• Modular Learning
  • Resource Database
  • Offerings
    • Partnership Program
    • Seed Fund
    • Modular Learning
    • Resource Database
  • DRIVEN Companies
    DRIVEN Accelerator HubDRIVEN Accelerator Hub
    • Modular Learning
    • Resource Database
    • Offerings
      • Partnership Program
      • Seed Fund
      • Modular Learning
      • Resource Database
    • DRIVEN Companies

      Modular Learning: Operations

      • Home
      • Modular Learning
      • Operations
      Modular LearningOperations
      • 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

        Unmet Need, Safety, Efficacy, Compliance, Costs

        Introduction

        What does your patient need? A survival benefit? Pain management? Fewer wrinkles? This is the unmet need, the goal, and the primary endpoint. Be specific, objective, and self-critical. How does your therapy stack up vs. everything else in the development pipeline?

        What

        Define the unmet need in terms of safety and efficacy. Typically, there is a minimum safety threshold that is acceptable (which varies widely between indications and class of intervention, e.g. a cancer therapy has a different minimum safety threshold than a pediatric vaccine), and value is typically driven by efficacy improvements. There may be other dimensions of unmet need, e.g. compliance, ease of use, or costs.

        When

        If you’ve really understood your patient, you’ve understood the standard of care they currently receive. Now is the time to project into the future to determine how the many competitive efforts may derail or supersede your own.

        Why

        If you’re unaware of the competition, you don’t know the goal, you can’t respond and react to competitive pressures, and you’ll most certainly make errors during development. Investors will demand a sober assessment of competition.

        Learning Goals

        Become familiar with basic competitive analysis in therapeutics.

         

        Prev Introduction
        Next Development Pipeline Analysis/Competitive Intelligence

        driven logo inverted web

        DRIVEN Accelerator Hub   .   info@drivenacceleratorhub.com   .   NIGMS UT2GM13017

        Founded By

        © 2021 DRIVEN Accelerator Hub. All rights reserved.

        Website by RYCO

        Modal title

        Message modal