Operational support to the clinical development program of a product for infectious diseases (borderline between medical device and drug) :
Management of the First-in-man clinical study, clinical center coordination/supervision
Management of the 2nd clinical study : scientific support, Scientific Steering Committee management

Design of the development strategy and operational support for a company developing products for supportive care in oncology :
Design of the risk management approach, based on the prevention and minimization of the interactions with anticancer therapies
Design of the medical development strategy of several products
Acting as Chief Medical Officer

Design of the early development strategy of a software – diagnosis medical device in respiratory diseases, and operational support :
For the CE mark approval and price/reimbursement dossier (France, Europe, USA)

Design of the early development strategy of a cell therapy product for an orphan disease :
Clarification of the most appropriate regulatory strategy, and design of the early non-clinical and clinical development steps (France, Europe, USA)
Support provided throughout the early steps of the development

Co-founder and member of the management board of ICUREsearch, a privately-held clinical research organization with high level expertise in clinical trials methodology and management

Project evaluation for a private equity – medical advisor at the Scientific Board

Member of the clinical research platform PARTNERS, member of the F-CRIN initiative (French initiative to promote the clinical research in France). This plat-form provides services in clinical research, combining the proactivity, quality and compliance to defined timetables usually displayed by private organizations with the expertise in design and methodology, quality and innovation ability characterizing university-based people.
Design of clinical trials, methodological support including innovative methodology enabling to spare patients, regulatory support, design and writing of clinical trial documents (protocol, study report, safety reports, e-CRF, etc.), clinical trial monitoring, data management and statistical expertise.
Able to conduct clinical trials in various therapeutic fields; specific expertise in paediatrics, rares disease, medical devices. Privileged relationships with F-CRIN investigators networks (more particularly in cardio-vascular diseases, cardio-renal diseases, thrombo-embolic diseases, inflammatory diseases, sepsis).

Training on ISO9001 and ISO13485 norms : design of the training handbook

Training on risk management approch in MD development
Training delivered to quality managers and R&D managers of start-ups from the Medic@lps network

Writing in English of documents associated to Clinical Trials :
  – Synopses, protocols, clinical study reports
+++++included in clinical development support
+++++isolated writing of clinical study protocol, such as a protocol for the European Neuroblastoma group study in very high risk neuroblastoma, or for a study in metastatic Ewing sarcoma (each time, included as co-author)
  – Summary of preclinical or clinical development, clinical investigator brochure
+++++writing of the first clinical investigator brochure of a medical device ;
+++++writing of the clinical investigator brochure under the MD template for a product having a MD status in the US whereas it has a drug status in Europe)
  – Abstracts and presentations for medical congresses, scientific articles

Writing in English of scientific articles for peer-reviewed journals
  – Mainly articles in intensive care and infectious diseases
  – Published by peer-reviewed journals at high impact factors (greater than 4)
  – Various levels of support :
+++++ Basic editorial review of the English writing,
+++++ Translation from French to English,
+++++ Initial writing or editorial in-depth review of the discussion, including bibliography search,
+++++ Full writing of the article, based on study results and protocol, including bibliography search
– Involved in a university team for the training of their students in medical writing of scientific articles
– In 2015, support provided to more than 10 articles submitted to peer-reviewed journals (impact factors greater than 4.8), including several articles fully written from rough results, or with in-depth review or full writing of the discussion

Medical writing of answer to call for projects: PHRC-N, PHRC-K, IMI, etc.
– Letter of intent,
– Full dossier

Writing as co-author
Protocol of a European clinical trial in very high risk neuroblastoma (clinical trial start expected in 2016)
Protocol of a clinical trial in metastatic Ewing sarcoma (start expected in 2016)
Article published in J Clin Pharmacol 2014 and describing a clinical study coordinated by EMIBiotech
Article published by Critical Care 2011

Scientific literature summary
Summary of the scientific literature performed for several projects, as the 1st step of the medical development plan design
Several bibliography summary performed in order to adjust the design of clinical studies, and select the appropriate endpoints