise of Precision Empathy

Jason Binder, Ember

Talk · Plenary · Evergreen Ballroom

Industry Pulse and CDISC's 2030 Vision

Chris Decker, CDISC

Talk · Plenary · Evergreen Ballroom

CDISC 360i and the State of the Standards: What Worked, What Didn't, and What Comes Next

Peter Van Reusel, CDISC

Break · Networking · Rocky Mountain Event Center

Morning Break

Talk · Main Conference CDISC · Evergreen A, B, C

360i Phase 2: The Journey of an Endpoint

Julie Smiley, CDISC

Talk · Main Conference TMF · Evergreen D, E

From Reference Model to Standard Model: How We Got Here

Donna Dorozinsky, Just in Time GCP · Paul Carter, Montrium

Talk · Main Conference CDISC · Evergreen A, B, C

Endpoint by Design: SOA Workbench and Data Definition Specifications

Darren Moreland, CDISC

Talk · Main Conference CDISC · Evergreen A, B, C

From Fragmentation to Interoperability: The Digital DTA Transformation

Valerie Sheft, Merck

Talk · Main Conference CDISC · Evergreen A, B, C

Analysis Concepts: A Standard for Executable Clinical Analysis

Edwin van Stein, CDISC

Talk · Main Conference TMF · Evergreen D, E

Understanding the Architecture of the TMF Standard Model

Lisa Mulcahy, Mulcahy Consulting · Gillian Gittens, TransPerfect

Talk · Main Conference CDISC · Evergreen A, B, C

Digital Therapeutic Area User Guides: A Modern Approach to Developing CDISC Standards

Bess LeRoy, CDISC

Talk · Main Conference TMF · Evergreen D, E

Integrating 4 Reference Models into 1 Standard

Paul Carter, Montrium

Other · Main Conference CDISC · Evergreen A, B, C

Joint Q&A

Break · Networking · Rocky Mountain Event Center

Lunch & Exhibition

Poster · Networking · Atrium

Exploiting Decentralized Trials, including Digital Endpoints, Master Protocols, Patient and Rare Disease Registries, Secondary use of Legacy Clinical Trials

Shweta Deherkar, Sycamore Informatics

Poster · Networking · Atrium

Enabling Cross-Trial Comparison of Eligibility Criteria Through Hybrid NLP and CDISC Biomedical Concepts

Mark Ediger, Medidata Solutions

Poster · Networking · Atrium

Transforming SDTM Annotated CRF Generation: A Dual-Format, Navigation-Optimized Framework Using the DXC Toolbox

Zheng Li, Bristol Myers Squibb

Poster · Networking · Atrium

Strengthening the Connection Between the TMF and Biometric Communities

Gillian Mulcahy, Mulcahy Consulting

Poster · Networking · Atrium

From TMF Index to TMF Health: Operationalizing Ownership, Metadata, and Oversight

Caitlin Saia, Merus BV

Poster · Networking · Atrium

Building a CDISC Offline Search Mobile App: A Practical Tool for Clinical Data Professionals

Sada Shiva Prasad, IQVIA

Poster · Networking · Atrium

Draft, Review, and Run: An Automation Framework for SDTM Mapping

Nahee Yun, JNPMEDI

Poster · Networking · Atrium

One Schedule of Activities (SoA) for All: A Layered Abstraction to Harmonize Protocol Schedules and Accelerate Digitization with USDM

Rachel Zebo, Merck

Poster · Networking · Atrium

Streamlining SDTM Development: An LLM-Driven Automated Approach

Uma Maheswari Adiseshan, Zifo

Poster · Networking · Atrium

Analysis Concepts: Framework in a Nutshell

Edwin van Stein, CDISC · Kirsten Langendorf, data4knowledge

Poster · Networking · Atrium

Unlocking eSource Potential: A Call for Ecosystem Alignment on AI/NLP Standards

Jo-Zahn Baxter, Axtria

Poster · Networking · Atrium

Operationalizing Digital Data Flow in Study Build Using CDISC Aligned Standards

Prasoon Sangwan, TCS

Poster · Networking · Atrium

Structuring the SAP: A USDM-Based Framework for Machine-Readable Analysis Definitions

Rajprakash Chennamaneni, Jazz Pharmaceutical

Poster · Networking · Atrium

Which SDTM Specification Artifacts Matter Most for AI-Assisted Code Generation? Lessons from Eight Production Transformation Functions

Rostislav Markov, Amazon Web Services

Talk · Main Conference CDISC · Evergreen A

ADaM 3.0 Update Part 1: Consolidation of Documents

Nancy Brucken, IQVIA · Tatiana Sotingco, Johnson & Johnson · Harivardhan Jampala, Sumitomo Pharma

Talk · Main Conference CDISC · Evergreen B

NGSI-LD as a Context Management Layer for CDISC 360i: Linking Standards Without Replacing Them

Bo Lora, Independent · Srinivasa Rao Mandava, Merck

Talk · Main Conference CDISC · Evergreen C

Use Case #1: Winner - Syn2Real

Julie Smiley, CDISC

Talk · Main Conference TMF · Evergreen D

Same Team, Different Worlds: Building AI Competency Across Every Level

Robert Jones, Arithmos · Steph Viscomi, Kymera Therapeutics

Talk · Main Conference TMF · Evergreen E

Elevating the Investigator Site File: Driving Standardization and Data Integrity in Global Clinical Trials

Guillaume Gerard, Agatha · Sarah Dean, Precision for Medicine

Talk · Main Conference CDISC · Evergreen C

Use Case #1: Runner-Up - Leova Synthetic Data Generator

Shirley Collie, BioInformatiCo · Robert Kieser, BioInformatiCo

Talk · Main Conference CDISC · Evergreen A

ADaM 3.0 Update Part 2: Curation of ADaM Examples as Part of ADaM 3.0 Update

Brian Harris, AstraZeneca

Talk · Main Conference CDISC · Evergreen B

Semantic Bridges: Linking Study Design to Analytical Concepts

Bhargav Koduru, Medidata Solutions · Luke Morgan, Medidata Solutions

Talk · Main Conference CDISC · Evergreen C

Use Case #2: Winner - Smart ClinSAP - AI Driven Generation of Statistical Analysis Plans

Chetan Tamballa, Saama Technologies · Murugesan Vadivel, Saama Technologies

Talk · Main Conference TMF · Evergreen D

Human + AI: Driving TMF Excellence Through Culture, Collaboration, and Connected Systems

Hari Gopichandran, Sycamore Informatics

Talk · Main Conference TMF · Evergreen E

From Transactional Support to Trusted Partnership: Achieving TMF Excellence Together

Jared Brooslin, Intellia Therapeutics · Seth Pearl, Phlexglobal

Talk · Main Conference CDISC · Evergreen C

Use Case #2: Runner-Up - SAP-Genie

Rajprakash Chennamaneni, Jazz Pharmaceuticals · Sachin Tiwari, Jazz Pharmaceuticals

Talk · Main Conference CDISC · Evergreen A

ADaM 3.0 Update Part 3: New Content

Sandra Minjoe, ICON · Alyssa Wittle, Atorus Research

Talk · Main Conference CDISC · Evergreen B

AI-Driven Study Orchestration and Implementation: Powered by CDISC Biomedical Concepts

Chetan Tamballa, Saama Technologies · Murugesan Vadivel, Saama Technologies

Talk · Main Conference CDISC · Evergreen C

Use Case #3: Winner - PAIR - AI TFL Generation

Talk · Main Conference TMF · Evergreen D

Transforming TMF Oversight: Applying AI to Address Persistent Site Personnel Record Gaps

Niamh Smith, CSL Behring · Aaron Grant, Just in Time GCP

Talk · Main Conference TMF · Evergreen E

From Daily Operations to Audit Spotlight: Standardizing Document Management and Quality Assurance Collaboration

Cristina Iannaccone, SGS

Talk · Main Conference CDISC · Evergreen C

Use Case #3: Runner-Up - TLFGenix

Break · Networking · Rocky Mountain Event Center

Afternoon Break

Talk · Main Conference CDISC · Evergreen A

Report from SDS: SDTM 3.0

Michael Wise, Edwards LifeSciences · Erin Muhlbradt, NIH/NCI

Talk · Main Conference CDISC · Evergreen B

ICH M11 Presentation

Ron Fitzmartin, Decision Analytics · Asif Karbhari, AstraZeneca

Talk · Main Conference CDISC · Evergreen C

Bridging the Gap: A Validated Pipeline for Transforming High-Frequency Sensor Data to SDTM

Aman Thukral, Abbvie · Sanjay Bhardwaj, Abbvie · Donna Sattler, Eli Lilly

Talk · Main Conference TMF · Evergreen D

Smarter TMFs: Solving Today's Challenges While Preparing for an AI-Enabled Future

Angie Gill, Phlexglobal · Christina Allen, Daiichi Sankyo · Marion Mays, Jerion Consulting

Talk · Main Conference TMF · Evergreen E

Change Management: From Strategy to Practical Execution

Rhonda Nolan, Regeneron Pharmaceuticals · Laurel-Ann Schrader, Transperfect

Talk · Main Conference CDISC · Evergreen A

Report from SDS: SDTMIG 4.0

Maria Sekac, Merck

Talk · Main Conference CDISC · Evergreen B

Interrupting the Conversation: AI-Assisted Clinical Submission Artifacts as a Model for Targeted AI Adoption

Carlo Radovsky, Immanant

Talk · Main Conference CDISC · Evergreen C

RWD Lineage: Data Point Traceability for Reliable Real-World Data Using Define-XML

Tasha Nagamine, Droice Labs · Anita Umesh, Droice Labs

Talk · Main Conference TMF · Evergreen D

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

Talk · Main Conference TMF · Evergreen E

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. · Miyuki Taguchi, inSeption Group

Talk · Main Conference CDISC · Evergreen A

Report from SDS: Future Directions

Dave Scocca, Rho

Talk · Main Conference CDISC · Evergreen B

Advancing Global Regulatory Submissions through Next Generation Submission (NGS): A Collaborative Implementation Case Study

Carrie Zhang, ClinChoice · Asif Karbhari, AstraZeneca

Talk · Main Conference CDISC · Evergreen C

From Wearables to Regulatory Submissions: The Evolving Role of Digital Health Technologies in Clinical Research

Varun Sethuraman, Hexaware Technologies

Talk · Main Conference TMF · Evergreen D

Redefining TMF Strategy with Agentic AI

Jim Horstmann, Veeva Systems

Talk · Main Conference TMF · Evergreen E

TMF TED Talks - Hot Takes

Rebecca Halbur, Moderna Therapeutics

Networking · Networking · Wings Over the Rockies Air & Space Museum

Evening Event

Other · Rocky Mountain Events Center

Registration / Check-In

Networking · Conifer Ballroom

Technology Vendor Roundtable Breakfast - MUST be Registered to Attend

Break · Networking · Rocky Mountain Event Center

Breakfast

Talk · Main Conference CDISC · Evergreen A

SUPP to NSV: Transforming Data Representation for Improved Reviewer Utility

Soumya Rajesh, IQVIA · Srinivasa Rao Mandava, Merck

Talk · Main Conference CDISC · Evergreen B

Closing the Digital Data Flow Gap: AI-Powered Protocol Digitalization with Pluggable EDC Adapters for Automated Study Builds

Uma Maheswari Adiseshan, Zifo Technologies · Sai Sri Sravya Deevi, Zifo Technologies · Erin Muhlbradt, NIH/NCI

Talk · Main Conference CDISC · Evergreen C

From Manual Writing to Intelligent Drafting: Leveraging GenAI to Create Data Reviewer's Guides for Regulatory Submissions

Sirisha Davuluri, Pfizer Inc. · Valerie Cadorett, Pfizer Inc. · Asif Karbhari, AstraZeneca

Talk · Main Conference TMF · Evergreen D

The Clinical Study Data Flow Diagram

Liz Farrell, Agios Pharmaceuticals · Lisa Mulcahy, Mulcahy Consulting · Steph Viscomi, Kymera Therapeutics

Talk · Main Conference TMF · Evergreen E

Your Clinical Systems Are Connected - Your TMF Governance Isn't

Olga Radyushkina, Epista · Tiffani Nelson, Gilead · Karen Roy, CDISC

Talk · Main Conference CDISC · Evergreen A

Around the Data DOSE-y Doe: Using DOSExx Variables within ADaM Data Sets

Richann Watson, InkaStat Solutions

Talk · Main Conference CDISC · Evergreen B

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

Talk · Main Conference CDISC · Evergreen C

Agentic AI Meets Data Simulation: A Framework for Self-Optimizing Clinical Trial Digital Twins

Ward Line, Clinventive

Talk · Main Conference TMF · Evergreen D

Leverage AI To Accomplish the Impossible: An Inspection Ready TMF

Marion Mays, Jerion Consulting · Chad Scribner, Epista

Talk · Main Conference TMF · Evergreen E

From Repository to Intelligent Platform: Connected Standards and AI for RWE eTMF

Thomas Stonehouse, Oracle · Chris Huang, Oracle

Talk · Main Conference CDISC · Evergreen A

Transforming Vendor Biomarker Data into CDISC Compliant SDTM Datasets

Devi Gohimukkula, BeOne Medicines · Saravanan Kandasamy, BeOne Medicines

Talk · Main Conference CDISC · Evergreen B

From Digital Protocols to Executable Trials: Neuro-Symbolic Intelligence Enabling CDISC Digital Data Flow

Jian Chen, EDETEK · Shakthi Kumar, EDETEK

Talk · Main Conference CDISC · Evergreen C

What Happens When Analysis and Display Are Independently Produced as Analysis Results DataSets (ARDS) and TFLs?

Andrew Miskell, Eli Lilly and Company

Talk · Main Conference TMF · Evergreen D

Case Study: The 12-Month TMF Turnaround : Oversight, Alignment, and Inspection Readiness

Suzanne Turner, ICE Consulting

Panel · Main Conference TMF · Evergreen E

Panel Discussion: End of Study Quality and Archiving Inspection Findings

Chris Sigley, Arkivum

Break · Networking · Rocky Mountain Event Center

Morning Break

Talk · Main Conference CDISC · Evergreen A

Seeking Validation: Verified or Truly Vetted? Challenges on the Path to Regulatory Approval

Julie Ann Hood, Pinnacle 21 by Certara · Harivardhan Jampala, Sumitomo Pharma

Talk · Main Conference CDISC · Evergreen B

A Guide to Utilizing USDM from Study Concept to Study Execution

Christopher Damato, Evinova AG · Ali Soltani, Evinova AG · Kent Letourneau, ICON

Talk · Main Conference CDISC · Evergreen C

The Evolving Landscape of eSouce to Sponsor Integration: Challenges and Opportunities with CDISC Standards

Heather Marino, Axtria Inc. · Jim Box, SAS

Talk · Main Conference TMF · Evergreen D

Integrating the Risk Based Principles of ICH E6 R3 to Drive TMF Inspection Steadiness

Dawn Niccum, inSeption Group · Donna Dorozinsky, Just in Time GCP

Talk · Main Conference TMF · Evergreen E

Leveraging Enterprise AI in TMF Management: How Governance Enables Confidence and Compliance

Brittany Walker, USDM · Lisa Mulcahy, Mulcahy Consulting

Talk · Main Conference CDISC · Evergreen A

Architectural Divergence Across Three Hemophilia Studies: Technical Implications for SDTM/ADaM Conformance, Metadata Governance, and CSR‚ Level Consistency

Prasanna Kakade, Ephicacy Consulting Group · Achin Wadhwa, Ephicacy Consulting Group

Talk · Main Conference CDISC · Evergreen B

What It Actually Takes: Lessons from Production USDM Adoption and the Path to Digital Data Flow

Bill Lynch, HumanTrue

Talk · Main Conference CDISC · Evergreen C

Operationalizing CDISC Biomedical Concepts as a Semantic Layer for EHR-to-EDC Data Transfer, AI-Grounded Extraction and Metadata-Driven Study Configuration

Miten Mistry, Paradigm Health · Abhishek Dabral, Paradigm Health

Talk · Main Conference TMF · Evergreen D

The Connected TMF Mindset: Embedding Risk-Based Thinking and Engagement at Scale

Christina Mantzioros, Montrium

Talk · Main Conference TMF · Evergreen E

Approaches to AI Validation in Regulated Clinical Systems and the eTMF

Jay Smith, TransPerfect

Talk · Main Conference CDISC · Evergreen A

From Framework to Practice: Practical ADaM Implementation

Jie Yang, SGS Pharma – Clinical Research

Break · Main Conference CDISC · Evergreen B

What Breaks First When You Go DDF?

Udiksha Jaiswal, Sycamore Informatics · Bill Qubeck, Sycamore Informatics

Talk · Main Conference CDISC · Evergreen C

Reimagining Clinical Trials with FHIR-to-CDISC Interoperability

Prasoon Sangwan, TCS · Arka Mazumder, TCS

Talk · Main Conference TMF · Evergreen D

Strengthening Inspection Readiness Through Proactive Reviews

Carol Radwanski, Just in Time GCP · Jenn Stamper, Just in Time GCP

Talk · Main Conference TMF · Evergreen E

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

Break · Networking · Rocky Mountain Event Center

Lunch & Exhibition

Talk · Main Conference CDISC · Evergreen A

From Human-Readable Mappings to Machine-Verifiable SDTM Transformation Specifications with AI-Assisted Authoring

Rostislav Markov, Amazon Web Services · Alana St. Clair, CDISC

Talk · Main Conference CDISC · Evergreen B

CDISC Open Rules: Progress, Performance, and Foundations for the Future

Tomás Sabat Stöfsel, Verisian · Kent Letourneau, ICON

Talk · Main Conference CDISC · Evergreen C

Beyond XPT: Reimagining the Clinical Submission for 2041

Rajprakash Chennamaneni, Jazz Pharmaceuticals · Donna Sattler, Eli Lilly

Talk · Main Conference TMF · Evergreen D, E

Metadata in the TMF SM V1

Aaron Grant, CDISC · Jamie Toth, BeOne Medicines

Talk · Main Conference CDISC · Evergreen A

Accelerating SDTM Engine Development and Adoption with a Multi-Agent AI Framework and RAG-Based Assistant

Proma Debnath, Merck & Co. · Srinivas Malipeddi, Merck & Co.

Talk · Main Conference CDISC · Evergreen B

From Protocol to CSR: Reimagining Clinical Trials with AI and Next-Gen CDISC Models

Bhavin Busa, Clymb Clinical

Talk · Main Conference CDISC · Evergreen C

From Intent to Execution: How Biomedical Concepts Quietly Rewired the Safety Data Pipeline

Chithra Subramaniam, Bristol Myers Squibb · Rohini Goyal, Bristol Myers Squibb

Talk · Main Conference TMF · Evergreen D, E

Change Management for TMF SM V1

Steph Viscomi, Kymera Therapeutics

Talk · Main Conference CDISC · Evergreen A

Governance Powered CDISC Implementation: Driving Standards Reuse at Scale

Minda Quiroz, Alcon

Talk · Main Conference CDISC · Evergreen B

Dataset-JSON Is Coming: What FDA Adoption Could Mean for Standards, Systems, and Submission Readiness

Bill Qubeck, Sycamore Informatics

Talk · Main Conference CDISC · Evergreen C

Unlocking eSource Potential: A Call for Ecosystem Alignment on AI/NLP Standards

Jo-Zahn Baxter, Axtria

Roundtable · Main Conference TMF · Evergreen D, E

eTMF Vendor Round Table

Aaron Grant, CDISC

Break · Networking · Rocky Mountain Event Center

Afternoon Break

Panel · Main Conference CDISC · Evergreen A, B, C

Panel Discussion: Clinical Trials, Reimagined: What the Next Decade Looks Like

Ron Fitzmartin, Decision Analytics LLC · Chris Decker, CDISC President and CEO

Talk · Main Conference TMF · Evergreen D, E

Inside TMF Standard Model V1: A Conversation with the Program Leadership Team

Jamie Toth, BeOne Medicines

Talk · Main Conference TMF · Evergreen D, E

Moving to a Standard and Beyond

Paul Carter, CDISC · Sydney Stamper, Just in Time GCP

Other · Main Conference CDISC · Evergreen A, B, C

Closing Remarks

Nicole Harmon, CDISC

Other · Main Conference TMF · Evergreen D, E

Closing Remarks

Jamie Toth, BeOne Medicines

Other · Spruce Foyer

Registration / Check-In

Break · Rocky Mountain Foyer

Breakfast

Workshop · Training · Conifer 1

Analysis Results Standard (ARS) Hands-On Implementation

Workshop · Training · Iris Room

Biomedical Concepts Hands-On Implementation

Workshop · Training · Larkspur Room

*NEW TRAINING* USDM Implementation Handbook Training: From SoA design to SDTM Define

Workshop · Training · Spruce 2

ADaM Advanced + Hands-On Implementation

Workshop · Training · Primrose Room

Fundamentals of the TMF Reference Model

Workshop · Training · Spruce 1

*NEW TRAINING* SDTM Fundamentals in Practice (Beginner to Practitioner - Part I)

Break · Rocky Mountain Foyer

Morning Break

Break · Rocky Mountain Foyer

Lunch

Workshop · Training · Larkspur Room

*NEW TRAINING* USDM Advanced: Extending USDM with Architecture, Design, and Practical Workflows

Workshop · Training · Iris Room

Dataset-JSON v1.1 Hands-On Implementation

Break · Rocky Mountain Foyer

Afternoon Break

Other · Spruce Foyer

Registration / Check-In

Break · Rocky Mountain Foyer

Breakfast

Workshop · Training · Spruce 2

ADaM Advanced + Hands-On Implementation (Day 2)

Workshop · Training · Spruce 1

*NEW TRAINING* SDTM Implementation in Clinical Data Flow (Practitioner to Experienced - Part II)

Break · Rocky Mountain Foyer

Morning Break

Break · Rocky Mountain Foyer

Lunch

Break · Rocky Mountain Foyer

Afternoon Break