<開放報名中> 2025/12/18 (星期四) 【FDA Modernization Act】New Era for Novel Non-clinical Approach in Drug Development Based on the 3R Principle

I. An Overview

(1) Timeline and Roadmap of New Drug Development
(2) The Federal Food, Drug, and Cosmetics Act 1938
(3) Non (Pre)-Clinical Development

II. Animal Model in New Drug R&D

(1) Definition of an Animal Model
(2) Purpose of Animal Model
(3) Categories of Diseased Animal Models

III. Regulation Requirement of Non-clinical Studies

(1) Why Non-clinical Testing
(2) Categories of Pharmacology Studies
(3) Toxicology Studies
(4) Summary

IV. Drug Development Failure

(1) Successful Rate of New Drug Development
(2) Causes of Failure in Clinical Trial
(3) Animal Model and Empirical Evidence

• Concordance from Animals to Human

(4) Striking Differences in Results between Animal and Human Studies

V. FDA Modernization Act

(1) The 3RS 1959
(2) Food and Drug Administration Modernization Act(FDAMA) 1997
(3) FDA Modernization Act 2.0 2022
(4) The 3RS and the ICH Guidance
(5) The 3RS and the FDA Modernization Act 2.0

• About Alternative Methods 2023
• Roadmap to Reducing Animal Testing in Preclinical Safety Studies 2025
• New Approach Methodologies (NAMs)

VI. In Vitro Human-Derived Systems

(1) General Introduction to Organoids, Microphysiological Systems,Bioengineered Tissue and Organ-on-a-chip
(2) Organoids

• iPSC-/ASCs-derived Organoids and Tumoroid
• Advantages, Limitations and Products
• Organoid Products

(3) Organ-on-a-Chip

• Single- and Multi-organ Chips
• Worldwide Organ-on-a-Chip Startups
• Scaling
• TNT005
• Summary

VII. In Silico Tools and Computational Modeling

(1) Physiologically-Based Pharmacokinetic (PBPK) Modeling
(2) ML and AI Predictive Models
(3) Quantitative Systems Pharmacology (QSP) and Modeling of Biological Pathways
(4) Bioinformatics and In Silico Off-target Screening
(5) The Unseen Challenges

VIII. Other Innovative Platforms

(1) Ex Vivo Human Tissues
(2) Microdosing and Imaging in Human Volunteers
(3) High-Throughput Cell-Based Screening
(4) Refined In Vivo Methods (for transition)

IX. FDA’s Future Plans for the FDA Modernization Act

(1) Implementation of Reduced Toxicity Testing in Animals at the FDA in the Next 3 Years
(2) Scientific and Technical Steps for FDA Adoption of NAMs
(3) Interagency Coordination through ICCVAM
(4) Recommendations and Policy Considerations

X. FDA Modernization Act 3.0

(1) Accelerating the Development of Alternatives to Animal Testing
(2) FDA response

XI. Conclusion