2022 Fierce TMF Summit Presentations

Please check back for updates as we confirm permission from the presenters to share their presentations.

 

Workshops

Building TMF Capabilities – What You Can Achieve with Functional Buy-in

• Laura Naranjo, M.S.J, Director, TMF Operations & Clinical Records, Daiichi Sankyo, Inc.
• Anusha Rameshbabu, TMF Lead, Alexion Pharmaceuticals, Inc.
• Stephanie Viscomi, Director, Global Regulatory Clinical Services, Eisai

FSP Model & Internal Functional Groups and Vendor Considerations - a Sponsors Perspective

• Jason D King-Andreini, Sr Manager, TMF Operations, Eidos Therapeutics, a Bridge Bio Company

Inspection Readiness as the Basis for Inspection Preparation

• Matthew Shore, Associate Director, Merck
• Jennifer Lennon, Associate Director, Essential Document Management, Merck

Managing Records & Data Integrity

• Hobson Lopes, Sr. Manager, Clinical Records & Archive Management, Regeneron Pharmaceuticals, Inc.
• Jamie Marie Toth, CPM, MS, Global Head, TMF, BeiGene USA, Inc.

Reporting & Archiving The Overlooked Value of Common eTMF Tasks

• Gene Filip, Senior Solutions Consultant Lead, Global Commercial Operations, ArisGlobal
• Dario Lirio, Senior Director, Product Management Clinical, ArisGlobal

TMF Fundamentals: The Essentials for TMF Managers

• Gillian Gittens, Director, e-Clinical Strategy & Solutions, TransPerfect Life Sciences
• Laurel-Ann Schrader, Director, Client Solutions, TransPerfect

 

General Sessions

Case Study: Successfully Connecting Sites and Sponsors with a Modern eTMF

• Ken Lownie, General Manager US Operations, Agatha

Creating TMF Professionals for the Future

• Ben Rogers, Manager of TMF Education and Employee Development, TransPerfect Life Sciences

Implementing an Internal Training Program for a Clinical Documentation Department

• Joe Pascual, Sr. Manager, Clinical Documentation Center, AbbVie

Intelligent Automation for The Trial Master File

• Gary Shorter, Head of Artificial Intelligence and Data Science, IQVIA Technologies

Keynote: The Harmonization of Clinical Research Information Standards

• David A. Evans, President & CEO, CDISC

The Impact of the EU Regulation on the TMF – So What Do We Do Now?

• Martina Duevel, Systems Excellence Project Leader, Bayer Pharmaceuticals
• Russell Joyce, Director & Principal Consultant, Heath Barrowcliff Consulting Ltd
• Karen Roy, Chief Strategy Officer, Phlexglobal

What Sites Can do to Alleviate ISF-Related Headaches

• Aryn Knight, Administrative Director, Center for Clinical Research, Texas Heart Institute
• Matt Lowery, ACRP-CP, CCRC, Director of Clinical Research, Suncoast Neuroscience Associates, Inc.

 

Inspections & Audits

Do you know your Record Trigger, Privacy and Data Integrity Breach Risks?

• Angel Ramos, CRM, IGP, MLIS, Senior Manager, Global Records, BeiGene USA, Inc.

Remote and Onsite Inspections: Ready for Both

• Dario Lirio, Senior Director, Product Management Clinical, ArisGlobal

 

TMF Standards & Formalization

Revisit the Application of your Organization’s TMF Plan – A Look a Cross Portfolios and Revisit your Metrics Program

• Matthew Shore, Associate Director, Merck

 

Process & Technology

Best Practice Approaches to Preserving TMF and Clinical Trial Data

• Rob Jones, Principal Business Consultant, Arkivum

How a Remediation Influenced Process and Technology Changes in an eTMF

• Rebecca Halbur, Associate Director, TMF Systems, Biogen

How to Fully Utilize TMF Office Hours and TMF Newsletters to Communicate Effectively with the Study Teams to Manage their TMF

• Samantha Mitchell, Manager, Clinical Records, Gilead

 

Strategy & Oversight 

Functional Quality Control: Revising Quarterly QC Reviews Through Strategy, System, and Resource Updates

• Adam Stillwagon, Manager, Clinical Records, Gilead

Sponsor Oversight and the Role of eTMF

• Kathie Clark, Product Director, CTMS and eTMF, Ennov

Stories from the Trenches: Lessons Learned from Working with a New TMF

• Michele Weitz, MA, RQAP-GCP, Senior Director, Clinical Operations Standards and Innovation, Clovis Oncology
• Chrystal Payne, Sr. Manager, TMF Operations, Xencor, Inc.