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Who Will You Be Joining?

Here's a small sample of attendees:

Sr. Clinical Systems Manager, Kodiak Sciences Inc.

Clinical Systems Associate, Kodiak Sciences Inc.

Sr. Clinical Systems Associate, Kodiak Sciences Inc.

Sr. System Management Specialist, Zealand Pharma A/S

Sr. CTA, Zealand Pharma A/S

Associate Director, Operational Process, Replimune

Clinical Trial Associate, Bausch Health

Analyst, Replimune

Senior Clinical Document Specialist, Replimune

Clinical Document Specialist, eTMF Operations, Replimune

Clinical Trial Specialist, Neurocrine Biosciences

Clinical Documentation Specialist, Replimune

Director, Clinical Quality & Compliance, Tango Therapeutics

Associate Manager, eTMF, Tango Therapeutics

Senior Manager, GxP Quality, Tango Therapeutics

CMO, Target Health

Sr. Clinical Trial Associate, Bausch Health

Manager, Clinical Process Excellence, ILiAD Biotechnologies

AD, TMF Operations, KalVista

Senior Clinical Trials Specialist, Connect Biopharma

TMF Manager, Axsome Therapeutics

Senior Specialist, Document Management & Archival, AbbVie

TMF Manager, Moderna

Sr. eTMF Specialist, Moderna

Senior TMF Specialist, Axsome Therapeutics

Director, R&D Business Systems and Ops Management, Daiichi Sankyo

Senior Document Specialist, KalVista Pharmaceuticals

Assoc. Director, TMF Process, Moderna

Director, TMF Oversight, Genmab

Associate Director of Quality Assurance, Sapience Therapeutics Inc.

Trial Master File Specialist, KalVista Pharmaceuticals

Sr. Director, Operational Excellence, Intellia Therapeutics

TMF Specialist, Crinetics Pharmaceuticals

Sr. Director, Global TMF Management & Records, BeOne Medicines USA, Inc.

Head TMF & Transparency, BMS

Sr. Manager, Global TMF, BeiGene

Clinical Records, Gilead

Sr. Specialist, Document & Clinical Systems, Neurocrine Biosciences Inc.

Clinical Trials Assistant II, Neurocrine Biosciences

Senior eTMF Manager, Zealand Pharma

Be Where the Industry’s Best Connect
FBW TMF Intro

Where Metrics, Oversight and Digital Innovation Converge

Gain insights into building a compliant, quality-driven TMF with risk-based oversight, automation, and AI to support global inspections and proactive decision-making. Discover how collaborative TMF systems are evolving to meet the demands of decentralized and digital trials.

Fierce Biotech Week 2026
May 12-14th

Stay in the Loop With the Industry’s Best

Conversations You Won't Want To Miss

Mastering the File:

TMF Experts You’ll Want to Hear From

Jamie Marie Toth

Jamie Marie Toth

Global Head, TMF Management & Records

BeOne Medicines USA Inc. (Formerly BeiGene USA, Inc.)
Grace Crawford

Grace Crawford

Global Head, Clinical Quality Management

AstraZeneca
Wendy Beeby

Wendy Beeby

Former Head, Clinical Trial Associated

Takeda
Rebecca Halbur

Rebecca Halbur

Associate Director, TMF Records Mangement, Cinical Trial Systems & Operations

Moderna
Etienne Hinton

Etienne Hinton

TMF System Specialist

Duke University Health System
Ashlyn Deshaies

Ashlyn Deshaies

Director, Clinical and TMF Operations

TG Therapeutics
Masoom Patel

Masoom Patel

Process Capability Manager, Clinical Documentation Management

Boehringer Ingelheim :Pharmaceuticals, Inc
Aryn Knight

Aryn Knight

Associate Vice President Clinical Research

Memorial Hermann Health System
Ashley Avery

Ashley Avery

Senior Specialist, Quality Documents & Archival

AbbVie
Meet the Speakers

Be part of the TMF Community that is collectively identifying key solutions.

Best practices to drive inspection readiness
Best practices to drive inspection readiness
Gain insights on best practices for establishing and monitoring metrics to drive inspection readiness and inform proactive decision-making in clinical trials.
Building a TMF organization with a culture of quality
Building a TMF organization with a culture of quality
Drive strategic advancement and build a culture of quality with the trial study organization from the start as the TMF evolves into a collaborative management system.
Risk-based approaches to ensure vendor oversight and data governance
Risk-based approaches to ensure vendor oversight and data governance
Build a compliant monitoring framework using risk-based approaches and methods to ensure vendor oversight and data governance.
Improve the quality and consistency of TMF by leveraging AI
Improve the quality and consistency of TMF by leveraging AI
Explore the latest automation and process improvements utilizing AI and machine learning as new inspections methods, digital, and decentralized trials become more common .
Harnessing AI and technology to accelerate trials and expand patient reach
Harnessing AI and technology to accelerate trials and expand patient reach
Explore process innovations and technologies like AI and wearables that are reducing the trial cycle and connecting researchers to more patients

Key topics covered in the Trial Master File Sessions:

  Inspections and audits

  Operations and collaboration

  Governance and oversight

  AI Innovation, technology and automation

  TMF Strategy 

FBW TMF Topics