Lucile has 20 years of experience in diagnostic and biological (genetics) fields, including product/assay design and development, technical expertise, clinical validation and clinical interpretation of data and test results.

Lucile gained experience in In Vitro Diagnostic (IVD) product development, specifically laboratory-developed tests (LDTs), in clinical laboratories located in the United States. During this time, she designed infectious disease molecular diagnostic (MDx) and pharmacogenetics tests, developed clinical contents and was responsible for the clinical interpretation of test results. She also trained clinical and sales teams on the scientific, clinical and technical aspects of the LDTs.

Lucile served as the Project Lead in multiple R&D projects where she designed and led several gene-editing projects. She also managed internal and client in vivo studies for a biotechnology company in France before joining NAMSA.

Lucile holds a BSc degree in Cell Biology and an MSc & PhD in Developmental Biology from Mediterranee University (Marseille, France). She also performed postdoctoral training in cardiovascular research at University of California (San Diego, CA). She successfully secured five fellowships and won two awards for her academic research (Thesis price from Mediterranean University and The Children’s Heart Foundation Research Award)..

CORE COMPETENCIES

• High knowledge with EU regulatory requirements
• Diagnostic expertise in MDx, infectious disease (respiratory, COVID-19, Strep A, etc.), antimicrobial resistance, hematology and oncology screening for colorectal cancer
• Medical and scientific writing (regulatory and scientific manuscripts)
• Design and conduct of systematic literature searches (Pubmed, Embase), critical appraisal, clinical data extraction and review of scientific literature
• Support for addressing non-conformities of IVD technical files (PER) from Notified Body audits
• Development of templates, work instructions and Standard Operating Procedures (SOPs) for performance evaluation
• U.S. Laboratory Developed Tests (LDTs) design, deployment and maintenance
• MDx assays (LC/MS-MS, lateral flow assay, ELISA, RT-PCR, etc.) and molecular biology scientific techniques

RECENT PROJECTS

• Performance Evaluation Report (PER) for multiple IVDR technical dossiers (Performance Evaluation Plan [PEP] and PER) assisting clients as they transitioned from IVDD to IVDR
• Scientific manuscript writing for a clinical study on an oncology IVD
• Preparation and review of CERs to MDR requirements

PUBLICATIONS

• Bertrand, N, Roux, M, Ryckebüsch, L, Niederreither, K, Dollé, P, Moon, A, Capecchi, M & Zaffran, S 2011, ‘Hox genes define distinct progenitor sub-domains within the second heart field’, Developmental biology, vol. 353, no. 2, pp. 266–274.
• El Robrini, N, Etchevers, HC, Ryckebüsch, L, Faure, E, Eudes, N, Niederreither, K, Zaffran, S & Bertrand, N 2016, ‘Cardiac outflow morphogenesis depends on effects of retinoic acid signaling on multiple cell lineages’, Developmental dynamics : an official publication of the American Association of Anatomists, vol. 245, no. 3, pp. 388–401.
• Ryckebüsch, L 2015, ‘Le poisson zèbre – Un modèle d’étude des dystrophies musculaires congénitales’, Medecine sciences : M/S, vol. 31, no. 10, pp. 912–919.
• Ryckebüsch, L, Bertrand, N, Mesbah, K, Bajolle, F, Niederreither, K, Kelly, RG & Zaffran, S 2010, ‘Decreased levels of embryonic retinoic acid synthesis accelerate recovery from arterial growth delay in a mouse model of DiGeorge syndrome’, Circulation research, vol. 106, no. 4, pp. 686–694.
• Ryckebüsch, L, Hernandez, L, Wang, C, Phan, J & Yelon, D 2016, ‘Tmem2 regulates cell-matrix interactions that are essential for muscle fiber attachment’, Development (Cambridge, England), vol. 143, no. 16, pp. 2965–2972.
• Ryckebusch, L, Wang, Z, Bertrand, N, Lin, S-C, Chi, X, Schwartz, R, Zaffran, S & Niederreither, K 2008, ‘Retinoic acid deficiency alters second heart field formation’, Proceedings of the National Academy of Sciences of the United States of America, vol. 105, no. 8, pp. 2913–2918.
• Totong, R, Schell, T, Lescroart, F, Ryckebüsch, L, Lin, Y-F, Zygmunt, T, Herwig, L, Krudewig, A, Gershoony, D, Belting, H-G, Affolter, M, Torres-Vázquez, J & Yelon, D 2011, ‘The novel transmembrane protein Tmem2 is essential for coordination of myocardial and endocardial morphogenesis’, Development (Cambridge, England), vol. 138, no. 19, pp. 4199–4205.