Full Schedule

7:00 AM – 8:00 AM MST

Registration - Workshop Attendees

Location: Arizona Grand Ballroom Foyer

8:00 AM – 5:00 PM MST

METRUM001 - Efficient reproducible Bayesian population PK modeling with NONMEM and Stan/Torsten, Metrum Research Group

Location: Mesquite

Speaker:

Speaker: – Metrum Research Group

Speaker:

Workshop

8:00 AM – 5:00 PM MST

Hands-On Introduction to InSilicoTrials' Cloud-Based Clinical Trial Simulator, InsilicoTrials

Location: Kaibab

Speaker: – InSilicoTrials

Speaker:

Workshop

8:00 AM – 5:00 PM MST

New and Advanced Features of NONMEM 7.5 Workshop, ICON Clinical Research LLC

Location: Noble

Speaker:

Workshop

8:00 AM – 5:00 PM MST

PUMAS001 - Scientific Modeling Augmented by Machine-Learning with DeepPumas, PumasAI

Location: Lantana

Speaker: – DeepPumas, Pumas-AI Inc.

Speaker: – Pumas-AI Inc., USA

Speaker: – PUMAS Inc

Speaker: – PumasAI

Workshop

1:00 PM – 5:00 PM MST

Practical Tools for Model Calibration with SimBiology, MathWorks

Location: Ocotillo B

Speaker: – MathWorks

Workshop

7:00 AM – 8:00 AM MST

Registration - Workshop Attendees and Preconference Attendees

Location: Arizona Grand Ballroom Foyer

8:00 AM – 8:15 AM MST

ACoP Preconference - Exploring New Frontiers: Quantitative Pharmacology for Emerging Therapeutic Modalities - Welcome, Introduction & Problem Statement

Location: Sonoran Sky Ballroom 4

Co-Chair: – Genentech

Co-Chair: – InSilicoTrials

Preconference

8:00 AM – 5:00 PM MST

Biologics (ADC) whole-body PBPK/QSP in PK-Sim and MoBi, ESQlabs GmbH

Location: Kaibab

Speaker: – ESQlabs

Speaker: – Systems Pharmacology Lead

Workshop

8:00 AM – 5:00 PM MST

METRUM002 - Efficient reproducible Bayesian population PK modeling with NONMEM and Stan/Torsten, Metrum Research Group

Location: Mesquite

Speaker:

Speaker: – Metrum Research Group

Speaker:

Workshop

8:00 AM – 5:00 PM MST

Modeling Delays in Pharmacokinetics and Pharmacodynamics using Phoenix, ISoP MCS SIG

Location: Palm 2A/B

Speaker: – University at Buffalo

Speaker: – Certara

Workshop

8:00 AM – 5:00 PM MST

PUMAS002 - Scientific Modeling Augmented by Machine-Learning with DeepPumas, PumasAI

Location: Lantana

Speaker: – DeepPumas, Pumas-AI Inc.

Speaker: – Pumas-AI Inc., USA

Speaker: – PUMAS Inc

Speaker: – PumasAI

Workshop

8:00 AM – 5:00 PM MST

Simcyp Designer PBPK-QSP Focused Workshop, Certara

Location: Noble

Speaker:

Speaker: – Certara

Workshop

8:15 AM – 9:00 AM MST

A brief history of model-informed discovery and development of advanced therapies

Location: Sonoran Sky Ballroom 4

Speaker: – Certara

Preconference

9:00 AM – 10:15 AM MST

Cell & Gene Therapies

Location: Sonoran Sky Ballroom 4

Moderator: – InSilicoTrials

Speaker: – Astellas

Speaker: – Genentech

Speaker: – Intellia

Preconference

9:00 AM – 9:25 AM MST

Hitting the target (dose) in one shot: MIDD for cell and gene therapies

Location: Sonoran Sky Ballroom 4

Speaker: – Astellas

Preconference

9:25 AM – 9:50 AM MST

Quantitative Pharmacology Considerations in the Development of Cell Therapies - Opportunities & Challenges

Location: Sonoran Sky Ballroom 4

Speaker: – Genentech

Preconference

9:50 AM – 10:15 AM MST

Quantitative Pharmacology Approach to Inform the Bench-to-Bed Translation of CRSPR-Based in-vivo Gene Editing Therapy across Multiple Development Phases

Location: Sonoran Sky Ballroom 4

Speaker: – Intellia

Preconference

10:15 AM – 10:30 AM MST

Coffee Break

Location: Sonoran Patio

10:30 AM – 11:45 AM MST

siRNA Therapies

Location: Sonoran Sky Ballroom 4

Moderator: – Alnylam Pharmaceuticals

Speaker: – Novartis

Speaker: – J&J Innovative Medicine

Speaker: – Alnylam Pharmaceuticals

Preconference

10:30 AM – 10:55 AM MST

First, Best, or Next in class? Applying forward and reverse translation approaches to accelerate siRNA projects from discovery to FIH.

Location: Sonoran Sky Ballroom 4

Speaker: – Novartis

Preconference

10:55 AM – 11:20 AM MST

Quantitative Pharmacology Principles and Model-Informed Development Approaches for RNAi Therapeutics

Location: Sonoran Sky Ballroom 4

Speaker: – J&J Innovative Medicine

Preconference

11:20 AM – 11:45 AM MST

Innovating the landscape: Is MIDD of siRNA unique?

Location: Sonoran Sky Ballroom 4

Speaker: – Alnylam Pharmaceuticals

Preconference

11:45 AM – 12:45 PM MST

Preconference Attendees Lunch/Posters

Location: Sonoran Sky Ballroom 1-3

12:00 PM – 1:00 PM MST

Workshop Attendees Lunch

Location: Sunset Patio and Grand Veranda

12:00 PM – 7:30 PM MST

ACoP 2024 Conference Registration

Location: Sonoran Sky Lobby

12:45 PM – 1:45 PM MST

The Regulatory Landscape of Quantitative Pharmacology for New Therapeutic Modalities at the FDA

Location: Sonoran Sky Ballroom 4

Moderator: – Genentech

Speaker: – FDA

Panelist: – ISoP

Preconference

1:45 PM – 3:00 PM MST

Emerging New Therapeutic Modalities

Location: Sonoran Sky Ballroom 4

Moderator: – Genentech

Speaker: – Ionis

Speaker: – Pfizer

Speaker: – Arvinas

Preconference

1:45 PM – 2:10 PM MST

Applications of A Platform PBPK Model of Antisense Oligonucleotides Towards Candidate Selection, Tox Study Design and Human Dose Projection

Location: Sonoran Sky Ballroom 4

Speaker: – Ionis

Preconference

2:10 PM – 2:35 PM MST

Model-Informed Drug Development Applications to Oncology Bispecifics and Antibody-Drug Conjugates

Location: Sonoran Sky Ballroom 4

Speaker: – Pfizer

Preconference

2:35 PM – 3:00 PM MST

Unique Model Informed Drug Development Opportunities with PROTAC Protein Degrader

Location: Sonoran Sky Ballroom 4

Speaker: – Arvinas

Preconference

3:00 PM – 3:15 PM MST

Coffee Break-Preconference Attendees

Location: Sonoran Patio

3:15 PM – 4:30 PM MST

Interactive Session: Development Challenges for New Therapeutic Modalities

Location: Sonoran Sky Ballroom 4

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

Preconference

4:30 PM – 4:45 PM MST

Preconference Concluding Remarks

Location: Sonoran Sky Ballroom 4

Speaker: – Genentech

Speaker: – InSilicoTrials

Preconference

4:45 PM – 5:15 PM MST

ISoP Awards & Fellow Reception (invitation only)

Location: Palms 3 Patio

5:30 PM – 7:30 PM MST

ACoP 2024 Opening Session

Location: Canyon Ballroom

Speaker: – Moderna

Speaker:

5:30 PM – 5:45 PM MST

Welcome to ACoP 2024

Location: Canyon Ballroom

Speaker: – Moderna

5:45 PM – 6:15 PM MST

Presentation of ISoP Awards & Induction of Fellows

Location: Canyon Ballroom

Speaker:

6:15 PM – 7:30 PM MST

Lewis B. Sheiner Award Lecture

Location: Canyon Ballroom

Speaker: – University at Buffalo, SUNY

7:30 PM – 10:00 PM MST

Welcome Reception

Location: Arizona Grand Ballroom/Palm Court/Paseo West

Sponsored By

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

Sponsored By

7:00 AM – 9:00 AM MST

Exhibits/Posters/Coffee Service

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

Sponsored By

7:00 AM – 5:00 PM MST

Professional Headshot Booth

Location: Arizona Grand Ballroom Foyer

Sponsored By

8:30 AM – 9:00 AM MST

In Memoriam: Dr. Thomas M Ludden

Location: Sonoran Sky Ballroom 1 - 4

Speaker:

Speaker: – Pfizer

Speaker:

9:00 AM – 10:15 AM MST

General Session - Quantitative clinical pharmacology/pharmacometrics facilitate decision making in drug development

Location: Canyon Ballroom

Keynote Speaker: – The U.S. Food and Drug Administration

10:15 AM – 11:15 AM MST

Fireside Chat - Charting New Frontiers: CDER's Quantitative Medicine Center of Excellence

Location: Canyon Ballroom

Moderator: – Moderna

Speaker: – FDA

Speaker: – ISoP

Speaker: – FDA

Speaker: – The U.S. Food and Drug Administration

11:15 AM – 12:30 PM MST

Presentation of Abstract Quality & Trainee Awards

Location: Canyon Ballroom

Presenter:

12:30 PM – 2:00 PM MST

Clinical Pharmacometrics SIG Lunch

Location: Palms 3AB

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

MCS SIG Lunch

Location: Mesquite & Noble

Speaker:

12:30 PM – 2:00 PM MST

SIG Programming Lunch & Learn: Embracing modern programming tools for pharmacometrics (PMx) dataset creation, review and reporting

Location: Palms 3C

Chair: – Merck & Co., Inc.

Chair and Speaker: – BMS

Speaker: – GSK

Panelist: – Johnson & Johnson

Lunch & Learn

12:30 PM – 1:00 PM MST

Introduction to CDISC standards for Population PK Analysis Datasets: Tools to facilitate the construction of CDISC ADPPK Dataset

Location: Palms 3C

Speaker: – BMS

Lunch & Learn

12:30 PM – 2:00 PM MST

Embracing modern programming tools for pharmacometrics (PMx) dataset creation, review and reporting

Location: Palms 3C

Chair: – Merck & Co., Inc.

Both: – BMS

Lunch & Learn

1:00 PM – 1:30 PM MST

Tools for streamlining PMx Dataset Review: Data Visualization, Exploration, and Quality Assurance

Location: Palms 3C

Speaker: – GSK

Lunch & Learn

1:30 PM – 2:00 PM MST

Panel Discussion

Location: Palms 3C

Panelist: – BMS

Panelist: – GSK

Panelist: – Johnson & Johnson

Lunch & Learn

2:00 PM – 3:30 PM MST

Visionary Analytics: Advancing Ophthalmology with historical insights and advanced modeling methodologies

Location: Canyon Ballroom

Chair and Speaker: – Genentech

Chair: – ISoP

Speaker: – Predictive Modelling and Data Analytics, Roche Pharma Research & Early Development, Roche Innovation Center Basel, Switzerland

Speaker: – DeepPumas, Pumas-AI Inc.

2:00 PM – 2:20 PM MST

Bridging new horizons for ophthalmology: State of the art methodologies and outlook

Location: Canyon Ballroom

Speaker: – Genentech

2:20 PM – 2:40 PM MST

Historical borrowing in nAMD: the present as a "prior" for designing more efficient future trials

Location: Canyon Ballroom

Speaker: – Predictive Modelling and Data Analytics, Roche Pharma Research & Early Development, Roche Innovation Center Basel, Switzerland

2:40 PM – 3:00 PM MST

Charting New Paths in Ophthalmology with DeepNLME-Powered Predictive Modeling

Location: Canyon Ballroom

Speaker: – DeepPumas, Pumas-AI Inc.

3:00 PM – 3:30 PM MST

Panel Discussion

Location: Canyon Ballroom

Panelist: – Genentech

Panelist: – ISoP

Panelist: – Predictive Modelling and Data Analytics, Roche Pharma Research & Early Development, Roche Innovation Center Basel, Switzerland

Panelist: – DeepPumas, Pumas-AI Inc.

2:00 PM – 3:30 PM MST

Leveraging quantitative models to design and develop the next generation of multi-specific T-Cell engager molecules

Location: Sonoran Sky Ballroom 1 - 4

Chair: – Gilead

Chair: – Genentech

Speaker: – J&J

Speaker:

Speaker: – Systems Pharmacology Lead

2:00 PM – 2:30 PM MST

Development of a Quantitative Systems Pharmacology Model to Support the Clinical Development of T cell Redirecting Bi- and Tri-specific Antibodies for Patients with Relapsed/Refractory Multiple Myeloma

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – J&J

2:30 PM – 3:00 PM MST

Utilizing platform QSP models for later phase trial design and dose selection

Location: Sonoran Sky Ballroom 1 - 4

Speaker:

3:00 PM – 3:30 PM MST

Bispecific T-cell engagers: From receptor to systems’ level modeling to rationalize dose-effect relationships

Location: Sonoran Sky Ballroom 1 - 4

Speaker: – Systems Pharmacology Lead

2:00 PM – 3:30 PM MST

Next generation M&S packages deployable and accessible for MIDD and Model Integrated Evidence - Advances Through GDUFA-Sponsored Research

Location: Sonoran Sky Ballroom 5 - 8

Chair: – Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Chair and Speaker: – Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo

Speaker: – Uppsala University

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

2:00 PM – 2:30 PM MST

User-Friendly Tools for Population PK and PBPK Modeling

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo

2:30 PM – 3:00 PM MST

Development of A User-Friendly Platform for Model-Integrated Bioequivalence Analysis

Location: Sonoran Sky Ballroom 5 - 8

Speaker: – Uppsala University

3:00 PM – 3:30 PM MST

Advancing Artificial Intelligence (AI) tools for drug R&D

Location: Sonoran Sky Ballroom 5 - 8

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

2:00 PM – 3:30 PM MST

Advancing QSP: From Virtual Patient To Digital Twin

Location: Kaibab & Lantana

Chair: – GlaxoSmithKline

Speaker: – Pfizer

Both: – InSysBio CY

Speaker: – Sanofi

2:00 PM – 2:20 PM MST

Does the Why Lead to the How to Build Virtual Populations?

Location: Kaibab & Lantana

Speaker: – Pfizer

2:20 PM – 2:40 PM MST

QSP modeling of engineered autologous T-cell therapies: random virtual patients vs virtual twins

Location: Kaibab & Lantana

Speaker: – InSysBio CY

2:40 PM – 3:00 PM MST

The Use of Quantitative Systems Pharmacology-based Digital Twins to Support Drug Development in Rare Diseases

Location: Kaibab & Lantana

Speaker: – Sanofi

3:00 PM – 3:30 PM MST

Panel Discussion

Location: Kaibab & Lantana

Panelist: – GlaxoSmithKline

Panelist: – InSysBio CY

Panelist: – Pfizer

Panelist: – Sanofi

3:30 PM – 5:00 PM MST

Exhibits/Posters Happy Hour

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

Sponsored By

5:00 PM – 6:00 PM MST

University of Buffalo Alumni Reception

Location: Ocotillo A

5:00 PM – 6:00 PM MST

University of Florida Alumni Reception

Location: Palm 3D

5:00 PM – 6:00 PM MST

University of Maryland Alumni Reception

Location: Palm 3A

5:00 PM – 6:00 PM MST

University of Minnesota Alumni Reception

Location: Grand Veranda

5:00 PM – 6:00 PM MST

University of North Carolina Alumni Reception

Location: Palm 2A/B

5:00 PM – 6:00 PM MST

University of Tennessee Alumni Reception

Location: Palms 3C

6:00 PM – 7:30 PM MST

President's Reception (by invitation only)

Location: Vista Exclusive

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

7:00 AM – 8:00 AM MST

Tutorial Coffee Service

8:00 AM – 12:00 PM MST

Tutorial: Using Past Models to Bridge to Open Models and Open Science using nlmixr2

Location: Sonoran Sky Ballroom 1 - 4

Chair: – Novartis

Speaker and Panelist: – Human Predictions

Speaker and Panelist: – Certara

Speaker and Panelist: – Occams

Tutorial

8:00 AM – 12:00 PM MST

Tutorial: Model-Based Meta-Analysis: towards more precisely predicted clinical scenarios

Location: Sonoran Sky Ballroom 5 - 8

Chair and Speaker: – Clinical Pharmacology Modelling and Simulation, Precision Medicine, GSK

Chair: – Modeling & Simulation, Clinical Pharmacology, Genentech

Speaker: – Certara Drug Development Solutions

Speaker: – Clinical Modeling, Clinical Modeling & Evidence Integration, Sanofi

Speaker: – FDA

Speaker: – Genentech

Tutorial

9:00 AM – 12:00 PM MST

Trainee Tutorial: Minimal PBPK Modeling: Tutorial and Applications

Location: Palms 3 CD

Co-Chair: – University of North Carolina

Co-Chair: – University of Minnesota

Speaker: – University of North Carolina at Chapel Hill

Speaker: – Takeda Pharmaceuticals

Speaker: – Janssen Research & Development

Tutorial

9:00 AM – 9:30 AM MST

Introduction: Minimal PBPK Modeling: Tutorial and Applications

Location: Palms 3 CD

Speaker: – University of North Carolina at Chapel Hill

Tutorial

9:30 AM – 10:15 AM MST

Small Molecule Minimal PBPK Models and Classic Hepatic Clearance Concept

Location: Palms 3 CD

Speaker: – Takeda Pharmaceuticals

Tutorial

10:45 AM – 11:15 AM MST

Large Molecule Minimal PBPK Models and FcRn Interactions

Location: Palms 3 CD

Speaker: – Janssen Research & Development

Tutorial

11:15 AM – 12:00 PM MST

Trainee Tutorial: Q&A

Location: Palms 3 CD

Tutorial

12:00 PM – 1:00 PM MST

Post Workshop Registration & Lunch (for workshop attendees only)

Location: Sunset Patio

1:00 PM – 5:00 PM MST

PHARM001 - (R)TTE analysis: MIDD applications, concept, methodology and NONMEM hands-on, Pharmetheus

Location: Mesquite & Noble

Speaker: – Uppsala University

Speaker: – Genentech

Speaker: – INSERM / Université Paris Cité

Workshop

1:00 PM – 5:00 PM MST

LAP&P course: An interactive translational pharmacometric case study for an antibody exhibiting TMDD, LAP&P Consultants BV

Location: Lantana

Speaker: – LAP&P Consultants BV

Speaker:

Workshop

8:00 AM – 5:00 PM MST

PHARM002 - (R)TTE analysis: MIDD applications, concept, methodology and NONMEM hands-on, Pharmetheus

Location: Mesquite & Noble

Speaker:

Speaker: – Pharmetheus

Workshop

8:00 AM – 5:00 PM MST

LAP&P course; An interactive translational pharmacometric case study for an antibody exhibiting TMDD, LAP&P Consultants BV

Location: Lantana

Speaker: – LAP&P Consultants BV

Speaker:

Workshop

12:00 PM – 1:00 PM MST

Workshop Lunch

Location: Grand Veranda