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
- Sleeping Sickness (Human African Trypanosomiasis)
- Visceral Leishmaniasis
- Cutaneous Leishmaniasis
- Chagas Disease