A public health oriented scientific strategy
Building on DNDi’s experience in developing an R&D pipeline for neglected diseases, GARDP’s strategy for antibiotic drug development comprises a mix of short- and long-term approaches. GARDP will focus on drug-resistant bacterial infections, including serious infections for which adequate treatment is not available. Bacterial infections are spread globally, so GARDP will maintain a global focus, including attention to the needs of low- and middle-income countries.
Short- to medium-term strategy
GARDP identifies and builds on short-term opportunities to help improve and extend the use of existing antibiotics and accelerate the entry of pipeline products for relevant public health needs. This also serves as a ‘bridge’ until novel antibiotics become available.
GARDP will explore and advance early-stage, needs-based R&D activities unpursued by other actors. GARDP will employ a portfolio approach, ensuring that projects begin with the end-goal in mind and are driven by target product profiles that define the key characteristics for a treatment and keep patients’ needs at the centre of decision making. GARDP will implement comprehensive programmes, each comprising specific projects that may start at any stage of the R&D pipeline – from discovery to implementation. Projects will be pushed through the pipeline until treatments reach patients.
GARDP will consider whether there is a valid entry point for an identified priority based on three major types of interventions. The choice of these interventions is based on consultation with external stakeholders and DNDi’s experience over the last 13 years.
- Optimizing the use of antibiotics by improving dosing, treatment duration, formulation, drug repurposing, and new combinations (with old, new, and non-antibiotics) to improve treatment for important and drug-resistant bacterial infections.
- Accelerating, re-starting, and recovering the development of new and abandoned drug candidates that address public health priorities and vulnerable populations (e.g. people living with sexually-transmitted infections (STIs), newborns).
- Exploring novel and innovative drug development approaches with a longer-term view towards meeting patients’ needs.
Portfolio selection process for initial business plan
At the heart of the portfolio selection process are Target Product Profiles (TPPs) which provide an overview of the ideal characteristics of a treatment or product being considered for inclusion into the GARDP portfolio. They guide the development, use, and impact of a product or treatment. They are also an important tool in go/no-go decision-making within a programme.
Guided TPPs are developed very early in the lifetime of every GARDP programme to manage the specific project and required work, serve as a communication tool internally and to the outside, and play a key role in discussions with regulatory bodies.