LL1 - Standardization and Best Practices as Bridges to the Future: Securing the Foundation for Growth of Model-Informed Drug Development

Monday, November 11, 2024

12:30 PM – 2:00 PM MST

Location: Palm 3 A/B

Chair(s)

WB

Wonkyung Byon, PhD

Senior Director
Vertex, United States
Shelly Wang, PhD (she/her/hers)

Principal Scientist II
Gilead Sciences, United States

JN

Jace Nielsen, Pharm.D.

Exploratory Development Fellow
Astellas, United States
NT

Neelima Thanneer, MS

Executive Director, Head of Data Science and Clin Pharm Analysis & Reporting
BMS, United States

Handouts
Yali Liang, MD

Director
Jazz Pharmaceuticals
Newtown, Pennsylvania, United States

Disclosure(s):

Wonkyung Byon, PhD: Vertex: Employment (Ongoing)

Shelly Wang, PhD: Gilead Sciences: Employment (Ongoing); Metrum Research Group: Employment (Terminated)

Jace Nielsen, Pharm.D.: Astellas: Employment (Ongoing)

Neelima Thanneer, MS: No financial relationships to disclose

Yali Liang, MD: No financial relationships to disclose

12:30 PM – 1:00 PM MST

Pharmacometrics Workflow: Points to Consider for Efficient, High-Quality, and Reproducible Analyses
Speaker: Jace Nielsen, Pharm.D. – Astellas
1:00 PM – 1:30 PM MST

How to Implement CDISC data standards for Population PK Analysis in your organization
Speaker: Neelima Thanneer, MS – BMS
1:30 PM – 2:00 PM MST

Working towards a standardized population PK/PD reporting template for the industry
Speaker: Yali Liang, MD – Jazz Pharmaceuticals