Optimizing Preclinical Proof of Concept

Overview of drug development stages, timelines, and the low overall success rate (<10%) for products entering clinical trials.View

Identifies key reasons for drug failures: toxicity (49%), unpredictability in bioavailability (15%), metabolism issues (3%), and faulty understanding of pathophysiology (33%).View

Discusses the importance of early animal models for target validation, biomarker establishment, selecting promising developments, and elucidating mechanisms of action.View

Highlights the need for potential indication identification early in development, based on target manifestation, mechanism of action, medical need, and market potential.View

Emphasizes planning backward from approval, ensuring preclinical programs support clinical strategies, including costs and timelines.View

Discusses challenges with animal models in predicting human efficacy and drug metabolism, as well as ethical and practical issues.View

Proposes approaches to enhance understanding of mechanism of action (MoA), using relevant animal models and disease mimicking designs.View

Focuses on the need for physiological evidence in IND filing, addressing dose determination based on NOAEL and HED.View

Emphasizes the importance of data quality, including using negative controls, protocol adherence, and GLP standards.View

Strategies for partnerships, enhancing patent positions, and ensuring preclinical strategies align with commercial goals.Advises on the establishment of a development plan, understanding disease physiology, and seeking experienced guidance before entering preclinical development.View