Conference: ACoP 2025
Date: October 18 - 21, 2025
Location: Aurora, CO
Booth: 17 & 18
Platinum Sponsor
Where to hear Certara insights and expertise
Workshops
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.
Preconference Sessions
Speaker: Hannah M. Jones, PhD
Location: Willow Lake 3-5
Speaker: Matthew Zierhut
Location: Willow Lake 3-5
Speaker: Paul M. Diderichsen
Location: Willow Lake 3-5
Conference Sessions
Special Populations
Speaker: Sibylle Neuhoff
Location: Colorado B-D
Chair: Fei Hua (panel)
Speaker: Doug Chung (panel)
Speaker/Panelist: Fei Hua (panel)
Location: Willow Lake 3-5
Chair: Matt Zierhut
Location: Red Rock 8&9
Speaker/Panelist: Kimiko McGirr
Speaker/Panelist: Kimiko McGirr
Location: Colorado B-D
Chair: Hunter Stephens
Location: Red Rock 8&9
Unravelling the pharmacokinetics of oligonucleotides by using a PBPK model
Speaker: Felix Stader
Location: Willow Lake 3-5
Post-conference workshop
Presenters: Matthew L. Zierhut, PhD, MBA and Paul M. Diderichsen, PhD
Location: 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
Posters
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
