2025 CDISC + TMF US Interchange Presentation Archive
Session 1: Opening Plenary & Keynote Presentation
Jennifer Duff, NA3C Chair, Merative; and Paul Carter, TMF Chair
Symphony Ballroom (Lobby Level)
Session 2: CDISC Plenary - 360i Vision & Roadmap
Chair: Srinivasa Rao Mandava, NA3C Vice-Chair, Merck
Symphony Ballroom I & II (Lobby Level)
CDISC 360i: Value of Transforming our Standards and Process to Drive Clinical Research
Chris Decker, CDISC President & CEO
CDISC 360i: Lessons Learned and Road Ahead
Peter Van Reusel, CDISC CSO
CDISC 360i Project Update: Demonstrating Progress in Driving the Automation Transformation
Julie Smiley, CDISC VP, Data Science
Session 2: TMF Plenary - The Future of TMF
Chair: Jamie Toth, BeOne Medicines USA, Inc.
Symphony III (Lobby Level)
The Future Unfolded: V4 of the TMF Reference Model
TMF RM V4 Project Management Team: Gill Gittens, Transperfect; Lisa Mulcahy, Mulcahy Consulting
Session 3: Track A - Validation
Chair: Charles Shadle, CDISC
Symphony I (Lobby Level)
Insights on Data Conformance Rules: Lessons from TIG v1.0
Els Janssens, SGS and Chris Connolly, CDISC
CORE Update and Open Rules
Charles Shadle, CDISC Head, Data Science Operations
Towards 360i, or At Least 180i: A Validation Perspective!
Marcelina Hungria and Allan Hungria, DIcore Group
Session 3: Track B - Foundational Standards (ADaM, CDASH)
Chair: Kent Letourneau, NA3C, ICON
Symphony II (Lobby Level)
ADaM Pet Peeves: Things Programmers Do That Make Us Crazy
Nancy Brucken, IQVIA; and Sandra Minjoe, ICON
Derived Parameters: Best Practices to Ensure Clear Sightlines to Traceable Data
Amanda Johnson, Merck
Enhancing Data Collection in Clinical Trials: Tips, Best Practices and Real-Life Applications
Maria Sekac and Amy Palmer, Merck
Session 3: Track C - AI Innovation Challenge
Srinivasa Rao Mandava, NA3C Vice-Chair, Merck; and Julie Smiley, CDISC VP, Data Science
Symphony III (Lobby Level)
Use Case #1: Protocol Library - Build USDM-Centric Repository of Study Definitions from Existing Protocols
Winner: Faro
Use Case #2: BC Acceleration - Accelerate Development of BCs to Drive Transformation and Automation
Winner: Saama
Use Case #3: Automated Traceability - Demonstrate Semantic Traceability from Analysis back to Study Design
Winner: Merck
Session 3: Track D - The Impact of Version 4 (TMF Track)
Dawn Niccum, InSeption
Starstruck (Mezzanine Level)
The ISF Reference Model: What You Need to Know About It!
Jamie Toth, BeOne Medicines USA, Inc.; Matt Lowery, MGH
Navigating eTMF Complexity in Real-World Data Research
Chris Huang and Tom Stonehouse, Oracle
Defining TMF in the Digital Era - Balancing Essential Records Management with Modern Digital Solutions
Martina Duevel, Bayer
Session 3: Track E - TMF Culture and Engagement (TMF Track)
Steph Viscomi, Apellis
Blackbird Studio A&B (Mezzanine Level)
Saddling Up on the TMF Culture Trail
Jared Brooslin, Intellia Therapeutics; Seth Pearl, Cencora
The Japanese TMF Community
Yuto Kanda, Chugai Pharmaceutical Co., Ltd.; Miyuki Taguchi, Inseption
Session 4: Track A - Digital Study Design
Chair: Erin Muhlbradt, NA3C, MSC
Symphony I (Lobby Level)
From Synergies to Risks: AI's Impact on Automated Study Build
Peter Sagarese, Oracle
Accelerating Digital Data Flow through Connected Standards-Driven Automation and AI
Mayank Bhatia and Prasoon Sangwan, TCS
Session 4: Track B - Transformative Vision of Data Collection and Delivery
Chair: Asif Karbhari, NA3C, AstraZeneca
Symphony II (Lobby Level)
Transforming the Creation of Study Instance Metadata using a Metadata Repository
Prathima Surabhi, AstraZeneca
Improving Population Health Outcomes through Enhanced Clinical Data Capture and Standardization
Donna Sattler, Independent and Brian Harris, AstraZeneca
Session 4: Track C - Regulatory Submission
Chair: Jennifer Duff, NA3C Chair, Merative
Symphony III (Lobby Level)
AstraZeneca RTOR Standards Implementation
Soma Sekhar Sriadibhatla, AstraZeneca
Collaborating on Standards: An Approach to Harmonizing Vaccine Regulatory Submissions
Sandra VanPelt Nguyen, Pfizer
A Comprehensive Review of Data Traceability and Standardization in Regulatory Submissions: Lessons from the Study Data Submission Plan (SDSP) and Variations Among FDA, PMDA, and NMPA
Pritesh Solanki, Merck
Session 4: Track D - The Impact of Version 4 (TMF Track)
Lisa Mulcahy, Mulcahy Consulting
Starstruck (Mezzanine Level)
Computerised System Records and the TMF
Jennifer Arters, Epista Life Science and Jennifer Peacock, Biogen
Metadata Matters: Standardising Metadata in the TMF RM V4
Aaron Grant, CDISC
Getting Ahead of the Curve: Strategic Planning for the TMF RM V4 Implementation
Steph Viscomi, Apellis, Kathleen Mellet, CDISC
Session 4: Track E - Partnerships in TMF Management (TMF Track)
Colleen Butler, Syneos Health
Blackbird Studio A&B (Mezzanine Level)
Performing TMF QC Oversight: A Sponsor's Perspective
Princess Barcelona Martin, Beacon Therapeutics
Enhancing Sponsor & External Service Provider TMF Management through Budget and Scope Alignment
Niamh Smith, CSL Behring
Building Smarter TMF Completeness Processes: A Framework for Better CRO and Sponsor Oversight
Katherine Novak, Epista
Session 5: Track A - 360i, Part II
Chair: Kent Letourneau, ICON, NA3C
Symphony I (Lobby Level)
CDISC 360i & OpenStudyBuilder: From Vision to Implementation
Rhona O'Donnell, Novo Nordisk
Analysis Concepts Definition: Initial Perspectives from the CDISC Working Group
Bhavin Busa, Clymb Clinical; and Brian Harris, AstraZeneca
Considerations for Implementing CDISC ARS: Balancing Flexibility and Standards
Steve Hamburg, Jazz Pharma
Session 5: Track B - What's New in SDTMIG 4.0 and SDTM 3.0
Chair: Mary Liang Dolegowski, SAS
Symphony II (Lobby Level)
What's New in SDTM 3.0
Dave Scocca, Rho
What's New in SDTMIG 4.0
Mike Wise, Edwards Lifesciences and Maria Sekac, Merck
An Overview of Demographics for Multiple Participations (DC): A New Domain in SDTMIG V4.0
Dana Booth, Merck and Carlo Radovsky, Immanant
Session 5: Track C - Innovation in Clinical Trials, Part I
Chair: Harivardhan Jampala, Fortrea
Symphony III (Lobby Level)
The AI Imperative: Accelerating the Pace of Standards Development
Sarah Jamal, Oracle
Digitally Decentralized: Reengineering Clinical Trials with Technology at the Core
Raj Kumar, Sycamore Informatics
Can ChatGPT Write CDISC Open Rules? Well, Now It Can!
Roman Radelicki, SGS
Session 5: Track D - Risk Based Approaches (TMF Track)
Sarah Hitching, Hedian
Starstruck (Mezzanine Level)
What Does a Risk Based Approach Really Mean? Summary of the TMF RM Risk Initiative
Joanne Malia, Regeneron
TMF Risk Management: Developing A Plan for Mitigating Risk Identified by the CDISC Risk Tool
Marion Mays, Jerion Consulting Group; Sarah Hitching, Hedian
Redefining Risk: Leveraging Clinical Data and Critical to Quality Factors (CTQs) to Drive Compliance in the R3 Era
Donna Dorozinsky, Just in Time GCP
Session 5: Track E - TMF Interoperability (TMF Track)
Bryan Souder, Merck
Blackbird Studio A&B (Mezzanine Level)
Don't Fear the Audit Trail: It's Your TMF's Insightful BFF
Lori Braun, Mulcahy Consulting
Breaking the Silos: TMF Integration Across the Trial Ecosystem
Ricky Lakhani, PHARMASEAL
Session 6: Track A - 360i Roundtable & What's Next
Chair: Erin Muhlbradt, NA3C, MSC
Symphony I (Lobby Level)
360i Roundtable Discussion
Session 6: Track B - New Data Sources (RWD)
Chair: Donna Sattler, NA3C Vice-Chair
Symphony II (Lobby Level)
RWD Lineage: A CDISC Standard for Reliable Real-World Data (RWD)
Tasha Nagamine, Droice Labs and Anita Umesh, Genentech
Incorporating Digital Health Technology (DHT) Data in SDTM - Challenges and Examples
Swarupa Sudini and Sandra VanPelt Nguyen, Pfizer
Don't Leave Encounters with Real-World Data to Chance
Ingeborg Holt, Orizaba Solutions and Sarah Ferko, IBM
Session 6: Track C - Innovation in Clinical Trials, Part II
Chair: Harivardhan Jampala, Fortrea
Symphony III (Lobby Level)
A Self-Structing Approach to Acquiring and Traversing JSON Extracts from the CDISC Library
Carlo Radovsky, Immanant
The Omics Standards Landscape and the Connection with CDISC
Chris Connolly, CDISC
Open to Integration: A Case Study on Open Source Tools for ISS Harmony
Steven Nicholas, Atorus
Session 6: Track D - Migrations / EOS (TMF Track)
Sarah Dean, Precision for Medicine
Starstruck (Mezzanine Level)
The Remix: Reworking Data for Modern TMF Migrations
Nisi Nazim, BeOne Medicines USA, Inc.
Acquisition Migrations: Weathering the Storm - The Voyage to TMF Ownership
Nita Whyte, Gilead Sciences, Inc.; Marion Mays, Jerion Consulting
Session 6: Track E - TMF Management (TMF Track)
Joanne Malia, Regeneron
Blackbird Studio A&B (Mezzanine Level)
How Pfizer is Modernizing Its TMF Strategy for Efficiency and Collaboration
Neha Ramani, Veeva Systems, Inc.; VonDiza Yvette Flix, Pfizer
From Insight to Impact: Driving Resilient and Compliant TMFs through Smarter Decision Making
Janice Cassamajor and Angie Gill, Cencora
Blueprint for A Successful TMF Rescue
Katie Hoover, Vital GxP Consulting LLC
Session 7: CDISC Plenary - Evolving Data Standards Role in Digital Age
Chair: Jennifer Duff, NA3C Chair, Merative
Symphony Ballroom I & II (Lobby Level)
Evolving Data Standards Role in the Digital Age
Session 7: TMF Plenary - The Future of TMF
David Ives, Novartis
Symphony Ballroom III (Lobby Level)
Presentation of the CDISC TMF Reference Model Roadmap
Paul Carter, Montrium
Ted Talks: ICH E6 R3 Impact on TMF
Dawn Niccum, inSeption Group and Jennifer Escobar, Alkeus Pharmaceuticals
Session 8: CDISC Closing Plenary
Chairs: Donna Sattler, NA3C Vice-Chair
Symphony Ballroom I & II (Lobby Level)
Session 8: TMF Closing Plenary - The Future of TMF
Paul Carter, Montrium
Symphony Ballroom III (Lobby Level)
Who's Afraid of Becoming a Digital TMF? The Challenges and Opportunities in the Future of the TMF Standard
Jay Smith, TransPerfect
ICH M11 - What Does this Really Mean to TMF