Entrepreneurship in the territories: is it the right time?
MSF Fondation is looking for two Implementation Microbiologists that will each be responsible for clinical study implementation in one laboratory in Laos.
The MSF Foundation is a specialized entity created by Médecins Sans Frontières (MSF) dedicated to medical innovation targeting patients living in contexts with limited resources. Ongoing projects relate, among other things, to the use of 3D printing to create personalized prostheses; the development of digital tools for epidemic control and surveillance; and the development of a smartphone application using machine learning to streamline and automate antibiotic susceptibility testing: Antibiogo.
The Antibiogo project will contribute to the fight against antibiotic resistance, a major public health concern that is expected to cause 10 million deaths per year by 2050.
Antibiogo is a free, open source, offline Android app, designed for laboratories in low- and middle-income countries (LMIC). It supports non-expert laboratory technicians in measuring and interpreting antimicrobial susceptibility tests (AST or Antibiogram), in order to help doctors, prescribe appropriate antibiotics to their patients and to provide accurate results that can be used for surveillance purposes.
A first version of Antibiogo that was clinically evaluated across three different sites and countries (Jordan, Mali & Senegal) has been CE self-certified since May 2022 (according to the In Vitro-Diagnostic Medical Devices Directive 98/79/EC) as a mobile device application used for the interpretation of antibiograms in resource-limited settings and is being deployed within MSF laboratories.
In parallel, a second version of the app integrating additional features is under development to be submitted for CE-marking according to the new In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. Clinical performance evaluation of this second version will be conducted during the second semester of 2023 in 2 countries: Kenya and Laos.
In Laos, 3 hospital-based microbiology laboratories will take part in the clinical evaluation study, implemented in collaboration with Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU). The implementation phase of the study will include for each laboratory: (i) training of the study team (1 week); (ii) repeatability and reproducibility testing (between 2 and 4 weeks); and (iii) supervision of enrolment of the first clinical isolates (2 weeks).
Within this framework, we are looking for two Implementation Microbiologists that will each be responsible for clinical study implementation in one laboratory in Laos. The Antibiogo Research Coordinator will be based in the 3rd laboratory.
Different teams work in collaboration on Antibiogo under the responsibility of Antibiogo program manager, including the clinical team, the product and development team, and the regulatory & quality insurance team. The Implementation Microbiologists will be part of the clinical team.
Mission
The Implementation Microbiologist will be responsible for implementing Antibiogo clinical evaluation study in one of the 3 participating laboratories in Laos, in accordance with the study protocol and procedures, ethical principles, MSF policy, European regulatory requirements for IVD medical devices, Good Clinical Practice (GCP) and local and international regulations.
The Implementation Microbiologist will be based in the microbiology laboratory. He/she will report to Antibiogo Research Coordinator and will work in close collaboration with LOMWRU and the local co-Principal Investigator.
The main duties of the Implementation Microbiologist will be (non-exhaustive list):
- Together with Antibiogo clinical team, take active part in the one-week initial training that will be organized at LOMWRU for the staffs of the 3 laboratories involved in the study.
- In particular, prepare and provide refresh training to laboratory technicians about Antimicrobial Susceptibility Testing (AST) procedures and reading rules according to EUCAST guidelines.
- In the microbiology laboratory, get a full understanding of the routine sample and data flow and how to best integrate and/or adapt study procedures within the local process.
- Proceed to pre-study start laboratory evaluation.
- Ensure that all needed documents, materials, and reagents are available for the study and stored in appropriate locations and conditions.
- Follow logistical aspects and material supply to the study site if needed.
- Ensure that all required quality controls procedures are in place.
- Complete the initial training with complementary training sessions on AST reading, study procedures and data collection.
- Implement repeatability and reproducibility testing, consisting in repeated AST readings by several laboratory technicians, several times per day for several days; depending on the results in case criteria defined as per regulatory requirements are not met, testing shall be repeated after re-training and until criteria are met.
- Supervise the enrolment of the first clinical isolates in the study and ensure that all procedures from enrolment to data collection are followed smoothly, and that those do not affect the routine process of the laboratory.
- Participate in problem-solving on a daily basis and conduct refresher training if needed.
- Liaise between Antibiogo Research Coordinator, LOMWRU, and the study site; be the local representative of the study team and the privileged partner of the laboratory.
- Participate in the relevant meetings with the study team in Laos and with Antibiogo team.
- Report on a daily basis about study preparation and progress and any relevant information concerning the study to the study co-Principal Investigators.
- Provide weekly written reporting as well as a final activity report to Antibiogo team.
- Travelling to plan between the study sites in Laos.
