2024 CDISC + TMF US Interchange Presentation Archive
Session 1 - Opening Plenary
Grand Ballroom (Main Level)
CDISC Vision: Rebuilding Our Foundation and Transforming the Standards Paradigm
Chris Decker, CDISC President & CEO
Presentation Media
Document
CDISC Roadmap: Focus on Realizing the Long-Term Vision
Peter Van Reusel, CDISC Chief Standards Officer
Presentation Media
Keynote Presentation: Unlocking the Power of Data to Modernize R&D and Improve Patient Outcomes
Dr. Rob DiCicco, VP of Portfolio Management, TransCelerate Biopharma Inc.
Presentation Media
Document
Session 2: Second Opening Plenary - Regulatory Presentations & Roundtable
Chris Decker, CDISC President & CEO
Grand Ballroom (Main Level)
Project PRISM Update: Use Cases and Pilots
Lisa Lin, FDA-CBER
Presentation Media
Document
Envisioning How Reviewers Could Leverage the M11 Digital Protocol in the Future
Dr. Ron Fitzmartin, FDA-CBER
Presentation Media
The Role of Standardized Study Data in Efficient and Effective Drug Application Reviews
Dr. Lilliam Rosario, FDA-CDER
Presentation Media
Data Submission Modernization
Dr. Jose Galvez, FDA-CDER
Presentation Media
Document
Panel Discussion- The Future of Regulatory Review: What Would a Dynamic and Collaborative Review from Protocol Through Submission Look Like?
Dr. Lilliam Rosario, FDA-CDER; Dr. Jose Galvez, FDA-CDER; Lisa Lin, FDA-CBER; Dr. Ron Fitzmartin, FDA-CBER
Session 2D+E: TMF Vision for the Future (TMF Track)
Karen Roy, CDISC
Rattlers & Bouchon (Main Level)
TMF Welcome
Karen Roy, CDISC
A Vision for the Journey to TMF RM Version 4
Donna Dorozinsky & Kathleen Mellet, Just in Time GCP; Gillian Gittens, TransPerfect; Paul Fenton, Montrium; Lisa Mulcahy, Mulcahy Consulting; Leila Canlas, Pfizer; Kate Santoro, Intellia Therapeutics
Lunch and Poster Session
Donna Sattler, Independent
Forum (Lower Level)
Enhancing the Efficacy of Validation Protocols for SEND Datasets via Error Analysis and Optimized Solutions.
Hee Young Jang, Korea Institute of Toxicology
Data Standards Adherence: Process, Challenges, and the Future
Ryan Dempsey & Aditya Parankusham, GSK
Establishing the Korean SEND User Group to Bridge the Gap in Standardization Before Regulatory Mandate
Yoongi Kim, Korea Institute of Toxicology
Optimizing Clinical Research Efficiency through SDTM Dataset Splitting: Insights from New SDTM Programmers
Maddie Hays & Tiffany Bainter, RHO
Cardiodynamic Data Submission: Key Concepts and Considerations for Regulatory Compliance and Analysis
Christopher McNamee, Celerion
Multi-trial Laboratory Data Quality Assessment and Profiling of SDTM data through a Hybrid Statistical-Machine Learning Approach
SoonJye Kho & Bhargav Koduru, Medidata Solutions
How to Automatically Create SDTM with APIs
Minji Lee, Celltrion
Elevate Your Game: Leveling Up SDTM Validation with the Magic of Data Managers
Julie Ann Hood & Jennifer Manzi, Pinnacle21 by Certara
Digital Assets in a Clinical Trial System
Dan Ringenbach, Nurocor
Use Case - Approach to Modeling Radiolabeled Investigational Drug Data in SDTM Exposure as Collected Domain
Lauren Shinaberry & Matthew Paulson, Abbvie
Beginning-to-End Clinical Data Standards: Connecting the Dots
Karel Lamberson, Abbvie
Efficiency in Handling BIMO CLINSITE.xpt Validation Activity
Yogesh Pande, Merck
Navigating Complexities: Integrating Data from Ongoing Studies in Regulatory Submissions
Natalie Freeland, RHO
ISS/ISE Journey: Learnings Highlighted with a few Intrinsic Limitations
Nithisha Kasam, Cytel
Risk Based Reviews, How to Manage the risk Level Going in Either Direction
Rob Jones, Cencora Pharmalex
From Chaos to Clarity
Ben Rogers, LMK Consulting Company
Containerization of CORE using Docker and Docker Hub
Samuel Johnson, Sam Hume, CDISC
Session 3A: Digital Protocol, Part I
Peter Van Reusel, CDISC
North Ballroom (Main Level)
ICH M11, TransCelerate, CDISC & HL7: Driving the Adoption of Digital Protocol
Peter Van Reusel, CDISC
Presentation Media
Digital Data Flow: Achieving Protocol Digitalization and Clinical Research Interoperability through Multi-stakeholder Collaboration
Bill Illis, TransCelerate Biopharma
Presentation Media
USDM in Action – From Protocol to SDTM
Dave Iberson-Hurst, data4knowledge
Presentation Media
Document
Session 3B: Real World Data Sources to CDISC
Jon Neville, CDISC
Center Ballroom (Main Level)
Using the CDISC SDTM Implementation in Observational Studies and Real World Data‚ Document in a Postmarketing Observational RWE Study: A Case Study
Phillip Jackson, IQVIA Technologies
Presentation Media
Document
Avoiding Problems with Analysis – Best Practices when Developing an eCOA Data Transfer
Terek Peterson, YPrime
Presentation Media
From Source to Submission: Getting the Best of Multiple Standards
Berber Snoeijer, ClinLine
Presentation Media
Document
Session 3C: CDISC Open Rules Workshop
Els Janssens, SGS
South Ballroom (Main Level)
CDISC Open Rules Update
Nick De Donder, CDISC
CDISC Open Rules Workshop
Els Janssens, SGS; Nick De Donder, CDISC
Session 3D: TMF Essentials (TMF Track)
Donna Dorozinsky, Just in Time GCP
Rattlers (Main Level)
Introduction to the TMF Reference Model and TMF Plan
Karen Roy, CDISC
Presentation Media
Press Start: Initiating Your TMF Set-Up Adventure
Marcin Hernik & Erin Markle, Cencora Pharmalex
Presentation Media
Navigating Change Resistance: Understanding Resistor Profiles and Strategies for Effective Change Management
Meghan Zuchlewski & Jim Markley, Just in Time GCP
Presentation Media
Session 3E: The Impact of Regulations (TMF Track)
Sarah Dean, Precision for Medicine
Bouchon (Main Level)
The Requirements of the 2023 EMA Guideline on Clinical Systems and the CSV Tab of the CDISC TMF RM
Lisa Mulcahy, Mulcahy Consulting
Presentation Media
The EU CTR and its Impact on the TMF
Karla Navera-Andersen, Ascendis Pharma A/S
Presentation Media
Unveiling the Secrets of eTMF Audit Trail Review
Nisi Nazim, BeiGene
Presentation Media
Afternoon Break
Forum (Lower Level)
Session 4A: Digital Protocol, Part II
Bron Kisler, Nurocor
North Ballroom (Main Level)
DDF and Breaking Down the Document Barrier
Bob Brindle and Frederik Malfait, Nurocor
Presentation Media
Transforming Vision into Reality: BMS Journey to Embrace the Digital Protocol
Viral Vyas, Bristol Myers Squibb
Presentation Media
Digital Protocol Panel Discussion
Session 4B: Standards Governance & MDRs
Kent Letourneau, ICON
Center Ballroom (Main Level)
Using a Standards Library to Support End-to-End CDISC Automation
Stuart Malcolm, Veramed (PRE-RECORDED PRESENTATION)
Presentation Media
Advancing Clinical Data Integrity: Moderna's Integrative Approach to Metadata Compliance and Governance
Fred Bermont & Erica Gonzales, Moderna
Presentation Media
Adjudication of Events and Findings
Jennifer Mastri and Diana Litvan, MSD
Presentation Media
Document
Session 4C: CDISC Open Rules Update
Els Janssens, SGS
South Ballroom (Main Level)
FDA Business Rules and CDISC Open Rules, the Road to Adoption
Nick De Donder, CDISC
Presentation Media
CDISC CORE Adoption and Certification
Bremer Louw, Bioforum
Presentation Media
Bending the Rules: A Deep Dive into Custom Rule Creation with the Open Rules Project
Roman Radelicki, SGS
Presentation Media
Session 4D: Risk Based Approaches (TMF Track)
Bryan Souder, Merck
Rattlers (Main Level)
Considerations for Risk-Based Approaches
Ramya Iyer, Regeneron, Marion Mays, Jerion Consulting Group
Presentation Media
How to Use Current Regulations to Take TMF Risk-Based Approaches?
Sarah Hitching, Hedian Records Management
Presentation Media
Applying Quality by Design to TMF Risk Management
Michael Agard, Epista Life Science
Presentation Media
Session 4E: TMF Management through Metrics (TMF Track)
Colleen Butler, Syneos
Bouchon (Main Level)
A Live Case Study in Using Reports to Address TMF Completion
Jared Brooslin & Kate Santoro, Intellia Therapeutics
Presentation Media
TMF Training Through Performance Metrics
Dawn Niccum, inSeption Group
Presentation Media
TMF Management through Metrics – 2024 TMF RM Survey
Todd Tullis, Veeva Systems
Presentation Media
Document
Evening Event (Must have registered for the Evening Event to attend)
Must have registered for the Evening Event to attend
Forum (Lower Level)
Session 5A: Concepts in Practice
Bess LeRoy, CDISC
North Ballroom (Main Level)
Concepts in Practice Presentation
Jon Neville, CDISC
Presentation Media
Document
Activity Concepts in OpenStudyBuilder
Mikkel Traun, Novo Nordisk
Presentation Media
Biomedical Concept/Analysis Concept Use Case - Protocol, Collection, Analysis, Mapping
Ryan Dempsey and Edwin van Stein, GSK
Presentation Media
Analysis Concepts at Roche
Chris Price, Roche
Presentation Media
Panel Discussion
Session 5B: Regulatory
Charles Shadle, CDISC
Center Ballroom (Main Level)
ICH Initiatives: M4Q(r2)/Q12/M11 and Global Harmonization; Impacts to Regulatory Submissions
Brooke Casselberry, Epista Life Science
Presentation Media
Navigating Regulatory Compliance: Complexities around the EU Clinical Trials Regulation
Anuj Thapar, TransPerfect
Presentation Media
Conventional Wisdom for Conventional Units
Lauren Shinaberry, Abbvie
Presentation Media
Food Allergy Research with CDISC Standards
Dave Scocca, Rho Inc.
Presentation Media
Document
Session 5C: Special Topics / Implementing CDISC
Sandra Minjoe, ICON
South Ballroom (Main Level)
Advancing Clinical Trial Diversity: Beyond the Traditional Race Categories
Donna Sattler, Independent
Presentation Media
Status of CDISC Implementation and Outreach Activities in Japanese Academia
Toshiki Saito, NHO Nagoya
Presentation Media
ADaM Adventures in Oncology
Paul Slagle, IQVIA
Presentation Media
Document
Session 5D: End of Study Challenges (TMF Track)
Lisa Mulcahy, Mulcahy Consulting
Rattlers (Main Level)
Navigating GCP Record Retention: A Practical Approach
Ashley Avery, Cerevel Therapeutics/AbbVie; Tom Lynam, Arkivum
Presentation Media
TMF Migrations and Transfers for Mergers and Acquisitions
Soraya Halligan & Madhvi Bajaj, Regeneron
Presentation Media
Panel Discussion: Managing Study TMFs between Sponsors and CROs: Before, During, and After TMF Delivery
Jess Vicari, Sage Therapeutics
Presentation Media
Session 5E: Partnerships in TMF Management (TMF Track)
Bryan Souder, Merck
Bouchon (Main Level)
Streamline the TMF Reference Model for Optimal Clinical Trial Document Management
Andrew Waite, Gilead; Katherine Novak, Epista Life Science
Presentation Media
PANEL: A Journey to TMF Excellence Using A Risk-Based Approach
Jessica Jackson, Galderma ; Gillian Gittens, TransPerfect
Session 6A: 360i - Moving from Proof of Concept to Implementation
North Ballroom (Main Level)
Transforming from Silos to End to End Realizing the Value of Standards
Chris Decker, CDISC
Presentation Media
The Past, Present, and Future of 360
Peter Van Reusel, CDISC
Presentation Media
Practical Benefits of the "Enable and Automate" Strategy to Support End-to-End Automation
Dr. Sam Hume, CDISC
Presentation Media
Industry Expert Panel: Industry Perspective on Delivering a 360 Vision
Session 6B: CDISC for Beginners
Terek Peterson, YPrime
Center Ballroom (Main Level)
Practical Guidance for Successful Global Regulatory Submissions: Understanding FDA and PMDA Data Standards Requirements
Sandra Minjoe & Kent Letourneau, ICON
Presentation Media
Name that ADaM Dataset Class
Nancy Brucken, IQVIA Technologies
Presentation Media
Document
SDTM as the Single Source of Clinical Data
Michael Goedde & Bremer Louw, Bioforum
Presentation Media
Session 6C: Analysis Results Standards - eTFL
Bess LeRoy, CDISC
South Ballroom (Main Level)
Launching the eTFL Portal
Bess LeRoy, CDISC
Presentation Media
Driving Efficiency and Automation in TFL Generation: A Case Study of Establishing an Oncology TFL Library and Analysis Results Metadata Repository
Bhavin Busa, Clymb Clinical, Salil Parab, Xencor Inc.
Presentation Media
Lilly’s Metadata-Driven Innovation Journey
Andrew Miskell and Keith Hibbets, Eli Lilly
Presentation Media
Session 6D: Audits and Inspections (TMF Track)
Dawn Niccum, inSeption Group
Rattlers (Main Level)
How to Use the TMF Index as an Auditing Tool
Pam Dellea-Giltner, PDG Clinical Consulting
Presentation Media
TMF Sub-Repositories
Debra Wells, Novartis
Presentation Media
Document
Panel Discussion: Inspections for Different Functions
Steph Viscomi, Apellis
Session 6E: TMF Reference Model Becoming a Standard (TMF Track)
David Ives, Novartis
Bouchon (Main Level)
Understanding Data Driven TMF
Nick Hargaden, Moderna; Paul Fenton-Carter, Montrium
Presentation Media
TMF Interopability: The Critical Importance of Standard Integrations of Clinical Trial Management Data to Promote eTMF Health and Completeness
Jay Smith, TransPerfect
Presentation Media
Document
Panel Discussion: TMF Standards from the Vendors Perspective
Moderator: Paul Fenton-Carter, Montrium
Session 7A: Data Science
Sam Hume, CDISC
North Ballroom (Main Level)
Dataset-JSON Update
Sam Hume, CDISC
Presentation Media
Running the CDISC Open Rules Engine (CORE) in BASE SAS
Lex Jansen, CDISC
Presentation Media
RWD Lineage Initiative
Tasha Nagamine, Droice Labs; and Anita Umesh, Roche
Presentation Media
Session 7B: Enable & Automate
Charles Shadle, CDISC
Center Ballroom (Main Level)
Automatic Data Classification in Action
Nathan Johnson, eClinical Solutions
Applying Guidance from “Submitting Patient-Reported Outcome Data in Cancer Clinical Trials” as a Best Practice for COA Data and Analysis in Non-Cancer Studies
Charity Quick, Emergent Biosolutions
Presentation Media
Document
Pharmaverse – Disrupting the Status Quo with Collaborative Solutions for Common Clinical Data Flow Processes
Michael Rimler, GSK, Pharmaverse
Presentation Media
Session 7C: Analysis Results Standards & eTFL Hands-On Workshop
Bess LeRoy, CDISC & Bhavin Busa, Clymb Clinical
South Ballroom (Main Level)
Workshop Slides
Presentation Media
Session 7D+E: Technology and Innovation in TMF Management
Paul Fenton-Carter, Montrium
Rattlers & Bouchon (Main Level)
AI-Onic TMFs: A Case Study
Lou Pasquale & Charles Pattrell, IQVIA Technologies
Presentation Media
The Interoperability Advantage: Streamline Your Clinical Trials with TMF Automation
David Ives, Novartis; Jason Methia, Veeva
Presentation Media
Brainstorming V4 Updates….. Be a Part of the Future of the TMF RM
Kathleen Mellet & Donna Dorozinsky, Just in Time GCP
Session 8A: AI & ML
Srinivasa Rao Mandava, Merck
North Ballroom (Main Level)
SDTM Transformation through Artificial Intelligence (AI) and Human in the Loop (HITL): Lessons Learnt from Abbvie Case Study
Aman Thukral & Sanjay Bhardwaj, Abbvie
Presentation Media
Document
Embracing Metadata Management with Artificial Intelligence (AI)
Prasoon Sangwan & Mayank Bhatia, TCS
Presentation Media
Harmony and Melody - The Role of Metadata Standards in Improving Machine Learning Efficiency
Steve Ross, Beaconcure
Presentation Media
Session 8B: Foundational Standards
Sandra Minjoe, ICON
Center Ballroom (Main Level)
Which ADaM Data Structure Is Most Appropriate? Gray Areas in BDS and OCCDS
Veronica Gonzalez, Biogen
Presentation Media
Advanced Approaches to Missing Data in Rare Disease Studies: Using SAS and ADaM Datasets to facilitate LOCF, MMRM, and MI Analysis
Olivia Hwang, Amgen
Presentation Media
Analyzing the Shift: From CDISC Define-XML 2.0 to 2.1
Dinesh Kumar Kumar, Zifo RnD
Presentation Media
Session 8C: COSA
Charles Shadle, CDISC
South Ballroom (Main Level)
Schedule of Activities in OpenStudyBuilder
Mikkel Traun, Novo Nordisk
Presentation Media
OAK
Shiyu Chen, Atorus Research; Rammprasad Ganapathy, Roche/Genentech
Presentation Media
Admiral: An Open-Source R Package for Creating ADaM Datasets with Modularized Functions in a Readable and Easily-Constructable Manner
Zelos Zhu, Atorus Research
Presentation Media
Document
Session 8D+E: Investigators and Inspectors (TMF Track)
Jamie Toth, BeiGene
Rattlers & Bouchon (Main Level)
FDA Update on Inspections across Sites, Sponsors and CROs
David Glasgow, FDA
Presentation Media
CDISC ISF Initiative
Jamie Toth, BeiGene; Anna Fehr & Nikki Jundt, One of a Kind Clinical Research Center; Matt Lowery, The Pathways Group, LLC
Presentation Media
Document
Panel Discussion: The Intersection between Sponsors, CROs, Vendors and Sites
Marion Mays, Jerion Consulting Group
Small Break
Closing Plenary
Center & South Ballroom (Main Level)
Closing Remarks
Nicole Harmon, CDISC COO
Presentation Media