Agenda
TMF leaders have a strategic opportunity to connect clinical systems, automate information flows, and drive digital execution. Join a fireside chat with Moderna’s vice president of clinical trial excellence and support, Margo Jaffee, to hear her vision for continued evolution in TMF to support increasingly complex clinical trials.
VP, Vault Clinical Operations Strategy
VP, Clinical Trial Excellence and Support
Fran Ross, member of the TMF Reference Model steering committee, discusses how remote inspections, new regulations, and leading industry guidance affect TMF operations. Get practical takeaways and expert analysis of ICH and ICMRA, and more.
Member
Various methods exist for effective sponsor-CRO collaboration, including having the CRO work directly in the sponsor’s system. Join this session to learn how Seagen has successfully implemented this model with leadership buy-in.
Sr. Manager, Clinical Systems & Records Management
Takeda shares the strategies they use to drive efficiencies and increase quality across their large portfolio. Learn how to combine business processes and innovative technology, like artificial intelligence, to improve TMF operations.
Director, Clinical, Metrics, Analytics Reporting & Technology (CMART)
Director, Clinical Document Management and Trial Support
Alexion shares how to go beyond selecting an eTMF system and build a multi-year TMF strategy. Get insights into setting a holistic strategy that aligns with the broader clinical operations and drug development ecosystem.
Sr. Director Clinical Operations Systems and Information Management
As merger and acquisition activity increases across the industry, Merck & Co., Inc. shares their M&A playbook. Learn how to develop processes to manage TMF acquisitions and transfers seamlessly.
Director, TMF Head
Speakers
Jason Methia
Veeva
VP, Vault Clinical Operations Strategy
Margo Jaffee
Moderna
VP, Clinical Trial Excellence and Support
Leila Ponce
Seagen
Sr. Manager, Clinical Systems & Records Management
Fran Ross
TMF Reference Model Steering Committee
Member
Melissa Chiasson
Takeda
Director, Clinical, Metrics, Analytics Reporting & Technology (CMART)
Wendy Beeby
Takeda
Director, Clinical Document Management and Trial Support
David Ives
Alexion
Sr. Director Clinical Operations Systems and Information Management
Bryan Souder
Merck & Co., Inc
Director, TMF Head