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Connecting the Industry
To Advance Strategic TMF

April 2, 2025 | The Rittenhouse Hotel, Philadelphia

Agenda

Tuesday, April 1

5:00 p.m. – 8:30 p.m.
5:00 p.m.
Welcome Dinner

Wednesday, April 2

8:00 a.m. — 4:00 p.m.
8:00 a.m.
Breakfast
9:00 a.m.
Opening Keynote

Pfizer: Changing TMF Operating Models for Simplicity and Connectivity

Pfizer shares how a new TMF operating model will enable simplicity and improve connectivity across the business and with sites. This includes practical tips for change management and examples of key processes to simplify.

Leila Canlas
Leila Canlas Pfizer
TMF Operations Lead, Director
10:10 a.m.
Session

Emerging Biotech: Strengthening CRO Partnerships for TMF Quality and Efficiency

Apellis’ head of TMF shares lessons learned from current and former companies, including how to build an operating model on strong CRO partnerships and align processes and metrics for TMF teams of all sizes.

Supriya Shoroff
Steph Viscomi Apellis Pharmaceuticals
Director, Clinical Documentation & TMF
11:10 a.m.
Facilitated Networking

Discussion: Understanding the CDISC TMF Reference Model Revision and Roadmap

CDISC shares how organizations can prepare for the latest revision of the TMF Reference Model, which aims to standardize and digitize the historical model. Discuss key takeaways from the revision, steps to prepare your organization, and what’s next on CDISC’s roadmap.

Paul Fenton CDISC
Chair of TMF Reference Model Working Group and TMF Standards Subgroup, Member of TMF Reference Model Steering Committee
Jamie Toth CDISC
Incoming Chair-Elect of the TMF Reference Model Working Group, Member of TMF Reference Model Steering Committee
Jason Methia Veeva Systems
Vice President, Clinical Operations Strategy

Discussion: Strategies to Improve Site Collaboration (Repeat Session)

More than 70% of total documents by volume in the TMF come from sites. Discuss strategies to improve site collaboration and TMF planning.

Frank Lin Veeva Systems
Director, Clinical Operations Strategy
Neha Ramani Veeva Systems
Manager, Customer Success, Clinical Operations
12:00 p.m.
Lunch
1:00 p.m.
Session

AbbVie: Driving Organizational Change with Strategic Partnerships

AbbVie shares the importance of TMF in leading organizational change. This includes how collaboration with study teams and sites and task distribution improve accuracy and completeness.

Renee Fate AbbVie
Director, Clinical Records Management
2:10 p.m.
Facilitated Networking

Discussion: How Technology Can Help Make Data-Driven Decisions

Discuss with peers how to use technology to identify actionable insights from your data. Veeva will also share TMF trends across studies that can inform decision-making.

Jim Horstmann Veeva Systems
Senior Product Manager, Veeva eTMF
Neha Ramani Veeva Systems
Manager, Customer Success, Clinical Operations

Discussion: Strategies to Improve Site Collaboration (Repeat Session)

More than 70% of total documents by volume in the TMF come from sites. Discuss strategies to improve site collaboration and TMF planning.

Angela Faircloth Veeva Systems
Senior Director, Clinical Operations Strategy
Lauren Garson Veeva Systems
Senior Director, Clinical Operations Strategy
3:10 p.m.
Session and Close

Biotech Panel: Unifying Clinical Processes and Teams with TMF

TMF experts from Biomea Fusion and Dren Bio share lessons learned about working cross-functionally and creatively solving challenges, all with lean teams and small budgets. Hear about their latest inspection experiences, methods of influencing users and stakeholders, and strategies for driving real-time TMF completeness.

Julie Kmiec
Annette Bugno Biomea Fusion
Associate Director, Clinical Records Management (TMF)
Ashley Sawaf Dren Bio
Senior Manager, TMF Operations
4:00 p.m.
End of Program

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