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
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Document
Welcome from the CDISC Board
Pam Howard, Chair, CDISC Board of Directors
Presentation Media
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)
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State of CDISC Standards
Amy Palmer, CDISC Head of Standards Development
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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
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Biomedical Concepts Vision and Value for the Community
Bess Leroy and Jon Neville, CDISC
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What you need to know about the CDISC Library
Dr. Sam Hume, CDISC
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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
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EMA Presentation
Marcia Rueckbeil, EMA
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PMDA Presentation
Dr. Yuki Ando, PMDA
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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
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SDTM Metadata Cross Checks to Improve Quality
Nicole Jones, Merck
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Processing real-world data for regulatory decisions: minimizing data loss, maximizing information
Mayur Saxena, Tasha Nagamine, Droice Labs
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Enable 10X Efficiency to Your Clinical Data Standardization and SDTM Submission Processes
Srinivasan Anandakumar, Saama
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Session 3: Track C - Digitization
Chair: Don Thampy, Merck
Bluebonnet
Automating the Digital Data Flow with a Standards Foundation
Venu Mallarapu, eClinical Solutions
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Changing outlooks of Clinical Trials life Operations and Clinical Data Management with Covid Pandemic
Srinivasa Rao Mandava, Merck
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Automation enabling standardization or Standards enabling automation? A preview of MOSAIC Biometrics, a tool for the AstraZeneca Output Standards
Suman Nayak, AstraZeneca
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Transcelerate DDF - SDR RI MVP implementation
Jennifer Duff and Mark Laney, Merative
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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
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Implementation of Kidney related TAUGs
Sai Jaya Nagajaran, Zifo RnD Solutions
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Sexual Orientation, Gender Identity, and Intersex Status Data Collection Implementation at Bristol Myers Squibb
Stacey Panfil and Donna Sattler, Bristol Myers Squibb
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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
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Real world data as a bridge between industry and patients
Sophia Zilber, Pfizer
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CDISC BASIC Implementation Guide
Dr. Diane Wold, Amy Palmer, Gary Walker, CDISC
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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
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Automating Efficiency with Machine Learning for Data Classification
Robert Musterer, eClinical Solutions
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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
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Document
Medical Imaging Data Standards, Analysis and Automation
Shyam Banuprakash and Kim Nguyen, Clario
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Clinical Data Standards, Change Request Process: How Far We've Come and Where We're Going
Donna Sattler and Sharon Hartpence, Bristol Myers Squibb
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Practical Steps for Implementing ML for SDTM Mapping
Sharon Rossouw, Bioforum
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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.
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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
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Concept-based standards in OpenStudyBuilder supporting structured protocol content and submission deliverables
Mikkel Traun, Novo Nordisk A/S
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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
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Making an ADaM Dataset Analysis-Ready
Sandra Minjoe, ICON PLC
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Document
Sound SDTM, Sound ADaM – Orchestrating SDTM and ADaM Harmonization
Nancy Brucken, Soumya Rajesh, David Neubauer, IQVIA
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Demonstrating Traceability in ADaM Datasets
Wayne Zhong, Accretion Softworks LLC
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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
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SDTM Standards for Genomics: Genomics Findings (GF) and Future Directions
Christine Connolly, CDISC; and Dr. Erin Muhlbradt, NCI-EVS
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What is and what should never be: Prevention, Evaluation, and Decisions surrounding source data errors discovered after data lock
Charity Quick, Rho, Inc.
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Standardizing ADRS and ADTTE per Lugano Criteria for Hematology Efficacy Analysis
Song Liu, BeiGene USA
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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
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COSA Dataset-JSON Hackathon Results
Dr. Sam Hume, CDISC
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Takeda's implementation to expand Terminology and LOINC mapping
Veena Nataraj, Takeda
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AstraZeneca's Path Toward End-to-end Clinical Data Standards
Brian Harris, AstraZeneca
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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
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Advancing Pre-Market Safety Analytics
Dr. Vaishali Popat, FDA-CDER; and Bess LeRoy, CDISC
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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
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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