Skip to main content
search

Conference: ACoP 2025

Date: October 18 - 21, 2025

Location: Aurora, CO 

Booth: 17 & 18

Platinum Sponsor

Where to hear Certara insights and expertise

Workshops

Friday, October 17, 2025 - 8am-5pm
Certara: QSP at Scale with Certara IQ

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.

Saturday, October 18, 2025 - 8am-5pm
A Hands-On Workshop with Simcyp Designer for Tailored PBPK-PD/QSP Models

Presenters: Abdallah Derbalah, Felix Stader

Would you like to modify and tailor population PBPK models? This course will review the principles of PBPK modelling, using the Simcyp Simulator and how to use Simcyp Designer to modify existing PBPK models with your own extension and link them to custom-built PD/QSP models. We will have lectures to introduce the PBPK models to be changed and have hands-on exercises to train the customization of PBPK models with the Designer. No prior knowledge is required. Access to the Simcyp Simulator and Simcyp Designer will be provided. Participant are required to bring their own laptops as the workshop is hands-on intensive.

Preconference Sessions

Saturday, October 18, 2025 - 9:15am-9:30am
PBPK to accelerate first registration

Speaker: Hannah M. Jones, PhD

Location: Willow Lake 3-5

Saturday, October 18, 2025 - 10:15am-11:15am
PC3 - Accelerating a medicine's path to patients - Beyond Registration

Speaker: Matthew Zierhut

Location: Willow Lake 3-5

Saturday, October 18, 2025 - 11am-11:15am
Dose selection and go/no-go decisions in a second indication by leveraging published clinical trial data for drugs/classes approved in multiple indications

Speaker: Paul M. Diderichsen

Location: Willow Lake 3-5

Conference Sessions

Sunday, October 19, 2025 - 11am-12:30pm
C1A - Differentiated MIDD strategies to accelerate clinical development in metabolic diseases are worth their weight - Merged GL-1/ Obesity Symposium
Special Populations
Considerations for physiologically based pharmacokinetic and pharmacodynamic (PBPK-PD) modeling to facilitate drug development in obese and related specific populations

Speaker: Sibylle Neuhoff

Location: Colorado B-D

Sunday, October 19, 2025 - 2pm-3:30pm
C2B - An immune booster: QSP modeling to advance the treatment for autoimmune diseases

Chair: Fei Hua (panel)

Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores

Speaker: Doug Chung (panel)

QSP Modeling Based Translational Approach to Support Higher First-in-human Study Starting Dose for Solid Tumor Compared to Exposure-based MABEL Approach

Speaker/Panelist: Fei Hua (panel)

Location: Willow Lake 3-5

Sunday, October 19, 2025 - 2pm-3:30pm
C2C - High-impact Applications of Model-based Meta-analyses (MBMA) in Drug Development

Chair: Matt Zierhut

Location: Red Rock 8&9

Monday, October 20, 2025 - 2pm-3:30pm
Symposium - Challenges and opportunities in integrating QSP with new modeling techniques and datatypes

Speaker/Panelist: Kimiko McGirr

Projecting Clinical Outcomes of Antibody-Drug Conjugates by Combining QSP and Virtual Populations

Speaker/Panelist: Kimiko McGirr

Location: Colorado B-D

Tuesday, October 21, 2025 - 9am-10:30pm
Symposium - Advances in Mathematical and Computational Modeling for Radiopharmaceutical Therapies

Chair: Hunter Stephens

Location: Red Rock 8&9

Tuesday, October 21, 2025 - 10:45am-12:15pm
RC2- Roller Coaster Session
Unravelling the pharmacokinetics of oligonucleotides by using a PBPK model

Speaker: Felix Stader

Location: Willow Lake 3-5

Post-conference workshop

Thursday, October 23, 2025 - 8am-5pm
Model-Based Meta-Analysis (MBMA): Concepts, Methodologies, and Hands-on 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