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Pharmacometrics & Pharmacokinetics (PMK)

Regulatory Science (RS)

Revolutionizing End-to-End Drug Discovery, Development, and Clinical Utilization Through Quantitative Medicine co-sponsored by ASCPT and ISoP

Saturday, May 31, 2025
8:30 AM - 3:00 PM East Coast USA Time
Location: National Harbor 3
Additional fee

Session Description

Bringing a new therapeutic agent to patients entails significant expenses, time, and risks, compounded by scientific, regulatory, and clinical utilization challenges. In response to these challenges, innovative quantitative approaches and technologies, collectively known as quantitative medicine (QM), are being incorporated into drug discovery and development to improve efficiencies and patient outcome. QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches using nonclinical, clinical, and real-world data to optimize end-to-end drug development efficiency. By enabling informed decision-making and treatment optimization, QM aims to bring transformative medicines to clinical utilization in a timely manner. In March 2024, the FDA announced the establishment of a CDER Quantitative Medicine (QM) Center of Excellence (CoE) to catalyze the integration and consistent application of QM methodologies across drug development lifecycles.

This post-conference session will delve into various aspects of QM employed in drug development across lifecycles, showcasing cutting-edge quantitative modeling tools such as population PK, exposure-response, mechanistic PK/PD modeling, quantitative pharmacology modeling, and artificial intelligence/machine learning (AI/ML), alongside their practical applications. Interdisciplinary teams will present how QM has bolstered decision-making confidence, streamlined drug development, and optimized clinical utilization from industry, global regulatory, and medical practice perspectives. Case studies elucidating model-informed dose optimization and novel modality development will be featured. An interactive workshop session will further reinforce key learning points.

Advance the science of drug development by joining leading experts in Quantitative Medicine to gain deeper insights, enhance decision-making, and contribute to better patient outcomes. Register Now!

Learning Objectives

  1. Gain insight into a spectrum of innovative quantitative tools, including population PK, exposure-response, mechanistic PK/PD modeling, quantitative pharmacology modeling (QSP), PBPK, and Artificial Intelligence/Machine learning (AI/ML).
  2. Understand optimal utilization of QM tools across drug discovery, development and clinical utilization, including target selection, lead optimization, translation, dose optimization, combination strategy, generic drug development, patient treatment.
  3. Identify the challenges hindering the wide adoption of QM in end-to-end drug development and explore potential solutions to promote global regulatory acceptance and medical application.

Session Schedule

Opening and Live Poll

Quantitative Medicine: A Regulatory Perspective on Impact and Return on Investment
Issam Zineh, PharmD, MPH

Risk-Based Regulatory Assessment of Quantitative Approaches Used During Decision-Making: EMA Perspective
Flora Musuamba Tshinanu, PhD

Application of QM to Inform End-to-End Drug Development: An Industry Perspective
Daniele Ouellet, PhD

Application of Quantitative Medicine to Individualized Patient Treatment
Joga Gobburu, PhD, MBA

Panel Discussion
Raj Madabushi, PhD

QM Applications in E2E Drug Discovery and Development
Application of In Silico Tools in Drug Discovery: Design and Optimization Towards an Ideal Product Profile
Rosa Sanchez, PhD

Translational PK/PD and First-in-Human Dose Prediction of Bispecific T-Cell Engagers
Yanguang Cao, PhD

Harnessing Quantitative Medicine to Advance Oncology Drug Development
Chunze Li, PhD

Quantitative Medicine: Better Drug Development Efficiency, Interactions & Decisions
Gianluca Nucci, PhD

Use of Quantitative Medicine Approach to Support Drug Development and Regulatory Decision-Making
Hao Zhu, PhD

Q&A

Interactive Workshop | Expanding QM’s Reach: Real-Time Examples of LLM Use to Enhance R&D Productivity and Decision-Making in Drug Development
Brian Corrigan, PhD

QM Application in Post-Approval
Leveraging QM and Real-World Evidence to Optimize Post-Approval Dosing Regimen
Lan Ni, PhD

Adopting the Model Master File Framework to Enhance Modeling and Simulations Approaches for Regulatory Use
Lanyan Fang, PhD

Collaborative Approaches to Drug Development, Approvals, and Access in Low- and Middle-Income Countries
Eric Jordie, MS

Digital Health Technology Driving Quantitative Medicine in Clinical Trials and Medical Affairs
John Wagner, MD, PhD

Q&A and Closing Remarks

Co-sponsored by:

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