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Saturday, Sep 9th
8:00 AM – 5:00 PM PT
PMWS: A Snapshot of Clinical Pharmacology Workflows With R
Location: Cedar Ballroom
Co-Chair & Faculty: Tao Long, PhD – Takeda Pharmaceutical Co Ltd
Co-Chair & Faculty: Daisy Zhu, PharmD, PhD (she/her/hers) – Pfizer Inc
Faculty: William S. Denney, PhD (he/him/his) – Human Predictions LLC
Faculty: Eliford Kitabi, PhD – US Food & Drug Administration
Faculty: Michael Neely, MD – Univ of Southern California
Faculty: Wenping Wang, PhD – Takeda Pharmaceutical Co Ltd
Clinical Drug Development & Investigations
CE: 6
Saturday, Sep 9th
8:00 AM – 5:00 PM PT
1 - A Broad Overview of R: Everything You Need to Know About R & Its Utilization in Data & Pharmacometrics Analysis in Clinical Development
Co-Chair & Faculty: Daisy Zhu, PharmD, PhD (she/her/hers) – Pfizer Inc
Clinical Drug Development & Investigations
Saturday, Sep 9th
8:00 AM – 5:00 PM PT
2 - R in Data Manipulation/Wrangling/Cleaning/Visualization
Faculty: Michael Neely, MD – Univ of Southern California
Clinical Drug Development & Investigations
Saturday, Sep 9th
8:00 AM – 5:00 PM PT
3 - R in Noncompartmental Analysis
Faculty: William S. Denney, PhD (he/him/his) – Human Predictions LLC
Clinical Drug Development & Investigations
Saturday, Sep 9th
8:00 AM – 5:00 PM PT
4 - R in Pharmacometric/Pharmacodynamic Modeling & Simulation
Faculty: Wenping Wang, PhD – Takeda Pharmaceutical Co Ltd
Clinical Drug Development & Investigations
Saturday, Sep 9th
8:00 AM – 5:00 PM PT
5 - R in Concentration-QTc Analysis
Co-Chair & Faculty: Tao Long, PhD – Takeda Pharmaceutical Co Ltd
Clinical Drug Development & Investigations
Saturday, Sep 9th
8:00 AM – 5:00 PM PT
6 - Development of Pharmacometric Applications Using R Shiny
Faculty: Eliford Kitabi, PhD – US Food & Drug Administration
Clinical Drug Development & Investigations
Saturday, Sep 9th
8:00 AM – 5:00 PM PT
7 - Discussion, Questions & Answers, Learner Feedback & Evaluations
Clinical Drug Development & Investigations
Sunday, Sep 10th
8:00 AM – 9:30 AM PT
Plenary Session: Scientific, Regulatory & Operational Considerations for Working With Gene-based Medicines: Are You Ready to Conduct Gene Therapy Research?
Location: Grand Ballroom E-K
Chair & Faculty: Myong-Jin Kim, PharmD – US Food & Drug Administration
Faculty: Christopher R. Doyle, PhD (he/him/his) – WCG Clinical Svcs
Faculty: James Riddle, MCSE, CIP, CPIA, CRQM – Advarra
Clinical Drug Development & Investigations
CE: 1.5
Sunday, Sep 10th
10:00 AM – 11:30 AM PT
Symposium 2: HIV Pre-exposure Prophylaxis: Evolving Clinical Practice & Product Development Guided by Clinical Pharmacology
Location: Grand Ballroom I-K
Co-Chair & Faculty: Robert Bies, PharmD, PhD – Univ of Buffalo
Co-Chair & Faculty: Craig W. Hendrix, MD, DABCP – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
Faculty: Charu Mullick, MD – US Food & Drug Administration
Faculty: Ethel Weld, MD, PhD – Johns Hopkins Univ School of Medicine
Clinical Drug Development & Investigations
CE: 1.5
Sunday, Sep 10th
10:00 AM – 11:30 AM PT
1 - Clinical State-of-the-Art HIV Pre-exposure Prophylaxis (PrEP): Proven Options Available Now & On the Horizon
Faculty: Ethel Weld, MD, PhD – Johns Hopkins Univ School of Medicine
Clinical Drug Development & Investigations
Sunday, Sep 10th
10:00 AM – 11:30 AM PT
2 - Clinical Pharmacology Innovations: Novel Methods to Inform Early Drug Development
Co-Chair & Faculty: Craig W. Hendrix, MD, DABCP – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
Clinical Drug Development & Investigations
Sunday, Sep 10th
10:00 AM – 11:30 AM PT
3 - Modeling & Simulation to Guide Optimized PrEP Implementation in Diverse Patient Populations
Co-Chair & Faculty: Robert Bies, PharmD, PhD – Univ of Buffalo
Clinical Drug Development & Investigations
Sunday, Sep 10th
10:00 AM – 11:30 AM PT
4 - Pivotal Clinical PrEP Trial Innovations: Considering Counterfactual Study Design & Innovative Control Groups
Faculty: Charu Mullick, MD – US Food & Drug Administration
Clinical Drug Development & Investigations
Sunday, Sep 10th
10:00 AM – 11:30 AM PT
5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 3:00 PM PT
1 - Clinical Pharmacology Regulatory Considerations for Recent Malignant Hematology Approvals
Chair & Faculty: Olanrewaju Okusanya, PharmD, MS – US Food & Drug Administration
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 3:00 PM PT
2 - Clinical Pharmacology Regulatory Considerations for Recent Oncology Approvals
Faculty: Ankit Shah, PhD – US Food & Drug Administration
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 3:00 PM PT
3 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 5:00 PM PT
Symposium 3: Novel Approaches for the Prediction of Drug Effects in Children
Location: Grand Ballroom E-H
Co-Chair & Faculty: Catherijne J. Knibbe, PharmD, PhD – Leiden Univ
Faculty: Jeffrey Barrett, PhD – Aridhia Digital Research Environment
Faculty: Andrea Edginton, PhD – Univ of Waterloo
Faculty: Elke Krekels, PhD – Leiden Univ
Clinical Drug Development & Investigations
CE: 3.0
Sunday, Sep 10th
1:30 PM – 5:00 PM PT
1 - Novel Approaches for the Prediction of Drug Effects in Children: Can We Move from Pharmacokinetic to Pharmacodynamic Modeling?
Co-Chair & Faculty: Catherijne J. Knibbe, PharmD, PhD – Leiden Univ
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 5:00 PM PT
2 - Advances in Pharmacodynamic Modeling of Pain & Sedation in Children: Applications of Item Response Theory & Repeated Time to Event Modeling
Faculty: Elke Krekels, PhD – Leiden Univ
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 5:00 PM PT
3 - How to Proceed to Modelling of Prediction of Effects in Children
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 5:00 PM PT
4 - How Can Partnerships Between Industry, Regulatory & Academia Innovate Drug Development in Children?
Faculty: Jeffrey Barrett, PhD – Aridhia Digital Research Environment
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 5:00 PM PT
5 - Quantifying Exposure in Breastfeeding Infants to Maternal Medications Using Physiologically-based Pharmacokinetics
Faculty: Andrea Edginton, PhD – Univ of Waterloo
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 5:00 PM PT
6 - What Do We Need to Optimize Trial Design in Neonatology & Pediatrics: Role of Industry, Academia & Regulatory
Clinical Drug Development & Investigations
Sunday, Sep 10th
1:30 PM – 5:00 PM PT
7 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
Monday, Sep 11th
8:00 AM – 9:30 AM PT
Symposium 5: Contemporary Issues Related to Pediatric Drug Development
Location: Grand Ballroom E-H
Chair & Faculty: Martina Sahre, PhD – US Food & Drug Administration
Faculty: Vikram Arya, PhD – US Food & Drug Administration
Faculty: Jeremiah D. Momper, PharmD, PhD – Univ of California San Diego
Faculty: Yumi Cleary, BSc, MSc – F. Hoffmann-La Roche Ltd
Clinical Drug Development & Investigations
CE: 1.5
Monday, Sep 11th
8:00 AM – 9:30 AM PT
Symposium 6: The Tightrope of Substance Abuse Potential: The Preclinical & Clinical Factors that Make or Break the Scheduling of a Substance, Using Kratom (Mitragyna Speciosa) as an Example
Location: Grand Ballroom I-K
Co-Chair & Faculty: Oliver Grundmann, PhD (he/him/his) – Univ of Florida
Co-Chair & Faculty: Kirsten E. Smith, PhD – National Inst on Drug Abuse
Faculty: Jack Henningfield, PhD – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program
Clinical Drug Development & Investigations
CE: 1.5
Monday, Sep 11th
8:00 AM – 9:30 AM PT
1 - Introduction, Brief History & Pharmacology of Kratom
Chair & Faculty: Oliver Grundmann, PhD (he/him/his) – Univ of Florida
Clinical Drug Development & Investigations
Monday, Sep 11th
8:00 AM – 9:30 AM PT
2 - The Current Regulatory 8-Factor Analysis & Its Use in Substance Abuse Liability
Faculty: Jack Henningfield, PhD – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program
Clinical Drug Development & Investigations
Monday, Sep 11th
8:00 AM – 9:30 AM PT
3 - Preclinical & Clinical Data on Kratom as Predictors for Abuse Liability
Chair & Faculty: Kirsten E. Smith, PhD – National Inst on Drug Abuse
Clinical Drug Development & Investigations
Monday, Sep 11th
8:00 AM – 9:30 AM PT
4 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
Symposium 7: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?
Location: Grand Ballroom E-H
Co-Chair & Faculty: Khamir Mehta, PhD – Amgen Inc
Co-Chair & Faculty: Piet van der Graaf, PhD, PharmD – Certara
Faculty: Haleh Saber, PhD (she/her/hers) – US Food & Drug Administration
Faculty: Fei Hua, PhD – Applied BioMath LLC
Faculty: Xiling Jiang, PhD – US Food & Drug Administration
Faculty: Alexander Ratushny, PhD – Bristol Myers Squibb
Faculty: Vincent Lemaire, PhD – Genentech Inc
Faculty: Julie Bullock, PharmD – Certara
Clinical Drug Development & Investigations
CE: 3.0
Monday, Sep 11th
1:30 PM – 5:00 PM PT
Symposium 8: Use of Real-time Simulation for Decision Making in Clinical Pharmacology
Location: Grand Ballroom I-K
Co-Chair & Faculty: Matthew Rosebraugh, PhD – AbbVie Inc
Co-Chair & Faculty: Stephan Schmidt, PhD – Univ of Florida
Faculty: Mohamad Shebley, PhD – AbbVie Inc
Faculty: Sven Stodtmann, PhD (he/him/his) – AbbVie Inc
Clinical Drug Development & Investigations
CE: 3
Monday, Sep 11th
1:30 PM – 5:00 PM PT
1 - Mechanistic Models for Multispecific Antibodies: An Introduction
Co-Chair & Faculty: Piet van der Graaf, PhD, PharmD – Certara
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
1 - Use of Adaptive Graphics Simulations for Device Selection in Parkinson’s Disease
Chair & Faculty: Matthew Rosebraugh, PhD – AbbVie Inc
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
2 - First-in-Human Dose Selection of Immune-activating Biotherapeutics in Oncology
Faculty: Haleh Saber, PhD (she/her/hers) – US Food & Drug Administration
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
2 - Real-time Trial Simulations to Understand the Impact of Assumptions & Design Choices on Expected Trial Results for Anti-amyloid Antibody in Alzheimer's Disease
Faculty: Sven Stodtmann, PhD (he/him/his) – AbbVie Inc
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
3 - A Next Generation Mathematical Model for the In-vitro to Clinical Translation of T Cell Engagers
Faculty: Fei Hua, PhD – Applied BioMath LLC
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
3 - Opportunities & Challenges to Implementing Precision Dosing
Faculty: Stephan Schmidt, PhD – Univ of Florida
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
4 - Harnessing the Power of Model-informed Drug Development to Support Clinical Development of T Cell Engagers
Faculty: Xiling Jiang, PhD – US Food & Drug Administration
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
4 - Session Recap & Points to Ponder
Co-Chair & Faculty: Mohamad Shebley, PhD – AbbVie Inc
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
5 - Case Studies in Mechanism-based Models for Immune-oncology
Co-Chair & Faculty: Khamir Mehta, PhD – Amgen Inc
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
6 - A Role of Multitherapy Quantitative Systems Pharmacology (QSP) Platforms in Clinical Development of Multispecific Drug Antibodies
Faculty: Alexander Ratushny, PhD – Bristol Myers Squibb
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
7 - Predicting Survival in Prospective Clinical Trials Using Weakly-supervised QSP
Faculty: Vincent Lemaire, PhD – Genentech Inc
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
8 - The Role of Model-informed Drug Development & QSP in Project Optimus
Faculty: Julie Bullock, PharmD – Certara
Clinical Drug Development & Investigations
Monday, Sep 11th
1:30 PM – 5:00 PM PT
9 - Faculty Panel Discussion: Panel Discussion: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 9:30 AM PT
Symposium 9: Enteral Feeding & Soft Foods: Supporting Medication Dosing in Pediatrics & the Hospitalized
Location: Grand Ballroom I-K
Chair & Faculty: Elimika Fletcher, PharmD, PhD – US Food & Drug Administration
Faculty: Rachel Meyers, PharmD – Rutgers Univ
Faculty: Karen Thompson, PhD – Merck & Co
Clinical Drug Development & Investigations
CE: 1.5
Tuesday, Sep 12th
8:00 AM – 9:30 AM PT
1 - It’s a Jungle Out There: Administering Medications With Enteral Feeding & Soft Foods to Pediatric Patients in the Real World
Faculty: Rachel Meyers, PharmD – Rutgers Univ
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 9:30 AM PT
2 - Clinical Pharmacology Perspective on Supporting Dosing of Drugs via Feeding Tubes & With Soft Foods
Chair & Faculty: Elimika Fletcher, PharmD, PhD – US Food & Drug Administration
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 9:30 AM PT
3 - Formulation Considerations to Support Dosing of Drugs via Feeding Tubes & With Soft Foods
Faculty: Karen Thompson, PhD – Merck & Co
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 9:30 AM PT
4 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 11:30 AM PT
Symposium 10: First-in-Patient Dose Prediction for Adeno-associated, Virus-mediated Gene Therapy
Location: Grand Ballroom E-H
Co-Chair & Faculty: Xiaofei Wang, PhD – US Food & Drug Administration
Co-Chair & Faculty: Peng Zou, PhD – Daiichi Sankyo Co Ltd
Faculty: Kefeng Sun, PhD – Takeda Pharmaceutical Co Ltd
Faculty: Tao Zhang, PhD (he/him/his) – Binghampton Univ
Clinical Drug Development & Investigations
CE: 3.0
Tuesday, Sep 12th
8:00 AM – 11:30 AM PT
1 - Clinical Pharmacology Considerations for Adeno-associated, Virus-mediated Gene Therapy: A Regulatory Perspective
Co-Chair & Faculty: Xiaofei Wang, PhD – US Food & Drug Administration
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 11:30 AM PT
1 - Clinical Pharmacology Considerations for Adeno-associated, Virus-mediated Gene Therapy: A Regulatory Perspective
Co-Chair & Faculty: Xiaofei Wang, PhD – US Food & Drug Administration
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 11:30 AM PT
2 - First-in-Patient Dose Prediction for Adeno-associated, Virus-mediated Gene Therapy
Co-Chair & Faculty: Peng Zou, PhD – Daiichi Sankyo Co Ltd
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 11:30 AM PT
3 - Interspecies Scaling of Transgene Products for Intramuscular & Intravesical Gene Therapies
Faculty: Tao Zhang, PhD (he/him/his) – Binghampton Univ
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 11:30 AM PT
4 - Clinical Pharmacology Considerations for Recombinant Adeno-associated, Virus-based Gene Therapy: Focus on Biodistribution, Immune Response & Durability
Faculty: Kefeng Sun, PhD – Takeda Pharmaceutical Co Ltd
Clinical Drug Development & Investigations
Tuesday, Sep 12th
8:00 AM – 11:30 AM PT
5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
Tuesday, Sep 12th
1:30 PM – 3:00 PM PT
Symposium 13: Clinical Pharmacology Challenges in Obesity & Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis: Mechanisms & Therapeutics
Location: Grand Ballroom E-H
Co-Chair & Faculty: Kim LR Brouwer, PharmD, PhD – Univ of North Carolina at Chapel Hill
Co-Chair & Faculty: Catherijne J. Knibbe, PharmD, PhD – Leiden Univ
Faculty: Manal Abdelmalek, MD, MPH – Mayo Clinic
Faculty: Insook Kim, PhD – US Food & Drug Administration
Faculty: Yurong Lai, PhD – Gilead Sciences Inc
Clinical Drug Development & Investigations
CE: 1.5
Tuesday, Sep 12th
1:30 PM – 3:00 PM PT
1 - The Obesity Epidemic: Consequences for Dosing in Adults & Children
Co-Chair & Faculty: Catherijne J. Knibbe, PharmD, PhD – Leiden Univ
Clinical Drug Development & Investigations
Tuesday, Sep 12th
1:30 PM – 3:00 PM PT
2 - Pathophysiologic Changes, Staging, Diagnosis & Trial Endpoints for NAFLD/NASH
Faculty: Manal Abdelmalek, MD, MPH – Mayo Clinic
Clinical Drug Development & Investigations
Tuesday, Sep 12th
1:30 PM – 3:00 PM PT
3 - Mechanistic Understanding of Physiological Changes in NASH that Impact Drug Disposition
Co-Chair & Faculty: Kim LR Brouwer, PharmD, PhD – Univ of North Carolina at Chapel Hill
Clinical Drug Development & Investigations
Tuesday, Sep 12th
1:30 PM – 3:00 PM PT
4 - Challenges & Current Regulatory Issues in Drug Development for Obesity & NAFLD/NASH
Faculty: Insook Kim, PhD – US Food & Drug Administration
Clinical Drug Development & Investigations
Tuesday, Sep 12th
1:30 PM – 3:00 PM PT
5 - Use of Physiologically-based Pharmacokinetic Modeling to Advance Clinical Trials in Obesity & NAFLD/NASH
Faculty: Yurong Lai, PhD – Gilead Sciences Inc
Clinical Drug Development & Investigations
Tuesday, Sep 12th
1:30 PM – 3:00 PM PT
6 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
Tuesday, Sep 12th
3:30 PM – 5:00 PM PT
Symposium 14: Recent Trends in Food Effect Assessment in Supporting Dosing Recommendations for Oral Oncology Drugs
Location: Grand Ballroom E-H
Co-Chair & Faculty: Xiaoming Cui, PhD (she/her/hers) – Novartis Inst for Biomedical Research
Co-Chair & Faculty: Yvonne Lau, PhD – Daiichi Sankyo Inc
Faculty: Brian Booth, PhD – US Food & Drug Administration
Faculty: Lawrence Lesko, PhD – Univ of Florida Coll of Pharmacy
Clinical Drug Development & Investigations
CE: 1.5
Tuesday, Sep 12th
3:30 PM – 5:00 PM PT
1 - Dose & Prandial Condition Optimization from Phase 1 to Post-marketing
Co-Chair & Faculty: Yvonne Lau, PhD – Daiichi Sankyo Inc
Clinical Drug Development & Investigations
Tuesday, Sep 12th
3:30 PM – 5:00 PM PT
2 - Can “Given With Food” Be a Default Food Condition?
Co-Chair & Faculty: Xiaoming Cui, PhD (she/her/hers) – Novartis Inst for Biomedical Research
Clinical Drug Development & Investigations
Tuesday, Sep 12th
3:30 PM – 5:00 PM PT
3 - Food: Leveraging the Clinical Pharmacology of Your Oncology Drug
Faculty: Brian Booth, PhD – US Food & Drug Administration
Clinical Drug Development & Investigations
Tuesday, Sep 12th
3:30 PM – 5:00 PM PT
4 - Why Are FDA-approved Drug Labels Pertaining to Food-Drug Interactions Essential to the Advancement of Therapeutic Optimization of Oral Cancer Drugs?
Faculty: Lawrence Lesko, PhD – Univ of Florida Coll of Pharmacy
Clinical Drug Development & Investigations
Tuesday, Sep 12th
3:30 PM – 5:00 PM PT
5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations