Activity Update: January 2017 – May 2017

 

GARDP has, within its first year, built up a team of 10 people with additional support staff from DNDi contributing directly to GARDP programmes. Recruitment is underway for a new Scientific Director.

GARDP 2017-2023 business plan

GARDP has finalized its first seven-year business plan, which outlines the overall R&D strategy, prioritization process, and sustainable access approach, and notably serves as a roadmap for its concrete R&D programmes for the coming years.

R&D programmes

An official Scientific Advisory Committee (SAC) has now been approved by the DNDi Board of Directors (GARDP’s governing body). This committee of experts in drug-resistant infections and in drug discovery and development advises on GARDP programmes and projects. The advice from the GARDP SAC is brought to the DNDi Board of Directors for validation. For a list of initial scientific advisors to GARDP, see the Business Plan above.


Progress made over the past 5 months on GARDP R&D programmes is as follows:

 

Neonatal Sepsis

While significant achievements have been made in reducing mortality in children under age five, mortality remains a burden in children less than one month of age with antimicrobial resistance posing a particular threat. This programme aims to develop and deliver a new first-line treatment for pathogens causing neonatal sepsis as well as a new treatment for confirmed multidrug-resistant pathogens. Two target product profiles (TPPs) have been generated to guide the development of the new treatments.

Status:

  • The Programme is ready for launch- strategy approved; first study reviewed by scientific advisors; on target to start pharmacokinetic and observational studies by end 2017/early 2018; stewardship and access plan under development and programme strategy to be published.

Antimicrobial Memory Recovery Programme

With the disengagement from antibiotic R&D of many of the large pharmaceutical actors, much of the knowledge and material resources that were part of the ‘golden era’ of antibiotic drug discovery and development have been forsaken. The Antimicrobial Memory Recovery Programme aims to recover the knowledge, contacts, data, and assets of forgotten, abandoned, or withdrawn antibiotics as a ‘bridging’ measure while the search for new classes of antibiotics is being pursued and while, hopefully, a new generation of researchers in antibiotic R&D is stimulated and rebuilt.

Status:

  • The Programme portal slated for launch in September 2017 at ASM/ESCMID Conference, Boston, USA – over 400 experts identified and 130 engaged to participate; five companies engaged with 16 molecules identified; key collaborations being built with CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), The Pew Charitable Trusts, and The Advanced Course on Antibiotics (AdCAb) co-organized by the Fondation Mérieux and Institut Pasteur.

Sexually transmitted infections

Over the past few years, serious concerns have been raised globally over the spread of resistant gonorrhoea. Neisseria gonorrhoeae is threatening to soon become untreatable due to its resistance to all available classes of available antimicrobials. This programme will seek to develop and deliver two new treatments for gonorrhoea patients with drug-resistant infections by combining existing antibiotics and by exploring new antibiotics that are already in development. Two target product profiles have been developed to guide the project.

Status:

  • The Programme is ready for launch (July 2017) and the strategy is soon to be published; preparatory work and negotiations have been conducted on potential new drug.

Paediatric Antibiotic Platform

This programme aims to establish a platform to optimize current and new antibiotics for children through improvements in dose, duration, formulation or through combinations based on the gap analysis that will be undertaken with WHO. Depending on the outputs of the initial scoping exercise to be undertaken throughout 2017, approximately two projects are anticipated.

Status:

  • Exploratory work is being undertaken with key stakeholders, including MSF, with initial gap and opportunity analysis under way; draft programme is under review.

 

Contact:

  • GARDP/DNDi: Gabrielle Landry, External Affairs, GARDP, glandry@dndi.org
  • WHO: Peter Beyer, Senior Advisor, beyerp@who.int