Interview with Claire Meunier
Claire Meunier, Pharmaceutical project manager at the Institut Pasteur Paris, involved in the pre-clinical development workstream (work package 6).
Work package description – what does your work package do overall within ERA4TB
With my colleague at iM4TB, we are working on CMC (Chemistry, Manufacturing and Controls) and pharmaceutical development.
The aim of this WP is to carry out regulatory studies to complete the research analysis and development to enable the compounds to enter Phase I or to support Phase II.
All the studies are outsourced, so we collaborate with validated external partners to carry out the requested studies.
Thanks to our network of subcontractors, we can carry out a broad panel of preclinical studies (non-GLP and GLP) both in-vitro and in-vivo i.e.: DMPK, DDI, dose range finding, single or repeated dose toxicology studies, safety pharmacology studies (CNS, respiratory safety, cardiovascular safety).
We are also able to carry out work on drug substance and drug product, from scratch or to improve current processes. This includes characterization, route scouting, formulations, scale up, development of analytical methods, production of GMP batch, stability studies, ….
We are doing our best to meet the needs of the molecule owners.
Length of time working on ERA4TB
I started working on ERA4TB in January 2020, at the beginning of the project.
Outline your background before joining ERA4TB e.g., previous job roles, areas of research, education
I am a pharmacist by training. Before joining Institut Pasteur I was project manager in a French pharmaceutical company, in the south of France; for 4 years.
Tell us about your role within ERA4TB
For pre-clinical development, I take care of the compounds that enter the pipeline and need preclinical studies. I discuss with the molecule owners to well understand their requirements and the timelines. Then, I contact subcontractors to find the best study proposition, based on requirements, timelines, and costs. When the Steering Committee approve our selection, I can finalize the service agreement that will cover the work. Finally, I follow up the study until the final rapport is obtained.
For Institut Pasteur Paris, I act as a link between our different teams and support them for the administrative tasks. And in January 2023, I organized the CM in Paris!
Who do you collaborate most with in ERA4TB?
As we are working on out-sourced studies, we work most closely with the molecule owners and our external partners. We have many interactions with them to define exactly which studies are required (the parameters, the legal framework) and to analyse the proposals in order to determine which one best suit their needs.
The deliverables of our studies are very different from those of the other WPs. In 2022, we had a lot of discussions with WP1 to set up a template to upload the study report into the database.
We also share with the ethics committee certificates of our subcontractors, for the studies carry out on in-vivo models.
We are also member of the Ethics Advisory Board (EAB) and give our opinion on ethical questions when required
From your point of view, what are ERA4TB’s key achievements to date?
The key achievements to date are:
- The development of new models (NHP), devices and experiments.
- The work done in collaboration between WPs to optimize the experiments.
From my point of view and from what I heard during the consortium meeting, having a work package dedicated to modelling is very useful and a great support for the other work packages (WP2, WP3)
Why is the ERA4TB important?
Globally, this project is a great opportunity to put together people from different backgrounds. This creates a great emulation to move forward in the development of new drugs and new techniques. Working in collaboration is always very beneficial and come to fruition
What would you like both yourself and the ERA4TB project as a whole to achieve by the end of the project?
Find new compounds or new combinations that are active against TB and MTB and that are perfectly safe for patients. Develop new experiments to study the effect of new drug on TB.
In what ways, if any, has being involved in ERA4TB been beneficial for you and your career, and what have you most enjoyed about being part of the project?
The project gave me a wonderful opportunity to work with partners from different backgrounds and expertise. It is very instructive to see the whole development of a new compound. I also learn a lot on TB and on in-vitro and in-vivo profiling.
Outside of work what do you enjoy doing?
I like to spend time with my family and my friends all around France. I also practice sport (gymnastics, running, surfing, swimming). I love sewing clothes for my family, my friends and me.