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Tuesday, September 16, 2025
7:00 AM - 7:45 AM
MST
ACCP Annual Meeting Program Committee (Invitation only)
7:00 AM - 7:45 AM
MST
ACCP Annual Meeting Program Committee (Invitation only)
Location: Gila
7:00 AM - 7:45 AM
MST
STEP & ESP Gathering:
Building Leadership Skills by Becoming Involved in ACCP
7:00 AM - 7:45 AM
MST
STEP & ESP Gathering:
Building Leadership Skills by Becoming Involved in ACCP
Location: Grand Ballroom South
7:00 AM - 8:00 AM
MST
Continental Breakfast
7:00 AM - 8:00 AM
MST
Continental Breakfast
Location: Grand Ballroom Foyer
7:00 AM - 3:30 PM
MST
ACCP Registration Open
7:00 AM - 3:30 PM
MST
ACCP Registration Open
Location: Grand Ballroom Foyer
8:00 AM - 9:30 AM
MST
Symposium 9: Drug-Drug Interaction Management With Investigational Medicinal Products: Can We Do Better?
Chair & Faculty:
David M. Burger, PharmD, PhD (he/him/his)
– Radboud Univ Medical Ctr
Faculty:
Thomas Kakuda, PharmD (he/him/his)
– J&J Innovative Medicine
Faculty:
Amin Rostami, PhD
– Univ of Manchester
Metabolism, Transporters & Drug Interactions
CE: 1.5
8:00 AM - 9:30 AM
MST
Symposium 9: Drug-Drug Interaction Management With Investigational Medicinal Products: Can We Do Better?
Location: Grand Ballroom North
Chair & Faculty:
David M. Burger, PharmD, PhD (he/him/his)
– Radboud Univ Medical Ctr
Faculty:
Thomas Kakuda, PharmD (he/him/his)
– J&J Innovative Medicine
Faculty:
Amin Rostami, PhD
– Univ of Manchester
Metabolism, Transporters & Drug Interactions
CE: 1.5
8:00 AM - 9:30 AM
MST
1 - DDI Management in Clinical Trials: Experiences from an IRB Member
Co-Chair & Faculty:
David M. Burger, PharmD, PhD (he/him/his)
– Radboud Univ Medical Ctr
8:00 AM - 9:30 AM
MST
2 - Inclusion vs Exclusion: How Physiologically-based Pharmacokinetic Modeling Could Help DDI Management in Clinical Trials
Faculty:
Amin Rostami, PhD
– Univ of Manchester
8:00 AM - 9:30 AM
MST
3 - DDI Management in Clinical Trials: Pharmaceutical Perspective
Faculty:
Thomas Kakuda, PharmD (he/him/his)
– J&J Innovative Medicine
8:00 AM - 9:30 AM
MST
4 - Discussion, Questions & Answers, Learner Feedback & Evaluation
8:00 AM - 11:30 AM
MST
Symposium 10: Model-informed Drug Development: Advancing Predictive Power With Biomarkers, Mechanistic Models & Artificial Intelligence/Machine Learning
Co-Chair & Faculty:
Lingjue Li, PhD (she/her/hers)
– Johnson & Johnson
Co-Chair & Faculty:
Khamir Mehta, PhD
– Amgen Inc
Faculty:
Vincent Lemaire, PhD
– Genentech Inc
Faculty:
Matthew Levine
– Basis Research Inst
Faculty:
Jiang Liu, PhD
– FDA
Faculty:
Piet H. van der Graaf, PharmD, PhD
– Certara Inc
Faculty:
Yifei Zhang, PhD
– US Food & Drug Administration
Model-informed Drug Development/Quantitative Clinical Pharmacology
CE: 3.0
8:00 AM - 11:30 AM
MST
Symposium 10: Model-informed Drug Development: Advancing Predictive Power With Biomarkers, Mechanistic Models & Artificial Intelligence/Machine Learning
Location: Grand Ballroom South
Co-Chair & Faculty:
Lingjue Li, PhD (she/her/hers)
– Johnson & Johnson
Co-Chair & Faculty:
Khamir Mehta, PhD
– Amgen Inc
Faculty:
Vincent Lemaire, PhD
– Genentech Inc
Faculty:
Matthew Levine
– Basis Research Inst
Faculty:
Jiang Liu, PhD
– FDA
Faculty:
Piet H. van der Graaf, PharmD, PhD
– Certara Inc
Faculty:
Yifei Zhang, PhD
– US Food & Drug Administration
Model-informed Drug Development/Quantitative Clinical Pharmacology
CE: 3.0
8:00 AM - 11:30 AM
MST
1 - Introduction
Co-Chair & Faculty:
Lingjue Li, PhD (she/her/hers)
– Johnson & Johnson
8:00 AM - 11:30 AM
MST
2 - Emerging Roles of Biomarker in Drug Development & Regulatory Decision Making
Faculty:
Yifei Zhang, PhD
– US Food & Drug Administration
8:00 AM - 11:30 AM
MST
3 - Recent Advances in Biomarker Data Informed MIDD
Faculty:
Jiang Liu, PhD
– FDA
8:00 AM - 11:30 AM
MST
4 - Developing a Hybrid Model to Predict Individualized Risk of Cytokine Release Syndrome Using Mechanistic Modeling & Machine Learning
Co-Chair & Faculty:
Khamir Mehta, PhD
– Amgen Inc
8:00 AM - 11:30 AM
MST
5 - AI/ML Applications in Model Search & Optimization
Faculty:
Matthew Levine
– Basis Research Inst
8:00 AM - 11:30 AM
MST
6 - Predicting Survival in (Neo)Adjuvant Trials by Transferring Virtual Population Dynamics Learned from Metastatic Trials
Faculty:
Vincent Lemaire, PhD
– Genentech Inc
8:00 AM - 11:30 AM
MST
7 - AI-enabled Quantitative Systems Pharmacology: Predicting Clinical Outcomes for Novel Treatments
Faculty:
Piet H. van der Graaf, PharmD, PhD
– Certara Inc
8:00 AM - 11:30 AM
MST
8 - Discussion, Questions & Answers, Learner Feedback & Evaluation
9:30 AM - 10:00 AM
MST
Coffee & Networking Break
9:30 AM - 10:00 AM
MST
Coffee & Networking Break
Location: Grand Ballroom Foyer
10:00 AM - 11:30 AM
MST
Symposium 11: Thinking Big by Going Small: Applications of Microsampling in Model-informed Precision Dosing & Pharmacokinetic Modeling
Co-Chair & Faculty:
Kevin Downes, MD (he/him/his)
– Children's Hospital of Philadelphia
Co-Chair & Faculty:
Manjunath Pai, PharmD
– Univ of Michigan - Ann Arbor
Faculty:
Abbie Leino, PharmD, PhD (she/her/hers)
– Cincinnati Children’s Hosp Medical Ctr
Faculty:
Nathaniel J. Rhodes, PharmD, MSc (he/him/his)
– Midwestern Univ
Innovative Clinical Pharmacology Strategies for Dose Optimization
CE: 1.5
10:00 AM - 11:30 AM
MST
Symposium 11: Thinking Big by Going Small: Applications of Microsampling in Model-informed Precision Dosing & Pharmacokinetic Modeling
Location: Grand Ballroom North
Co-Chair & Faculty:
Kevin Downes, MD (he/him/his)
– Children's Hospital of Philadelphia
Co-Chair & Faculty:
Manjunath Pai, PharmD
– Univ of Michigan - Ann Arbor
Faculty:
Abbie Leino, PharmD, PhD (she/her/hers)
– Cincinnati Children’s Hosp Medical Ctr
Faculty:
Nathaniel J. Rhodes, PharmD, MSc (he/him/his)
– Midwestern Univ
Innovative Clinical Pharmacology Strategies for Dose Optimization
CE: 1.5
10:00 AM - 11:30 AM
MST
1 - Precision in a Drop: Mapping the Microsampling Landscape
Co-Chair & Faculty:
Manjunath Pai, PharmD
– Univ of Michigan - Ann Arbor
10:00 AM - 11:30 AM
MST
2 - Pediatric Clinical Trial Applications: Challenges & Opportunities
Co-Chair & Faculty:
Kevin Downes, MD (he/him/his)
– Children's Hospital of Philadelphia
10:00 AM - 11:30 AM
MST
3 - Patient-centered Therapeutic Drug Monitoring of Immunosuppression
Faculty:
Abbie Leino, PharmD, PhD (she/her/hers)
– Cincinnati Children’s Hosp Medical Ctr
10:00 AM - 11:30 AM
MST
4 - Microsampling for Model-informed Precision Dosing
Faculty:
Nathaniel J. Rhodes, PharmD, MSc (he/him/his)
– Midwestern Univ
10:00 AM - 11:30 AM
MST
5 - Discussion, Questions & Answers, Learner Feedback & Evaluation
11:30 AM - 1:30 PM
MST
Lunch Buffet
11:30 AM - 1:30 PM
MST
Lunch Buffet
Location: Grand Ballroom Foyer
11:45 AM - 1:15 PM
MST
Lunch & Annual Business Meeting (Open to all)
11:45 AM - 1:15 PM
MST
Lunch & Annual Business Meeting (Open to all)
Location: Grand Ballroom North
1:30 PM - 3:00 PM
MST
Symposium 12: Clinical Pharmacology Considerations & Dose Selection Strategies of Antibody-Drug Conjugates From Early Development to Approval
Co-Chair & Faculty:
Salaheldin Hamed, PhD
– Astellas Pharma US Inc
Co-Chair & Faculty:
Yvonne (Yi Yang) Lau, PhD
– Daiichi Sankyo Co Ltd
Faculty:
Ana Ruiz-Garcia, PharmD, PhD (she/her/hers)
– Gilead Sciences Inc
Faculty:
Zhu Zhou, PhD
– CUNY York Coll
Innovative Clinical Pharmacology Strategies for Dose Optimization
CE: 1.5
1:30 PM - 3:00 PM
MST
Symposium 12: Clinical Pharmacology Considerations & Dose Selection Strategies of Antibody-Drug Conjugates From Early Development to Approval
Location: Grand Ballroom North
Co-Chair & Faculty:
Salaheldin Hamed, PhD
– Astellas Pharma US Inc
Co-Chair & Faculty:
Yvonne (Yi Yang) Lau, PhD
– Daiichi Sankyo Co Ltd
Faculty:
Ana Ruiz-Garcia, PharmD, PhD (she/her/hers)
– Gilead Sciences Inc
Faculty:
Zhu Zhou, PhD
– CUNY York Coll
Innovative Clinical Pharmacology Strategies for Dose Optimization
CE: 1.5
1:30 PM - 3:00 PM
MST
1 - Dose Selection of DXd ADC in Early Clinical Development of Solid Tumors
Co-Chair & Faculty:
Yvonne (Yi Yang) Lau, PhD
– Daiichi Sankyo Co Ltd
1:30 PM - 3:00 PM
MST
2 - Pharmacokinetic/Pharmacodynamic Modeling to Support the Re-approval of Gemtuzumab Ozogamicin With a New Dosing Regimen in CD33-positive Acute Myeloid Leukemia
Faculty:
Ana Ruiz-Garcia, PharmD, PhD (she/her/hers)
– Gilead Sciences Inc
1:30 PM - 3:00 PM
MST
3 - A Clinical Pharmacology Perspective on Antibody-Drug Conjugate Payloads
Faculty:
Zhu Zhou, PhD
– CUNY York Coll
1:30 PM - 3:00 PM
MST
4 - Clinical Pharmacology of ADCs: An MIDD Program to Expedite the Development of Enfortumab Vedotin
Co-Chair & Faculty:
Salaheldin Hamed, PhD
– Astellas Pharma US Inc
1:30 PM - 3:00 PM
MST
5 - Discussion, Questions & Answers, Learner Feedback & Evaluation
1:30 PM - 3:00 PM
MST
Symposium 13: Developing Anti-obesity Therapies: Integrating Science, Regulation & Innovation
Chair & Faculty:
Clayton A. Dehn, MS
– Evolution Research Group
Faculty:
Melissa Jones, PhD
– Foundation for the National Inst of Health
Faculty:
Sabina Paglialunga, PhD
– Celerion
Specific Populations/Rare Diseases
CE: 1.5
1:30 PM - 3:00 PM
MST
Symposium 13: Developing Anti-obesity Therapies: Integrating Science, Regulation & Innovation
Location: Grand Ballroom South
Chair & Faculty:
Clayton A. Dehn, MS
– Evolution Research Group
Faculty:
Melissa Jones, PhD
– Foundation for the National Inst of Health
Faculty:
Sabina Paglialunga, PhD
– Celerion
Specific Populations/Rare Diseases
CE: 1.5
1:30 PM - 3:00 PM
MST
1 - Opportunities & Obstacles in Developing Anti-obesity Therapies
Chair & Faculty:
Clayton A. Dehn, MS
– Evolution Research Group
1:30 PM - 3:00 PM
MST
2 - GLP-1 Drug Development & Optimized Study Designs
Faculty:
Sabina Paglialunga, PhD
– Celerion
1:30 PM - 3:00 PM
MST
3 - Rethinking Obesity Beyond BMI
Faculty:
Melissa Jones, PhD
– Foundation for the National Inst of Health
1:30 PM - 3:00 PM
MST
4 - Discussion, Questions & Answers, Learner Feedback & Evaluation
3:00 PM - 3:30 PM
MST
Coffee & Networking Break
3:00 PM - 3:30 PM
MST
Coffee & Networking Break
Location: Grand Ballroom Foyer
3:30 PM - 5:00 PM
MST
Symposium 14: Drug Development for Mitochondrial Diseases: Mitochondrial Dysfunction in Autism Spectrum Disorders & Renal Diseases
Co-Chair & Faculty:
Oliver Grundmann, PhD (he/him/his)
– Univ of Florida
Co-Chair & Faculty:
Volkmar Weissig, ScD, PhD
– Midwestern Univ Coll of Pharmacy-Glendale
Faculty:
Richard Boles, MD
– Mitochondrial & Molecular Medicine
Faculty:
Richard Eugene Frye, MD, PhD (he/him/his)
– Autism Discovery & Treatment Foundation
Faculty:
Rick Schnellmann, PhD
– Univ of Arizona
Specific Populations/Rare Diseases
CE: 1.5
3:30 PM - 5:00 PM
MST
Symposium 14: Drug Development for Mitochondrial Diseases: Mitochondrial Dysfunction in Autism Spectrum Disorders & Renal Diseases
Location: Grand Ballroom North
Co-Chair & Faculty:
Oliver Grundmann, PhD (he/him/his)
– Univ of Florida
Co-Chair & Faculty:
Volkmar Weissig, ScD, PhD
– Midwestern Univ Coll of Pharmacy-Glendale
Faculty:
Richard Boles, MD
– Mitochondrial & Molecular Medicine
Faculty:
Richard Eugene Frye, MD, PhD (he/him/his)
– Autism Discovery & Treatment Foundation
Faculty:
Rick Schnellmann, PhD
– Univ of Arizona
Specific Populations/Rare Diseases
CE: 1.5
3:30 PM - 5:00 PM
MST
1 - Mitochondria as Targets for Diseases
Co-Chair & Faculty:
Oliver Grundmann, PhD (he/him/his)
– Univ of Florida
3:30 PM - 5:00 PM
MST
2 - Drug Development for the Therapy of Mitochondrial Diseases
Co-Chair & Faculty:
Volkmar Weissig, ScD, PhD
– Midwestern Univ Coll of Pharmacy-Glendale
3:30 PM - 5:00 PM
MST
3 - Mitochondrial Dysfunction in Autism-spectrum Disorders
Faculty:
Richard Eugene Frye, MD, PhD (he/him/his)
– Autism Discovery & Treatment Foundation
3:30 PM - 5:00 PM
MST
4 - Mitochondrial DNA Polymorphism & Energy Metabolism
Faculty:
Richard Boles, MD
– Mitochondrial & Molecular Medicine
3:30 PM - 5:00 PM
MST
5 - Mitochondrial Dysfunction in Renal Diseases
Faculty:
Rick Schnellmann, PhD
– Univ of Arizona
3:30 PM - 5:00 PM
MST
6 - Discussion, Questions & Answers, Learner Feedback & Evaluation