Take the Kineticos 5-Section/5-Minute TPP Assessment to see if your TPP supports all the critical and timely decisions necessary to take your therapeutic asset from early discovery to successful launch.

The following sections are included in this assessment:

  • INDICATION & USAGE PLAN - Questions 1-4
  • PATIENT PROFILE - Questions 5-8
  • REGULATORY & LEGAL PLANNING - Questions 9-12
  • MARKETS & COMMERCIALIZATION STRATEGY - Questions 13-16
  • EFFICACY & 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".

Name
1. INDICATION & 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 & USAGE PLAN - Concise and clear explanation of the unmet need for the patient/provider fulfilled by this therapy.
3. INDICATION & USAGE PLAN - The usage rate (how often doses are needed) and administration of the therapy are consistent with the intended use.
4. INDICATION & 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.
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.
9. REGULATORY & LEGAL PLANNING - Identification of the regulatory pathway for the therapeutic asset, aligned with indication plan.
10. REGULATORY & LEGAL PLANNING - A clinical and manufacturing plan, including any cooperation with companion diagnostic partners,  completed and aligned with regulatory pathway.
11. REGULATORY & LEGAL PLANNING - Regional market requirements in the plan for all geographies targeted by the commercial plan.
12. REGULATORY & LEGAL PLANNING - Any Patent/IP issues known and accounted for and leading to Freedom to Operate in all regions for the commercial plan.
13. MARKETS & COMMERCIALIZATION STRATEGY - Value proposition supports intended use for all stakeholders (patient, provider, payer) and is a basis of differentiation from current standard of care.
14. MARKETS & COMMERCIALIZATION STRATEGY  - Commercial launch dates for all regions consistent with technical, clinical, and regulatory plans.
15. MARKETS & COMMERCIALIZATION STRATEGY  - Market analysis including patient incidence and competitive analysis for all targeted regions.
16. MARKETS & COMMERCIALIZATION STRATEGY  - Market analysis including patient incidence and competitive analysis for all targeted regions.
17. EFFICACY & SAFETY - Specifc minimal (comparable to market) and target (market leader) comparison exists with standard of care expectations.
18. EFFICACY & SAFETY - Measurement scale (test, outcome measurement) plan created. Examples: Cure disease, long-term control of chronic condition, better quality of life.
19. EFFICACY & SAFETY - Risk/Adverse Event potential analysis completed.
20. EFFICACY & SAFETY - Treatment duration documented.