Program of events is subject to change.

2021 CDISC US Interchange Program

All times in US Eastern Time

Session 1: Opening Plenary

8:30 - 10:30

8:30 - 8:35

Housekeeping & Hybrid Experience

Bernard Klinke, CDISC Virtual Experiences Manager

8:35 - 8:50

Welcome Address & State of the CDISC Union

Dave Evans, CDISC President and CEO

8:50 - 9:00

Welcome from the CDISC Board

Margaret Keegan, Chair, CDISC Board of Directors

9:00 - 10:00

Keynote Presentation: The Post Covid "wild west" of DCTs, and technology - is there a place for standards?

  • Dr. Isaac R. Rodriguez-Chavez, Ph.D., M.H.S., M.S., Senior Vice President for Scientific & Clinical Affairs, ICON plc
  • Kent Thoelke, Chief Innovation Officer, ICON plc

10:00 - 10:30

State of CDISC Standards

Amy Palmer, CDISC Head of Standards Development

Coffee Break

10:30 - 11:00

Session 2: Second Opening Plenary - CDISC Looking Ahead

11:00 - 13:00
Rhonda Facile, CDISC VP, Development Opportunities & Partnerships

11:00 - 11:30

CDISC 360: What’s in It for Me?

Peter Van Reusel, CDISC Chief Standards Officer; Bess LeRoy, CDISC Head of Standards Development

11:30 - 12:00

Behind the Scenes with CDISC Data Science

Dr. Sam Hume, CDISC VP, Data Science

12:00 - 12:30

Biomedical Concepts in Practice

Dave Iberson-Hurst, A3 Informatics

12:30 - 13:00

CDISC Open Rules Engine (CORE)

Peter Van Reusel, CDISC Chief Standards Officer; and Dr. Sam Hume, CDISC VP, Data Science

Lunch Break

13:00 - 14:00

Session 3: Track A - Questionnaires, Ratings and Scales

14:00 – 15:30
Terek Peterson, YPrime

14:00 - 14:30

Introduction to QRS Instrument Supplements

Dana Booth and Steve Kopko, CDISC; and Dr. Stephen Wilson, FDA

14:30 - 15:00

Clinical Classifications: Getting to Know the New Kid on the QRS Block!

Soumya Rajesh, CSG; and Michael Wise, Apellis Pharmaceuticals

15:00 - 15:30

Best Practices and Considerations for the Integration of CDISC Standards to Questionnaire Libraries

Karl McEvoy, YPrime

Session 3: Track B - COVID-19

14:00 – 15:30
Donna Sattler, Bristol Myers Squibb

14:00 - 14:30

ISARIC and IDDO: Highlights from a Global Collaboration Collecting and Sharing COVID-19 Clinical Data to Maximise Research

Kalynn Kennon, IDDO

14:30 - 15:00

COVID-19 ADaM Implementation Challenges: A Deep Dive Into Different Analysis Needs During the Pandemic

Amanda Johnson, Syneos Health; and Liana Forman, Gilead

15:00 - 15:30

COVID Complications: An NDA Submission Case Study

Zheng Zhao, Alnylam Pharmaceuticals

Secondary Authors: Kristi Garner, CSG; Wei Duan, Alnylam Pharmaceuticals

Coffee Break

15:30 – 16:00

Session 4: Track A - ADaM, Part I

16:00 – 17:30
Sandra Minjoe, ICON Clinical Research

16:00 - 16:30

Current & Forthcoming ADaM Publications

Brian Harris, AstraZeneca

16:30 - 17:00

CDISC ADaM Phases, Periods, and Subperiods: A Case Study

Jennifer Fulton, Westat

17:00 - 17:30

Complex ADaM ADSL and Traceability

Mario Widel, Reata Pharmaceuticals

Session 4: Track B - Real World Data

16:00 – 17:30
Rhonda Facile, CDISC

16:00 - 16:30

Real World Data - FHIR and CDISC Standards - The What and the Why

Rebecca Baker, CDISC

16:30 - 17:00

CDISC-SDTM, Real World Data, FHIR, HL7-Vulcan and the Future of Regulatory Submissions

Jozef Aerts, XML4Pharma

17:00 - 17:30

Impact of HHS Final Data Blocking Rule on RWD/RWE Generation

Inder Jaggi, Clinakos, Inc.

Session 5: Track A - ADaM, Part II

9:00 – 10:30
Terek Peterson, YPrime

9:00 - 9:30

ADaM ADQRS Sub-team Update

Karin LaPann, Independent

9:30 - 10:00

Alternatives to Static Data Listings for Clinical Study Reports

Nancy Brucken, CSG; Mercidita Navarro, Genentech

10:00 - 10:30

When DTYPE isn't Enough

Sandra Minjoe, ICON Clinical Research

Session 5: Track B - Impact of CDISC Standards on Business Optimization

9:00 – 10:30
Srinivasa Rao Mandava, Merck

9:00 - 9:30

Controlled Terminology Designer: A CDISC Library Use Case

Mike Molter, LabCorp

9:30 - 10:00

Metadata Driven Case Report Tabulation for Regulatory Submissions

Rajashekar Thota, Merck & Co.

10:00 - 10:30

Implementation of an MDR

Jeannine Hughes, Boehringer Ingelheim; and Charusheela Thakur, Tata Consultancy Services

Session 5: Track C - CDISC Fundamentals

9:00 – 10:30
Amy Palmer, CDISC

9:00 - 9:30

Why A New Major Version of the SDTM?

Dr. Diane Wold, Ph.D., CDISC

9:30 - 10:00

SDTM and SDTMIG Up-versioning and Its Effects on Specimen-based Lab Data: aka “Dude, Where’s my Data?"

Dr. Erin Muhlbradt, NCI-EVS; and Ward Puttemans, UCB

10:00 - 10:30

CDISC SDTM Standards for Biospecimens Support Precision Medicine and Biobanking

Dr. Oliver Karch, Merck Healthcare KGaA and Christine Connolly, CDISC

Coffee Break

10:30 – 11:00

Session 6: Track A - Cross Collaboration / Special Projects

11:00 – 12:30
Anthony Chow, CDISC

11:00 - 11:30

TransCelerate Digital Data Flow Project

TransCelerate BioPharma Representative Invited

11:30 - 12:00

CDISC Certification Program

John Ezzell, CDISC

12:00 - 12:30

Non-standard Variables in Standards Development - Isn't That an Oxymoron?

John Owen, CDISC

Session 6: Track B - Analysis Results Standard

11:00 – 12:30
Bess LeRoy, CDISC

11:00 - 11:30

Analysis Results Concept Selection

Dante Di Tommaso, Sanofi; and Prafulla Girase, Alexion

11:30 - 12:00

Analysis Results Data Model

Cedric Davister, Merck; and Jeffrey Abolafia, Pinnacle 21

12:00 - 12:30

Analysis Results Metadata Extension

Bhavin Busa, Vita Data Sciences

Session 6: Track C - Open Source Projects

11:00 – 12:30
Charles Shadle, CDISC Data Science Program Manager

11:00 - 11:30

CDISC Open Source Alliance (COSA)

Dr. Sam Hume, CDISC VP, Data Science

11:30 - 12:00

Leveraging CDISC for Deeper Insights into Table Data with Tplyr

Michael Stackhouse and Maya Gans, Atorus Research

12:00 - 12:30

Integration of Real World Data with Research Data Collection: Analysis of Data from the ‘All of Us’ Research Program in US

Vojtech Huser and Craig Mayer, National Institutes of Health

Lunch Break

12:30 – 13:30

Session 7: Global Regulatory Presentations, Part I

13:30 – 15:30
Sandra Minjoe, ICON Clinical Research

13:30 - 14:00

EMA Presentation

Frank Pétavy, Head of Methodology, Data Analytics and Methods Task Force, European Medicines Agency

14:00 - 14:30

FDA Presentation

Amy Malla, MT(ASCP), PMP, CMQ/OE, Regulatory Health Information Specialist, Office of Science (OS), Division of Regulatory Science Informatics (DRSI), Center for Tobacco Products (CTP), U.S. Food and Drug Administration

14:30 - 15:00

FDA Presentation

FDA Representative Invited

15:00 - 15:30

PMDA Presentation

Dr. Yuki Ando, Senior Scientist for Biostatistics, Pharmaceutical and Medical Devices Agency

Coffee Break

15:30 – 16:00

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

16:00 – 17:30
Dhananjay Chhatre, Gilead

16:00 - 16:40

Closing Keynote Presentation: Facilitating the Development of COVID-19 Vaccines

Dr. Peter Marks, Director, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration

16:40 - 17:30

Regulatory Roundtable Discussion

Panelists:

  • Dr. Matilde Kam, Associate Director, Analytics and Informatics, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration

  • Dr. Amy Malla, Regulatory Health Information Specialist, Office of Science (OS), Division of Regulatory Science Informatics (DRSI), Center for Tobacco Products (CTP), U.S. Food and Drug Administration

  • Dr. Peter Marks, Director, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration

  • Dr. Rajesh Nair, Assistant Director for Biostatistics Team 4, Division of Clinical Evidence and Analysis 2 (Biostatistics)  Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration

  • Dr. Vaishali Popat, Associate Director, Biomedical Informatics and Regulatory Review Science, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration