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-aroundsTPPs will evolve over time: early stage TPPs are critical, but inherently less precise than later stage profilesValuable insights will come from your critical and clear assessments to identify gaps and areas for further evaluationA 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 1-4Patient Profile - Questions 5-8Regulatory and Legal Planning - Questions 9-12Markets and Commercialization Strategy - Questions 13-16Efficacy and Safety - Questions 17-20Answers are based on your confidence level. Confidence rankings are from 1-10, with 1 being "No Confidence" to 10 being "Highest Confidence". Name 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…)12345678910 2. Indication and Usage Plan - Concise and clear explanation of the unmet need for the patient/provider fulfilled by this therapy.12345678910 3. Indication and Usage Plan - The usage rate (how often doses are needed) and administration of the therapy are consistent with the intended use.12345678910 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.12345678910 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.12345678910 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.12345678910 7. Patient Profile - Accurate measure of target patient population incidence and prevalence of condition indicated in all regions for the commercial plan.12345678910 8. Patient Profile - Protocol identifies appropriate patients in actual clinical practice.12345678910 9. Regulatory and Legal Planning - Identification of the regulatory pathway for the therapeutic asset, aligned with indication plan.12345678910 10. Regulatory and Legal Planning - A clinical and manufacturing plan, including any cooperation with companion diagnostic partners, completed and aligned with regulatory pathway.12345678910 11. Regulatory and Legal Planning - Regional market requirements in the plan for all geographies targeted by the commercial plan.12345678910 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.12345678910 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.12345678910 14. Markets and Commercailization Strategy - Commercial launch dates for all regions consistent with technical, clinical, and regulatory plans.12345678910 15. Markets and Commercailization Strategy - Market analysis including patient incidence and competitive analysis for all targeted regions.12345678910 16. Markets and Commercailization Strategy - Market analysis including patient incidence and competitive analysis for all targeted regions.12345678910 17. Efficacy and Safety - Specifc minimal (comparable to market) and target (market leader) comparison exists with standard of care expectations.12345678910 18. Efficacy and Safety - Measurement scale (test, outcome measurement) plan created. Examples: Cure disease, long-term control of chronic condition, better quality of life.12345678910 19. Efficacy and Safety - Risk/Adverse Event potential analysis completed.12345678910 20. Efficacy and Safety - Treatment duration documented.12345678910 Time is Up!