Selecting for success in the field: The Target Product Profile

As a prerequisite to building a portfolio strategy, the desired R&D outcome for each disease is defined as the target product profile (TPP). Each R&D project in the portfolio is selected, progressed, and managed according to well-defined decision matrices based on these TPPs.

Used properly, the TPP can play a central role in the entire drug discovery and development process. This role includes effective optimization of drug candidates, decision-making within an organization, design of clinical research strategies, and constructive communication with regulatory authorities.

 

Characteristics of a Target Product Profile

  • Indications: Which diseases?
  • Population: Which patients and where?
  • Clinical Efficacy: Does it kill the parasite effectively?
  • Safety and Tolerability: What kind and how many adverse events?
  • Stability: How long can it be stored in the field?
  • Route of Administration: How is it given to patients?
  • Dosing Frequency: How often and how long must it be given?
  • Cost: Will it be affordable to target population?
  • Time to Availability: How long will it take to develop?

 

DNDi Target Product Profiles