Program of events is subject to change.

Session 1: Opening Plenary and Keynote Address

9:00 - 11:00
David R. Bobbitt, CDISC President and CEO
All Times are in US Eastern Time

9:00 - 9:05

How to Use the Virtual Conference Platform

CDISC

9:05 - 9:35

Welcome Address & State of the CDISC Union

David R. Bobbitt, CDISC President and CEO

9:35 - 10:20

Keynote Address

Andy Lee, Senior Vice President and Head, Global Clinical Trial Operations (GCTO), Merck

10:20 - 11:00

State of the CDISC Standards

Amy Palmer, CDISC

Break

11:00 - 11:30

Session 2: Second Opening Plenary

11:30 - 13:00
Peter Van Reusel, CDISC

11:30 - 12:10

CDISC 360: The Road Ahead

Peter Van Reusel, CDISC

12:10 - 12:35

Introducing the Next Generation CDISC Library

Dr. Sam Hume, CDISC

12:35 - 13:00

Presentation by Microsoft

Lunch

13:00 - 14:00

Session 3, Track A: Implementation Use Cases

14:00 - 15:30
Sandra Minjoe, PRA Health Sciences

14:00 - 14:30

Using Therapeutic Area User Guides to fill the Gaps in Foundational Standards

Varma Nadimpalli, NIAID

14:30 - 15:00

The CT Conundrum – What Version to Use – What Version am I Using – Oh No?

Barrie Nelson, Nurocor

15:00 - 15:30

Managing Terminology. A Better Way

Dave Iberson-Hurst, S-cubed

Session 3, Track B: RWD, AI & Mobile Devices

14:00 - 15:30
Terek Peterson, YPrime

14:00 - 14:30

Solving Issues in Urban Super-Aging Society through Clinical, Social and Medical Services Approaches Using CDISC Standards

Satoshi Ueno, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology

14:30 - 15:00

Automation and machine learning for clinical trial data in CDISC and pharmacovigilance

Dr. Wenjun Bao, JMP Life Sciences

15:00 - 15:30

Fully Automated Generation of COVID-19 SDTM Datasets from Electronic Health Records

Dr. Jozef Aerts, XML4Pharma

Session 3, Track C: CDISC 360, Part I

14:00 - 15:30
Peter Van Reusel, CDISC

14:00 - 14:30

Biomedical concepts, what did we learn?

Bess LeRoy and Jon Neville, CDISC

14:30 - 15:00

Enhancing the standards with biomedical concepts

Sally Cassells, CDISC

15:00 - 15:30

MACE+ case-study; how it fits together

Amy Palmer, Jon Neville and Sally Cassells, CDISC

Break

15:30 - 16:00

Session 4, Track A: Open Source

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

16:00 - 16:30

TidyCDISC: An open-source application to interactively create tables, figures, and patient profiles from ADaM data

Nate Mockler, Biogen

16:30 - 17:00

Replicating the CDISC Pilot Project through open source R language

Mike Stackhouse, Atorus Research

17:00 - 17:30

FAIR Principles and Open Source Tools to Generate SDTM Datasets

Harish Kandaswamy, NIAID

Session 4, Track B: Rules & Tools

16:00 - 17:30
Donna Sattler, Bristol Myers Squibb

16:00 - 16:30

Clean data one click away: using back-end library rules to clean on SDTM datasets

Glenn Borgmans, SGS Life Sciences

16:30 - 17:00

Too Little, Too Late: Re-assessing the landscape of CDISC conformance

Carlo Radovsky, Immanant

17:00 - 17:30

Clinical Data Standards and the TransCelerate DDF Hackathon

Frederik Malfait, Nurocor

Session 4, Track C: CDISC 360, Part II

16:00 - 17:30
Bess LeRoy, CDISC

16:00 - 16:30

PoC for Study Design and Configuration using CDISC 360 Concept-Based Standards

Mikkel Traun, Novo Nordisk; and Nicolas De Saint Jorre, XClinical

16:30 - 17:00

Automation of SDTM Generation & Artifacts using CDISC 360 Enriched Standards

Bhavin Busa, Jianhui Zhao, Vita Data Sciences

17:00 - 17:30

Automation of ADaM & TFL Generation using CDISC 360 Enriched Standards

Bhavin Busa, Prasanna Murugesan, Stuart Malcolm, Vita Data Sciences

Session 5, Track A: CDISC Core

9:00 - 10:30
Amy Palmer, CDISC
All Times are in US Eastern Time

9:00 - 9:30

CDASH eCRF Project

Alana St. Clair, CDISC

9:30 - 10:00

Why Are There So Many ADaM Documents, and How Do I Know Which to Use?

Sandra Minjoe, PRA Health Sciences

10:00 - 10:30

Analysis Results Standard

Bess LeRoy, CDISC

Session 5, Track B: COVID-19 Impact, Part I

9:00 - 10:30
Donna Sattler, Bristol Myers Squibb

9:00 - 9:30

Ongoing clinical trials in the times of COVID-19: The impact on systems and processes through the data management perspective

Katherine Castaño and Sofia Villareal, Merck

9:30 - 10:00

A Forward-Thinking, Analysis-Based Approach to Clinical Trial Data Collection During the COVID-19 Pandemic

Deepika Jethwani and Heather Miscikowski, Neurocrine Biosciences

10:00 - 10:30

COVID-19 Impact Across Clinical Data States of Ongoing Studies

Jennifer Britt and Dhananjay Chhatre, Gilead Sciences, Inc.

Session 5, Track C: Regulatory Submissions

9:00 - 10:30
Mike Hamidi, CDISC

9:00 - 9:30

Developing SEND for CBER

Lisa Lin, FDA-CBER, Susan DeHaven, Sanofi

9:30 - 10:00

MSG 2.0 Highlights & XPT vs Dataset-XML Packages

Marcelina Hungria, DIcore Group, LLC; and Richard Lewis, Data Standards Consulting Group

10:00 - 10:30

New Technical Rejection Criteria for Study Data: Are You Ready?

Shannon Heacock, WAYS Pharmaceutical Services, LLC

Break

10:30 - 11:00

Session 6: COVID-19 Impact, Part II

11:00 - 12:30
Dr. Stephen Wilson, Senior Staff Fellow, FDA-CDER; and David R. Bobbitt, CDISC President and CEO

11:00 - 11:30

CDISC Response to COVID-19

Peter Van Reusel and Amy Palmer, CDISC

11:30 - 12:30

COVID-19 Roundtable Discussion

Speakers Invited

Presenters from Session 5, Track B; and Invited Speakers

Lunch

12:30 - 13:30

Session 7: Global Regulatory Presentations, Part I

13:30 - 15:30
Dhananjay Chhatre, Gilead

13:30 - 14:00

EMA Presentation

Sofia Zastavnik and Frank Pétavy, EMA

14:00 - 14:30

FDA-CDER Presentation

Dr. Lilliam Rosario, FDA-CDER

14:30 - 15:00

FDA-CDER Presentation

Helena Sviglin, FDA-CDER

15:00 - 15:30

PMDA Presentation

Dr. Yuki Ando, PMDA

Break

15:30 - 16:00

Session 8: Closing Plenary - Global Regulatory Presentations, Part II

16:00 - 17:30
Chris Decker, CDISC Board of Directors, d-Wise Technologies

16:00 - 16:45

Keynote Presentation

Mary Ann Slack, Director, Office of Strategic Programs, FDA-CDER

16:45 - 17:30

Roundtable Discussion

Representatives from FDA-CDER, FDA-CBER, EMA and PMDA