2024 Presentations

Build Your Company’s TMF Culture Club through Vendor / Sponsor Collaboration

• Laurel-Ann Schrader, Director, Client Solutions, TransPerfect Life Sciences
• Karry Calderon, Senior Manager, Clinical Systems & TMF Operations, Axsome Therapeutics

Game On! Strategies for Conquering the Final Boss: TMF Close-Out

• Rob Jones, Director of Professional Services, Phlexglobal
• Erin Markle, TMF Programme Lead, Phlexglobal

Panel: Building a TMF Organization for Success

• Moderator: Curran Murphy, Senior Director Clinical Operations / Head of TMF Operations, Blueprint Medicines
• Hilary Craven, Clinical Operations Leader, Genentech
• Rino Nascari, Head, TMF & Transparency, Bristol Myers Squibb
• John Saviski, Director, Clinical Documentation, GSK
• Matthew Shore, Associate Director, Merck

Case Study: Developing a Culture of Inspection Readiness and How ICH E6 (R3) Impacts TMF Management

• Ranee DiCarlo, Sr. Manager, Documentation (eTMF), Aadi Bioscience
• Candace Rieder, Director, Trial Master File (TMF) Operations, Eikon Therapeutics

The Pivot—Establishing a TMF Functional Area with Long-Term Viability

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

Case Study: Regeneron’s Heated Journey to TMF Completeness and Study Team Compliance

• Vishwani Naul, TMF Lead, Regeneron Pharmaceuticals, Inc.
• Jason Weinstein, Associate Director Trial Master File, Regeneron Pharmaceuticals, Inc.

Successful Change Framework for Quality Oversight and Inspection Readiness Using Data Analytics

• Colleen Maude, Sr Director of Quality Investigations & Analytics, AstraZeneca

Drumroll please! Introducing…the Investigator Site File Reference Model Initiative

• 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.

eTMF Audit: An Auditor’s Perspective

• Anna Borowiecka, Director, Quality Assurance, Corcept Therapeutics

eTMF Artificial Intelligence and Machine Learning – 2nd Generation (eTMF AI/ML 2G+)

• Louis Pasquale, Director, eTMF Client Services, IQVIA

CDISC and the Future for the TMF Reference Model

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

Case Study: A Simple Approach to Implementing a Risk-Based TMF Quality Review

• Sandi Harrison, Director eTMF & Inspection Readiness, Clinical Program Optimization, Global R&D Operations, Endo

Inspection Ready TMF: Using Tools to Set Expectations

• Christina Allen, Associate Director, TMF Operations, Daiichi Sankyo
• Rochelle Fountain, TMF Operations Manager, Daiichi Sankyo

From Chaos to Organized: Building a Successful TMF Foundation for Inspection Readiness

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

Harmonizing Partnerships: Navigating the Sponsor-CRA Relationship Through a Collaborative Approach

• Iris Castillo, Director, Clinical Document Management, bluebird bio
• Pooja Khemchandani, Senior Manager, Clinical Document Management, bluebird bio
• Dana Martin, Clinical Operations Consultant, bluebird bio
• David Weinstein, eTMF Specialist, Clinical Document Management, bluebird bio

Workshop C: Effective Study & Vendor Oversight: A Risk Proportionate Approach

• Grace Crawford, MS, MT (ASCP), Head, Clinical Operations Quality & Learning, AstraZeneca
• Colleen Maude, Sr Director of Quality Investigations & Analytics, AstraZeneca

Workshop D: TMF Inspection Readiness Essentials: Understanding Document Lifecycles, Translations, Regulatory Expectations, and Reducing Risk

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