2022 US Interchange Program
2022 US Interchange Program
All times in US Central Time
8:30 - 10:30
Session 1: Opening Plenary
Chair: Dave Evans, CDISC President and CEO
Ballroom A + B
8:30 - 9:00
Welcome Address & State of the CDISC Union
Dave Evans, CDISC President and CEO
9:00 - 9:15
Welcome from the CDISC Board
Pam Howard, Chair, CDISC Board of Directors
9:15 - 10:00
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)
10:00 - 10:30
State of CDISC Standards
Amy Palmer, CDISC Head of Standards Development
10:30 - 11:00
Coffee Break, Exhibition & Poster Session
Rio Grande A&B
11:00 - 12:30
Session 2: Second Opening Plenary - CDISC Looking Ahead
Chair: Dr. Sam Hume, CDISC
Ballroom A
11:00 - 11:30
CDISC Open Rules and the CORE Engine Progress and Roadmap
Peter Van Reusel, CDISC Chief Standards Officer
11:30 - 12:00
Biomedical Concepts Vision and Value for the Community
Bess Leroy and Jon Neville, CDISC
12:00 - 12:30
What you need to know about the CDISC Library
Dr. Sam Hume, CDISC
12:30 - 13:30
Lunch Break, Exhibition and Poster Session
Rio Grande A&B
13:30 – 15:30
Session 3: Track A - Regulatory Topics
Chair: Donna Sattler, Bristol Myers Squibb
Ballroom A
13:30 - 14:00
An Overview of FDA’s Study Data Policy Framework
Helena Sviglin, FDA-CDER
14:00 - 14:30
EMA Presentation
Marcia Rueckbeil, EMA
15:00 - 15:30
PMDA Presentation
Dr. Yuki Ando, PMDA
13:30 – 15:30
Session 3: Track B - Impact of CDISC Standards on Business Optimization
Chair: Terek Peterson, YPrime
Ballroom B
13:30 - 14:00
Thinking Ahead: Using CDISC standards helps get the most of your eCOA data
Monali Khanna, YPrime
14:00 - 14:30
SDTM Metadata Cross Checks to Improve Quality
Nicole Jones, Merck
14:30 - 15:00
Processing real-world data for regulatory decisions: minimizing data loss, maximizing information
Mayur Saxena, Tasha Nagamine, Droice Labs
15:00 - 15:30
Enable 10X Efficiency to Your Clinical Data Standardization and SDTM Submission Processes
Srinivasan Anandakumar, Saama
13:30 - 15:30
Session 3: Track C - Digitization
Chair: Don Thampy, Merck
Bluebonnet
13:30 - 14:00
Automating the Digital Data Flow with a Standards Foundation
Venu Mallarapu, eClinical Solutions
14:00 - 14:30
Changing outlooks of Clinical Trials life Operations and Clinical Data Management with Covid Pandemic
Srinivasa Rao Mandava, Merck
14:30 - 15:00
Automation enabling standardization or Standards enabling automation? A preview of MOSAIC Biometrics, a tool for the AstraZeneca Output Standards
Suman Nayak, AstraZeneca
15:00 - 15:30
Transcelerate DDF - SDR RI MVP implementation
Jennifer Duff and Mark Laney, Merative
15:30 – 16:00
Coffee Break, Exhibition & Poster Session
16:00 – 17:30
Session 4: Track A - Implementation Use Cases, Part I
Chair: Sandra Minjoe, ICON
Ballroom A
16:00 - 16:30
Confused about Oncology Response Mappings? We're Here to Help!
Melanie Paules, Takeda; Kim Musgrave, Amgen; and Erin Muhlbradt, NCI-EVS
16:30 - 17:00
Implementation of Kidney related TAUGs
Sai Jaya Nagajaran, Zifo RnD Solutions
17:00 - 17:30
Sexual Orientation, Gender Identity, and Intersex Status Data Collection Implementation at Bristol Myers Squibb
Stacey Panfil and Donna Sattler, Bristol Myers Squibb
16:00 – 17:30
Session 4: Track B - Real World Data
Chair: Rhonda Facile, CDISC
Ballroom B
16:00 - 16:30
Real World Data Considerations for Study Data Submissions to FDA/CDER
Dr. Gideon Scott Gordon, FDA-CDER
16:30 - 17:00
Real world data as a bridge between industry and patients
Sophia Zilber, Pfizer
17:00 - 17:30
CDISC BASIC Implementation Guide
Dr. Diane Wold, Amy Palmer, Gary Walker, CDISC
16:00 - 17:30
Session 4: Track C - Artificial Intelligence
Chair: Srinivasa Rao Mandava, Merck
Bluebonnet
16:00 - 16:30
Is AI/ML A Reality or A Day Dream
Harinarayan Gopichandran, Saama Technologies
16:30 - 17:00
Automating Efficiency with Machine Learning for Data Classification
Robert Musterer, eClinical Solutions
17:00 - 17:30
Digitization: Transformation of Mindsets, Processes, and Organization to Realize Value
Don Thampy, Merck
18:30 - 20:30
Evening Networking Event
Must be registered for Evening Networking Event to attend.
Rio Grande A&B
8:30 – 10:30
Session 5: Track A - Implementation Use Cases, Part II
Chair: Amy Palmer, CDISC
Ballroom A
8:30 - 9:00
Trace CDISC Application in FDA NDAs and CRs for Clinical Trial Safety
Dr. Wenjun Bao, JMP Life Sciences
9:00 - 9:30
Medical Imaging Data Standards, Analysis and Automation
Shyam Banuprakash and Kim Nguyen, Clario
9:30 - 10:00
Clinical Data Standards, Change Request Process: How Far We've Come and Where We're Going
Donna Sattler and Sharon Hartpence, Bristol Myers Squibb
10:00 - 10:30
Practical Steps for Implementing ML for SDTM Mapping
Sharon Rossouw, Bioforum
8:30 – 10:30
Session 5: Track B - Trial Design
Chair: Dave Evans, CDISC
Ballroom B
8:30 - 9:00
TransCelerate Digital Data Flow: An Update on DDF Phase 2
Mikkel Traun, Novo Nordisk A/S and Vijay Reddi, Roche Products Ltd.
9:00 - 9:30
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
9:30 - 10:00
Concept-based standards in OpenStudyBuilder supporting structured protocol content and submission deliverables
Mikkel Traun, Novo Nordisk A/S
8:30 – 10:30
Session 5: Track C - CDISC Fundamentals
Chair: Terek Peterson, YPrime
Bluebonnet
08:30 - 9:00
CDISC Analysis Results Standards - Approach and Development Update
Bhavin Busa, Independent; and Andrew Miskell, Eli Lilly and Company
9:00 - 9:30
Making an ADaM Dataset Analysis-Ready
Sandra Minjoe, ICON PLC
9:30 - 10:00
Sound SDTM, Sound ADaM – Orchestrating SDTM and ADaM Harmonization
Nancy Brucken, Soumya Rajesh, David Neubauer, IQVIA
10:00 - 10:30
Demonstrating Traceability in ADaM Datasets
Wayne Zhong, Accretion Softworks LLC
10:30 – 11:00
Coffee Break, Exhibition & Poster Session
Rio Grande, A&B
11:00 – 13:00
Session 6: Track A - Implementation Use Cases, Part III
Chair: Sandra Minjoe, ICON
Ballroom A
11:00 - 11:30
The Continuing Evolution of SDTM Metadata
Dr. Diane Wold, CDISC
11:30 - 12:00
SDTM Standards for Genomics: Genomics Findings (GF) and Future Directions
Christine Connolly, CDISC; and Dr. Erin Muhlbradt, NCI-EVS
12:00 - 12:30
What is and what should never be: Prevention, Evaluation, and Decisions surrounding source data errors discovered after data lock
Charity Quick, Rho, Inc.
12:30 - 13:00
Standardizing ADRS and ADTTE per Lugano Criteria for Hematology Efficacy Analysis
Song Liu, BeiGene USA
11:00 – 13:00
Session 6: Track B - Business Optimization & Technical Topics
Chair: Anthony Chow, CDISC
Ballroom B
11:00 - 11:30
COSMoS Technical Implementation, API Layer and Use Cases
Lex Jansen & Linda Lander, CDISC
11:30 - 12:00
COSA Dataset-JSON Hackathon Results
Dr. Sam Hume, CDISC
12:00 - 12:30
Takeda's implementation to expand Terminology and LOINC mapping
Veena Nataraj, Takeda
12:30 - 13:00
AstraZeneca's Path Toward End-to-end Clinical Data Standards
Brian Harris, AstraZeneca
13:00 - 14:00
Lunch Break, Exhibition & Poster Session
Rio Grande A&B
14:00 - 15:00
Session 7: CDISC Special Topics
Chair: Peter Van Reusel, CDISC Chief Standards Officer
Ballroom A
14:00 - 14:30
TMF Implementation Plan
Karen Roy, Phlexglobal; Paul Fenton, Montrium; and Kathie Clark, Ennov
14:30 - 15:00
Advancing Pre-Market Safety Analytics
Dr. Vaishali Popat, FDA-CDER; and Bess LeRoy, CDISC
15:00 – 15:30
Coffee Break, Exhibition & Poster Session
Rio Grande A&B
15:30 – 17:30
Session 8: Closing Plenary, Global Regulatory Presentations and Panel Discussion
Chair: Dave Evans, CDISC President and CEO
Ballroom A
15:30 - 16:00
Study Data Standards Update for CBER: Your Guide To A Successful Submission
Dr. Lisa Lin, FDA-CBER
16:00 - 16:30
FDA-CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Christine Connolly, CDISC; and Amy Malla, FDA-CTP
16:30 - 17:20
Regulatory Roundtable Discussion
Regulatory Speakers
Dr. Yuki Ando, PMDA
Dr. Gideon Scott Gordon, FDA
Dr. Lisa Lin, FDA
Amy Malla, FDA
Frank Pétavy, EMA
Dr. Vaishali Popat, FDA
Helena Sviglin, FDA
17:20 - 17:30
Closing Remarks
Dave Evans, CDISC President and CEO