Full Schedule

8:00 AM - 10:30 AM MST

ASCPT Board Meeting (by invitation only)

Location: Valley 2

12:00 PM - 6:30 PM MST

Registration & Information Desk

Location: Aurora Pre-Function

12:00 PM - 6:30 PM MST

Speaker Ready Room

Location: Crest 2

3:00 PM - 4:00 PM MST

Opening Session

Location: Aurora Ballroom A

Chair: – Quantivis LLC, ASCPT President

Award Recipient: – Metrum RG

Award Recipient: – University of Florida

Award Recipient: – GalenusRx

Award Recipient: – FDA

Award Recipient: – Vanderbilt University Medical Center

Award Recipient: – Johns Hopkins School of Medicine

4:00 PM - 5:00 PM MST

State of the Art Lecture - Sarah Emond

Location: Aurora Ballroom A

State of the Art Speaker: – Institute for Clinical and Economic Review

Chair: – Quantivis LLC, ASCPT President

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

4:00 PM - 4:05 PM MST

Introduction

Chair: – Quantivis LLC, ASCPT President

4:05 PM - 4:45 PM MST

Value Assessment: An Overview and Discussion of Its Utility in Improving Prescription Drug Affordability

State of the Art Speaker: – Institute for Clinical and Economic Review

4:45 PM - 5:00 PM MST

Q&A and Closing Remarks

5:00 PM - 6:30 PM MST

Opening Reception

Location: Aurora Hall 1

5:00 PM - 7:00 PM MST

Poster Session I

Location: Aurora Hall 1

5:00 PM - 7:00 PM MST

Poster & Partner Pavilion

Location: Aurora Hall 1

5:15 PM - 5:45 PM MST

Presidential Trainee Showcase

Location: Aurora Hall 1

7:00 AM - 8:00 AM MST

Network/Community Networking Breakfast

Location: Aurora Ballroom B

7:00 AM - 6:30 PM MST

Registration & Information Desk

Location: Aurora Pre-Function

7:00 AM - 6:30 PM MST

Speaker Ready Room

Location: Crest 2

7:00 AM - 7:00 PM MST

Poster & Partner Pavilion

Location: Aurora Hall 1

8:15 AM - 9:00 AM MST

Dolores Shockley Diversity and Inclusion in Clinical Research Award Lecture

Location: Aurora Ballroom A

Award Lecturer: – University of Montana

Chair: – Quantivis LLC, ASCPT President

8:15 AM - 8:20 AM MST

Introduction

8:20 AM - 8:45 AM MST

TBD

Award Lecturer: – University of Montana

8:45 AM - 9:00 AM MST

Q&A and Closing Remarks

9:15 AM - 10:00 AM MST

2025 Darrell Abernethy Early Stage Investigator Award Lecture

Location: Crest 4

Award Lecturer: – University of Pennsylvania

Pharmacogenomics (PGx)

9:15 AM - 9:20 AM MST

Introduction

9:20 AM - 9:45 AM MST

Precision Medicine in Post-Surgical Dental Pain

Award Lecturer: – University of Pennsylvania

9:45 AM - 10:00 AM MST

Q&A and Closing Remarks

9:15 AM - 10:15 AM MST

State of the Art Lecture - Ted Love

Location: Aurora Ballroom A

State of the Art Speaker: – BIO, Immediate Past Chairman

Chair: – Merck

Specific Populations (SPO)

9:15 AM - 9:20 AM MST

Introduction

Chair: – Merck

9:20 AM - 10:00 AM MST

The Role of Healthcare Disparities in Drug Discovery and Development

State of the Art Speaker: – BIO, Immediate Past Chairman

10:00 AM - 10:15 AM MST

Q&A and Closing Remarks

9:15 AM - 11:45 AM MST

Precision Pharmacology Across the Spectrum of Kidney Disease

Location: Aurora Ballroom C

Chair: – Cincinnati Children's Hospital Medical Center

Chair: – Mayo Clinic AZ

Speaker: – Ann and Robert H. Lurie Children’s Hospital of Chicago

Speaker: – MediBeacon

Speaker: – Dalhousie University

Speaker: – University of Utah

Speaker: – Cincinnati Children's Hospital Medical Center

Speaker: – U.S. Food and Drug Administration

Specific Populations (SPO)Precision Dosing (PD)

9:15 AM - 9:20 AM MST

Introduction

Chair: – Cincinnati Children's Hospital Medical Center

Chair: – Mayo Clinic AZ

9:20 AM - 9:35 AM MST

Finding the Right Dose for Selah: The Importance of Precision Pharmacology for a Child with Kidney Disease

Speaker: – Cincinnati Children's Hospital Medical Center

9:35 AM - 9:50 AM MST

Incorporation of Novel Serum and Urinary Biomarkers in Estimating GFR and Drug Pharmacokinetics

Speaker: – Ann and Robert H. Lurie Children’s Hospital of Chicago

9:50 AM - 10:05 AM MST

Point-of-Care GFR Assessment with the Transdermal GFR System: Application to Chronic Kidney Patients and Capability to Follow Dynamic Changes

Speaker: – MediBeacon

10:05 AM - 10:15 AM MST

Audience Q&A

10:15 AM - 10:45 AM MST

Break

10:45 AM - 11:00 AM MST

The Pharmacology of Commonly Administered Drugs to Adults Receiving Extracorporeal Therapy

Speaker: – Dalhousie University

11:00 AM - 11:15 AM MST

The Pharmacology of Commonly Administered Drugs to Children Receiving Extracorporeal Therapy

Speaker: – University of Utah

11:15 AM - 11:35 AM MST

Regulatory Perspective of the Impact of Kidney Impairment on Drug Dosing in Adults and Children.

Speaker: – U.S. Food and Drug Administration

11:35 AM - 11:45 AM MST

Panel Discussion and Q&A

9:15 AM - 11:45 AM MST

Exceptional and Not the Exception: Innovation and Rigor in Maternal Pharmacotherapeutics Research

Location: Aurora Ballroom D

Chair: – Thomas Jefferson University

Chair: – Biogen

Speaker: – March of Dimes

Speaker: – U.S. Food and Drug Administration

Speaker: – Certara UK Ltd

Speaker: – University of Texas Medical Branch

Speaker: – Johnson & Johnson

Specific Populations (SPO)

9:15 AM - 9:20 AM MST

Introduction

Chair: – Thomas Jefferson University

Chair: – Biogen

9:20 AM - 9:30 AM MST

Call to Action: Moving Beyond Repurposing Existing Therapies to Novel Therapeutics for Pregnancy-Specific Conditions

Speaker: – March of Dimes

9:30 AM - 9:45 AM MST

Regulatory Framework and Ethical Considerations for Clinical Research in Pregnancy

Speaker: – U.S. Food and Drug Administration

9:45 AM - 10:15 AM MST

Audience Q&A

10:15 AM - 10:45 AM MST

Break

10:45 AM - 11:00 AM MST

Innovations and Recent Applications of PBPK Modeling for Therapeutics in Pregnancy

Speaker: – Certara UK Ltd

11:00 AM - 11:15 AM MST

Feto-Maternal Interface Organ on a Chip Models: Recent Innovations, Limitations, and Future Directions for Evaluating Placental Transfer, Fetal Exposure, and Novel Drug Development

Speaker: – University of Texas Medical Branch

Specific Populations (SPO)

11:15 AM - 11:30 AM MST

Biologics: Improving Our Understanding of Fetal Exposure and Framework for Risk/Benefit for Use in Pregnancy

Speaker: – Johnson & Johnson

11:30 AM - 11:45 AM MST

Audience Q&A and Closing Remarks

10:15 AM - 10:45 AM MST

Networking Break

Location: Aurora Hall 1

10:45 AM - 11:30 AM MST

Rawls-Palmer Progress in Medicine Award Lecture

Location: Crest 4

Award Lecturer: – Cincinnati Children's Hospital Medical Center, NDA Partners

Award Presenter: – Principle, NDA Partners/Treximo

Precision Dosing (PD)Specific Populations (SPO)

10:45 AM - 10:50 AM MST

Introduction

Award Presenter: – Principle, NDA Partners/Treximo

10:50 AM - 11:15 AM MST

The Coming of Age of Model-informed Precision Therapeutics for Children

Award Lecturer: – Cincinnati Children's Hospital Medical Center, NDA Partners

11:15 AM - 11:30 AM MST

Q&A and Closing Remarks

10:45 AM - 11:45 AM MST

From Black Box to Better Health: Debating AI’s Role in Clinical Pharmacology and Drug Development

Location: Aurora Ballroom A

Chair: – Pfizer

Chair: – AbbVie

Speaker: – Merck

Speaker: – Johns Hopkins School of Medicine

Speaker: – EMD Serono

Speaker: – Novo Nordisk

Translational Informatics (TI)Student & Trainee (ST)

10:45 AM - 10:50 AM MST

Introduction

Chair: – Pfizer

Chair: – AbbVie

10:50 AM - 10:55 AM MST

Audience Poll

10:55 AM - 11:00 AM MST

Pro Team: Advocates for the Readiness and Potential of AI in Augmenting Clinical Pharmacology and Drug Development and Promoting Pharmacoequity

Speaker: – EMD Serono

Speaker: – Novo Nordisk

Translational Informatics (TI)

11:00 AM - 11:05 AM MST

Con Team: Highlights the Limitations, Risks, and Complexities of Integrating AI Into Clinical Pharmacology, Drug Development Workflows, and Equity Efforts

Speaker: – Merck

Speaker: – Johns Hopkins School of Medicine

11:05 AM - 11:15 AM MST

Dispute 1: Predictive Power vs. Physiologic Insight? – When Should AI Take the Lead?

11:15 AM - 11:25 AM MST

Dispute 2: AI for Equity? – Can AI Models Reduce Systemic Bias in model-informed drug development (MIDD)?

11:25 AM - 11:35 AM MST

Dispute 3: Whose Knowledge Counts? – Shifting Expertise in the AI-MIDD Era

11:35 AM - 11:45 AM MST

Audience Reflection & Closing Remarks

11:45 AM - 1:15 PM MST

Leadership Accelerator Lunch (by invitation only)

Location: Crest 1

11:45 AM - 1:15 PM MST

Networking Lunch

Location: Aurora Ballroom B

1:15 PM - 2:15 PM MST

Scaling the Summit of Membrane Protein Knowledge to Treat Rare Diseases

Location: Aurora Ballroom D

Chair: – State University of New York at Buffalo

Chair: – Washington State University

Speaker: – University of North Carolina Eshelman School of Pharmacy

Speaker: – Simulations Plus, Inc.

Membrane Transporter (MT)

1:15 PM - 1:25 PM MST

Introduction and Audience Poll

Chair: – State University of New York at Buffalo

Chair: – Washington State University

1:25 PM - 1:40 PM MST

Targeting OSTα/β: A Critical Basolateral Bile Acid Transporter and Hepatic “Safety Valve” in Patients with Cholestatic Disease

Speaker: – University of North Carolina Eshelman School of Pharmacy

1:40 PM - 1:55 PM MST

Simulating Canalicular Transporter Impairment Using Quantitative Systems Toxicology Modeling Can Represent and Provide Insights into Rare Cholestatic Liver Diseases

Speaker: – Simulations Plus, Inc.

1:45 PM - 1:55 PM MST

Rare Diseases Linked to Genetic Forms of Neurological Channelopathies

1:55 PM - 2:15 PM MST

Q&A and Closing Remarks

1:15 PM - 2:15 PM MST

Mapping the Mind: Neuroimaging as the Key to CNS Drug Discovery and Action

Location: Crest 4

Chair: – National Institute on Alcohol Abuse and Alcoholism

Chair: – Genentech

Speaker: – Children's Mercy Kansas City

Speaker: – University of Colorado

Mental Health & Addiction (MHA)Biomarkers & Translational Tools (BTT)

1:15 PM - 1:20 PM MST

Introduction

Chair: – National Institute on Alcohol Abuse and Alcoholism

Chair: – Genentech

1:20 PM - 1:33 PM MST

Neuroimaging as a Biomarker to Support Drug Development for CNS Drugs

1:33 PM - 1:46 PM MST

Unlocking the Adolescent Brain: Using Neuroimaging Biomarkers to Understand CNS Response

Speaker: – Children's Mercy Kansas City

1:46 PM - 1:59 PM MST

Brain Imaging Markers of Alcohol Use and Psychopharmacology

Speaker: – University of Colorado

1:59 PM - 2:15 PM MST

Q&A and Closing Remarks

1:15 PM - 2:45 PM MST

Pharmacoequity through Indigenous Lenses: Perspectives on Healthcare, Research, and Tribal Sovereignty

Location: Aurora Ballroom A

Chair: – University of Montana

Moderator: – University of Colorado Anschutz

Speaker: – Confederated Salish and Kootenai Tribes

Speaker: – Flint Point LLC

Speaker: – University of Washington School of Medicine

1:15 PM - 3:30 PM MST

Advancing Pharmacoequity in Pediatric Drug Development: Addressing Challenges and Innovating Solutions for Equitable Access

Location: Aurora Ballroom C

Chair: – Bristol Myers Squibb

Speaker: – The Hospital for Sick Children

Speaker: – U.S. Food and Drug Administration

Speaker: – Certara

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

1:15 PM - 1:18 PM MST

Introduction

Chair: – Bristol Myers Squibb

1:18 PM - 1:37 PM MST

Enhancing Pediatric Drug Development Through Early Collaboration and Innovative Initiatives

Speaker: – The Hospital for Sick Children

1:37 PM - 1:56 PM MST

Advancing Pharmacoequity in Pediatric Drug Development: Uncovering Regulatory Gaps and Pathways to Solutions

Speaker: – U.S. Food and Drug Administration

1:56 PM - 2:15 PM MST

The Essential Role of Clinical Pharmacology in Driving Pharmacoequity Forward

Speaker: – Certara

2:15 PM - 2:30 PM MST

Break

2:30 PM - 2:45 PM MST

Industry Trends in Adolescent Inclusion in Adult Clinical Trials

Speaker: – Eli Lilly and Company

2:45 PM - 3:00 PM MST

Crowdsourced Approaches

3:00 PM - 3:15 PM MST

Q&A and Closing Remarks

2:30 PM - 3:15 PM MST

Sheiner-Beal Pharmacometrics Award Lecture

Location: Crest 4

Award Lecturer: – Pfizer

Award Presenter: – Pfizer R&D

Pharmacometrics & Pharmacokinetics (PMK)

2:30 PM - 2:35 PM MST

Introduction

Award Presenter: – Pfizer R&D

2:35 PM - 3:00 PM MST

Quantitative Systems Pharmacology in Drug Development: From Targets to Treatments and from Niche to Mainstream

Award Lecturer: – Pfizer

3:00 PM - 3:15 PM MST

Q&A and Closing Remarks

2:30 PM - 3:30 PM MST

One Size Never Fits All: The Promise and Pitfalls of Precision Medicine

Location: Aurora Ballroom D

Chair: – Simulations Plus

Chair: – Cincinnati Children's Hospital Medical Center

Speaker: – Cincinnati Children's Hospital Medical Center, NDA Partners

Speaker: – A2-Ai LLC

Precision Dosing (PD)

2:30 PM - 2:40 PM MST

Introduction

Chair: – Simulations Plus

Chair: – Cincinnati Children's Hospital Medical Center

2:40 PM - 2:45 PM MST

Debate Motion

2:45 PM - 2:50 PM MST

From One-Size-Fits-All to One-in-a-Million: Precision Medicine and the Future of Care

Speaker: – Cincinnati Children's Hospital Medical Center, NDA Partners

2:50 PM - 2:55 PM MST

High-Tech, Low Reach: The Paradox of Precision Medicine in Global Health

Speaker: – A2-Ai LLC

2:55 PM - 3:05 PM MST

Rebuttals

3:05 PM - 3:15 PM MST

Final Arguments

3:15 PM - 3:20 PM MST

Audience Vote

3:20 PM - 3:30 PM MST

Debrief, Reflections and Q&A

3:30 PM - 4:00 PM MST

Networking Break

Location: Aurora Hall 1

4:00 PM - 4:45 PM MST

Oscar B. Hunter Career Award in Therapeutics Lecture

Location: Crest 4

Award Lecturer: – Johns Hopkins University

Award Presenter: – University of California, San Francisco

Infectious Diseases (INF)Global Health (GH)

4:00 PM - 4:05 PM MST

Introduction

Award Presenter: – University of California, San Francisco

4:05 PM - 4:30 PM MST

Challenges Developing Drugs for HIV Prevention: An Ounce of Prevention Is Not So Simple

Award Lecturer: – Johns Hopkins University

4:30 PM - 4:45 PM MST

Q&A and Closing Remarks

4:00 PM - 4:45 PM MST

Featured Speaker - Eric Chun Yong Chan

Location: Aurora Ballroom A

Featured Speaker: – National University of Singapore

Chair: – Certara UK Ltd

Drug Utilization & Outcomes (DUO)Oncology (ONC)

4:00 PM - 4:05 PM MST

Introduction

Chair: – Certara UK Ltd

4:05 PM - 4:30 PM MST

Q&A and Closing Remarks

4:30 PM - 4:45 PM MST

Optimizing Abiraterone Therapy: Integrating Molecular Insight with Clinical Evidence

Featured Speaker: – National University of Singapore

4:00 PM - 5:00 PM MST

Oral Abstracts I: Quantitative Systems Pharmacology for Therapeutic Optimization and Decision-Making

Location: Aurora Ballroom D

4:00 PM - 5:00 PM MST

Pharmacogenetic Testing for Everyone: Pro-Con Debate

Location: Aurora Ballroom C

Chair: – University of Florida

Chair: – Cincinnati Children's Hospital Medical Center

Speaker: – Children's Mercy Hospital

Speaker: – Cincinnati Children's Hospital Medical Center

Speaker: – Nemours Children's Health

Speaker: – The Hospital for Sick Children

Pharmacogenomics (PGx)Biomarkers & Translational Tools (BTT)

4:00 PM - 4:05 PM MST

Introduction

Chair: – University of Florida

Chair: – Cincinnati Children's Hospital Medical Center

4:05 PM - 4:16 PM MST

Pro: Everyone in the United States Should Have Comprehensive Pharmacogenetic Testing at Birth

Speaker: – Children's Mercy Hospital

4:16 PM - 4:27 PM MST

Con: Everyone in the United States Should Have Comprehensive Pharmacogenetic Testing at Birth

Speaker: – Cincinnati Children's Hospital Medical Center

4:27 PM - 4:38 PM MST

Pro: Clinicians Are Responsible for Pharmacogenetic Testing Results Ordered by Other Clinicians or Patients

Speaker: – Nemours Children's Health

4:38 PM - 4:49 PM MST

Con: Clinicians Are Responsible for Pharmacogenetic Testing Results Ordered by Other Clinicians or Patients

Speaker: – The Hospital for Sick Children

4:49 PM - 5:00 PM MST

Q&A and Closing Remarks

5:00 PM - 6:30 PM MST

President’s Networking Reception

Location: Aurora Hall 1

5:00 PM - 7:00 PM MST

Poster Session II

Location: Aurora Hall 1

5:20 PM - 5:50 PM MST

Poster Walk I: Precision Therapeutics with Multimodal AI

Location: Aurora 1 Pre-Function

5:55 PM - 6:25 PM MST

Poster Walk II: Genetic Discovery Research to Personalize Medications in Understudied Populations

Location: Aurora 1 Pre-Function

6:30 PM - 7:30 PM MST

LMIC Welcome Reception (by invitation only)

Location: Summit 3

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