Program of events is subject to change.

More information coming soon.

16 Oct 2019

Session 1: Opening Plenary & Keynote Address

Pacific Ballroom 21-23-24
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

Paul Slater, Co-Founder, Clinical Research Innovation Hub, Microsoft Corporation

State of the CDISC Union

David R. Bobbitt, CDISC President and CEO

State of CDISC Standards

Amy Palmer, CDISC

Break

Pacific Ballroom 18-20
10:45 - 11:15

Session 2: Second Opening Plenary

Dr. Douglas Peddicord, Chair, CDISC Board of Directors
Pacific Ballroom 21-23-24
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 & Poster Session

Pacific Ballroom 22-25-26
13:00 - 14:00
Poster Session to be held from 13:30 - 14:00.

Session 3, Track A: Real World Data I

Trisha Simpson, UCB
Pacific Ballroom 21-23-24
14:00 – 15:30

Using BRIDG to Connect to Healthcare Standards

Smita Hastek, Samvit Solutions

CDISC & FHIR

Mike Hamidi, CDISC

FDA & Real World Data

Dr. Scott Gordon, FDA-CDER

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

Peter Van Reusel, CDISC
Pacific Ballroom 14-15
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

Dr. Heather Ribaudo, Center for Biostatistics in AIDS Research
Pacific Ballroom 16-17
14:00 – 15:30

Controlled Terminology Enhancements

Dr. Erin Muhlbradt, NCI-EVS

CDISC Knowledge Base

Kit Howard, CDISC

New Initiative: CDISC RWD Connect

Rhonda Facile, CDISC

Break & Poster Session

Pacific Ballroom 18-20
15:30 - 16:00

Session 4, Track A: Real World Data II

Rhonda Facile, CDISC
Pacific Ballroom 21-23-24
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
Pacific Ballroom 14-15
16:00 - 17:30

CDISC Library: New Tools and Functionality

Mike Hamidi, CDISC

CDISC Library API 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
Pacific Ballroom 16-17
16:00 - 17:30

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

Evening Networking Event

Marina Terrace
18:30 - 20:00
17 Oct 2019

Session 5, Track A: End to End I

Donna Sattler, Bristol Myers Squibb
Pacific Ballroom 21-23-24
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

Mike Ward, Eli Lilly

Session 5, Track B: Tools II

Dr. Sam Hume, CDISC
Pacific Ballroom 14-15
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
Pacific Ballroom 16-17
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

Pacific Ballroom 18-20
10:30 - 11:00

Session 6, Track A: End to End II

Donna Sattler, Bristol Myers Squibb
Pacific Ballroom 21-23-24
11:00 - 12:30

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

Barrie Nelson, Nurocor, and Djenan Ganic, intilaris LifeSciences

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
Pacific Ballroom 14-15
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
Pacific Ballroom 16-17
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,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

Ramachandra Adusumalli, Merck

Lunch

Pacific Ballroom 22-25-26
12:30 - 13:30

Session 7, Track A: SEND

Lou Ann Kramer, CDISC
Pacific Ballroom 21-23-24
13:30 - 15:00

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

Susie Lendal Antvorskov, Gitte Frausing, Data Standards Decisions Aps

Session 7, Track B: QRS & Glossary

Kit Howard, CDISC
Pacific Ballroom 14-15
13:30 - 15:00

Questionable Questionnaires

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

Srinivasa Rao Mandava, Merck
Pacific Ballroom 16-17
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

Pacific Ballroom 18-20
15:00 - 15:30

Session 8: Regulatory Session

Trisha Simpson, UCB
Pacific Ballroom 21-23-24
15:30 – 17:30

PMDA Presentation

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

Panel Discussion

Dr. Yuki Ando, PMDA; Matilde Kam, FDA-CDER; Dr. Ken Quinto, FDA-CDER; Dr. Matthew Whittaker, FDA-CDER

Closing Remarks