Fierce Trial Master File Summit 2024 | Fierce Life Sciences Events | 18 March 2024 | Hyatt Regency Savannah , 2 W. Bay Street, Savannah, GA 31401, USA

The role of clinical document management continues to rapidly evolve to meet the needs of complex clinical trials across multinational sites. TMF professionals, as experts in the subject, need to stay updated on system migration, efficiency improvements, budget constraints, partnerships, new technologies like AI/ML, and evolving regulations to maintain a high-quality and inspection-ready TMF.

For over a decade, the summit has been the cornerstone event for clinical operations, document management, technology, and compliance leaders, TMF administrators, and partners in the global trial master file community. Join your clinical document peers in collaborative discussions about regulatory changes, automation, interoperability, and enhancing stakeholder relationships to improve TMF quality, timeliness, and completeness.

Focus areas:
• Inspections & Audits gain insights on best practices for establishing and monitoring metrics to drive inspection readiness and inform proactive decision-making in clinical trials.
• Operations & Collaboration 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.
• Governance & Oversight build a compliant monitoring framework using risk-based approaches and methods to ensure vendor oversight and data governance.
• AI & Automation explore the latest automation and process improvements utilizing AI and machine learning as new inspections methods, digital, and decentralized trials become more common.
• TMF Strategy learn insights and strategies for implementing and maintaining a compliant TMF according to inspection trends and changing global regulations.

2024 Speakers

Grace Crawford, MS, MT (ASCP)
Head, Clinical Operations Quality & Learning, AstraZeneca

Christina Allen
Associate Director, TMF Operations, Daiichi Sankyo

Ashley Avery
Senior Specialist, Quality Documents and Archival, Cerevel Therapeutics

Wendy Beeby
Head, Clinical Trial Associates, Takeda Pharmaceuticals

MCKenzie Beets
Senior Manager, Clinical Document Management, Takeda

Joseph Bolster
Associate Director, TMF operations, Prothena Biosciences

Jared Brooslin
Manager, Trial Master File, Intellia Therapeutics, Inc.

Karry Calderon
Senior Manager, Clinical Systems & TMF Operations, Axsome Therapeutics

Deborah Castellana
Director, TMF Archival Global Process Lead, Bristol Myers Squibb

Iris Castillo
Director, Clinical Document Management, bluebird bio

Hilary Craven
Clinical Operations Leader, Genentech

Mano Das
Director of IT, Trial Operations Capabilities, Bristol Meyers Squibb

Ashlyn (Creech) Deshaies
Director, Clinical and TMF Operations, TG Therapeutics, Inc.

Ranee DiCarlo
Sr. Manager, Documentation (eTMF), Aadi Bioscience

Sandra Dodd
Sr. Manager, TMF Operations, Xencor

Donna Dorozinsky
Founder & CEO, Just in Time GCP

Liz Farrell
Director, Trial Master File Process Lead, Agios Pharmaceuticals

Jennifer Ford
Senior Manager Trial Master File, Agios Pharmaceuticals

Rochelle Fountain
TMF Operations Manager, Daiichi Sankyo

India Gardner
Associate Director, TMF Operations, inSeption Group

Gillian Gittens
Director, e-Clinical Strategy & Solutions, TransPerfect Life Sciences

Marna Grim
Principal, Clinical Development Excellence, DELFI Diagnostics

Sandi Harrison
Director eTMF & Inspection Readiness, Clinical Program Optimization, Endo

Etienne Hinton
TMF Systems Specialist, Duke Clinical Research Institute

Tonia Huggins
Director of TMF Operations, Sage Therapeutics

Rob Jones
Director of Professional Services, Phlexglobal

CJ Joshi
Associate Director, Clinical Document Management, bluebird bio

Katie Kelly
Associate Director of Clinical Study Business Operations, Praxis Precision Medicines

Pooja Khemchandani
Senior Manager, Clinical Document Management, bluebird bio

Jason King-Andreini
Associate Director, TMF Operations, BridgeBio Therapeutics, Inc.

Aryn Knight, BS, CCRP
Associate Vice President, Clinical Research, Memorial Hermann Health System

Matt Lowery, ACRP-CP, CCRC
Director of Clinical Research, Suncoast Neuroscience Associates, Inc.

Erin Markle
TMF Programme Lead, Phlexglobal

Dana Martin
Clinical Operations Consultant, bluebird bio

Colleen Maude
Sr Director of Quality Investigations & Analytics, AstraZeneca

Cristina Monastero
Associate Director, Clinical Document Management, Larimar Therapeutics

Curran Murphy
Senior Director Clinical Operations / Head of TMF Operations, Blueprint Medicines

Laura Naranjo, M.S.J.
Head of TMF Operations and Records Management, Daiichi Sankyo, Inc.

Rino Nascari
Head, TMF & Transparency, Bristol Myers Squibb

Vishwani Naul
TMF Lead, Regeneron Pharmaceuticals, Inc.

Caroline Nielson
Associate Director of TMF Operations, 4D Molecular Therapeutics

Louis Pasquale
Director, eTMF Client Services, IQVIA

Candace Rieder
Director, Trial Master File (TMF) Operations, Eikon Therapeutics

Karen Roy
Co-Chair and Founder, TMF Reference Model, CDISC

Luann Sager
TMF Operations Senior Manager, Pfizer

Jodi Scarola
Director, TMF Operations and Records Management, Takeda

Laurel-Ann Schrader
Director, Client Solutions, TransPerfect Life Sciences

Matthew Shore
Associate Director, Merck

Supriya Shoroff
Senior Director, TMF Operations, Eisai

Shannon Simpson
Senior Manager, Trial Master File (TMF) Lead, Lexicon Pharmaceuticals

Pallavi Tadimeti
Sr. Manager, Trial Master Files, Blueprint Medicines

Jamie Marie Toth
Trial Master File Management & Records, and Chair of HSRAA Operations, BeiGene USA, Inc.

Lauren Valiente
Sr. Manager, TMF Operations and Records Management, Takeda Pharmaceuticals

Steph Viscomi
Director, TMF Services, Eisai

Fiona Wallace
Snr Manager TMF Operations, Alnylam

David Weinstein
eTMF Consultant, bluebird bio

Jason Weinstein
Associate Director Trial Master File, Regeneron Pharmaceuticals, Inc

2024 Sponsors

GOLD SPONSORS:
• Cencora
• inSeption
• TransPerfect

SILVER SPONSORS:
• IQVIA
• GCP

SUPPORTER:
• Health Sciences Records & Archives Association