Program of events is subject to change.

More information coming soon.

16 Oct 2019

Session 1: Opening Plenary & Keynote Address

09:00 - 10:45

Opening Remarks

David R. Bobbitt, CDISC President and CEO

Welcome Address

Dr. Douglas Peddicord, Chair, CDISC Board of Directors

Keynote Presentation

State of the CDISC Union

David R. Bobbitt, CDISC President and CEO

State of CDISC Standards

Amy Palmer, CDISC

Break

10:45 - 11:15

Session 2: Second Opening Plenary

Dr. Douglas Peddicord, Chair, CDISC Board of Directors
11:15 - 13:00

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

Lunch

13:00 - 14:00

Session 3, Track A: Real World Data I

Trisha Simpson, UCB
14:00 – 15:30

Using BRIDG to Connect to Healthcare Standards

TBD

CDISC & FHIR

CDISC Data Science Team

FDA & Real World Data

FDA Representative Invited

Session 3, Track B: CDISC 360 Use Cases - Industry Perspectives

Peter Van Reusel, CDISC
14:00 – 15:30

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

14:00 – 15:30

Controlled Terminology Enhancements

Dr. Erin Muhlbradt, NCI-EVS

CDISC Knowledge Base

CDISC Knowledge Base Team

New Initiative: CDISC Standards for Academic Researchers

Rhonda Facile, CDISC

Break

15:30 - 16:00

Session 4, Track A: Real World Data II

16:00 - 17:30

Mapping FHIR R4 Resources to CDISC Mental Health TAUGs

Jen Nash, Dr. Meredith Zozus, University of Arkansas for Medical Sciences

A Novel Approach to Fit for Use RWD/RWE Generation

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

Dr. Sam Hume, CDISC
16:00 - 17:30

CDISC Library: New Tools and Functionality

CDISC Data Science Team

CDISC Library Wrapper

Dmitry Kolosov, Sergei Krivtcov, PAREXEL

CDISC Library try-out: from implementation to evaluation of the API

Roman Radelicki, SGS

Session 4, Track C: Development Trends & Topics II

Amy Palmer, CDISC
16:00 - 17:30

SEND

CDASH

SDTM

ADaM

Data Exchange Standards

Evening Networking Event

19:00 - 21:00
17 Oct 2019

Session 5, Track A: End to End I

Donna Sattler, Bristol Myers Squibb
09:00 - 10:30

Synthetic Data and Predictive Data Modeling: Benefits in Driving Standards and Quality Outcomes

W. Stetson Line, Clinventive LLC

Value-Level Metadata Done Properly

Sandra Minjoe, Mario Widel, PRA Health Sciences

The TransCelerate Digital Data Flow Project

Bill Illis, Novartis Pharmaceuticals

Session 5, Track B: Tools II

Dr. Sam Hume, CDISC
09:00 - 10:30

R/R-Shiny Application in Clinical Trial Development for Cardiovascular Study

Yingshan You, Janssen R&D

End to End SDTM Automation: A Metadata Centric Approach

Annelies Van Zeveren, SGS

Data Transformation: Best Practices for When to Transform Your Data

Janet Stuelpner, SAS Institute, and Mira Shapiro, Analytic Designers LLC

Session 5, Track C: Implementation Use Cases I

Dhananjay Chhatre, Gilead
09:00 - 10:30

Handling Multiple Enrollments and Screenings Subjects in SDTM: Are We There Yet?

Carlo Radovsky, Etera Solutions

Virtual Assistant for Conversational Experience with Clinical Data

Srinivasa Anandakumar, Saama

Ensuring Consistency Across CDISC Dataset Programming Processes

Jennifer Fulton, Rachel Brown, Rick Mitchell, Westat

Break

10:30 - 11:00

Session 6, Track A: End to End II

Donna Sattler, Bristol Myers Squibb
11:00 - 12:30

3D Standardization in Clinical Development to achieve End-to-End Automation

Barrie Nelson and Djenan Ganic, Nurocor

The Business Value of Machine-Readable Value-Level Metadata

Philippe Verplancke, XClinical

Putting SDTM at the Heart of Roche/Genentech’s Drive Towards F.A.I.R. Data

Rammprasad Ganapathy, Genentech/Roche

Session 6, Track B: ADaM

Sandra Minjoe, PRA Health Sciences
11:00 - 12:30

Efficacy ADaMs in Oncology – Step by Step (Dataset by Dataset)

Ilya Krivelevich, Ran Xie, Simon Lin, Eisai

Too Soon! ADaM Data Structures for Integrations - A Case Study

Clio Wu, FMD K&L

ADaM Analysis and Reporting Using the CDISC Library

Valerie Williams, ICON Clinical Research, LLC

Session 6, Track C: Implementation Use Cases II

Dhananjay Chhatre, Gilead
11:00 - 12:30

Stay Ahead of the Curve: How to Implement New FDA Recommendation Study Data Standardization Plan (SDSP) in Your Organization

Aakar Shah, Heather Riley, Nektar Therapeutics

Complex Innovative Designs - Challenges and Opportunities for ADaM

Dana Soloff, Mandira Consulting

Encoding data from external partner collaborative studies

Ramachandra Adusumalli, Merck

Lunch

12:30 - 13:30

Session 7, Track A: SEND

13:30 - 15:00

Applying SEND to Flow Cytometry Data: Considerations for SEND Updates

Susie Lendal Antvorskov, Gitte Frausing, Data Standards Decisions Aps

FDA SEND Presentation

FDA Representative Invited

SEND Presentation

CDISC SEND Team

Session 7, Track B: QRS & Glossary

13:30 - 15:00

Questionable Questionnaires

Jennifer Britt, Nikki Flores, Michael Calcagno, Gilead Sciences

QRS Presentation

Speaker TBD

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

Srinivasa Rao Mandava, Merck
13:30 - 15:00

How Standards Metadata Can Help Drive the Creation of Tables, Listings and Figures

Judith Goud and Stephen Castellano, Nurocor

Implementation of Metadata Repository and Protocol Automation Tool at Bayer

Girish Rajeev, Bayer Pharmaceuticals

Using Standards and Metadata Repositories for Clinical Research Data Operations

Narayanarao Pavuluri and Donald Thampy, Merck Inc

Break

15:00 - 15:30

Session 8: Regulatory Session

Trisha Simpson, UCB
15:30 – 17:30

PMDA Presentation

Dr. Yuki Ando, PMDA

FDA-CBER Presentation

TBD

FDA-CDER Presentation

TBD

FDA Review Process: Recommendations for Review-Ready Submissions to CDER

Matilde Kam, FDA-CDER

FDA-CDER Presentation

TBD

Closing Remarks