2023 CDISC TMF Interchange Presentation Archive
Session 1: Opening Plenary
Dave Evans, Karen Roy, CDISC
Calvert Ballroom / Salon C
CDISC TMF Welcome
Karen Roy, CDISC
Keynote Presentation: How TransCelerate Initiatives Impact the TMF
Dr. Rob DiCicco, TransCelerate BioPharma Inc.
Presentation Files
Document
Panel Discussion – The Trial Master File: Future Direction and Vision
Moderator: Karen Roy, CDISC
Session 2: Regulations and Inspections
Laura Naranjo, Daiichi Sankyo
Calvert Ballroom / Salon C
Panel: ICH E6 (R3) - Analyzing the Impact on the TMF
Moderator: Donna Dorozinsky, Just in Time GCP
Panel: Inspections from the View of All Stakeholders
Moderator: Vittoria Sparacio, Novartis
Lunch
Multiple Presenters
LB Tavern
Poster Session
Multiple Presenters
Session 3A: TMF Reference Model as a Tool
Monica Alaimo, Syneos
Calvert Ballroom / Salon C
TMF Reference Model to improve TMF Management
Jackie Morrill, TransPerfect
Presentation Files
Harnessing the Power of Your TMF Index
Laura Wiggins, Just In Time GCP
Presentation Files
Demystifying Data Management and TMF
Laura Naranjo, Vishaal Patel, Daiichi Sankyo
Presentation Files
Session 3B: TMF Reference Model Becoming a Standard
Paul Fenton, Montrium
Baltimore Theatre
TMF Reference Model (and EMS) Becoming a Standard
Bess LeRoy, CDISC
Presentation Files
Document
An Overview of NCI EVS Services and Its Collaboration with CDISC
Jordan Li, NCI EVS
Presentation Files
A Deep Dive into the TMF Reference Model Change Control
Kate Santoro, Intellia Therapeutics; Leila Ponce, Seagen
Presentation Files
Session 4A: TMF Health
Bryan Souder, Merck
Calvert Ballroom / Salon C
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
Presentation Files
How to Manage Study Teams and CROs Using TMF Metrics, Action Plans, and Escalations
Jason Weinstein, Regeneron
Panel: The Next Level of Risk-Based Quality Review
Moderator: Dawn Niccum, inSeption Group
Session 4B: TMF Interoperability
Sarah Dean, Precision for Medicine
Baltimore Theatre
Data Standardization and Integration: Turning Data Chaos into Data Intelligence
Nisi Nazim, BeiGene
Presentation Files
Clinical / Regulatory Interoperability: A World of Opportunity
Kathie Clark, Ennov
Presentation Files
Leveraging Data Enablement for Enhanced eTMF Interoperability and Colllaboration
Meghan Valnoski, NNIT
Presentation Files
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.
Session 6: Opening Innovation Panel
Karen Roy, CDISC
Calvert Ballroom / Salon C
Panel: Practical Ways to Leverage Automation and AI to Reduce Effort While Increasing Compliance in TMF Management
Moderator: James O'Keefe, Astrix
Session 7A: Technology in TMF Management
Donna Dorozinsky, Just In Time GCP
Calvert Ballroom / Salon C
Case Study: How Merck Drives Efficiencies and Quality with AI
Bryan Souder, Merck; Chris McSpiritt, Veeva
Presentation Files
Document
Enhancing Data Integrity by Applying Edit Checks to Your TMF
Christina Mantzioros, Todd Georgieff, Montrium
Presentation Files
Session 7B: TMF Culture and Engagement
Dawn Niccum, Inseption
Baltimore Theatre
Is TMF Really Too Much Fun? Challenging the TMF Culture Through Education and Collaboration
India Gardner, inSeption Group
Presentation Files
Characteristics of the 5 Generations of People and Considerations for TMF Management
Lisa Mulcahy, Mulcahy Consulting
Presentation Files
Session 8A: Sponsor-CRO Co-Operation
Monica Alaimo, Syneos
Calvert Ballroom / Salon C
Sponsor and CRO: Creating a Sustainable TMF Partnership
Alex Markiel, TMF Consultant; Annette Bugno, Biomea Fusion
Presentation Files
Fostering Effective Collaboration: An In-Depth Look at Sponsor-CRO Co-Operation
Yen Phan, elderbrook solutions GmbH
Presentation Files
Session 8B: End of Study
Vittoria Sparacio, Novartis
Baltimore Theatre
End of Study Transfer
Marion Mays & Toban Zolman, Kivo
Presentation Files
Revolutionizing eTMF Archiving and Preservation
Ashley Avery, Cerevel Therapeutics; Antonia Witten, Arkivum
Presentation Files
Session 9: Engagement Across Sponsor, CROs, and Vendors
Lisa Mulcahy, Mulcahy Consulting
Calvary Ballroom / Salon C
Panel: The Challenges of the TMF Engagement - Accountabilities and Bad Habits Across Pharma, CROs, and Vendors
Moderator: Anne-Noëlle Charles, GSK
Session 10: Interactive Session
Calvary Ballroom / Salon C
Interactive Exercise: Presenting Solutions for TMF Challenges
Karen Roy, CDISC; Paul Fenton, Montrium; Jamie Toth, BeiGene
Closing Remarks