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