Full Schedule

7:00 AM – 9:00 AM MST

Exhibits/Posters/Coffee Service

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

Sponsored By

9:00 AM – 10:30 AM MST

What is the future and impact of artificial intelligence and machine learning (AI/ML) in each SIGs

Location: Canyon Ballroom

Chair: – Pfizer, Inc.

Chair: – Incyte Corporation

Speaker: – ISoP

Speaker: – Rutgers University

Speaker: – University of Michigan College of Pharmacy

Panelist: – Pharmetheus

Panelist: – Johnson & Johnson

Panelist: – BMS

Panelist: – Pfizer, Inc.

9:00 AM – 9:20 AM MST

Use of AI/ML to Support New Drug Development and Enhance Patient Care

Location: Canyon Ballroom

Speaker: – ISoP

9:20 AM – 9:40 AM MST

QSP in the era of ML

Location: Canyon Ballroom

Speaker: – Rutgers University

9:40 AM – 10:00 AM MST

Using machine learning and multiomics to predict the pharmacokinetics of immunosuppressants and clinical outcomes in renal transplant patients

Location: Canyon Ballroom

Speaker: – University of Michigan College of Pharmacy

10:00 AM – 10:30 AM MST

Panel Discussion

Location: Canyon Ballroom

Panelist: – ISoP

Panelist: – University of Michigan College of Pharmacy

Panelist: – Pharmetheus

Panelist: – Johnson & Johnson

Panelist: – BMS

Panelist: – Pfizer, Inc.

9:00 AM – 10:30 AM MST

Challenges in characterizing treatment response in oncology - Pitfalls and solutions

Location: Sonoran Sky Ballroom 1 - 4

Chair: – Pharmetheus AB

Chair: – Merck & Co., Inc.

Speaker: – Daiichi Sankyo Inc

Speaker: – Uppsala University

Speaker: – INSERM / Université Paris Cité

9:00 AM – 9:30 AM MST

Dose Selection and Optimization in Oncology: Focus on ADCs

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – Daiichi Sankyo Inc

9:30 AM – 10:00 AM MST

The flawed assumption of proportional hazards in oncology studies - What are the alternatives?

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – Uppsala University

10:00 AM – 10:30 AM MST

Joint modeling of longitudinal biomarker data and progression free survival to accelerate drug approvals in oncology

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – INSERM / Université Paris Cité

9:00 AM – 10:30 AM MST

Decoding the Past, Crafting the Future: Unraveling the Role of Confounding in Exposure-Response Relationships for Small and Large Molecules

Location: Sonoran Sky Ballroom 5 - 8

Chair: – Genentech

Speaker: – The Ohio State University

Chair and Speaker: – Mural Oncology

Speaker: – FDA, MD

Speaker:

9:00 AM – 9:30 AM MST

Mechanisms that drive E-R confounding for large and small molecules: do we need to understand these to address E-R confounding in our analyses?

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – The Ohio State University

9:30 AM – 10:00 AM MST

Exposure, response, and baseline-factor triangle for large and small molecules: a search for the right angle

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Mural Oncology

10:00 AM – 10:30 AM MST

Untangling Cause-and-Effect for Oncology Dose Selection: Exposure-Response Confounding with Small Molecules

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – FDA, MD

Speaker:

9:00 AM – 10:30 AM MST

Opening New Frontiers in Pharmacometrics & QSP Modeling: Leveraging Physics- and Pharmacology-informed Neural Networks

Location: Kaibab & Lantana

Chair and Speaker: – Clinical Pharmacology, Genentech Inc.

Chair: – Quantitative Clinical Pharmacology, AstraZeneca

Speaker: – Biomedical Engineering, Brown University

Speaker: – Quantitative Clinical Pharmacology, AstraZeneca

9:00 AM – 9:30 AM MST

Merging Multimodal with Longitudinal data: Leveraging Graph Neural Networks and Neural-ODEs

Location: Kaibab & Lantana

Speaker: – Clinical Pharmacology, Genentech Inc.

9:30 AM – 10:00 AM MST

Pharmacometrics Modeling via Physics-Informed Neural Networks: Integrating Time-Variant Absorption Rates and Fractional Calculus for Enhancing Prediction Accuracy

Location: Kaibab & Lantana

Speaker: – Biomedical Engineering, Brown University

10:00 AM – 10:30 AM MST

Machine Learning for Developing Interpretable Population PK Models

Location: Kaibab & Lantana

Speaker: – Quantitative Clinical Pharmacology, AstraZeneca

10:45 AM – 12:15 PM MST

Roller Coaster 1

Location: Canyon Ballroom

Moderator: – Eli Lilly and Company

Speaker: – US FDA

Speaker: – University of Maryland

Speaker: – BridgeBio

Speaker: – Johnson and Johnson

Speaker: – Critical Path Institute

10:50 AM – 11:05 AM MST

Use of quantitative tools to facilitate TCE development—CRS and beyond

Location: Canyon Ballroom

Speaker: – US FDA

11:05 AM – 11:20 AM MST

Transforming Healthcare with Large Language Models: Opportunities and challenges

Location: Canyon Ballroom

Speaker: – University of Maryland

11:20 AM – 11:35 AM MST

Opportunities between ASA BioPharm and ISOP: Training the next generation Quantitative Scientists

Location: Canyon Ballroom

Speaker: – BridgeBio

11:35 AM – 11:50 AM MST

Optimizing Dosing and Efficiency in Developing Direct Oral Anticoagulants Through Modeling-Informed Approaches

Location: Canyon Ballroom

Speaker: – Johnson and Johnson

11:50 AM – 12:05 PM MST

Bridging to New Horizons in Pharmacometrics and Drug Development through Digital Health Innovation

Location: Canyon Ballroom

Speaker: – Critical Path Institute

10:45 AM – 12:15 PM MST

Roller Coaster 2

Location: Sonoran Sky Ballroom 1-4

Moderator: – Biogen

Speaker: – AstraZeneca

Speaker: – Simulations Plus Inc

Speaker: – Genmab

Speaker: – Amgen

Speaker: – Catholic university of Korea

10:50 AM – 11:05 AM MST

Decoding complex drug-drug-renal disease interaction mediated by hepatic enzymes and transporters using PBPK approach

Location: Sonoran Sky Ballroom 1-4

Chair: – AstraZeneca

11:05 AM – 11:20 AM MST

Hitting the Sweet Spot: Mechanism-Based Modeling to Evaluate the Interplay of Liver Compound Exposure and Liver Toxicity to Identify Safe Dosing Regimens

Location: Sonoran Sky Ballroom 1-4

Speaker: – Simulations Plus Inc

11:20 AM – 11:35 AM MST

Validating QSP Models with Finesse: Elevating Performance through Biologically Anchored Precision

Location: Sonoran Sky Ballroom 1-4

Speaker: – Genmab

11:35 AM – 11:50 AM MST

Quantitative Systems Pharmacology Modeling to Inform Preclinical-to-Clinical Translation of T-cell Engager Programs

Location: Sonoran Sky Ballroom 1-4

Speaker: – Amgen

11:50 AM – 12:05 PM MST

Integrated Microphysiological System and PBPK Modeling for Prediction of Human Diclofenac Pharmacokinetics

Location: Sonoran Sky Ballroom 1-4

Speaker: – Catholic university of Korea

10:45 AM – 12:15 PM MST

Roller Coaster 3

Location: Sonoran Sky Ballroom 5 - 8

Moderator: – Johnson and Johnson

Speaker: – Eli Lilly and Company

Speaker: – LAP&P Consultants BV

Speaker: – Janssen RnD

Speaker: – University of Florida, Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology

Speaker: – Abbvie

10:50 AM – 11:05 AM MST

Advancing Drug Development through Model Informed Drug Development: Insights from the ICH M15 MIDD Guidance Working Group

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Eli Lilly and Company

11:05 AM – 11:20 AM MST

Overadjustment bias and mediation analysis in PK/PD modeling

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – LAP&P Consultants BV

11:20 AM – 11:35 AM MST

MIDD in the clinical development of gene therapy: from bench to bedside

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Janssen RnD

11:35 AM – 11:50 AM MST

Breaking down barriers within and across disciplines: the power of data integration

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – University of Florida, Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology

11:50 AM – 12:05 PM MST

Power Determination During Drug Development: Is Optimizing the Sample Size Based on Exposure- Response Analyses Underutilized?

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Abbvie

10:45 AM – 12:15 PM MST

Roller Coaster 4 - Birds of a Feather 5

Location: Kaibab & Lantana

Moderator: – Clinical Pharmacology Modeling & Simulation, Amgen

Speaker: – Clinical Pharmacology Modeling & Simulation, Amgen

Speaker: – Regeneron Pharmaceuticals Inc.

Speaker: – St Jude Children's Research Hospital

Speaker: – ESQlabs

Speaker: – Simulations Plus

10:50 AM – 11:05 AM MST

Mechanistic physiologically-based pharmacokinetic models for optimal development of bi-specific T cell engagers

Location: Kaibab & Lantana

Speaker: – Clinical Pharmacology Modeling & Simulation, Amgen

11:05 AM – 11:20 AM MST

A mechanistic model to inform step-up dosing that limits cytokine release following a bispecific T cell engaging antibody treatment for B-cell lymphomas

Location: Kaibab & Lantana

Speaker: – Regeneron Pharmaceuticals Inc.

11:20 AM – 11:35 AM MST

Fludarabine Therapeutic Drug Monitoring in Lymphodepletion Therapy for Pediatric CAR T-cell therapy

Location: Kaibab & Lantana

Speaker: – St Jude Children's Research Hospital

11:35 AM – 11:50 AM MST

The Future of Pharmacokinetics: Digital Twins and OoC in Harmony

Location: Kaibab & Lantana

Speaker: – ESQlabs

11:50 AM – 12:05 PM MST

Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model

Location: Kaibab & Lantana

Speaker: – Simulations Plus

12:15 PM – 1:45 PM MST

Lunch/Exhibits/Posters

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

12:15 PM – 1:45 PM MST

QSP SIG Lunch

Location: Mesquite & Noble

12:15 PM – 1:45 PM MST

SxP SIG Lunch

Location: Palms 3 CD

12:15 PM – 1:45 PM MST

Building high performing teams to influence decisions in drug development.

Location: Palm 3A

Chair and Speaker: – Syndax Pharmaceuticals

Speaker: – Confo Therapeutics

Lunch & Learn

12:15 PM – 1:15 PM MST

Diversity and management of differences. Group-decision making and the role of psychological safety in effective decision making

Location: Palm 3A

Speaker: – Syndax Pharmaceuticals

Lunch & Learn

1:15 PM – 1:45 PM MST

Leveraging effective communication skills to deliver complex pharmacometrics results to non-pharmacometricians

Location: Palm 3A

Speaker: – Confo Therapeutics

Lunch & Learn

1:45 PM – 3:15 PM MST

Quantitative clinical pharmacology of antibody drug conjugate development: challenges and opportunities

Location: Canyon Ballroom

Chair: – Genmab

Chair: – Gilead Sciences

Speaker: – Metrum Research Group

Speaker: – Pfizer

Speaker: – U.S. Food and Drug Administration

1:45 PM – 2:15 PM MST

Mechanistic QSP modeling for a deeper understanding of ADC toxicities and combination effects with immunotherapies

Location: Canyon Ballroom

Speaker: – Metrum Research Group

2:15 PM – 2:45 PM MST

Dose Optimization of ADCs

Location: Canyon Ballroom

Speaker: – Pfizer

2:45 PM – 3:15 PM MST

Regulatory Experiences and Considerations for Model-Informed Approaches in Antibody-drug conjugates (ADCs) Drug Development

Location: Canyon Ballroom

Speaker: – U.S. Food and Drug Administration

1:45 PM – 3:15 PM MST

The Practical Bayesian: How Bayesian Methodology is Incorporated into Clinical Drug Development

Location: Sonoran Sky Ballroom 1-4

Chair: – Pfizer, Inc.

Speaker: – Metrum Research Group

Speaker: – North Carolina State University

Speaker: – Genentech

1:45 PM – 2:15 PM MST

Hybrid Approaches in Pharmacometric Modeling: Integrating Maximum Likelihood and Bayesian Estimation

Location: Sonoran Sky Ballroom 1-4

Speaker: – Metrum Research Group

2:15 PM – 2:45 PM MST

Parameter Selection and Uncertainty Quantification Techniques for Pharmacokinetic Models

Location: Sonoran Sky Ballroom 1-4

Speaker: – North Carolina State University

2:45 PM – 3:15 PM MST

Applying Bayesian Methods for Dose Optimization in Pediatric Oncology: Leveraging from Adult Population Pharmacokinetics

Location: Sonoran Sky Ballroom 1-4

Speaker: – Genentech

1:45 PM – 3:15 PM MST

Deep Learning in PKPD and Pharmacometrics: Diversity of Approaches and Applications

Location: Sonoran Sky Ballroom 5 - 8

Chair and Speaker: – Merck Research Laboratories

Speaker: – Genentech Inc.

Speaker: – Preclinical and Translational Pharmacokinetics/Pharmacodynamics, Genentech

1:45 PM – 2:15 PM MST

Protein Language Models to incorporate PKPD considerations in early antibody design and generation

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Preclinical and Translational Pharmacokinetics/Pharmacodynamics, Genentech

2:15 PM – 2:45 PM MST

Towards Generalizability of Neural ODEs in predictive applications in pharmacometrics

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Merck Research Laboratories

2:45 PM – 3:15 PM MST

Integration of Graph Neural Network and Neural-ODEs for Tumor Dynamic Prediction

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Genentech Inc.

1:45 PM – 3:15 PM MST

Is Pharmacometrics limited by the industry settings?

Location: Kaibab & Lantana

Chair: – Eli Lilly and Company

Chair: – Metrum Research Group

Panelist: – Gilead Sciences

Panelist: – Metrum Research Group

Panelist: – Eli Lilly and Company

Panelist: – University of Maryland

1:45 PM – 3:15 PM MST

Panel Discussion

Location: Kaibab & Lantana

Panelist: – Gilead Sciences

Panelist: – Metrum Research Group

Panelist: – Eli Lilly and Company

Panelist: – University of Maryland

Panelist: – Executive Director at Astellas/ Editor-in-Chief, JPKPD

3:30 PM – 4:00 PM MST

Closing General Session

Location: Canyon Ballroom

Speaker: – Moderna

4:30 PM – 6:00 PM MST

ACoP 2024 Meets ACoP 2025 (invite only)

Location: Palms 3 CD