A Target Product Profile (TPP) is a defined series of characteristics which a life sciences product should/must have in order to fulfill the requirements of technical, regulatory, and commercial success.

  • Characteristics include specific measurable targets (e.g., patient population, basis for differentiation) and minimum standards (e.g., regulatory requirements, medical appropriateness)
  • Medical, technical, regulatory, and commercial planning are all involved at early stages to prevent poor approaches and minimize late and costly work-arounds
  • TPPs will evolve over time: early stage TPPs are critical, but inherently less precise than later stage profiles
  • Valuable insights will come from your critical and clear assessments to identify gaps and areas for further evaluation

A comprehensive Target Product Profile provides a critical structure to support efficient and successful product development and commercialization. Does your product development and commercialization contain all the key elements for success?  Take the Kineticos          5-Section/5-Minute TPP Assessment to see if your TPP is up to date and robust enough to support key decisions and resource allocation.

The following sections are included in this assessment:

  • Indication and Usage Plan - Questions 1-4
  • Patient Profile - Questions 5-8
  • Regulatory and Legal Planning - Questions 9-12
  • Markets and Commercialization Strategy - Questions 13-16
  • Efficacy and Safety - Questions 17-20

Answers are based on your confidence level. Confidence rankings are from 1-10, with 1 being "No Confidence" to 10 being "Highest Confidence".

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