Program Overview
This program provides a comprehensive understanding of the global drug discovery and development lifecycle, spanning target identification, preclinical research, clinical trials, regulatory pathways, and commercialization strategies. Participants will gain clarity on key processes, industry challenges, and success factors while exploring real-world case studies, regulatory requirements, and future trends such as AI-driven discovery and personalized medicine. Through expert-led discussions, practical exercises, and simulations, this course equips pharma professionals with actionable insights to navigate R&D complexities and drive successful market entry.
Features
- Understand the end-to-end process of drug discovery, development, and commercialization.
- Identify key challenges, risks, and regulatory requirements at each stage of the pipeline.
- Apply practical frameworks to clinical trial design, regulatory submissions, and launch strategies.
- Leverage industry insights and case studies to solve real-world R&D and market entry challenges.
Target audiences
- R&D Professionals
- Regulatory Affairs and Quality Assurance Teams
- Clinical Development Teams
- Strategy & Ops Teams
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
Instructor
