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".

1. Indication and Usage Plan - Clear intended use statement for the therapeutic asset, including anticipated indication pathway through time (e.g., 3rd line, then 2nd line…)
2. Indication and Usage Plan - Concise and clear explanation of the unmet need for the patient/provider fulfilled by this therapy.
3. Indication and Usage Plan - The usage rate (how often doses are needed) and administration of the therapy are consistent with the intended use.
4. Indication and Usage Plan - Indication and usage plan consistent with defined minimum (base approval level) and target (market leader) efficacy and safety criteria is established for each patient sub-type.
1 out of 5
5. Patient Profile - Clear identification of appropriate patients, and stage of disease, and who should use therapy consistent with indication plan. Characteristics of this patient set is complete and unambiguous.
6. Patient Profile - Current gap in treatments or unmet medical need being addressed for this patient group. Use and dosage form appropriate for this patient population.
7. Patient Profile - Accurate measure of target patient population incidence and prevalence of condition indicated in all regions for the commercial plan.
8. Patient Profile - Protocol identifies appropriate patients in actual clinical practice.
2 out of 5
9. Regulatory and Legal Planning - Identification of the regulatory pathway for the therapeutic asset, aligned with indication plan.
10. Regulatory and Legal Planning - A clinical and manufacturing plan, including any cooperation with companion diagnostic partners,  completed and aligned with regulatory pathway.
11. Regulatory and Legal Planning - Regional market requirements in the plan for all geographies targeted by the commercial plan.
12. Regulatory and Legal Planning - Any Patent/IP issues known and accounted for and leading to Freedom to Operate in all regions for the commercial plan.
3 out of 5
13. Markets and Commercailization Strategy - Value proposition supports intended use for all stakeholders (patient, provider, payer) and is a basis of differentation from current standard of care.
14. Markets and Commercailization Strategy - Commercial launch dates for all regions consistent with technical, clinical, and regulatory plans.
15. Markets and Commercailization Strategy - Market analysis including patient incidence and competitive analysis for all targeted regions.
16. Markets and Commercailization Strategy - Market analysis including patient incidence and competitive analysis for all targeted regions.
4 out of 5
17. Efficacy and Safety - Specifc minimal (comparable to market) and target (market leader) comparison exists with standard of care expectations.
18. Efficacy and Safety - Measurement scale (test, outcome measurement) plan created. Examples: Cure disease, long-term control of chronic condition, better quality of life.
19. Efficacy and Safety - Risk/Adverse Event potential analysis completed.
20. Efficacy and Safety - Treatment duration documented.
5 out of 5