With strong scientific basis, I manage research and product development in the topic of in vitro diagnostic (IVD) tests:- Manage and organize scientific and technical developments of diagnostic and screening tests developed by the Company, including Colox® Colorectal Cancer Screening Test; Including: . Responsible of global Quality Management System organization; . Responsible and Supervisor of development and regulation processes of Laboratory Developed Tests (LDT),… Show more With strong scientific basis, I manage research and product development in the topic of in vitro diagnostic (IVD) tests:- Manage and organize scientific and technical developments of diagnostic and screening tests developed by the Company, including Colox® Colorectal Cancer Screening Test; Including: . Responsible of global Quality Management System organization; . Responsible and Supervisor of development and regulation processes of Laboratory Developed Tests (LDT), . Organize and Manage technical transfers and workflow implementation for collaborative Medical Laboratories, . Responsible and Supervisor of development, regulation processes, manufacturing and quality control of the CE-IVD products, . Responsible and Supervisor of Technology Follow-up, System and Assay Development of the products, . Supervisor of Product/System Support Program to insure Quality Control with collaborative Medical Laboratories.- Supervise technicians work related to research and product development;- Contribute to every part of research and development activities of the company;- Contribute to business development, global market strategy and corporate strategy of the company;- Contribute to additional products and systems development decision processes;- Take part to clinical development activities of the company (including observational studies, screening studies and cost-effectiveness studies); Show less

Antioxidant Power minimal measurement with O2score System :- Monitor Physiological exercise response, body recovery for Elite Sport People, Wellness and Nutrition programs- Quality control marker after treatments in Platelet Concentrates and Plasma Samples

We bring profitable proof of markets to startups and scale-ups using groundbreaking solutions and business ideas.Mitra’s business system is to ensure we deliver the right innovation, at the right customer, time and again. Our starting point is always to focus on products requirements: this way, we work out what your potential buyers’ true needs are.

“Colox®: A blood based diagnostic test for colorectal cancer screening”As scientist I led and managed research and product development in the topic of diagnostic tests, mainly in the gastroenterology area:- Central role in Product and Assay Development: laboratory and team management, clinical study design and management, CE-IVD regulation for medical device and informatics technologies systems: . Documentation for CE marking according the council directive for In-Vitro… Show more “Colox®: A blood based diagnostic test for colorectal cancer screening”As scientist I led and managed research and product development in the topic of diagnostic tests, mainly in the gastroenterology area:- Central role in Product and Assay Development: laboratory and team management, clinical study design and management, CE-IVD regulation for medical device and informatics technologies systems: . Documentation for CE marking according the council directive for In-Vitro Diagnostic Medical Devices (IVDD) 98/79/EC; . Laboratory staff management and supervision of daily operations, following GLP rules, according the council directive 2004/10/EC; . Experimental design including platform and service provider; . Design History File and Design Control for IVD product development, following FDA Regulation CFR 21 820; . Evaluation and selection, sample set identification, establishment of protocols and SOPs; . Literature review and database mining, final biomarker selection; . Data analysis, such as data quality assessment and data mining, and data interpretation in close collaboration with the biostatistician;- Central role as reviewer for different types of scientific, clinical and regulatory affairs documents: editing, proof Participation as clinical research scientist in large multi-centric clinical studies;- Responsible for scientific communication: technical report writing, conference abstracts, preparation of poster and slide presentations, writing of peer-reviewed scientific articles;- Major contribution to study design (validation, non-inferiority), site selection, vendor identification and selection;- Large contribution to protocol and report drafting, case report form design, analysis plan, data analysis and interpretation, advisory board meeting;- Take part in management of the intellectual property of the company: patent application drafting, freedom to operate searches, trademarks. Show less

"Technical development of a blood-based molecular signature for detection of colorectal cancer: a clinical pilot study"

"HPV vaccination: HPV genotype distribution in high grade lesions (CIN2/3) and cervical cancer in France" - A national study directed by Sanofi Pasteur MSD