nicolas ponroy

Manager Post-Marketing Study / Clinical Evaluation at BioHorizons Camlog Global
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Contact Information
us****@****om
(386) 825-5501
Location
CH
Languages
  • English Full professional proficiency
  • Français Native or bilingual proficiency
  • Allemand Limited working proficiency

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Experience

    • Switzerland
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Manager Post-Marketing Study / Clinical Evaluation
      • Sep 2018 - Present

    • Medical Device
    • 1 - 100 Employee
    • Product Development Specialist
      • May 2014 - Jun 2017

      How can we help improving the diagnostic of infectious disease? What are the unmeet needs to answer that will ultimately benefits to the patients? The diagnostic of bacterial and fungal infections still relies on methods that are up to 100 years old! By introducing molecular biology for the diagnostic of infectious diseases we want to provide truly actionable information to medical doctors within the critical window of opportunity to have to treat efficiently and accurately. By shifting the diagnostic approach from a single “trial and error” testing to a multiplexing approach, we can determine: - the identification of the causative agents of the pathology - together with the type of antibiotic the pathogen is potentially resistant. - within a single assay in less than 4 hours. Among Hutman Diagnostics, my role focuses on the market and the customer questions. In close interaction with key opinion leaders, clinicians and diagnostic laboratory personal I am working to identify their unmeet needs and to support the development of the best solution to answer them. The translation of the Voice of the Customer into customer then product requirements is conducted taking into account our regulatory environment (ISO13485, CE-IVD), and extensive competitive intelligence and market analysis. Finally, while supporting the scientific team and the regulatory affairs during the phase of development and verification, I design and organize the clinical validation studies required for the CE-IVD approval of a product’ intended use and to support the market launch. The cross-functionality of Hutman’s team is the key to succeed developing IVD solutions that could truly impact positively the patients’ management. Show less

    • Switzerland
    • Higher Education
    • 700 & Above Employee
    • Ph.D. in Medical Virology
      • Oct 2009 - Jan 2014

      All around us, people are infected with the human cytomegalovirus (HCMV). Many of us just don’t know it. HCMV infection results in a persistent, but asymptomatic infection, and up to 80% of the population harbor the disease by the age of 70. Inflammation of the arterial wall, typically because of hypercholesterolemia, trigger HCMV reactivation within the artery cells. This contributes to atherosclerosis, an inflammatory disorder that results arterial thickening and calcification. Which is responsible for the majority of cardiovascular diseases today. Statins, the major family of cholesterol-lowering drugs, stop the development of atherosclerosis. Interestingly, statins also display anti-viral effects. Within my PhD I evaluated which statins have anti-HCMV activity in human endothelial cells, the cells that form the arteries wall. I also gained understanding of how statins prevent HCMV replication and examined the potential benefits of this “side-effect” of the drug. For example when used in a combination treatment with specific anti-viral drugs, and for the treatment of resistant viral strains. These findings were published and described in the reference below. Ultimately, they provide new insight into the mechanism utilized by statins to stop the development of atherosclerosis, and open new potential targets for the management of active CMV disease. Show less

    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Tools Coordinator Clinical Operations
      • Apr 2008 - Jun 2009

      The approval of a novel drug by the health authorities does not end the clinical investigation. On the contrary following the market launch, medical affairs start so-called “post-marketing studies” to continue collecting insight on safety and investigate for extension of the intended use. Among sanofi aventis, these studies are organized by the clinical operations of the Global Medical Affairs. All are referenced in a common database, used to track the study status in all the subsidiaries worldwide. The challenge of such database relies on the accuracy of the information. In other word, data should only be entered once to reduce the risk of errors. As part of the IT support team for the clinical operations, we improved the current database by successfully integrating a Clinical Trial Monitoring System. I implement the user requirements to develop a fully integrated and user-friendly system, with a strong focus on a single data entry principle. Following the successful validation, we launched the new system together with an efficient training program for the users. This include an e-learning module, to ensure the success of this upgraded tool and a high level of compliance for the future. Show less

Education

  • Universität Zürich
    Doctor of Philosophy (Ph.D.)
    2009 - 2013
  • École de Biologie Industrielle
    Master of Science and Engineering Degree
    2002 - 2007

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