Full Schedule

7:00 AM - 7:45 AM EDT

STEP & ESP Gathering

7:00 AM - 8:00 AM EDT

Continental Breakfast

7:00 AM - 8:00 AM EDT

Exhibit Hall Open

7:00 AM - 5:00 PM EDT

ACCP Registration Open

8:00 AM - 9:30 AM EDT

Symposium 4: Leveraging Innovative Quantitative Systems Pharmacology, Artificial Intelligence & Machine Learning Approaches for Cytokine Release Syndrome Risk Management in T-Cell Redirecting Therapies

Co-Chair & Faculty: – Genentech Inc

Co-Chair & Faculty: – Johnson & Johnson

Faculty: – St Jude Children's Research Hosp

Faculty: – Genentech Inc

Innovative Clinical Pharmacology Strategies for Dose Optimization/Model-Informed Drug Development

CE: 1.5

8:00 AM - 9:30 AM EDT

1 - An Introduction to Cytokine Release Syndrome Risk Management for T-cell Redirecting Therapies

Faculty: – Genentech Inc

Innovative Clinical Pharmacology Strategies for Dose Optimization/Model-Informed Drug Development

8:00 AM - 9:30 AM EDT

2 - Cytokine Dynamics During Chimeric Antigen Receptor T-cell Therapy in Pediatric Acute Lymphoblastic Leukemia

Faculty: – St Jude Children's Research Hosp

Innovative Clinical Pharmacology Strategies for Dose Optimization/Model-Informed Drug Development

8:00 AM - 9:30 AM EDT

3 - A Pragmatic Roadmap for Cytokine Release Syndrome Risk Prediction: From Quantitative System Pharmacology Foundations to a Machine-Learning Integrated Future

Faculty: – Genentech Inc

Innovative Clinical Pharmacology Strategies for Dose Optimization/Model-Informed Drug Development

8:00 AM - 9:30 AM EDT

4 - Predicting Cytokine Release Syndrome Risk of Teclistamab or Talquetamab in Patients With Multiple Myeloma Using Quantitative System Pharmacology & Machine Learning

Faculty: – Johnson & Johnson

Innovative Clinical Pharmacology Strategies for Dose Optimization/Model-Informed Drug Development

8:00 AM - 9:30 AM EDT

5 - Discussion, Questions & Answers, Learner Feedback & Evaluation

Innovative Clinical Pharmacology Strategies for Dose Optimization/Model-Informed Drug Development

8:00 AM - 9:30 AM EDT

4 - Discussion, Questions & Answers, Learner Feedback & Evaluation

Regulatory Science/Legal/Bioethical Considerations

8:00 AM - 9:30 AM EDT

Symposium 5: Toward Global Harmonization of Mechanistic Modeling Assessment: Perspectives From the European Medicines Agency and US Food & Drug Administration

Chair & Faculty: – Simulations Plus

Faculty:

Regulatory Science/Legal/Bioethical Considerations

CE: 1.5

8:00 AM - 9:30 AM EDT

1 - Harmonization of Mechanistic Model Performance Evaluation: An Industry Perspective

Faculty: – Simulations Plus

Regulatory Science/Legal/Bioethical Considerations

8:00 AM - 9:30 AM EDT

2 - Qualification of Mechanistic Models: Lessons Learned

Faculty:

Regulatory Science/Legal/Bioethical Considerations

8:00 AM - 9:30 AM EDT

3 - Use of Mechanistic Modeling to Support New Drug Development: An FDA Perspective

Regulatory Science/Legal/Bioethical Considerations

9:30 AM - 10:00 AM EDT

Coffee & Networking Break

10:00 AM - 11:30 AM EDT

Invited Keynote: Harnessing Leadership & Collaboration to Drive Change

Chair & Faculty:

Novel Mechanisms & Emerging Therapeutic Modalities

11:30 AM - 1:30 PM EDT

Lunch Buffet

11:45 AM - 1:15 PM EDT

Lunch & Awards

1:30 PM - 3:00 PM EDT

5 - Discussion, Questions & Answers, Learner Feedback & Evaluation

Specific Populations/Rare Diseases

1:30 PM - 3:00 PM EDT

Symposium 6: Pharmacogenetics in Specific Populations: Using Novel Experimental Approaches and Modeling & Simulation to Solve Complex Cases

Co-Chair & Faculty: – Leiden Univ & St Antonius Hosp

Co-Chair & Faculty: – Certara UK Ltd

Faculty: – Children’s Mercy Kansas City

Faculty: – AstraZeneca plc

Specific Populations/Rare Diseases

CE: 1.5

1:30 PM - 3:00 PM EDT

1 - Novel Experimental & Computational Approaches to Identify Pre-systemic Liver & Gut Metabolism.

Faculty: – Leiden Univ & St Antonius Hosp

Specific Populations/Rare Diseases

1:30 PM - 3:00 PM EDT

2 - Relative Impact of CYP2D6 Phenotype on Antidepressant Exposure During Pregnancy & Lactation: Extrapolation Approach Using RWD & PBPK Modelling

Faculty: – Certara UK Ltd

Specific Populations/Rare Diseases

1:30 PM - 3:00 PM EDT

3 - Exposure to Drugs in Breastfed Neonates: The Interacting Role of Pharmacogenetics, Metabolites & Maternal & Neonatal Ontogeny of Metabolism & Elimination

Faculty: – Children’s Mercy Kansas City

Specific Populations/Rare Diseases

1:30 PM - 3:00 PM EDT

4 - Pharmacogenetic Assessment in Drug Development: Implementation of M&S Strategies

Faculty: – AstraZeneca plc

Specific Populations/Rare Diseases

1:30 PM - 5:00 PM EDT

Symposium 7: HOT TOPIC: Integrating Agentic Artificial Intelligence into Quantitative Clinical Pharmacology: Promise, Practice & Pitfalls

Chair & Faculty: – Pfizer Inc

Faculty: – Univ at Buffalo

Faculty: – Insight Rx

Faculty: – Vivpro Corp

Faculty:

Artificial Intelligence/Technology Platforms from Drug Discovery to Patient Care

CE: 3.0

1:30 PM - 5:00 PM EDT

1 - Agentic Workflows in Clinical Pharmacology: Implementation Opportunities & Challenges

Faculty: – Pfizer Inc

Artificial Intelligence/Technology Platforms from Drug Discovery to Patient Care

1:30 PM - 5:00 PM EDT

2 - Challenges & Innovative Strategies for Training Clinical Pharmacologists Amidst AI-Driven Transformations

Faculty: – Univ at Buffalo

Artificial Intelligence/Technology Platforms from Drug Discovery to Patient Care

1:30 PM - 5:00 PM EDT

3 - From Search, Intelligence to Submission Ready Content, AI Powered Clinical Pharmacology Workflows

Faculty: – Vivpro Corp

Artificial Intelligence/Technology Platforms from Drug Discovery to Patient Care

1:30 PM - 5:00 PM EDT

4 - Automated Dataset Construction: AI-Powered Literature Mining for Model-Based Meta-Analysis and Beyond

Faculty:

Artificial Intelligence/Technology Platforms from Drug Discovery to Patient Care

1:30 PM - 5:00 PM EDT

5 - Modernizing PK/PD Workflows: From Manual Analysis to Agentic Orchestration

Faculty: – Insight Rx

Artificial Intelligence/Technology Platforms from Drug Discovery to Patient Care

1:30 PM - 5:00 PM EDT

6 - Use of AI in Drug Development & Regulatory Reviews

Artificial Intelligence/Technology Platforms from Drug Discovery to Patient Care

1:30 PM - 5:00 PM EDT

7 - Discussion, Questions & Answers, Learner Feedback & Evaluation

Artificial Intelligence/Technology Platforms from Drug Discovery to Patient Care

3:00 PM - 3:30 PM EDT

Coffee & Networking Break

3:30 PM - 5:00 PM EDT

Symposium 8: When Rare Meets Young: Harnessing Clinical Pharmacology to Facilitate Dose Selection & Approval for Pediatric Rare Diseases

Co-Chair & Faculty: – Otsuka Pharmaceutical Co Ltd

Faculty: – US Food & Drug Administration

Faculty: – Certara

Specific Populations/Rare Diseases

CE: 1.5

3:30 PM - 5:00 PM EDT

1 - Introduction & Dose Selection Strategies Used in Recently Approved Pediatric Rare Disease Drugs

Specific Populations/Rare Diseases

3:30 PM - 5:00 PM EDT

2 - Delivering the Right Dose: Optimizing Pediatric Dosing in Rare Disease Clinical Trials

Faculty: – Otsuka Pharmaceutical Co Ltd

Specific Populations/Rare Diseases

3:30 PM - 5:00 PM EDT

3 - Challenges & Approaches to Identify Safe & Effective Dosing Regimens in Young Patients

Faculty: – US Food & Drug Administration

Specific Populations/Rare Diseases

3:30 PM - 5:00 PM EDT

4 - On Posology & Clinical Pharmacology Considerations for Drugs Developed for Rare Pediatric Diseases: A Pharmaceutical Industry Perspective

Faculty:

Specific Populations/Rare Diseases

3:30 PM - 5:00 PM EDT

5 - Discussion, Questions & Answers, Learner Feedback & Evaluation

Specific Populations/Rare Diseases

5:00 PM - 7:00 PM EDT

Evening Reception, Exhibits & Poster Session 2

7:00 PM - 9:00 PM EDT

JCP & CPDD Editorial Board Dinner (Invitation only)