2024 CDISC + TMF US Interchange Program
2024 US Interchange Program
All Presentation Times are Subject to Change
8:30 - 10:20
Session 1 - Opening Plenary
8:30 - 8:35
CDISC Welcome
8:35 - 9:05
CDISC Vision: Rebuilding Our Foundation and Transforming the Standards Paradigm
Chris Decker, CDISC President & CEO
9:05 - 9:35
CDISC Three-Year Roadmap: Focus on the First Step to Realize the Long-Term Vision
Peter Van Reusel, CDISC Chief Standards Officer
9:35 - 10:20
Keynote Presentation
Speaker Invited
10:20 - 11:00
Morning Break
11:00 - 13:00
Session 2A: Concepts in Practice
Bess LeRoy, CDISC
Concepts in Practice Presentations
Industry Experts Invited
12:30 - 13:00
CDISC & Industry Panel Discussion
11:00 - 13:00
Session 2B: Regulatory Session
Dan Crawford, Veeva
11:00 - 11:30
ICH Initiatives: M4Q(r2)/Q12/M11 and Global Harmonization; Impacts to Regulatory Submissions
Brooke Casselberry, Epista Life Science
11:30 - 12:00
Navigating Regulatory Compliance: Complexities around the EU Clinical Trials Regulation
Anuj Thapar, Trial Interactive - TransPerfect Life Sciences
12:00 - 12:30
Conventional Wisdom for Conventional Units
Lauren Shinaberry, Abbvie
12:30 - 13:00
Food Allergy Research with CDISC Standards
Dave Scocca, Rho, Inc.
11:00 - 13:00
Session 2C: CDISC CORE Workshop
Els Janssens, SGS
11:00 - 11:30
CDISC CORE Update
Nick De Donder, CDISC
11:30 - 13:00
CDISC CORE Workshop
Nick De Donder, CDISC
11:00 - 13:00
Session 2D+E: TMF Welcome (TMF Track)
Karen Roy, CDISC
11:00 - 11:15
TMF Welcome
Karen Roy, CDISC
11:15 - 12:30
The Future of the TMF Reference Model: The Next Version
TMF Reference Model Steering Committee
12:30 - 13:00
Interactive Exercise
TMF Reference Model Steering Committee
13:00 - 14:00
Lunch
14:00 - 15:30
Session 3A: Digital Protocol, Part I
Peter Van Reusel, CDISC
14:00 - 14:30
ICH M11, TransCelerate, CDISC & HL7: Driving the Adoption of Digital Protocol
Peter Van Reusel, CDISC
14:30 - 15:00
Digital Data Flow: Achieving Protocol Digitalization and Clinical Research Interoperability through Multi-stakeholder Collaboration
Bill Illis, TransCelerate Biopharma
15:00 - 15:30
USDM in Action – From Protocol to SDTM
Dave Iberson-Hurst, data4knowledge
14:00 - 15:30
Session 3B: Real World Data Sources to CDISC, Part I
Rhonda Facile, CDISC
14:00 - 14:30
Digital Health Technologies
Christine Connolly, CDISC
14:30 - 15:00
RWD Lineage Initiative
Sam Hume, Pharma Project Lead
15:00 - 15:30
CDMH Presentation
Speaker Invited
14:00 - 15:30
Session 3C: CDISC CORE
14:00 - 14:30
FDA Business Rules and CORE, the Road to Adoption
Nick De Donder, CDISC; Jesse Anderson, FDA-CDER
14:30 - 15:00
CDISC CORE Adoption and Certification
Bremer Luow, Bioforum
15:00 - 15:30
Bending the Rules: A Deep Dive into Custom Rule Creation with the CORE Project
Roman Radelicki, SGS
14:00 - 15:30
Session 3D: TMF Essentials (TMF Track)
Donna Dorozinsky, Just in Time GCP
14:00 - 14:30
Introduction to the TMF Reference Model and TMF Plan
Speaker Invited
14:30 - 15:00
Press Start: Initiating Your TMF Set-Up Adventure
Marcin Hernik, Cencora Pharmalex
15:00 - 15:30
Navigating Change Resistance: Understanding Resistor Profiles and Strategies for Effective Change Management
Meghan Zuchlewski, Just in Time GCP
14:00 - 15:30
Session 3E: The Impact of Regulations (TMF Track)
Sarah Dean, Precision for Medicine
14:00 - 14:30
The Requirements of the 2023 EMA Guideline on Clinical Systems and the CSV Tab of the CDSIC TMF RM
Lisa Mulcahy, Mulcahy Consulting
14:30 - 15:00
The EU CTR and it's Impact on the TMF
Karla Navera-Andersen, Ascendis Pharma A/S
15:00 - 15:30
Unveiling the Secrets of eTMF Audit Trail Review
Nisi Nazim, BeiGene
15:30 - 16:00
Afternoon Break
16:00 - 17:30
Session 4A: Digital Protocol, Part II
Bron Kisler, Nurocor
16:00 - 16:30
DDF and Breaking Down the Document Barrier
Bob Brindle and Frederik Malfait, Nurocor
16:30 - 17:00
Trial CAD: Constrained Optimisation Approaches to Parametric Clinical Study Design
Daniel Roythorne, AstraZeneca
17:00 - 17:30
Digital Protocol Panel Discussion
16:00 - 17:30
Session 4B: Real World Data Sources to CDISC, Part II
Rhonda Facile CDISC
16:00 - 16:30
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
16:30 - 17:00
Avoiding Problems with Analysis – Best Practices when Developing an eCOA Data Transfer
Terek Peterson, YPrime
17:00 - 17:30
From Source to Submission: Getting the Best of Multiple Standards
Berber Snoeijer, ClinLine
16:00 - 17:30
Session 4C: Special Topics / Implementing CDISC
Sandra Minjoe, ICON
16:00 - 16:30
Advancing Clinical Trial Diversity: Beyond the Traditional Race Categories
Donna Sattler, Bristol Myers Squibb
16:30 - 17:00
Status of CDISC Implementation and Outreach Activities in Japanese Academia
Toshiki Saito, NHO Nagoya
17:00 - 17:30
Advanced Approaches to Missing Data in Rare Disease Studies: Using SAS and ADaM Datasets to facilitate LOCF, MMRM, and MI Analysis
Olivia Hwang, Amgen
16:00 - 17:30
Session 4D: Risk Based Approaches (TMF Track)
Laura Naranjo, Daiichi Sankyo
16:00 - 16:30
Considerations for Risk-Based Approaches
Joanne Malia, Regeneron
16:30 - 17:00
How to Use Current Regulations to Take TMF Risk-Based Approaches?
Sarah Hitching, Hedian Records Management
17:00 - 17:30
Applying Quality by Design to TMF Risk Management
Michael Agard, NNIT
16:00 - 17:30
Session 4E: TMF Management through Metrics (TMF Track)
Monica Alaimo, Syneos
16:00 - 16:30
CRO-Sponsor Metrics
Colleen Butler, Syneos Health; Joaquin Sosa, Cidara
16:30 - 17:00
TMF Training Through Performance Metrics
Dawn Niccum, inSeption Group
17:00 - 17:30
Speaker Invited
Speaker Invited
8:30 - 10:00
Session 5: Regulatory Session
8:30 - 9:00
Speaker Invited
Speaker Invited
9:00 - 9:30
Speaker Invited
Speaker Invited
9:30 - 10:00
Speaker Invited
Speaker Invited
8:30 - 10:00
Session 5D: End of Study Challenges (TMF Track)
Lisa Mulcahy, Mulcahy Consulting
8:30 - 9:00
Navigating GCP Record Retention: A Practical Approach
Ashley Avery, Cerevel Therapeutics; Tom Lynam, Arkivum
9:00 - 9:30
Work/Life Balance
Soraya Halligan & Madhvi Bajaj, Regeneron
9:30 - 10:00
Panel Discussion: Managing Studies between Sponsors and CROs
Panelists & Speakers Invited
8:30 - 10:00
Session 5E: Partnerships in TMF Management (TMF Track)
Bryan Souder, Merck
8:30 - 9:00
Managing Effective Oversight of Outsourced Studies
Christina Allen, Daiichi Sankyo
9:00 - 9:30
A Journey to TMF Excellence Using A Risk-Based Approach
Elondo Roby, Teva; Gillian Gittens, TransPerfect
9:30 - 10:00
Streamline the TMF Reference Model for Optimal Clinical Trial Document Management
Andrew Waite, Gilead; Morten Nielsen, Epista Life Science
10:00 - 10:30
Morning Break
10:30 - 12:00
Session 6A: CDISC for Beginners
Terek Peterson, YPrime
10:30 - 11:00
Practical Guidance for Successful Global Regulatory Submissions: Understanding FDA and PMDA Data Standards Requirements
Sandra Minjoe & Kent Letourneau, ICON
11:00 - 11:30
Name that ADaM Dataset Class
Nancy Brucken, IQVIA
11:30 - 12:00
SDTM as the Single Source of Clinical Data
Speaker Invited
10:30 - 12:00
Session 6B: Enable & Automate
Hari Jampala, Fortrea
10:30 - 11:00
End to End R Submission from Roche Oncology Study
Jingyuan Chen, Genentech/Roche
11:00 - 11:30
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
11:30 - 12:00
Speaker Invited
Speaker Invited
10:30 - 12:00
Session 6C: Analysis Results Standards - eTFL
Bess LeRoy, CDISC
10:30 - 11:00
Launching the eTFL Portal
Speaker Invited
11:00 - 11:30
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.
11:30 - 12:00
Lilly’s Metadata-Driven Innovation Journey
Andrew Miskell and Keith Hibbets, Eli Lilly
10:30 - 12:00
Session 6D: Audits and Inspections (TMF Track)
Dawn Niccum, inSeption Group
10:30 - 11:00
How to Use the TMF Index as an Auditing Tool
Pam Dellea-Giltner, PDG Clinical Consulting
11:00 - 11:30
TMF Sub-Repositories
Debra Wells, Novartis
11:30 - 12:00
Panel Discussion: Inspections for Different Functions
Steph Viscomi, Panelists Invited
Session 6E: TMF Reference Model Becoming a Standard (TMF Track)
David Ives, Novartis
10:30 - 11:00
Understanding Data Driven TMF
Paul Fenton, Montrium
11:00 - 11:30
TMF Interopability: The Critical Importance of Standard Integrations of Clinical Trial Management Data to Promote eTMF Health and Completeness
Jay Smith, TransPerfect
11:30 - 12:00
Speaker Invited
Speaker Invited
12:00 - 13:00
Lunch
13:00 - 14:30
Session 7A: Data Science
Sam Hume, CDISC
13:00 - 13:30
Dataset-JSON Update
Jesse Anderson, FDA-CDER
13:30 - 14:00
Running the CDISC Open Rules Engine (CORE) in BASE SAS
Lex Jansen, CDISC
14:00 - 14:30
Practical Benefits of the CDISC Enable and Automate Strategy to Support End-to-End Automation
Sam Hume, CDISC
13:00 - 14:30
Session 7B: Standards Governance & MDRs
Kent Letourneau, ICON
13:00 - 13:30
Using a Standards Library to Support end-to-end CDISC Automation
Stuart Malcolm, Veramed
13:30 - 14:00
Advancing Clinical Data Integrity: Moderna's Integrative Approach to Metadata Compliance and Governance
Fred Bermont, Moderna
14:00 - 14:30
Adjudication of Events and Findings
Jennifer Mastri & Diana Litvan, Merck
13:00 - 14:30
Session 7C: Analysis Results Standards & eTFL Hands-On Workshop
Bess LeRoy, CDISC & Bhavin Busa, Clymb Clinical
13:00 - 14:30
Session 7D+E: Technology and Innovation in TMF Management
Paul Fenton, Montrium
13:00 - 13:30
AI-Onic TMFs: A Case Study
Lou Pasquale, IQVIA
13:30 - 14:00
A Live Case Study in Using Reports to Address TMF Completion
Jared Brooslin & Kate Santoro, Intellia Therapeutics
14:00 - 14:30
How to Improve Interoperability and Increase TMF Automation
David Ives, Novartis; Jason Methia, Veeva
14:30 - 15:00
Afternoon Break
15:00 - 16:30
Session 8A: AI & ML
Srinivasa Rao Mandava, Merck
15:00 - 15:30
SDTM Transformation through Artificial Intelligence (AI) and Human in the Loop (HITL): Lessons Learnt from Abbvie Case Study
Aman Thukral & Sanjay Bhardwaj, Abbvie
15:30 - 16:00
Embracing Metadata Management with Artificial Intelligence (AI)
Prasoon Sangwan, TCS
16:00 - 16:30
Harmony and Melody - The Role of Metadata Standards in Improving Machine Learning Efficiency
Steve Ross, Beaconcure
15:00 - 16:30
Session 8B: Foundational Standards
Sandra Minjoe, ICON
15:00 - 15:30
Which ADaM Data Structure Is Most Appropriate? Gray Areas in BDS and OCCDS
Veronica Gonzalez, Biogen
15:30 - 16:00
Challenges Implementing SDTM and ADAM in Oncology Platform Trials
Saloni Shah, Fortrea
16:00 - 16:30
Analyzing the Shift: From CDISC Define-XML 2.0 to 2.1
Dinesh Kumar Kumar, Zifo RnD
15:00 - 16:30
Session 8C: COSA Session
Charles Shadle, CDISC
15:00 - 15:30
Schedule of Activities in OpenStudyBuilder
Mikkel Traun, Novo Nordisk
15:30 - 16:00
OAK
Ramprasad Ganapathy, Roche
16:00 - 16:30
Admiral: An Open-Source R Package for Creating ADaM Datasets with Modularized Functions in a Readable and Easily-Constructable Manner
Zelos Zhu, Atorus Research
15:00 - 16:30
Session 8D+E: Investigators and Inspectors (TMF Track)
Jamie Toth, BeiGene
15:00 - 15:30
FDA Update on Inspections
Speaker Invited
15:30 - 16:00
CDISC ISF Initiative
Jamie Toth, BeiGene
16:00 - 16:30
Panel Discussion: The Intersection between Sponsors, CROs, Vendors and Sites
Marion Mays, Jerion Consulting Group
16:30 - 16:50
Small Break
16:50 - 17:15
Closing Plenary
Bingo Winners
Closing Remarks