Kevin Lenders

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Kevin Lenders, born in 1983 in Belgium, obtained his Master’s Degree in Biomedical Sciences at the University of Antwerp. He delivered a Master Thesis for Neurochemistry & Behaviour covering the phenotype of depression-related symptoms in a transgenic mouse model for Alzheimer’s disease. Straight after his studies he started working at AML (in Antwerp), a clinical diagnostic laboratory for human and veterinary samples. He performed Immunological assays and specialized in Flow Cytometry. With this acquired know-how he returned to the University of Antwerp and started working as a Junior Scientist & Cell Manipulator for the Laboratory of Experimental Hematology of Prof. Van Tendeloo & Prof. Berneman which was part of the consortium VAXINFECTIO (cfr. Prof. Van Damme, member of the Board of Directors of Novosanis). Here he worked for several vaccination studies (for example HepB, VZV or HPV) optimizing the cryopreservation, cryotransportation & T-cell and B-cell immunology (pre-vaccination versus post-vaccination) using ELISPOT, ELISA and Flowcytometry techniques. Furthermore he started the bioluminescence tracking of tumor cells in a mouse model.

After more than 5 years academic career he made the switch to the private sector and started at the Regulatory Affairs Department of a Veterinary Pharmaceutical Company (KELA N.V., Hoogstraten) where he was in charge of the registration of generic pharmaceuticals, cosmetics, detergents, feed supplements and herbal products primarily in Latin-American countries (LATAM like Mexico, Brazil, Chile and Central-American countries), secondary in Asian (ASEAN like Thailand, Vietnam, Malaysia…but also Korea and Pakistan) and Eurasian countries (Russia, Belarus, Ukraine, Uzbekistan, Kazakhstan,…) as well as non-EU countries like Albania and Serbia.

In the summer of 2017 he joined the Novosanis team as Regulatory Affairs Manager to obtain CE-marking (EU) and FDA registrations and/or listings (USA) for all the Novosanis products and to extrapolate the registrations on a more global level entering submission files in Latin-American, Asian and Middle-Eastern countries so Novosanis can expand the potential markets of their products. The RA Manager is involved in RA Strategy, RA Intelligence and follow-up of the registration portfolio, RA networking, writing of technical and clinical registration files, liaise with the competent authorities of the different countries, laws and guidelines of packaging, labeling, transportation and clearance of the products and shipments. The RA Manager is involved in Risk Assessment of the products and is single point of contact (SPOC) for Post-Market Surveillance.