Symposium 15: Project Optimus: A Paradigm Shift in Quantitative Clinical Pharmacology or Business as Usual? Part 1

Tuesday, September 10, 2024

1:30 PM – 3:00 PM ET

Location:Grand Ballroom A-C

CE: 1.5

Co-Chair & Faculty(s)

Nan Zheng, PhD

Team Lead
Cancer Pharmacology I, Office of Clinical Pharmacology, OTS, CDER
US Food & Drug Administration

Slides
Honghui Zhou, PhD

Head, Pharmacometrics
Global Clinical Pharmacology & Pharmacometrics
Jazz Pharmaceuticals Inc

Faculty(s)

Brian Booth, PhD

Division Director
Cancer Pharmacology I, Office of Clinical Pharmacology, OTS, CDER
US Food & Drug Administration
Chunze Li, PhD

Executive Director & Distinguished Scientist, Head, Oncology Clinical Pharmacology
Clinical Pharmacology
Genentech Inc
Bernd Meibohm, PhD, FCP, FAAPS

Professor
Pharmaceutical Sciences
The Univ of Tennessee Health Science Ctr
Weirong Wang, PhD

Senior Director, Scientific Fellow
Clinical Pharmacology & Pharmacometrics
Janssen Research & Development

Target Audience:

The target audience for this Symposium is DMPK scientists, toxicologists and clinical pharmacologists who are involved in the preclinical and clinical development of oncology drugs, pharmacometricians who are involved in pharmacometrics analyses, QSP models, MIDD projects and other quantitative clinical pharmacology analyses and physicians or oncologists who are involved in oncology drug development.

Description:

Dose optimization is of paramount importance to ensure that patients will benefit from the treatments with maximized efficacy and minimized toxicity. The complex nature of oncology drug development, coupled with the diverse types of therapeutic modalities, have presented tremendous challenges to oncology drug dose optimization. In this Symposium, the Speakers (from regulatory agency, industry and academia) will provide a comprehensive analysis of the oncology drug dose selection paradigms and present case studies in which quantitative clinical pharmacology analyses (e.g., Quantitative Systems Pharmacology (QSP) modeling, population pharmacokinetics and exposure-response analyses, physiologically-based pharmacokinetics/pharmacodynamics (PBPK/PD) modeling analyses, etc.) were conducted to support dose optimization of different types of oncology drug products including small molecules, T-cell engagers, bispecific antibodies, antibody-drug conjugates and combination treatments. The strengths and limitations of each methodology will be elaborated. Opportunities and future perspectives for applying innovative strategies such as the use of real-world evidence and machine learning methods in the dose optimization arena will also be discussed.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:

Describe the unique mechanism of action of different types of oncology drugs, plus the complexities and challenges in dose selection;
Identify appropriate quantitative clinical pharmacology analyses methods to address specific questions in oncology drug dose optimization;
Identify areas where innovative quantitative analysis methods are being explored to support oncology drug dose optimization.

Presentations:

Is There a One Size Fits All Approach?: An Overview of the Complexity of Oncology Dose Selection Paradigms in Different Settings
Faculty: Brian Booth, PhD – US Food & Drug Administration
Pharmacometrics in Drug Development of Oncology Therapies of Different Modalities: Bispecific Antibody, Small Molecule, T-Cell Redirector
Co-Chair & Faculty: Honghui Zhou, PhD – Jazz Pharmaceuticals Inc
Application of QSP Modeling in T-Cell Redirecting Bispecific Antibody Dose Optimization
Faculty: Weirong Wang, PhD – Janssen Research & Development