Drug Discovery and Development Short Course Outline

Introduction

•Purpose and Goals

•Drug Discovery and Development Logic Plans

•Overview on Regulatory Agency Submissions

•Meetings with Regulatory Agencies

Drug Discovery and Developability Assessment

•Drug Discovery Aspects

>Target Identification

>In Vitro Pharmacology Screen

>Discovery Lead Generation

>‘Leads’ to ‘Hits’

>Structural Activity Relationships

>In Vivo Pharmacology Screen

•Developability Assessment Overview

>Scientific Disciplines Involved

>Logic Plan for Discovery Lead Selection

Early Formulation Evaluations

•Analytical Chemistry Method Development and Characterization

•Early Formulation Definition and Assessments

•Stability and Solubility Requirements

Preclinical/Nonclincal Drug Development or CTD Safety

•Safety Pharmacology

•Pharmacokinetics and Drug Metabolism

•Toxicology

>Acute, Subchronic, Chronic

>Genotoxicity

>Reproductive and Developmental Toxicology

>Carcinogenicity

>Special Toxicology Studies

Chemistry, Manufacturing, and Control (CMC) or CTD Quality

Drug Substance Characterization and Development

Drug Product Characterization and Development

Clinical Drug Development or CTD Efficacy

•First-in-Human Clinical Trial Protocol and Investigator’s Brochure

•Human Pharmacology (Phase 1)

•Therapeutic Exploratory (Phase 2)

•Therapeutic Confirmation (Phase 3)

•Therapeutic Use (Phase 4)

Marketing Application Submission

•CTD Overview

•CTD Overviews and Summaries in Module 2

•Module 3 (Quality), Module 4 (Nonclinical Study Reports), Module 5 (Clinical Study Reports)

Summary and Conclusions

Workshop to Design and Discuss Participant Prepared Drug Development Logic Plans