Full Schedule

7:00 AM - 8:00 AM MST

Network/Community Networking Breakfast

Location: Aurora Ballroom B

7:00 AM - 2:00 PM MST

Poster & Partner Pavilion

Location: Aurora Hall 1

7:00 AM - 3:00 PM MST

Registration & Information Desk

Location: Aurora Pre-Function

7:00 AM - 3:30 PM MST

Speaker Ready Room

Location: Crest 2

8:15 AM - 9:00 AM MST

Featured Speaker - Rajesh Krishna

Location: Aurora Ballroom A

Featured Speaker: – Certara

Chair: – Quantivis LLC, ASCPT President

Drug Utilization & Outcomes (DUO)Biomarkers & Translational Tools (BTT)

8:15 AM - 8:20 AM MST

Introduction

Chair: – Quantivis LLC, ASCPT President

8:20 AM - 8:45 AM MST

From Models to Meaning: The Integrator Pharmacologist's Role in Advancing Pharmacoequity Across the Drug Development Continuum

Featured Speaker: – Certara

8:45 AM - 9:00 AM MST

Q&A and Closing Remarks

8:15 AM - 9:15 AM MST

Accelerating Global Market Access Through Early Japanese Clinical Pharmacology Studies: Insights from JSCPT and ASCPT Collaboration

Location: Aurora Ballroom C

Chair: – Yokohama City University

Chair: – Pfizer

Speaker: – Pharmaceuticals and Medical Devices Agency (PMDA)

Speaker: – Pfizer R&D Japan

Speaker: – U.S. Food and Drug Administration

Speaker: – Kitasato University Kitasato Institute Hospital

Drug Utilization & Outcomes (DUO)Regulatory Science (RS)

8:15 AM - 8:20 AM MST

Introduction

Chair: – Yokohama City University

Chair: – Pfizer

8:20 AM - 8:28 AM MST

Importance of Leveraging Clinical Pharmacology to Assess Race and Ethnic Differences from Regulatory Perspective and Latest Updates in Japan

Speaker: – Pharmaceuticals and Medical Devices Agency (PMDA)

8:28 AM - 8:36 AM MST

Case Studies of Improvement and Efficiency of Global Development by Using Clinical Data Obtained in Japanese

Speaker: – Pfizer R&D Japan

8:36 AM - 8:44 AM MST

Critical Clinical Pharmacology Evaluation Considerations in the Setting of MRCTs: A Regulatory Perspective

Speaker: – U.S. Food and Drug Administration

8:36 AM - 8:44 AM MST

Experience from Conducting FIH Studies in Japan, and Future Strategies for Early Development Capitalizing on Opportunities in Japan

8:44 AM - 8:52 AM MST

Capability/Strength of Clinical Pharmacology Studies Conducted in Japan

Speaker: – Kitasato University Kitasato Institute Hospital

8:52 AM - 9:15 AM MST

Q&A and Closing Remarks

8:15 AM - 9:15 AM MST

From Data Deserts to Pharmacoequity: Community-Led Participatory Research and Implementation-Focused Approaches for Inclusive Pharmacogenomics

Location: Aurora Ballroom D

Chair: – University of Cincinnati

Chair: – University of Florida

Speaker: – University of Florida, Gainesville, FL

Speaker: – Virginia Commonwealth University

Speaker: – University of Montana

Speaker: – Agenda Bioscience

Pharmacogenomics (PGx)

8:15 AM - 8:20 AM MST

Introduction

Chair: – University of Cincinnati

Chair: – University of Florida

8:20 AM - 8:30 AM MST

Achieving Pharmacoequity in Aging Through an Inclusive Precision Medicine Framework

Speaker: – Virginia Commonwealth University

8:30 AM - 8:40 AM MST

Partnering with Indigenous Communities to Advance Equity in Precision Medicine Research

Speaker: – University of Montana

8:40 AM - 8:50 AM MST

Clinical Pharmacogenetics Trials in Medically Underserved Patient Populations

Speaker: – University of Florida, Gainesville, FL

8:50 AM - 9:00 AM MST

Moving Beyond ‘Tier 1’: Updating Laboratory Standards to Include Diverse Genetic Ancestry

Speaker: – Agenda Bioscience

9:00 AM - 9:15 AM MST

Q&A and Closing Remarks

8:15 AM - 9:15 AM MST

Getting It Right from the Start: MIDD-Driven Strategies for Including Individuals with Obesity in Clinical Trials

Location: Crest 4

Chair: – U.S. Food and Drug Administration

Chair: – Merck

Speaker: – U.S. Food and Drug Administration

Speaker: – Simulations Plus

Speaker:

Physiological Based Pharmacokinetic Modeling and Simulation (PBPK)Specific Populations (SPO)

8:15 AM - 8:18 AM MST

Introduction

Chair: – U.S. Food and Drug Administration

Chair: – Merck

8:18 AM - 8:32 AM MST

Regulatory Perspective on the Assessment of the Impact of Obesity in Drug Development: Current Status and Opportunities

Speaker: – U.S. Food and Drug Administration

8:32 AM - 8:46 AM MST

Using QSP Modeling Approaches to Predict Weight Loss and Nausea, Enabling the Optimization of Dosing Paradigms in Clinical Trials for Treatments in Patients with Obesity

Speaker: – Simulations Plus

8:46 AM - 9:00 AM MST

Adapting Population PK/PD Models for Obese Populations: A Semi-Mechanistic Allometric Framework Using Body Weight Composition

Speaker:

9:00 AM - 9:15 AM MST

Q&A and Closing Remarks

9:30 AM - 10:30 AM MST

State of the Art Lecture - Utibe Essien

Location: Aurora Ballroom A

State of the Art Speaker: – University of California, Los Angeles

Chair: – Cincinnati Children's Hospital Medical Center

9:30 AM - 9:35 AM MST

Introduction

Chair: – Cincinnati Children's Hospital Medical Center

9:35 AM - 10:15 AM MST

Advancing Pharmacoequity: A Prescription for Health Justice

State of the Art Speaker: – University of California, Los Angeles

10:15 AM - 10:30 AM MST

Q&A and Closing Remarks

9:30 AM - 10:30 AM MST

Regional Variations in Efficacy: Insights and Interpretation

Location: Aurora Ballroom C

Chair: – Genentech

Chair: – Pfizer

Speaker: – Pfizer

Speaker: – Gilead Sciences

Speaker: – Pharmaceuticals and Medical Devices Agency (PMDA)

Oncology (ONC)

9:30 AM - 9:33 AM MST

Introduction

Chair: – Genentech

Chair: – Pfizer

9:33 AM - 9:47 AM MST

General Considerations for the Geographical Regional Effect on Clinical Trial Outcomes in Oncology

Speaker: – Pfizer

9:47 AM - 10:01 AM MST

Ethnic Sensitivity in Clinical Trials: Bridging the Gap with Clinical Pharmacology

Speaker: – Gilead Sciences

10:01 AM - 10:15 AM MST

Learnings and Considerations on Regional Differences in MRCTs: from Regulatory Science Perspective in Japan

Speaker: – Pharmaceuticals and Medical Devices Agency (PMDA)

10:15 AM - 10:30 AM MST

Q&A and Closing Remarks

9:30 AM - 10:30 AM MST

Beyond Survival: Transforming Autoimmune Therapy Through Model-Informed Development of CAR-T and TCEs

Location: Aurora Ballroom D

Chair: – Merck

Chair: – Third Arc Bio

Speaker: – Genentech

Speaker: – Cullinan Therapeutics

Speaker: – Metrum Research Group

Speaker: – U.S. Food and Drug Administration

Biologics (BIO)Cell, Gene, Regenerative Medicine & Nucleic Acid (CGRN)

9:30 AM - 9:33 AM MST

Introduction

Chair: – Merck

Chair: – Third Arc Bio

9:33 AM - 9:44 AM MST

B Cell Depletion in Autoimmune Disease: From Therapeutic Concept to Clinical Reality-A Case Study with Mosunetuzumab in Lupus

Speaker: – Genentech

9:44 AM - 9:55 AM MST

Transitioning Assets from Oncology to Autoimmune Indications

Speaker: – Cullinan Therapeutics

9:55 AM - 10:06 AM MST

Making Drugs from T Cells: Model-Informed Design and Deployment of T Cell Therapies for Autoimmune Diseases

Speaker: – Metrum Research Group

10:06 AM - 10:17 AM MST

Regulatory Expectations on First in Rheumatology Study for T Cell Engagers

Speaker: – U.S. Food and Drug Administration

10:17 AM - 10:30 AM MST

Audience Q&A and Closing Remarks

9:30 AM - 10:30 AM MST

Elevating Precision Medicine: Innovative Translational Technologies to Advance Pharmacoequity

Location: Crest 4

Chair: – Merck

Chair: – Pfizer

Speaker: – Northwestern University

Speaker: – Mayo Clinic

Speaker: – Pfizer

Pharmacogenomics (PGx)Membrane Transporter (MT)

9:30 AM - 9:35 AM MST

Introduction

Chair: – Merck

Chair: – Pfizer

9:35 AM - 9:40 AM MST

Integrated Omics Research in Underrepresented Groups: Pathways to Equality

Speaker: – Northwestern University

9:40 AM - 9:45 AM MST

Equity-Driven Innovation: From Diverse Cancer Models to Inclusive Precision Medicine

Speaker: – Mayo Clinic

9:45 AM - 9:50 AM MST

Science at Speed: Leveraging AI and Advanced Trial Designs to Meet Public Health Needs

Speaker: – Pfizer

9:50 AM - 10:15 AM MST

Fireside Chat

10:15 AM - 10:30 AM MST

Q&A and Closing Remarks

10:30 AM - 11:00 AM MST

Networking Break

Location: Aurora Hall 1

11:00 AM - 11:45 AM MST

Leon I. Goldberg Early Investigator Award Lecture

Location: Aurora Ballroom A

Award Lecturer: – Cincinnati Children's Hospital Medical Center

Award Presenter: – Cincinnati Children's Hospital Medical Center

Specific Populations (SPO)Precision Dosing (PD)

11:00 AM - 11:05 AM MST

Introduction

Award Presenter: – Cincinnati Children's Hospital Medical Center

11:05 AM - 11:30 AM MST

Beta-Lactam Precision Dosing in Pediatrics: Translating Research into Reality

Award Lecturer: – Cincinnati Children's Hospital Medical Center

11:30 AM - 11:45 AM MST

Q&A and Closing Remarks

11:00 AM - 12:00 PM MST

Beyond Submission: Navigating Peer Review and Promoting Your Published Work

Location: Crest 4

Chair: – Certara UK Ltd

Chair: – Aditum Bio and Tempero Bio

Speaker: – Genentech

Speaker: – Regeneron Pharmaceuticals, Inc.

Speaker: – National University of Singapore

11:00 AM - 12:00 PM MST

Oral Abstracts II: Integrative Approaches to CNS Drug Pharmacology: From Mechanisms to Clinical Outcomes

Location: Aurora Ballroom D

11:00 AM - 12:00 PM MST

ASCPT Cross-Community Face-Off: Perspectives on Advancing Pharmacoequity Across the ASCPT Community Spectrum

Location: Aurora Ballroom C

Chair: – Pfizer

Chair: – GSK

Early Career (EC)

11:00 AM - 12:00 PM MST

Introduction to the ASCPT Community Face-Off

Chair: – Pfizer

Chair: – GSK

12:00 PM - 1:30 PM MST

Clinical Pharmacology Program Directors Meeting (by invitation only)

Location: Valley 2

12:00 PM - 1:30 PM MST

Networking Lunch

Location: Aurora Ballroom B

1:30 PM - 3:30 PM MST

Pharmacoequity in Global Health: Advancing Equitable Access to Preventive Vaccines, Prophylactics, and Gene Therapies for All Populations

Location: Aurora Ballroom C

Chair: – Certara

Chair: – Genmab Pharmaceuticals

Speaker: – Federal Agency for Medicines and Health Products

Speaker: – GSK

Speaker: – Monash University

Speaker: – ViiV Healthcare

Speaker: – Certara

Global Health (GH)Cell, Gene, Regenerative Medicine & Nucleic Acid (CGRN)

1:30 PM - 1:40 PM MST

Welcome & Framing the Challenge

Chair: – Certara

Chair: – Genmab Pharmaceuticals

1:40 PM - 1:50 PM MST

Leveraging Clinical Pharmacology, MIDD, PBPK/QSP to Optimize Preventive Dosing Across Populations

Speaker: – Certara

1:50 PM - 2:00 PM MST

Power of Nonclinical Translation to Clinical Extrapolation in Vaccines, Prophylaxis (PrEP), and Gene Therapy Access

Speaker: – GSK

2:00 PM - 2:10 PM MST

MBMA, Real-World Data, and Health Economic Modeling in Global Decision-Making

Speaker: – Monash University

2:10 PM - 2:20 PM MST

Regulatory Innovation & Accelerated Pathways for Preventive, Biosimilars, and Generics for Prevention

Speaker: – Federal Agency for Medicines and Health Products

2:20 PM - 2:30 PM MST

Public-Private Partnerships & Global Health Infrastructure: Lessons from HIV and More

Speaker: – ViiV Healthcare

2:30 PM - 3:00 PM MST

Moderated Panel Discussion

3:00 PM - 3:20 PM MST

Interactive Case

3:20 PM - 3:30 PM MST

Closing Reflections & Call to Action

1:30 PM - 3:30 PM MST

Escaping Inequity: An Escape Room Experience to Promote Bias Mitigation in Drug Development and Utilization

Location: Aurora Ballroom D

Chair: – Thomas Jefferson University

Chair: – Gilead Sciences

Moderator: – University of Montana

Moderator: – Cincinnati Children's Hospital Medical Center

Student & Trainee (ST)Early Career (EC)

1:30 PM - 1:40 PM MST

Session Overview

1:40 PM - 1:55 PM MST

Group Selections and Orientation

1:55 PM - 2:55 PM MST

Escape Room Challenges

2:55 PM - 3:30 PM MST

Game Debrief Discussion

1:30 PM - 5:30 PM MST

Deciding Together: An Interactive Workshop on Integrating Evidence for Compatible Medicine Use During Lactation

Location: Crest 4

Chair: – Certara UK Ltd

Chair: – Johns Hopkins School of Medicine

Speaker: – University of Colorado

Speaker: – Medicines and Healthcare products Regulatory Agency (MHRA)

Speaker: – Pfizer

Speaker: – Certara UK

Speaker: – University of Florida

Specific Populations (SPO)Drug Utilization & Outcomes (DUO)

1:30 PM - 1:35 PM MST

Opening Remarks and Workshop Framing

Chair: – Certara UK Ltd

Chair: – Johns Hopkins School of Medicine

1:35 PM - 1:55 PM MST

The Clinical Reality of Medicine Use During Lactation

Speaker: – University of Colorado

1:55 PM - 2:10 PM MST

Hands-On A: Starting Point

2:10 PM - 2:30 PM MST

Predicting Drug Transfer into Breastmilk

Speaker: – Medicines and Healthcare products Regulatory Agency (MHRA)

2:30 PM - 2:45 PM MST

Hands-On B: M/P Ratio Prediction Data

2:45 PM - 3:05 PM MST

Designing Clinical Lactation Studies: Lessons from Practice

Speaker: – Pfizer

3:05 PM - 3:20 PM MST

Hands-On C: Clinical Data Layer

3:20 PM - 3:35 PM MST

Break

3:35 PM - 3:55 PM MST

The Utility and Supplementary Role of Model-Informed Approaches in Lactation Medicine

Speaker: – Certara UK

3:55 PM - 4:10 PM MST

Hands-On D: Model Layer

4:10 PM - 4:30 PM MST

Real-World Evidence for Medicine Use During Lactation

Speaker: – University of Florida

4:30 PM - 4:50 PM MST

Hands-On E: Integrating the Evidence: Final Decision Point

4:50 PM - 5:05 PM MST

Break

5:05 PM - 5:25 PM MST

Collaborative Panel Discussion: What Would You Do?

Chair: – Certara UK Ltd

5:25 PM - 5:30 PM MST

Summary and Closing Remarks

Chair: – Certara UK Ltd

5:00 PM - 6:30 PM MST

ASCPT Board Meeting (by invitation only)

Location: Valley 2