Building Portfolio

Current Treatments

DNDi continues to identify and engage partners who share our vision and commitment, and to ensure that a well-balanced pipeline is established for the 3 diseases of primary focus: sleeping sickness (HAT), visceral leishmaniasis (VL), and Chagas disease.

Maintaining a portfolio of projects at all stages of development, DNDi harnesses the expertise of its partners by bringing together all current knowledge and capacities in a coordinated manner. With a strategic approach to identify and to bridge the gaps across the drug development pipeline, DNDi implements its pharmaceutical R&D programmes in collaboration with public and private partners from around world and prioritises its efforts based on the most urgent treatment needs of the targeted patient populations.

DNDi’s portfolio continues to be a mix of projects in-sourced at any stage of the development process, from early discovery through post-registration, with the objective to bring new, field-relevant tools to patients in the shortest time and most efficient way possible. DNDi populates its portfolio by seeking out projects which fall into the following 5 categories, based on the nature of the compound/treatment under consideration and according to its stage of development or expected time to reach patients:

• New drugs from novel compounds identified through screening and lead optimisation
• New drugs from compounds with known antimicrobial/antiparasitic activities (may start at lead optimisation or preclinical development)
• New indications for existing medicines in the field of the most neglected diseases (therapeutic switching)
• Reformulations and combinations better adapted to field conditions (paediatric, long-acting, new route of administration, fixed-dose combinations, co-packaging, or co-administration)
• Existing drugs for target diseases (geographical extension of registration; completion of regulatory dossiers of existing drug candidates)

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 optimisation of drug candidates, decision-making within an organisation, design of clinical research strategies, and constructive communication with regulatory authorities.


Characteristics of a TPP

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?