Full Schedule

7:00 AM - 9:00 AM MDT

Exhibits/ Posters/ Coffee Service

Location: Colorado Ballroom A & Foyer

7:00 AM - 3:30 PM MDT

ACoP Registration Desk - Hours

Location: Colorado Foyer

9:00 AM - 10:30 AM MDT

Leveraging Real-World Data in Pharmacometrics: Augmenting Clinical Trials and Advancing Research in Understudied Populations

Location: Colorado B-D

Chair: – Genentech, Inc

Speaker: – Genentech

Speaker: – Pfizer

Speaker: – UCSF

PMx

9:00 AM - 9:20 AM MDT

Integrating Real-World Data and PBPK Modeling to Optimize Drug-Drug Interaction Assessments in Rare Diseases

Location: Colorado B-D

Speaker: – Genentech

9:20 AM - 9:40 AM MDT

Leveraging Real-World Data to Extend Adult Drug Approvals to Pediatric Populations: A Pharmacometric Approach

Location: Colorado B-D

Speaker: – Pfizer

9:40 AM - 10:00 AM MDT

Harnessing Real-World Data to Advance Pharmacometrics in Understudied Populations: Computational Strategies, Study Design, and Machine Learning Approaches

Location: Colorado B-D

Speaker: – UCSF

10:00 AM - 10:30 AM MDT

Panel - Leveraging Real-World Data in Pharmacometrics: Augmenting Clinical Trials and Advancing Research in Understudied Populations

Location: Colorado B-D

Panelist: – Genentech

Panelist: – Pfizer

Panelist: – UCSF

9:00 AM - 10:30 AM MDT

Scaling Peaks Unclimbed: How QSP is Shaping the Future Landscape of MIDD in Diseases Beyond Oncology

Location: Willow Lake 3 - 5

Co-Chair: – Johnson & Johnson Innovative Medicine

Co-Chair: – Simulations Plus, Inc

Speaker: – GSK

Speaker: – Cardiorenal QSP, LLC

Speaker: – J&J Innovative Medicine

Speaker: – QSP - Precision Medicine

QSP/ PBPK

9:00 AM - 9:15 AM MDT

Expanding Horizons: Shaping the Future Landscape of MIDD Across Disease Areas

Location: Willow Lake 3 - 5

Speaker: – GSK

9:15 AM - 9:35 AM MDT

Quantitative Systems Pharmacology for Cardiorenal Drug Development: Integrating Safety and Efficacy Predictions in patients with multiple comorbidities and comedications

Location: Willow Lake 3 - 5

Speaker: – Cardiorenal QSP, LLC

9:35 AM - 9:55 AM MDT

Paving New Paths in Immunology: Development and Credibility Assessment of a Disease QSP Model for Rheumatoid Arthritis (RA)

Location: Willow Lake 3 - 5

Speaker: – J&J Innovative Medicine

9:55 AM - 10:15 AM MDT

Past, Present and Future of Tackling Infectious Diseases and Vaccine Through the Lens of QSP and QST

Location: Willow Lake 3 - 5

Speaker: – QSP - Precision Medicine

9:00 AM - 10:30 AM MDT

Advances in Mathematical and Computational Modeling for Radiopharmaceutical Therapies

Location: Red Rock 8/9

Co-Chair: – Novartis Pharmaceuticals Corporation

Co-Chair: – Certara

Co-Chair: – Genentech, Inc.

Speaker: – Yale University

Speaker: – Novartis Pharmaceutical Corporation

Speaker: – University of Bern

Speaker: – AstraZeneca/Novartis

General Pharmacometrics

9:00 AM - 9:22 AM MDT

Predictive Dosimetry and Dose Personalization in Targeted Radiopharmaceutical Therapy

Location: Red Rock 8/9

Speaker: – Yale University

9:22 AM - 9:45 AM MDT

An Integrated model Lu-PSMA-617 dose, tumor dosimetry, PSA and OS to enable future study design

Location: Red Rock 8/9

Speaker: – Novartis Pharmaceutical Corporation

9:45 AM - 10:07 AM MDT

Digital Twins for Personalized Radiopharmaceutical Therapy

Location: Red Rock 8/9

Speaker: – University of Bern

10:07 AM - 10:30 AM MDT

Reduced dosimetry using NLME

Location: Red Rock 8/9

Speaker: – AstraZeneca/Novartis

10:30 AM - 10:45 AM MDT

Coffee Break

Location: Colorado Foyer

10:45 AM - 12:15 PM MDT

Roller Coaster Session - RC1

Location: Colorado B-D

Chair: – Genentech

10:45 AM - 11:00 AM MDT

Design of a First-in-Human Study for ARV-102, a Brain-Penetrant PROteolysis TArgeting Chimera (PROTAC) LRRK2 Degrader, Using Pharmacokinetic (PK)-Pharmacodynamic (PD) Modeling

Location: Colorado B-D

Speaker: – Arvinas

11:00 AM - 11:15 AM MDT

Full Random Effects Modelling (FREM): Scaling the Heights of Covariate Modelling

Location: Colorado B-D

Speaker: – Pharmetheus AB

11:15 AM - 11:30 AM MDT

Pharmacometric methods used in the assessment of pulmonary drug deposition

Location: Colorado B-D

Chair: – Cipla Ltd

11:30 AM - 11:45 AM MDT

Machine Learning Augmented Tumor Growth and Survival Models: Insights from Hepatocellular Carcinoma Data

Location: Colorado B-D

Speaker: – Metrum Research Group

10:45 AM - 12:15 PM MDT

Roller Coaster Session - RC2

Location: Willow Lake 3 - 5

Chair: – GlaxoSmithKline

10:45 AM - 11:00 AM MDT

Unravelling the pharmacokinetics of oligonucleotides by using a PBPK model

Location: Willow Lake 3 - 5

Speaker: – Certara Predictive Technologies

11:00 AM - 11:15 AM MDT

A copula-based approach for generating realistic virtual patient populations in quantitative pharmacology

Location: Willow Lake 3 - 5

Speaker: – Leiden University

11:15 AM - 11:30 AM MDT

Will harmonization in guidance lead to consistency in assessment and regulatory decisions, with a focus on PBPK modeling in new drug approvals (NDAs) and marketing authorization applications (MAAs)?

Location: Willow Lake 3 - 5

Speaker: – Simulations Plus

11:30 AM - 11:45 AM MDT

Hepatitis Viral Disease QSP Model Can Inform Efficacious Dose for Immunotherapy

Location: Willow Lake 3 - 5

Speaker: – AstraZeneca

11:45 AM - 12:00 PM MDT

12 years of modeling ADCs in oncology: lessons learned, insights gleaned, creativity unleashed

Location: Willow Lake 3 - 5

Speaker: – Novartis

10:45 AM - 12:15 PM MDT

Roller Coaster Session - RC3

Location: Red Rock 8/9

Chair: – A*STAR Bioinformatics Institute

10:45 AM - 11:00 AM MDT

Machine learning algorithms for structural model selection - comparison and implementation

Location: Red Rock 8/9

Speaker: – Simulations Plus

11:00 AM - 11:15 AM MDT

Logic-based machine learning to repurpose drugs for heart disease

Location: Red Rock 8/9

Speaker: – University of Virginia

11:15 AM - 11:30 AM MDT

Finding complex relationships between random effects and covariates using data-driven distributions

Location: Red Rock 8/9

Speaker: – Pumas-AI Inc.

11:30 AM - 11:45 AM MDT

Trustworthy AI: A multidisciplinary review of the guiding principles for the implementation of AI/ML

Location: Red Rock 8/9

Speaker: – Pfizer, Inc.

11:45 AM - 12:00 PM MDT

Generating QSP-based Digital Twins for TCR-engineered T cell Therapies

Location: Red Rock 8/9

Speaker: – Preclinical and Translational Pharmacokinetics/Pharmacodynamics, Genentech

12:15 PM - 1:45 PM MDT

Exhibits/ Posters/ Lunch

Location: Colorado Ballroom A & Foyer

12:15 PM - 1:45 PM MDT

Clinical Pharmacometrics - SIG LUNCH

Location: Red Rock 4/5

12:15 PM - 1:45 PM MDT

MCS - SIG LUNCH

Location: Red Rock 2/3

1:45 PM - 3:15 PM MDT

Advancing Automation Tools to Accelerate Drug Development: Cross-SIG Perspectives

Location: Colorado B-D

Co-Chair: – UNC-Chapel Hill

Co-Chair: – Merck & Co., Inc.

Speaker: – Pfizer

Speaker: – Bristol Myers Squibb

Speaker: – Genentech, Inc.

Panelist: – Pfizer Inc

Panelist: – AstraZeneca

Panelist: – Novartis

Panelist: – GSK

General Pharmacometrics

1:45 PM - 2:05 PM MDT

Automation tools for pharmacometrics (PMX) dataset creation, review, and reporting

Location: Colorado B-D

Speaker: – Bristol Myers Squibb

2:05 PM - 2:25 PM MDT

PoissonERM: An example of an automation tool

Location: Colorado B-D

Speaker: – Pfizer

2:25 PM - 2:45 PM MDT

Workstream for conducting a tumor growth inhibition-overall survival (TGI-OS) analysis and automation tool to streamline survival simulation

Location: Colorado B-D

Speaker: – Genentech, Inc.

2:45 PM - 3:15 PM MDT

Panel - Advancing Automation Tools to Accelerate Drug Development: Cross-SIG Perspectives

Location: Colorado B-D

Panelist: – GSK

Panelist: – Pfizer

Panelist: – Genentech, Inc.

Panelist: – Pfizer Inc

Panelist: – AstraZeneca

Panelist: – Novartis

Panelist: – Incyte Corportation

Panelist: – Bristol Myers Squibb

1:45 PM - 3:15 PM MDT

FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches

Location: Red Rock 8/9

Co-Chair: – US FDA

Co-Chair: – Pfizer, Retired

Speaker: – FDA

Speaker: – Pfizer

Speaker: – Dr. Reddy’s Laboratories Ltd

General Pharmacometrics

1:45 PM - 2:05 PM MDT

The Development and Framework of MMF as a Regulatory Initiative.

Location: Red Rock 8/9

Speaker: – US FDA

2:05 PM - 2:25 PM MDT

Use of Fit-for-Purpose Program to Support the Reusability of Novel Tools for New Drug Development

Location: Red Rock 8/9

Speaker: – FDA

2:25 PM - 2:45 PM MDT

Model Development Lifecycle (MDLC) and Applications in Clinical Development. Implications for MMF

Location: Red Rock 8/9

Speaker: – Pfizer

2:45 PM - 3:05 PM MDT

Model Master File Framework in Generic Product Development: Challenges, Opportunities and Case Examples

Location: Red Rock 8/9

Speaker: – Dr. Reddy’s Laboratories Ltd

3:05 PM - 3:15 PM MDT

Panel - FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches

Location: Red Rock 8/9

Panelist: – US FDA

Panelist: – FDA

Panelist: – Pfizer

Panelist: – Dr. Reddy’s Laboratories Ltd

1:45 PM - 3:15 PM MDT

Bridging Causal Inference and Pharmacometric Modeling

Location: Willow Lake 3 - 5

Chair: – Johnson & Johnson

Speaker: – Metrum Research Group

Speaker: – Uppsala University

Speaker: – Novartis

Panelist: – Roche-Genentech

Big Data/AI/Machine Learning

1:45 PM - 2:05 PM MDT

Landmarking Strategies for Causal Mediation Analyses with Longitudinal Biomarkers

Location: Willow Lake 3 - 5

Speaker: – Metrum Research Group

2:05 PM - 2:25 PM MDT

Instrumental variable analyses of exposure – response relationships

Location: Willow Lake 3 - 5

Speaker: – Uppsala University

2:25 PM - 2:45 PM MDT

Non-linear mixed effects modeling as a tool for causal inference

Location: Willow Lake 3 - 5

Speaker: – Novartis

2:45 PM - 3:15 PM MDT

Panel - Bridging Causal Inference and Pharmacometric Modeling

Location: Willow Lake 3 - 5

Panelist: – Metrum Research Group

Panelist: – Uppsala University

Panelist: – Novartis

Panelist: – Roche-Genentech

3:30 PM - 4:00 PM MDT

Closing - General Session

Location: Colorado B-D

Presenter: – Genentech

Presenter: – InSilicoTrials

Presenter: – Pharmetheus

4:30 PM - 6:00 PM MDT

ACoP 2025 Meets ACoP 2026 (Invite Only)

Location: Red Rock 2/3