Who is the Patient? 4
- Section1.1
  
  Introduction
- Section1.2
  
  Precision/Personalization, Segmentation, and Incidence/Prevalence
- Section1.3
  
  Patient Journey
- Section1.4
  
  Expansion/Secondary Indications
Standard of Care & Competition 4
- Section2.1
  
  Introduction
- Section2.2
  
  Unmet Need, Safety, Efficacy, Compliance, Costs
- Section2.3
  
  Development Pipeline Analysis/Competitive Intelligence
- Section2.4
  
  Competition in Therapeutics (5 forces)
Business Model 4
- Section3.1
  
  Introduction
- Section3.2
  
  Product, Platform or Service
- Section3.3
  
  Mission, Vision, Strategy, Tactics, Operations
- Section3.4
  
  Who is the Customer?
Regulatory 4
- Section4.1
  
  Introduction
- Section4.2
  
  FDA Introduction
- Section4.3
  
  FDA Guidelines
- Section4.4
  
  Selecting FDA Consultants
Exit/End Goal 4
- Section5.1
  
  Introduction
- Section5.2
  
  Trade Sales
- Section5.3
  
  Sales
- Section5.4
  
  Partnerships

Introduction

A business model describes how the business creates and captures value. Is it a product or service? Who is the customer? What problem is the business solving for the customer? Who is the payor? Where (geographically) is the opportunity? Etc. The last decades have yielded an explosion in creative business models, most based on Internet businesses. The number of business models in therapeutics development is, however, more limited. The main questions are typically:

Product, platform, or service?
Asset-focused or pipeline-focused?
Virtual or not?
Build to operate or build to sell?
Partner early or late?
Bootstrap, venture, or alternative?
Indication/modality/region/stage of development?

Resources

Prev Competition in Therapeutics (5 forces)

Next Product, Platform or Service

Modular Learning: Operations

Who is the Patient? 4

Standard of Care & Competition 4

Business Model 4

Regulatory 4

Exit/End Goal 4

Introduction

Resources

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