Curriculum
- 7 Sections
- 32 Lessons
- 1 Day
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- Introduction to the Pharma R&D Ecosystem4
- Drug Discovery – From Target to Lead Candidate5
- 2.1Target identification & validation
- 2.2Hit-to-lead and lead optimization (HTS, AI/ML in drug discovery, biomarkers)
- 2.3Attrition rates and cost implications
- 2.4Case Example: How Pfizer/Novartis identify and validate targets
- 2.5Exercise: Prioritize potential drug targets based on hypothetical disease data
- Preclinical Development5
- Clinical Trials – Phases I to IV5
- 4.1Objectives of each phase (safety, efficacy, dosage, long-term monitoring)
- 4.2Patient recruitment challenges
- 4.3Role of CROs & digital technologies (ePRO, remote monitoring)
- 4.4Regulatory milestones – IND, NDA, BLA, ANDA
- 4.5Role-Play: Designing a Phase II clinical trial protocol under cost & time constraints
- Regulatory Pathways & Global Compliance4
- Commercialization & Market Launch5
- 6.1Pricing & market access strategies
- 6.2Pharmacoeconomics & HTA (Health Technology Assessment)
- 6.3Lifecycle management: line extensions, generics, biosimilars
- 6.4Case Example: Launch strategy of a blockbuster drug vs a niche orphan drug
- 6.5Interactive Activity: Build a go-to-market plan for a simulated molecule
- Future of Drug Discovery & Development4
Sustainability in pharma R&D
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