- Alexandra Powell-Smith, PhD, Head of regulatory affairs
- Hasnae Niang, Head of Quality
- Thierry Menguy, PhD, Head of CMC activities
- Valérie Bouchara, PhD, Head of clinical operations
Alexandra Powell-Smith, PhD, Head of regulatory affairs
Alexandra has 20 years’ experience in regulatory affairs obtained within pharmaceuticals companies. She has developed and registered drugs on a global scale and acquired in-depth knowledge of sterile injectables. She has successfully devised strategies for the development of pharmaceuticals at all stages of their lifecycle (toxicology, clinical and above all analytical, production, regulatory and commercial), with a view to bringing them to market.
Alexandra holds a doctorate in pharmacy from Paris V University and an Executive MBA in Healthcare Management from IAE Sorbonne Business School.
Hasnae Niang, Head of Quality
Hasnae is a quality specialist with 18 years’ experience within a variety of healthcare industries, including pharmaceuticals, forensic laboratories, CRO, CMO and biotechnology companies (biomarkers, companion diagnostics and IVDs), at companies such as TcLand and Eurofins. Before joining LinKinVax, Hasnae was head of Global Quality at Voisin Consulting Life Sciences. Hasnae holds a DESS graduate diploma in Quality Control and Assurance in gene and cell therapy from Paris XI University, as well as an MBA from Audencia in Responsible management, Innovation and CSR.
Thierry Menguy, PhD, Head of CMC activities
Thierry has over 20 years’ experience in clinical trials and chemistry, manufacturing and controls (CMC) activities, from preclinical stage to stage 3 with therapeutic proteins such as monoclonal antibodies (MABs) and protein and viral vaccines (poxvirus, adenovirus). He has obtained extensive and in-depth knowledge of the pharmaceuticals and biotechnology sectors, notably at Transgène, Elsalys Biotech (which he co-founded in 2013), Biométhodes and Genodyssee, where he successfully led the various stages of development, from devising the R&D strategy to implementation, including managing the outsourced activities of various CDMOs.
Thierry holds a doctorate in Protein Structure, Function and Engineering from Paris-Sud University.
Valérie Bouchara Pomar, PhD, Head of clinical operations
Over nearly 30 years, Valérie has developed solid expertise in clinical research and operational models both in France and abroad, notably at GSK and Amgen, where she held a variety of roles right through to head of clinical operations in France.
Valérie holds a doctorate in pharmacy and completed the Advanced General Management programme at ESSEC business school. Due to her leadership skills, she is a regular speaker at university management programmes.
Thanks to the potential of its technology platform and the advances in its portfolio, LinKinVax aims to make a decisive contribution to the global public health challenges of infectious diseases and cancer.
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LinKinVax press contact:
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About LinKinVax technology
LinKinVax’s vaccine platform is built around a humanized monoclonal antibody, which is merged with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells, DC, which play a key role in stimulating the immune system. The results obtained demonstrate the benefits of this strategy owing to the small quantity of antigens required to activate the immune system, with or without an adjuvant, and its ability to trigger a lasting cellular and humoral and immune response. The platform also benefits from the experience and safety profile of the protein-based vaccines that have been widely used for over 30 years now.
Three products are in or about to enter clinical trials: a prophylactic vaccine for HIV, currently in phase I led by Inserm/ANRS-EID), a SARS-CoV-2 vaccine covering variants of interest, and a therapeutic vaccine for human papillomavirus-related cancers.
LinKinVax was founded in 2020 and is led by two internationally renowned personalities in the worlds of medicine, industry and business, namely André-Jacques Auberton-Hervé, Honorary Chairman and founder of SOITEC, and Prof. Yves Levy, MD, PhD, immunologist, and Director of the Vaccine Research Institute (VRI/INSERM/UPEC). LinKinVax is developing an innovative protein-based vaccine platform that can accelerate availability of vaccines by leveraging the research conducted at the Vaccine Research Institute (VRI). This DC Targeting-based protein vaccine platform can adapt to changes and mutations in the target pathogens. For further information, please visit www.linkinvax.com