Full Schedule

7:00 AM – 9:00 AM MST

Exhibits/Posters/Coffee Service

Location: Arizona Grand Ballroom/Palm Court/Paseo West

Sponsored By

7:00 AM – 5:00 PM MST

Professional Headshot Booth

Location: Arizona Grand Ballroom Foyer

Sponsored By

9:00 AM – 10:45 AM MST

General Session: President's Address and State-of-the-Art Lecture

Location: Canyon Ballroom

Speaker: – PUMAS Inc

Speaker: – CEO, Phase Advance AI

9:00 AM – 9:45 AM MST

President's Address

Location: Canyon Ballroom

Speaker: – ISoP

Speaker: – PUMAS Inc

9:45 AM – 10:45 AM MST

AI-aided Virtual Disease Progression Clinical trials – the marriage of nonlinear mathematical modeling, biology, and AI in predicting future individual patient responses in global health

Location: Canyon Ballroom

Speaker: – CEO, Phase Advance AI

11:00 AM – 12:30 PM MST

Quantitative Systems Pharmacology in Late Stage Oncology Drug Development– New Horizons to Dose Optimization

Location: Canyon Ballroom

Chair: – Certara

Chair and Speaker: – Clinical Pharmacology

Speaker: – Genmab

Speaker: – FDA

11:00 AM – 11:30 AM MST

Dose guidance for a novel combination therapy to treat head and neck squamous cell carcinoma (HNSCC) for patients with HRAS/PIK3CA variants using QSP model

Location: Canyon Ballroom

Speaker: – Clinical Pharmacology

11:30 AM – 12:00 PM MST

Model-based Dose Selection for Epcoritamab, a subcutaneous CD3xCD20 bispecific antibody

Location: Canyon Ballroom

Speaker: – Genmab

12:00 PM – 12:30 PM MST

QSP Modeling and Dose Optimization: A Regulatory Perspective

Location: Canyon Ballroom

Speaker: – FDA

11:00 AM – 12:30 PM MST

Intersecting Realities: Showcasing the Power of Imaging and Modeling in Biomedicine and Drug Development

Location: Sonoran Sky Ballroom 1 - 4

Chair and Speaker: – Genentech, Inc.

Co-Chair: – Yale University

Speaker: – Yale University

Speaker: – University of California, Davis

11:00 AM – 11:30 AM MST

Image-Based Computational Fluid Dynamics Modeling of Inthrathecal Drug Delivery for CNS Diseases

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – Genentech, Inc.

11:30 AM – 12:00 PM MST

Positron Emission Tomography and Tracer Kinetic Modeling for Quantitative Molecular Imaging in Drug Discovery and Development

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – Yale University

12:00 PM – 12:30 PM MST

Total-Body PET Kinetic Modeling and Its Potential Applications to Drug Development and Evaluation

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – University of California, Davis

11:00 AM – 12:30 PM MST

Modeling approaches in pregnancy and lactation for drug development: operational, ethical and regulatory perspectives

Location: Sonoran Sky Ballroom 5 - 8

Chair: – Certara UK Ltd

Chair: – Regeneron Pharmaceuticals, Inc.

Speaker: – University of Liverpool, UK and Infectious Diseases Institute, Makerere University, Uganda

Speaker: – Indiana University School of Medicine

Speaker: – Thomas Jefferson University

Speaker: – U.S. Food and Drug Administration

Speaker: – Department of Biomedical Informatics, College of Medicine, The Ohio State University

11:00 AM – 11:15 AM MST

Bridging the Gap – Clinical Studies Supported by Modeling in a Community Setting

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – University of Liverpool, UK and Infectious Diseases Institute, Makerere University, Uganda

11:15 AM – 11:30 AM MST

Modeling and simulation to support therapy in pregnancy and lactation

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Indiana University School of Medicine

11:30 AM – 11:45 AM MST

Ethical and Operational Considerations for Clinical Study Design and Conduct in Neonatal & Pregnancy Research

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Thomas Jefferson University

11:45 AM – 11:55 AM MST

Regulatory Experiences and Considerations for Model-Informed Approaches to Drug Development in Pregnancy and Lactation

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – U.S. Food and Drug Administration

11:55 AM – 12:05 PM MST

Large language model and active learning guided pharmacology therapy knowledge gap discovery in maternal and pediatric patients

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Department of Biomedical Informatics, College of Medicine, The Ohio State University

12:05 PM – 12:30 PM MST

Panel Discussion

Location: Sonoran Sky Ballroom 5 - 8

Panelist: – Thomas Jefferson University

Panelist: – University of Liverpool, UK and Infectious Diseases Institute, Makerere University, Uganda

Panelist: – U.S. Food and Drug Administration

Panelist: – Department of Biomedical Informatics, College of Medicine, The Ohio State University

Panelist: – Indiana University School of Medicine

11:00 AM – 12:30 PM MST

Overcoming the Challenges of Cancer Drug Resistance: Applying Evolutionary Principles from Bench to Bedside

Location: Kaibab & Lantana

Chair: – Novartis

Co-Chair: – Gilead Sciences

Speaker: – H. Lee Moffitt Cancer Center & Research Institute

Speaker: – University of North Carolina at Chapel Hill

Speaker: – Novartis

11:00 AM – 11:30 AM MST

Designing evolution-based treatment strategies based on the principles of convexity and concavity

Location: Kaibab & Lantana

Speaker: – H. Lee Moffitt Cancer Center & Research Institute

11:30 AM – 12:00 PM MST

Evolutionary and spatiotemporal response dynamics in metastatic colorectal cancers

Location: Kaibab & Lantana

Speaker: – University of North Carolina at Chapel Hill

12:00 PM – 12:30 PM MST

Drug combinations paired with strategic scheduling: leveraging quantitative systems pharmacology to overcome drug resistance

Location: Kaibab & Lantana

Speaker: – Novartis

12:30 PM – 2:00 PM MST

Lunch/Exhibits/Posters

Location: Arizona Grand Ballroom, and Palm Court and Paseo West

12:30 PM – 2:00 PM MST

Trainee Lunch

Location: Mesquite & Noble

12:30 PM – 2:00 PM MST

Standardization and Best Practices as Bridges to the Future: Securing the Foundation for Growth of Model-Informed Drug Development

Location: Palm 3 A/B

Chair: – Vertex

Chair: – Gilead Sciences

Speaker: – Astellas

Speaker: – BMS

Speaker: – Jazz Pharmaceuticals

Lunch & Learn

12:30 PM – 1:00 PM MST

Pharmacometrics Workflow: Points to Consider for Efficient, High-Quality, and Reproducible Analyses

Location: Palm 3 A/B

Speaker: – Astellas

Lunch & Learn

1:00 PM – 1:30 PM MST

How to Implement CDISC data standards for Population PK Analysis in your organization

Location: Palm 3 A/B

Speaker: – BMS

Lunch & Learn

1:30 PM – 2:00 PM MST

Working towards a standardized population PK/PD reporting template for the industry

Location: Palm 3 A/B

Speaker: – Jazz Pharmaceuticals

Lunch & Learn

2:00 PM – 3:00 PM MST

ACoP Special Session-The Future is Now: Envisioning the Next Era of Pharmacometrics

Location: Canyon Ballroom

Chair:

Panelist: – ISoP

Panelist: – Pfizer

Panelist: – Gilead Sciences

Panelist: – Department of Bioengineering and Therapeutic Sciences, School of Pharmacy, UCSF

3:00 PM – 3:15 PM MST

Coffee Break

Location: Canyon Ballroom Patio & Sonoran Patio

Sponsored By

3:15 PM – 4:45 PM MST

Enabling Progress Against Alzheimer's Disease: Power of Diverse Pharmacometrics Approaches

Location: Canyon Ballroom

Chair: – Merck & Co., Inc.

Chair: – Eisai, Inc

Speaker and Panelist: – Biogen

Speaker and Panelist: – Eli Lilly and Company

Speaker and Panelist: – Merck & Co., Inc.

Panelist: – Certara

3:15 PM – 3:35 PM MST

Pharmacometrics for the Win: How Modeling Helps Demonstrate Efficacy in Alzheimer’s Disease and Provides Insight into Drug Activity

Location: Canyon Ballroom

Speaker: – Biogen

3:35 PM – 3:55 PM MST

Model Informed Drug Development (MIDD) in Alzheimer’s Disease

Location: Canyon Ballroom

Speaker: – Eli Lilly and Company

3:55 PM – 4:15 PM MST

Mapping Longitudinal Biomarker Relationships in Alzheimer’s Disease with Latent Time Joint Mixed Effects Modeling

Location: Canyon Ballroom

Speaker: – Merck & Co., Inc.

4:15 PM – 4:45 PM MST

Panel Discussion

Location: Canyon Ballroom

Panelist: – Merck & Co., Inc.

Panelist: – Eisai, Inc

Panelist: – Biogen

Panelist: – Eli Lilly and Company

Panelist: – Certara

3:15 PM – 4:45 PM MST

Mind the gap – successful bridging of QSP and PMX in drug development

Location: Sonoran Sky Ballroom 1 - 4

Chair: – Certara

Chair: – Genentech, South San Francisco, CA

Speaker: – Certara

Speaker: – Genentech

Speaker: – Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA

Panelist: – Pfizer

Panelist: – Genentech, Inc.

Panelist: – United States FDA

Panelist: – Bristol Myers Squibb

3:15 PM – 3:35 PM MST

Joined PMX and QSP modeling to guide step-up dosing of a bispecific antibody for prostate cancer

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – Certara

3:35 PM – 3:55 PM MST

Convergence of QSP and Pharmacometrics - Are we there yet?

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – Genentech

3:55 PM – 4:15 PM MST

The best of both worlds? Integration of QSP and PMx modeling in support of MIDD in oncology

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA

4:10 PM – 4:45 PM MST

Panel Discussion

Location: Sonoran Sky Ballroom 1 - 4

Panelist: – Genentech, South San Francisco, CA

Panelist: – Certara

Panelist: – Pharmacometrics & Systems Pharmacology, Pfizer Research and Development, La Jolla, CA

Panelist: – Genentech

Panelist: – Pfizer

Panelist: – Genentech, Inc.

Panelist: – Bristol Myers Squibb

3:15 PM – 4:45 PM MST

Integration of modelling, endogenous biomarkers, and real-world study approaches to support precision dosing in special populations

Location: Sonoran Sky Ballroom 5 - 8

Chair and Speaker: – Drug Clinical Trial Center, Peking University Third Hospital

Chair and Speaker: – University of Manchester

Speaker: – F. Hoffmann-La Roche

Speaker: – FDA

3:15 PM – 3:25 PM MST

The current clinical needs and gaps for precision medicine of special populations

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Drug Clinical Trial Center, Peking University Third Hospital

3:25 PM – 3:50 PM MST

Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug–Drug Interactions in Children

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – F. Hoffmann-La Roche

3:50 PM – 4:15 PM MST

Application of endogenous biomarkers of drug transporters and liquid biopsy coupled with PBPK modelling to support precision dosing in renal impairment

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – University of Manchester

4:15 PM – 4:35 PM MST

Utilization of Real-World Data in Clinical Pharmacology – Regulatory Perspectives

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – FDA

4:35 PM – 4:45 PM MST

Panel Discussion

Location: Sonoran Sky Ballroom 5-8

Speaker: – Drug Clinical Trial Center, Peking University Third Hospital

Speaker: – F. Hoffmann-La Roche

Speaker: – University of Manchester

Speaker: – FDA

3:15 PM – 4:45 PM MST

Harnessing Efficiency in Quantitative Systems Pharmacology (QSP) Modeling: Integrating Workflows, Automation, and Visualization Tools for Enhanced Cross-Functional Communication

Location: Kaibab & Lantana

Chair: – Johnson & Johnson

Chair and Speaker: – Clinical Pharmacology Modelling & Simulation – Vaccines & Infectious Diseases, Precision Medicine, GSK

Speaker: – Center for Drug Evaluation and Research, US Food and Drug Administration

Speaker: – Simulations Plus, Inc.

Panelist: – College of Medicine University of Cincinnati

Panelist: – Clinical Pharmacology and Pharmacometrics Johnson & Johnson

3:15 PM – 3:35 PM MST

A streamlined QSP workflow for digital-twin enabled in silico trials with chronic Hepatitis B infection

Location: Kaibab & Lantana

Speaker: – Clinical Pharmacology Modelling & Simulation – Vaccines & Infectious Diseases, Precision Medicine, GSK

3:35 PM – 3:55 PM MST

A streamlined communication framework needed for unleashing the power of QSP-informed drug development

Location: Kaibab & Lantana

Speaker: – Center for Drug Evaluation and Research, US Food and Drug Administration

3:55 PM – 4:15 PM MST

Thales: A unified framework for clinical-scale QSP modeling

Location: Kaibab & Lantana

Speaker: – Simulations Plus, Inc.

4:15 PM – 4:45 PM MST

Panel Discussion

Location: Kaibab & Lantana

Panelist: – Clinical Pharmacology Modelling & Simulation – Vaccines & Infectious Diseases, Precision Medicine, GSK

Panelist: – Center for Drug Evaluation and Research, US Food and Drug Administration

Panelist: – Simulations Plus, Inc.

Panelist: – College of Medicine University of Cincinnati

Panelist: – Clinical Pharmacology and Pharmacometrics Johnson & Johnson

5:00 PM – 6:30 PM MST

Communication Challenge

Location: Sonoran Sky Ballroom 1 - 4

5:00 PM – 6:30 PM MST

QSP SIG Event: Strategies for Successful Application of QSP Platform Models for Clinical Development and Regulatory Engagement

Location: Sonoran Sky Ballroom 5 - 8

Chair: – Simulations Plus, Inc.

Chair: – J&J Innovative Medicine

Chair:

Speaker: – Sanofi US

Speaker: – Bristol Myers Squibb

Speaker: – Pfizer

Speaker: – Genentech

Speaker: – Pfizer

Panelist: – Genentech, Inc.

Panelist: – Pharmetheus

Panelist: – Sanofi

5:00 PM – 6:00 PM MST

Case application vignettes of QSP platform models informed by clinical data

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Sanofi US

Speaker: – Bristol Myers Squibb

Speaker: – Pfizer

Speaker: – Genentech

6:00 PM – 6:30 PM MST

Panel Discussion

Location: Sonoran Sky Ballroom 5 - 8

Panelist: – Pfizer

Panelist:

Panelist: – Genentech, Inc.

Panelist: – Pharmetheus

Panelist: – Sanofi

7:15 PM – 11:00 PM MST

Social Dinner Event

Location: Canyon Ballroom

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