2023 CDISC TMF Interchange Program
08:00 - 09:00
Registration and Networking Breakfast
9:00 - 11:00
Session 1: Opening Plenary
Dave Evans, Karen Roy, CDISC
Calvert Ballroom / Salon C
9:00 - 9:20
CDISC TMF Welcome
Karen Roy, CDISC
9:20 - 10:10
Keynote Presentation: How TransCelerate Initiatives Impact the TMF
Dr. Rob DiCicco, TransCelerate BioPharma Inc.
10:10 - 11:00
Panel Discussion – The Trial Master File: Future Direction and Vision
Moderator: Karen Roy, CDISC
- Dave Evans, CDISC
- Rob DiCicco, TransCelerate Biopharma
- Paul Fenton, Montrium
- Jamie Toth, BeiGene
- Kelley Robinson, Sention Therapeutic
11:00 - 11:30
Morning Break
11:30 - 13:00
Session 2: Regulations and Inspections
Laura Naranjo, Daiichi Sankyo
Calvert Ballroom / Salon C
11:30 - 12:15
Panel: ICH E6 (R3) - Analyzing the Impact on the TMF
Moderator: Donna Dorozinsky, Just in Time GCP
Panelists:
- Gillian Gittens, TransPerfect
- Eldin Rammell, Phlexglobal
- Jamie Toth, BeiGene
12:15 - 13:00
Panel: Inspections from the View of All Stakeholders
Moderator: Vittoria Sparacio, Novartis
Panelists:
- Monica Alaimo, Syneos
- Christina Allen, Daiichi Sankyo
- Adriana Robinson, BeiGene
13:00 - 14:00
Lunch
Multiple Presenters
LB Tavern
13:00-14:00
Poster Session
Multiple Presenters
- Two Houses One Home; Rochelle Fountain, Daiichi Sankyo Inc
- TMF Takes a Village ; Traci Wendler, Syneos Health
- Working with Non-TMFers; Miyuki Taguchi, inSeption Group
- Charting the Future: Merging AI and Process Refinement for Advanced TMF Management; Daisy Zhu, Taimei Technology
- Sponsor-CRO Collaboration: When Too Much Fun is a Team Effort; Samantha McKenna, inSeption Group
- Embracing Innovation in TMF Management to Simplify User Experience; Lina Gaggi, Viedoc Technologies
- The Importance of Standard Integrations to Clinical Trial Management Data for eTMF Health and Completeness; Daniel Peitroske, TransPerfect
14:00 - 15:30
Session 3A: TMF Reference Model as a Tool
Monica Alaimo, Syneos
Session Sponsor
Calvert Ballroom / Salon C
Session Sponsor
14:00 - 14:30
TMF Reference Model to improve TMF Management
Jackie Morrill, TransPerfect
14:30 - 15:00
Harnessing the Power of Your TMF Index
Laura Wiggins, Just In Time GCP
15:00 - 15:30
Demystifying Data Management and TMF
Laura Naranjo, Vishaal Patel, Daiichi Sankyo
14:00 - 15:30
Session 3B: TMF Reference Model Becoming a Standard
Paul Fenton, Montrium
Baltimore Theatre
14:00 - 14:30
TMF Reference Model (and EMS) Becoming a Standard
Bess LeRoy, CDISC
14:30 - 15:00
An Overview of NCI EVS Services and Its Collaboration with CDISC
Jordan Li, NCI EVS
15:00 - 15:30
A Deep Dive into the TMF Reference Model Change Control
Kate Santoro, Intellia Therapeutics; Leila Ponce, Seagen
15:30 - 16:00
Afternoon Break
16:00 - 17:30
Session 4A: TMF Health
Bryan Souder, Merck
Session Sponsor
Calvert Ballroom / Salon C
Session Sponsor
16:00 - 16:30
The TMF Trinity and How Simple is Best. The Importance of Timeliness, Quality and Completeness and How They are Early Warning Systems for TMF Health
Robert Jones, Jake McDonald, Phlexglobal
16:30 - 17:00
How to Manage Study Teams and CROs Using TMF Metrics, Action Plans, and Escalations
Jason Weinstein, Regeneron
17:00 - 17:30
Panel: The Next Level of Risk-Based Quality Review
Moderator: Dawn Niccum, inSeption Group
Panelists:
- Ryan Ling, Pfizer
- Curran Murphy, Blueprint Medicines
- Steph Viscomi, Eisai
16:00 - 17:30
Session 4B: TMF Interoperability
Sarah Dean, Precision for Medicine
Baltimore Theatre
16:00 - 16:30
Data Standardization and Integration: Turning Data Chaos into Data Intelligence
Nisi Nazim, BeiGene
16:30 - 17:00
Clinical / Regulatory Interoperability: A World of Opportunity
Kathie Clark, Ennov
17:00 - 17:30
Leveraging Data Enablement for Enhanced eTMF Interoperability and Colllaboration
Meghan Valnoski, NNIT
17:40 - 18:45
Session 5: Interactive Session
Calvert Ballroom / Salon C
Interactive Exercise: Finding Solutions for TMF Challenges
Karen Roy, CDISC; Paul Fenton, Montrium; Jamie Toth, BeiGene
Evening Event
Attendees must have noted their participation during the registration process.