Drug Development Product Management Specialization Course Syllabus
Full curriculum breakdown — modules, lessons, estimated time, and outcomes.
Overview (80-120 words) describing structure and time commitment.
Module 1: Drug Discovery
Estimated time: 9 hours
- Target selection and identification in drug discovery
- Molecular biology tools and techniques
- Bioinformatics in compound screening
- From lead compound to Investigational New Drug (IND) application
Module 2: Pre-Clinical Development
Estimated time: 9 hours
- Designing pre-clinical studies
- Assessing pharmacokinetics and toxicology
- Regulatory requirements for pre-clinical data
- Preparing for transition to clinical trials
Module 3: Clinical Development: Phase 0 to Phase 3
Estimated time: 9 hours
- Objectives and design of Phase 0 microdosing studies
- Phase 1 safety and dose-ranging trials
- Phase 2 proof-of-concept studies
- Phase 3 pivotal trials and data analysis
Module 4: Regulatory Affairs and Compliance
Estimated time: 9 hours
- Filing a New Drug Application (NDA)
- Good Clinical Practices (GCP) and regulatory standards
- Role of the FDA in drug approval
- Post-marketing surveillance and Phase 4 requirements
Module 5: Drug Commercialization
Estimated time: 9 hours
- Marketing strategy for pharmaceutical products
- Pricing and reimbursement models
- Patient access and U.S. healthcare system considerations
- Strategic partnerships and portfolio management
Module 6: Final Project
Estimated time: 10 hours
- Develop a comprehensive drug development and commercialization plan
- Present regulatory strategy from IND to NDA
- Create a market launch and patient access strategy
Prerequisites
- Basic understanding of biology or life sciences
- Interest in pharmaceutical or biotechnology industries
- No prior experience in drug development required
What You'll Be Able to Do After
- Explain the full lifecycle of drug development from discovery to market
- Evaluate scientific and regulatory strategies in drug development
- Design a clinical development pathway for a new therapeutic
- Create a commercialization strategy including pricing and access
- Apply product management principles to pharmaceutical product portfolios