Thank you for attending the 2019 US Interchange. You will find a link to each of the presentation slides from the event below.
Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates.
Session 1: Opening Plenary
Welcome Address
Dr. Douglas Peddicord, Chair, CDISC Board of Directors
State of the CDISC Union
David R. Bobbitt, CDISC President and CEO
State of CDISC Standards
Amy Palmer, CDISC
Session 2: Second Opening Plenary
CDISC 360: Preparing for a Bright Future
Chris Decker and Dave Evans, CDISC Board
CDISC 360 Update
Peter Van Reusel, CDISC
CDISC Library: Integrating and Surfacing 360 Content
Sam Hume, CDISC
Session 3, Track A: Real World Data I
Using BRIDG to Connect to Healthcare Standards
Smita Hastek, Samvit Solutions
FDA & Real World Data
Dr. Scott Gordon, FDA-CDER
Session 3, Track B: CDISC 360 Use Cases - Industry Perspectives
Use Case 1: End to Start Standards Specification
Mikkel Traun, Novo Nordisk
Use Case 2: Study Configuration & Artifact Creation
Tianna Umann, Microsoft
Use Case 3: Automated Data Processing
Bhavin Busa, Vita Data Sciences
Session 3, Track C: Development Trends & Topics I
Controlled Terminology Enhancements (Paper)
Dr. Erin Muhlbradt, NCI-EVS
CDISC Knowledge Base
Kit Howard, CDISC
New Initiative: CDISC RWD Connect
Rhonda Facile, CDISC
Session 4, Track A: Real World Data II
Mapping FHIR R4 Resources to CDISC Mental Health TAUGs (Paper)
Jen Nash, Dr. Meredith Zozus, University of Arkansas for Medical Sciences
A Novel Approach to Fit for Use RWD/RWE Generation (Paper)
Deepti Jaggi, Clinakos Inc.
Promoting the Use of CDISC Standards for Open Data Utilization
Satoshi Ueno, Mariko Doi, National Institute of Public Health, Japan
Session 4, Track B: Tools I
CDISC Library: New Tools and Functionality
Mike Hamidi, CDISC
CDISC Library API Wrapper (Paper)
Dmitry Kolosov, Sergei Krivtcov, PAREXEL
CDISC Library try-out: from implementation to evaluation of the API (Paper)
Roman Radelicki, SGS
Session 4, Track C: Development Trends & Topics II
SEND
Audrey Walker, Charles River Laboratories
CDASH
Mike Ward, Eli Lilly
SDTM
Gary Walker, Gary G Walker, LLC
ADaM
Tatiana Sotingco, Johnson & Johnson
Data Exchange Standards
Sally Cassells, CDISC
Session 5, Track A: End to End I
Synthetic Data and Predictive Data Modeling: Benefits in Driving Standards and Quality Outcomes (Paper)
W. Stetson Line, Clinventive LLC
Value-Level Metadata Done Properly (Paper)
Sandra Minjoe, Mario Widel, PRA Health Sciences
The TransCelerate Digital Data Flow Project
Mike Ward, Eli Lilly
Session 5, Track B: Tools II
R/R-Shiny Application in Clinical Trial Development for Cardiovascular Study (Paper)
Yingshan You, Janssen R&D
End to End SDTM Automation: A Metadata Centric Approach (Paper)
Annelies Van Zeveren, SGS
Data Transformation: Best Practices for When to Transform Your Data (Paper)
Janet Stuelpner, SAS Institute, and Mira Shapiro, Analytic Designers LLC
Session 5, Track C: Implementation Use Cases I
Handling Multiple Enrollments and Screenings Subjects in SDTM: Are We There Yet? (Paper)
Carlo Radovsky, Etera Solutions
Virtual Assistant for Conversational Experience with Clinical Data (Paper)
Srinivasa Anandakumar, Saama
Ensuring Consistency Across CDISC Dataset Programming Processes (Paper)
Jennifer Fulton, Rachel Brown, Rick Mitchell, Westat
Session 6, Track A: End to End II
3D Standardization in Clinical Development to achieve End-to-End Automation (Paper)
Barrie Nelson, Nurocor, and Djenan Ganic, intilaris LifeSciences
The Business Value of Machine-Readable Value-Level Metadata (Paper)
Philippe Verplancke, XClinical
Putting SDTM at the Heart of Roche/Genentech’s Drive Towards F.A.I.R. Data (Paper)
Rammprasad Ganapathy, Genentech/Roche
Session 6, Track B: ADaM
Efficacy ADaMs in Oncology – Step by Step (Dataset by Dataset) (Paper)
Ilya Krivelevich, Ran Xie, Simon Lin, Eisai
Too Soon! ADaM Data Structures for Integrations - A Case Study (Paper)
Clio Wu, FMD K&L
ADaM Analysis and Reporting Using the CDISC Library (Paper)
Valerie Williams, ICON Clinical Research, LLC
Session 6, Track C: Implementation Use Cases II
Stay Ahead of the Curve: How to Implement New FDA Recommendation Study Data Standardization Plan (SDSP) in Your Organization (Paper)
Aakar Shah, Nektar Therapeutics, and Heather Riley, Pfizer
Complex Innovative Designs - Challenges and Opportunities for ADaM
Dana Soloff, Mandira Consulting
Encoding data from external partner collaborative studies (Paper)
Ramachandra Adusumalli, Merck
Session 7, Track A: SEND
SEND Presentation: Standards Development Process and Recent Publications
Audrey Walker, Charles River; Fred Wood, Data Standards Consulting Group
The Impact of SEND on FDA Review of Nonclinical Study Data
Dr. Matthew Whittaker, FDA-CDER
Applying SEND to Flow Cytometry Data: Considerations for SEND Updates (Paper)
Susie Lendal Antvorskov, Gitte Frausing, Data Standards Decisions Aps
The SEND Implementation Guide for Animal Rule (SENDIG-AR) Public Review
Fred Wood, Data Standards Consulting Group
Session 7, Track B: QRS & Glossary
Questionable Questionnaires (Paper)
Jennifer Britt, Nikki Flores, Michael Calcagno, Gilead Sciences
Increasing Value: Use of QRS supplements in eCOA
Terek Peterson, YPrime
CDISC Glossary: Terminology Matters, A CDISC Volunteer Effort with Value to Industry
Dr. Erin Muhlbradt, NCI-EVS
Session 7, Track C: Implementation Use Cases III - MDR
How Standards Metadata Can Help Drive the Creation of Tables, Listings and Figures (Paper)
Judith Goud and Stephen Castellano, Nurocor
Implementation of Metadata Repository and Protocol Automation Tool at Bayer (Paper)
Girish Rajeev, Bayer Pharmaceuticals
Using Standards and Metadata Repositories for Clinical Research Data Operations (Paper)
Narayanarao Pavuluri and Donald Thampy, Merck Inc
Session 8: Regulatory Session
PMDA Update
Dr. Yuki Ando, PMDA
FDA-CDER Presentation
Dr. Ken Quinto, FDA-CDER
FDA Review Process: Recommendations for Review-Ready Submissions to CDER
Dr. Matilde Kam, FDA-CDER