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Conference: AAPS 2025 PharmSci 360

Date: November 9 - 12, 2025

Location: San Antonio, TX

Booth: 3548

Certara at AAPS 2025 PharmSci 360

Certara is proud to participate as a Sustaining Partner at AAPS 2025 PharmSci 360, occurring November 9-12, 2025 at the Henry B. Gonzalez Convention Center in San Antonio, TX.

Visit us at booth #3548 or join us for the presentations listed below to learn how Certara is transforming drug development.

Where to hear Certara insights and expertise

Monday, November 10th, 9:30-10:30am
Chalk Talk – Stage C
Presentation: Advancing Physiologically Based Pharmacokinetic (PBPK) Modeling for Dermal and Ocular Drug Development

Abstract: PBPK modeling provides a mechanistic framework to address key questions throughout drug development while reducing reliance on extensive in vivo or even animal studies. PBPK modeling is particularly valuable for dermal and ocular delivery routes of administration. These applications involve unique physiological barriers, exposure considerations, and complex formulation-dependent processes that benefit from a mechanistic approach.

This presentation highlights two PBPK models:

1. A mechanistic dermal absorption model that enables a bottom-up approach for dermal absorption to predict local and systemic compound exposures. The model supports in vitro in vivo extrapolation (IVIVE), informs experimental design, and incorporates dynamic re-parameterization of formulation characteristics to capture metamorphic processes critical for topical products.

2. A mechanistic ocular model developed to addresses challenges in predicting drug disposition in the eye, where diseases such as glaucoma and macular degeneration, as well as off-target toxic effects of systemic therapeutics, demand precise assessment of exposure within the different parts of the eye. To simulate the particular complexities of the eye, the model integrates finite element methods, anterior chamber convection, melanin binding, and intravitreal injection geometries. Here we provide verification studies against rabbit and human data for topical, intravitreal, oral, and IV administration routes that demonstrate its utility in supporting ocular drug development.

Presenters:
Bryan Holland, PhD, Senior Research Scientist at Certara
Daniel Paterson, PhD, Research Scientist II at Certara

Monday, November 10th, 10:30-11:30am
Partner Presentation - Stage 1
Presentation: Plan Early to Ensure a Successful ADA Assessment

Abstract: Early planning for anti-drug antibody (ADA) assessment is essential to the successful development of biologic therapies. This presentation will highlight the importance of a phase-appropriate ADA assay strategy, show how proactive immunogenicity planning can support regulatory compliance and risk mitigation, while also enabling meaningful interpretation of translational pharmacokinetic and pharmacodynamic data to inform clinical decision-making. Attendees will gain practical insights into ADA assay design across development stages – from preclinical through to BLA submission. The presentation will also explore how to address the impact of ADA in translational and early development – illustrated through real-world case studies that demonstrate the benefits of early ADA considerations.

Presenters:
Ha Bruno, PhD, Associate Director, Chemistry, Manufacturing & Controls at Certara
Elliott Offman, BSc Pharm, MSc, PhD, Vice President, Clinical Pharmacology & Translational Medicine at Certara

Monday, November 10th, 9:30-10:00am
Symposium: Advances and Case Examples of in silico Modeling for Drug Development
Presentation: Where are we for Successful Modeling for Oral Macrocyclic Peptide?

Presenter: Armin Sepp, PhD, Senior Principal Scientist at Certara

Monday, November 10th, 10:00-10:30am
Symposium: Advances and Case Examples of in silico Modeling for Drug Development
Presentation: Mechanistic PBPK Modeling for the Locally Acting GIT Drug: Mesalamine

Presenter: David B. Turner, PhD, Senior Scientific Advisor and Head of Mechanistic Oral Absorption Modeling, Certara

Monday, November 10th, 10:30-11:30am
Poster presentation: (M1030-05-30) Modelling and Simulation of Fentanyl Matrix Patches and Risk Assessment from Manufacturing Errors

Presenting author: Dan Paterson, PhD, Research Scientist at Certara

Monday, November 10th, 11:30am-12:30pm
Poster presentation: (M1130-05-31) A Mathematical Model Describing the Activity of Proton Gradient-Driven MATE Transport

Presenting author: Dan Paterson, PhD, Research Scientist at Certara

Tuesday, November 11th, 10:30-11:30am
Poster presentation: (T1030-05-28) Enhanced Intravitreal Pharmacokinetics in the Simcyp Ocular Model

Presenting author: Bryan W. Holland, PhD, Senior Research Scientist at Certara

Tuesday, November 11th, 3:30-4:25pm
Special Poster Collection: (M1130-05-31) A Mathematical Model Describing the Activity of Proton Gradient-Driven MATE Transport

Presenting author: Dan Paterson, PhD, Research Scientist at Certara