2025 CDISC + TMF US Interchange Program

Program is preliminary and subject to change.
Session 1: Opening Plenary & Keynote Presentation
Symphony Ballroom
Morning Break
Symphony Foyer
Session 2: Track A, B, & C - 360i Vision & Roadmap
Symphony Ballroom
Session 2: Track D+E - The Future of TMF (TMF Track)
Blackbird Studio A&B
Lunch Break & Poster Session
Symphony Foyer & Starstruck
Session 3: Track A - 360i Progress & Next Steps
Symphony I
Session 3: Track B - Foundational Standards (ADaM, CDASH)
Symphony II
Session 3: Track C - AI Innovation Challenge
Symphony III
The 2025 AI Innovation Challenge: A global call to vendors, researchers, and innovators to create AI/ML-driven solutions that advance the digitization and automation of clinical research using CDISC Standards.
During this session, the winner and runner-up from each of the three use cases during the Challenge will present on their solutions.
Interested in joining the Challenge? Join our webinar on Tuesday, 1 July 2025 from 10:00 AM - 11:00 AM EDT to get a comprehensive overview of the challenge's objectives, timeline, and three targeted use cases, ranging from protocol design to metadata traceability throughout the lifecycle. You will hear directly from CDISC leaders about how your solutions can help shape the future of standards-driven research and earn a spotlight at the 2025 CDISC US Interchange.
Session 3: Track D - The Impact of Version 4 (TMF Track)
Blackbird Studio A&B
Session 3: Track E - TMF Culture and Engagement (TMF Track)
Southern Ground A&B
- Matt Lowery, MGH
- Colleen Butler, Syneos
- Steph Viscomi, Apellis
Afternoon Break
Symphony Foyer
Session 4: Track A - Digital Study Design
Symphony I
Session 4: Track B - Special Topics
Symphony II
Session 4: Track C - Regulatory Submission
Symphony III
Session 4: Track D - The Impact of Version 4 (TMF Track)
Blackbird Studio A&B
Session 4: Track E - Partnerships in TMF Management (TMF Track)
Southern Ground A&B
Interchange Evening Networking Event (MUST be Registered for the Evening Event to Attend)
Session 5: Track A - 360i, Part II
Symphony I
Session 5: Track B - What's New in SDTMIG 4.0 and SDTM 3.0
Symphony II
Session 5: Track C - Innovation in Clinical Trials
Symphony III
Session 5: Track D - Risk Based Approaches (TMF Track)
Blackbird Studio A&B
Session 5: Track E - TMF Interoperability (TMF Track)
Southern Ground A&B
- Jamie Toth, BeOne
- Bryan Souder, Merck
- Deb Wells, Novartis
Morning Break
Symphony Foyer
Session 6: Track A - 360i, Part III (DDF / Protocol)
Symphony I
Session 6: Track B - New Data Sources (RWD)
Symphony II
Session 6: Track C - Innovation in Clinical Trials
Symphony III
Session 6: Track D - Migrations / EOS (TMF Track)
Blackbird Studio A&B
Session 6: Track E - TMF Management (TMF Track)
Southern Ground A&B
Lunch
Symphony Foyer
Session 7: Tracks A, B, & C - Evolving Data Standards Role in Digital Age
Symphony Ballroom
The digitalization of healthcare and advancing science and technologies are driving evolution. Biopharma companies, regulatory agencies, academic institutes, technology vendors and standards development organizations must adapt to this new environment. Hence, a significant challenge for the data standards community is keeping pace with the sheer breadth and depth of disease areas for which therapies are being developed across the biopharmaceutical industry, and the myriad of data types (including biomarker, genomic, imaging real world data, and various digital health technologies) being collected and used for analysis and reporting for decision making.
Leaders in the data standards community will share examples for current Data Standards Governance and evolving Data Standards roles, challenges being faced and aspects of where we are going, and how the Data Standards roles are evolving to thrive in the Digital Age with rapidly advancing science and healthcare needs.
Speakers and Panelists:
- Miho Hashio, GSK
- Jonathan Chainey, Roche
- Other speakers invited
Session 7: Track D+E - The Future of TMF (TMF Track)
Blackbird Studio A&B
- Rob Jones, Cencora
- Marion Béhier, Agatha
- Eleanor Hewes, Syneos