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Clinical Trial Events
CDISC US Interchange 2026

Talk Main Conference TMF track

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

Tue, Oct 6, 2026 · 3:30–4:00 PM MDT Evergreen D, E, Denver Marriott Tech Center

About this session

Part of Session 8: TMF Closing Plenary (Chair: Jamie Toth, BeOne Medicines).

Presented by TMF V1 Project Leadership.

The development of TMF Standard Model V1 has been a multi-year, community-driven effort shaped by evolving regulatory expectations, operational experience, and the need for a more comprehensive and sustainable industry standard. In this panel discussion, members of the V1 Program Leadership Team will share perspectives from behind the scenes on how the model has evolved, the decisions that have shaped its development, and the principles guiding the program as it moves toward release.
Panelists will discuss some of the most significant changes introduced in V1, the challenges and tradeoffs considered along the way, and how feedback from across the industry has influenced the emerging standard. The conversation will also explore what the team has learned through the development process, what organizations should be thinking about as they prepare for adoption, and how the model is expected to continue evolving beyond the initial V1 release.
Attendees will have an opportunity to hear directly from the leaders driving the program and gain greater insight into not only what is changing, but why.
Panelists:
Paul Carter, MontriumDonna Dorozinsky, Just in Time GCPGillian Gittens, TransPerfectLisa Mulcahy, Mulcahy ConsultingSteph Viscomi, Kymera Therapeutics

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