ACoP 2025

Presenters: Joshua F. Apgar, Andrew Matteson, Sasha Sherman, David Flowers

With hundreds of FDA and EMA submissions supported by QSP models, QSP has finally come of age. The now proven high return of investment from QSP has led to every major pharma company, and a significant number of biotechs investing in QSP groups or partnering with QSP vendors. However, the vast majority of preclinical and clinical programs are still not supported by QSP. At this point we see this not as a limitation of the value of QSP but as a challenge for implementing QSP at scale. This workshop will unveil Certara IQ, an innovative QSP environment that enables the scaling of QSP from only supporting a small minority of projects, to supporting the entire pipeline. We will focus on four key decision points in the drug development pipeline:

• New Target Feasibility
• Determining Best in Class Properties
• First In Human Dose Projection
• Recommended Phase 2 Dose

For each we will demonstrate how to use Certara IQ to efficiently answer these questions with worked practical examples.

讲师： Hannah M. Jones, PhD

地点： Willow Lake 3-5

讲师： Matthew Zierhut

地点： Willow Lake 3-5

讲师： Paul M. Diderichsen

地点： Willow Lake 3-5

讲师： Sibylle Neuhoff

地点： Colorado B-D

Chair: Fei Hua (panel)

讲师： Doug Chung (panel)

Speaker/Panelist: Fei Hua (panel)

地点： Willow Lake 3-5

Chair: Matt Zierhut

地点： Red Rock 8&9

Speaker/Panelist: Kimiko McGirr

Speaker/Panelist: Kimiko McGirr

地点： Colorado B-D

Chair: Hunter Stephens

地点： Red Rock 8&9

讲师: Felix Stader

地点： Willow Lake 3-5

Presenters: Matthew L. Zierhut, PhD, MBA and Paul M. Diderichsen, PhD

地点： Red Rock 2

Attendees of this one-day workshop will learn about model-based meta-analysis (MBMA) – starting with the basic principles of meta-analysis and moving toward detailed applications of complex MBMA methodologies.   Concepts will be explained using case studies, accompanied by detailed hands-on R scripts and real datasets.  We will also explore datasets and perform directed analyses using Certara’s CODEX software platform.

• Some critical topics include:
• MBMA of binary and continuous data
• Dose-response MBMA
• Longitudinal MBMA
• Relative effect vs absolute outcome modeling
• Unstructured (nonparametric) placebo methodology
• Random effects and weighting of data
• Data transformations
• MBMA covariate exploration
• Joint MBMA of multiple endpoints

Authors: Bill Poland, Irene Bae

Sponsor: Merck & Co., Inc.

Authors: Shuang Xu, Bill Poland

Sponsor: Kartos

Authors: Leandro Pippa, Hunter Stephens, Stephen Duffull, Mirjam Trame

Sponsor: Certara

Authors: Hunter Stephens, Mirjam Trame; Diane-Charlotte Imbs, Amandine Manon

Sponsor: Certara

Author: Hunter Stephens

Sponsors: Certara, Novartis, Genentech

Authors: Shuang Xu, Bill Poland

Sponsor: Gilead

Authors: Anna Gaffney, Mirjam Trame

Sponsor: Certara

Authors: Carol Conchon Costa, Keith Nieforth, Mark Sale

Sponsor: Certara

Authors: Ahmed Abulfathi, Sergio Iadevaia, Stephen Duffull

Sponsor: Certara

Authors: Ahmed Abulfathi, Mirjam Trame

Sponsors: Certara, GMRI

Authors: Li Qin, Shuai Fu, Ahmed Abulfathi, Matt Zierhut

Sponsors: Certara, GSK

Authors: Todd Dumas, Shahram Mehr

Sponsors: Certara, ADMA Biologics

Authors: Bill Poland, Shuang Xu

Sponsor: Gilead Sciences

Authors: Swati Debroy, Shahram E. Mehr, Craig Comisar

Sponsor: Tourmaline Bio

Author: Dennis Reddyhoff