2022 US Interchange Presentation Archive
2022 US Interchange Program
All times in US Central Time
Session 1: Opening Plenary
Chair: Dave Evans, CDISC President and CEO
Ballroom A + B
Welcome Address & State of the CDISC Union
Dave Evans, CDISC President and CEO
Presentation Files
Document
Welcome from the CDISC Board
Pam Howard, Chair, CDISC Board of Directors
Presentation Files
Keynote Presentation: Impact of International Privacy Regulations on Health Data Standards
Dr. Pierre-Yves Lastic, Secretary General, European Federation of Data Protection Officers (EFDPO), and Vice President, French Union of Data Protection Officers (UDPO)
Presentation Files
State of CDISC Standards
Amy Palmer, CDISC Head of Standards Development
Presentation Files
Coffee Break, Exhibition & Poster Session
Rio Grande A&B
Session 2: Second Opening Plenary - CDISC Looking Ahead
Chair: Dr. Sam Hume, CDISC
Ballroom A
CDISC Open Rules and the CORE Engine Progress and Roadmap
Peter Van Reusel, CDISC Chief Standards Officer
Presentation Files
Biomedical Concepts Vision and Value for the Community
Bess Leroy and Jon Neville, CDISC
Presentation Files
What you need to know about the CDISC Library
Dr. Sam Hume, CDISC
Presentation Files
Document
Lunch Break, Exhibition and Poster Session
Rio Grande A&B
Session 3: Track A - Regulatory Topics
Chair: Donna Sattler, Bristol Myers Squibb
Ballroom A
An Overview of FDA’s Study Data Policy Framework
Helena Sviglin, FDA-CDER
Presentation Files
EMA Presentation
Marcia Rueckbeil, EMA
Presentation Files
PMDA Presentation
Dr. Yuki Ando, PMDA
Presentation Files
Session 3: Track B - Impact of CDISC Standards on Business Optimization
Chair: Terek Peterson, YPrime
Ballroom B
Thinking Ahead: Using CDISC standards helps get the most of your eCOA data
Monali Khanna, YPrime
Presentation Files
SDTM Metadata Cross Checks to Improve Quality
Nicole Jones, Merck
Presentation Files
Processing real-world data for regulatory decisions: minimizing data loss, maximizing information
Mayur Saxena, Tasha Nagamine, Droice Labs
Presentation Files
Enable 10X Efficiency to Your Clinical Data Standardization and SDTM Submission Processes
Srinivasan Anandakumar, Saama
Presentation Files
Session 3: Track C - Digitization
Chair: Don Thampy, Merck
Bluebonnet
Automating the Digital Data Flow with a Standards Foundation
Venu Mallarapu, eClinical Solutions
Presentation Files
Changing outlooks of Clinical Trials life Operations and Clinical Data Management with Covid Pandemic
Srinivasa Rao Mandava, Merck
Presentation Files
Automation enabling standardization or Standards enabling automation? A preview of MOSAIC Biometrics, a tool for the AstraZeneca Output Standards
Suman Nayak, AstraZeneca
Presentation Files
Transcelerate DDF - SDR RI MVP implementation
Jennifer Duff and Mark Laney, Merative
Presentation Files
Coffee Break, Exhibition & Poster Session
Session 4: Track A - Implementation Use Cases, Part I
Chair: Sandra Minjoe, ICON
Ballroom A
Confused about Oncology Response Mappings? We're Here to Help!
Melanie Paules, Takeda; Kim Musgrave, Amgen; and Erin Muhlbradt, NCI-EVS
Presentation Files
Implementation of Kidney related TAUGs
Sai Jaya Nagajaran, Zifo RnD Solutions
Presentation Files
Sexual Orientation, Gender Identity, and Intersex Status Data Collection Implementation at Bristol Myers Squibb
Stacey Panfil and Donna Sattler, Bristol Myers Squibb
Presentation Files
Document
Session 4: Track B - Real World Data
Chair: Rhonda Facile, CDISC
Ballroom B
Real World Data Considerations for Study Data Submissions to FDA/CDER
Dr. Gideon Scott Gordon, FDA-CDER
Presentation Files
Real world data as a bridge between industry and patients
Sophia Zilber, Pfizer
Presentation Files
CDISC BASIC Implementation Guide
Dr. Diane Wold, Amy Palmer, Gary Walker, CDISC
Presentation Files
Document
Session 4: Track C - Artificial Intelligence
Chair: Srinivasa Rao Mandava, Merck
Bluebonnet
Is AI/ML A Reality or A Day Dream
Harinarayan Gopichandran, Saama Technologies
Presentation Files
Automating Efficiency with Machine Learning for Data Classification
Robert Musterer, eClinical Solutions
Presentation Files
Digitization: Transformation of Mindsets, Processes, and Organization to Realize Value
Don Thampy, Merck
Evening Networking Event
Must be registered for Evening Networking Event to attend.
Rio Grande A&B
Session 5: Track A - Implementation Use Cases, Part II
Chair: Amy Palmer, CDISC
Ballroom A
Trace CDISC Application in FDA NDAs and CRs for Clinical Trial Safety
Dr. Wenjun Bao, JMP Life Sciences
Presentation Files
Document
Medical Imaging Data Standards, Analysis and Automation
Shyam Banuprakash and Kim Nguyen, Clario
Presentation Files
Document
Clinical Data Standards, Change Request Process: How Far We've Come and Where We're Going
Donna Sattler and Sharon Hartpence, Bristol Myers Squibb
Presentation Files
Document
Practical Steps for Implementing ML for SDTM Mapping
Sharon Rossouw, Bioforum
Presentation Files
Session 5: Track B - Trial Design
Chair: Dave Evans, CDISC
Ballroom B
TransCelerate Digital Data Flow: An Update on DDF Phase 2
Mikkel Traun, Novo Nordisk A/S and Vijay Reddi, Roche Products Ltd.
Presentation Files
Document
How Does the CDISC Community Benefit and the View Forward: An Update on CDISC's Activities on DDF, Benefits for the Community, and Looking Ahead
Dave Iberson-Hurst, data4knowledge
Presentation Files
Document
Concept-based standards in OpenStudyBuilder supporting structured protocol content and submission deliverables
Mikkel Traun, Novo Nordisk A/S
Presentation Files
Session 5: Track C - CDISC Fundamentals
Chair: Terek Peterson, YPrime
Bluebonnet
CDISC Analysis Results Standards - Approach and Development Update
Bhavin Busa, Independent; and Andrew Miskell, Eli Lilly and Company
Presentation Files
Making an ADaM Dataset Analysis-Ready
Sandra Minjoe, ICON PLC
Presentation Files
Document
Sound SDTM, Sound ADaM – Orchestrating SDTM and ADaM Harmonization
Nancy Brucken, Soumya Rajesh, David Neubauer, IQVIA
Presentation Files
Demonstrating Traceability in ADaM Datasets
Wayne Zhong, Accretion Softworks LLC
Presentation Files
Document
Coffee Break, Exhibition & Poster Session
Rio Grande, A&B
Session 6: Track A - Implementation Use Cases, Part III
Chair: Sandra Minjoe, ICON
Ballroom A
The Continuing Evolution of SDTM Metadata
Dr. Diane Wold, CDISC
Presentation Files
SDTM Standards for Genomics: Genomics Findings (GF) and Future Directions
Christine Connolly, CDISC; and Dr. Erin Muhlbradt, NCI-EVS
Presentation Files
What is and what should never be: Prevention, Evaluation, and Decisions surrounding source data errors discovered after data lock
Charity Quick, Rho, Inc.
Presentation Files
Document
Standardizing ADRS and ADTTE per Lugano Criteria for Hematology Efficacy Analysis
Song Liu, BeiGene USA
Presentation Files
Document
Session 6: Track B - Business Optimization & Technical Topics
Chair: Anthony Chow, CDISC
Ballroom B
COSMoS Technical Implementation, API Layer and Use Cases
Lex Jansen & Linda Lander, CDISC
Presentation Files
COSA Dataset-JSON Hackathon Results
Dr. Sam Hume, CDISC
Presentation Files
Takeda's implementation to expand Terminology and LOINC mapping
Veena Nataraj, Takeda
Presentation Files
AstraZeneca's Path Toward End-to-end Clinical Data Standards
Brian Harris, AstraZeneca
Presentation Files
Lunch Break, Exhibition & Poster Session
Rio Grande A&B
Session 7: CDISC Special Topics
Chair: Peter Van Reusel, CDISC Chief Standards Officer
Ballroom A
TMF Implementation Plan
Karen Roy, Phlexglobal; Paul Fenton, Montrium; and Kathie Clark, Ennov
Presentation Files
Advancing Pre-Market Safety Analytics
Dr. Vaishali Popat, FDA-CDER; and Bess LeRoy, CDISC
Presentation Files
Document
Document
Coffee Break, Exhibition & Poster Session
Rio Grande A&B
Session 8: Closing Plenary, Global Regulatory Presentations and Panel Discussion
Chair: Dave Evans, CDISC President and CEO
Ballroom A
Study Data Standards Update for CBER: Your Guide To A Successful Submission
Dr. Lisa Lin, FDA-CBER
Presentation Files
FDA-CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Christine Connolly, CDISC; and Amy Malla, FDA-CTP
Regulatory Roundtable Discussion
Regulatory Speakers
Closing Remarks