Detailed Syllabus

Semester 1: Pharmaceutical Industry Foundations

1. Introduction to Pharmaceutical Business
   • Global market trends (small molecules vs. biologics vs. biosimilars)
   • Case: Pfizer’s COVID-19 vaccine vs. Gilead’s antiviral pricing strategy
2. Healthcare Economics & Policy
   • Drug pricing models (US vs. India vs. EU)
   • Impact of universal healthcare systems (NHS, Obamacare)
3. Pharmaceutical Marketing & Branding
   • Direct-to-consumer (DTC) advertising regulations (FDA vs. EMA)
   • Brand lifecycle management (Viagra’s patent cliff strategies)
4. Regulatory Affairs & Compliance
   • FDA/EMA/WHO approval pathways
   • ICH-GCP guidelines for clinical trials
5. Pharma Supply Chain & Logistics
   • Cold chain management (Moderna vaccine distribution)
   • Track-and-trace technologies (Blockchain in pharma)

Semester 2: Core Business Operations

1. Drug Discovery & Development
   • R&D cost structures ($2.6B per drug avg.)
   • AI in target identification (BenevolentAI case)
2. Clinical Trials Management
   • Phase I-IV trial design
   • Patient recruitment strategies (Apple ResearchKit)
3. Pharma Sales & Market Access
   • Key account management (hospital formulary inclusion)
   • Health technology assessment (HTA) frameworks
4. Intellectual Property & Patents
   • Hatch-Waxman Act (Generics vs. Innovators)
   • Evergreening strategies (Humira’s 247 patents)
5. Digital Health & MedTech
   • Connected drug delivery devices (Novo Nordisk’s smart pens)
   • Prescription digital therapeutics (Pear Therapeutics)

Semester 3: Specializations

Track 1: Global Pharma Strategy

1. Emerging Markets Expansion
   • China’s NMPA approval process
   • Africa’s vaccine manufacturing initiatives (BioNTech in Rwanda)
2. Mergers & Acquisitions
   • Due diligence in pharma M&A (Bristol-Myers Squibb-Celgene deal)
   • Post-merger integration challenges

Track 2: Biotech & Innovation

1. Cell & Gene Therapy Business Models
   • CAR-T pricing ($475K per treatment economics)
   • CRISPR commercialization (Vertex’s sickle-cell therapy)
2. Personalized Medicine
   • Companion diagnostics (Foundation Medicine)
   • Pharmacogenomics market potential

Electives (Choose 2)

• Cannabis Pharmaceuticals (FDA-approved Epidiolex case)
• Rare Disease Orphan Drugs (Ultragenyx’s pricing strategies)
• OTC & Nutraceuticals (Haleon’s post-GSK spin-off)
• Military Pharma Logistics (DoD vaccine procurement)

Semester 4: Capstone & Industry Immersion

1. Live Consulting Project
   • Optimize launch strategy for a diabetes drug in India
   • Design patient access program for a $500K gene therapy
2. Internship with Industry Leaders
   • Roles:
     • Market Access Analyst at Roche
     • Business Development at Moderna
     • Regulatory Affairs at Cipla
3. Certification Prep
   • RAPS (Regulatory Affairs Professionals Society)
   • Six Sigma for Pharma
4. Thesis Options
   • "AI for Adverse Event Prediction"
   • "Parallel Trade Impacts in EU Pharma"

Innovative Learning Components

• Regulatory Simulation Lab
  • Mock FDA advisory committee meetings
  • EMA centralized procedure role-play
• Pharma Hackathons
  • 48-hour challenge to design a digital adherence solution
• Global Site Visits
  • Boston/Cambridge biotech hub
  • Hyderabad’s "Genome Valley"