Hot Topic: Predictive Scale-Up/Scale-Down for Pharmaceuticals/Biopharmaceuticals

Tuesday, November 11, 2025

9:00 AM - 10:00 AM CT

Location:220

Manufacturing and Analytical Characterization

Hot Topic Moderator(s)

Sheetal Pai-Wechsung, PhD (she/her/hers)

Group Leader- Senior Principal Scientist
Pfizer Inc
Andover, Massachusetts

Hot Topic Speaker(s)

Kirk Roffi, M.S.

Senior Scientist
Pfizer
Nima Yazdanpanah, PhD (he/him/his)

Principal Consultant
Procegence
Chevy Chase, Maryland
Mahaveer Satra, MS

Senior Application Engineer
MathWorks
David Spencer, PhD (he/him/his)

Principal Scientist I
AbbVie

The hot topic session will include a panel discussion and/or individual presentations aimed at communicating the latest advancements in modeling and simulation, applied to predictive scale-up and scale-down of pharmaceuticals and biopharmaceuticals.

Learning Objectives:

Upon completion, participants will be able to understand how modeling and simulation can be applied towards predictive scale-up and scale-down.
Upon completion, participants will be able to understand how laboratory measurments can be used to build data-based models.
Upon completion, participants will be able to explore further how modeling and simulation tools can be applied to solve technical challenges in their own organizations.
Upon completion, participants will be able to explore how they can accelerate their product development lifecycles by learnings from other industries which leverage simulation.