Agnès REPRESA TISSERANT

• Expertise, consultancy and support for biotechnology companies throughout the development phases of their drug candidates, from the early research phases (selection of the "lead" candidate) to the clinical trials aimed at registration (phase 3).
• Supervision of the analytical CMC (Physicochemical methods, Biological activity, Contaminants monitoring) and Bioanalytical parts (methods for PK, Immunogenicity and soluble Biomarkers monitoring), critical for the development of drug candidates. From method development to validation in accordance with regulatory requirements.
• Participation in writing regulatory submission dossiers

(EU and US) and in the associated consultations.

• Collaboration with internal and external scientists and experts to share ideas and technical knowledges.
• Quick adaptation to different people and situations.
• Analysis of needs and constraints to provide the most appropriate response.

Management of the multidisciplinary "Analytical, BioAnalytical and Non Clinical Safety" Department, with functional teams, technical platforms experts and project managers: "Analytical Development and Characterization", "Immunoanalysis", "Biomolecular Interactions", "Immunogenicity", "Bioassay" and "Non Clinical Safety".

• Helping to define strategy in the areas of analytical and bioanalytical expertise.
• Supervision of in-house and/or external (CRO) teams in charge of developing CMC analysis methods (release, batch stability monitoring, characterization and batch comparability study) for drug candidates (classical antibodies, multi-specific antibodies or ADCs) : physicochemical methods (UV, SEC, cIEF, CE, PS80, LC/MS, µDSF, nanoDSC, etc.), analysis of contaminants (Endotoxin, Bioburden, Residual protein A and DNA, HCP) and biological activity (LBA (ELISA, SPR) or CBA (ADCC, cytotoxicity, etc.)).
• Supervision of in-house and/or external (CROs) teams in charge of developing bioanalytical methods for Pharmacokinetics (PK), Immunogenicity (ADA, NAb, HCP) and Soluble Biomarkers monitoring, in pre-clinical (in animals) and clinical (in humans) for various drug candidates (classical antibodies, multi-specific antibodies or ADCs).
• Supervision of the methods qualification and/or validation (CROs) in accordance with GMP and GLP (GLP and GCLP) regulatory requirements.
• Review of protocols and reports for analytical and bioanalytical methods development, validation and product characterization.
• Contribution to the writing of regulatory documentation (EU and US) for analytical and bioanalytical aspects.
• Contribution to the preparation of pre-clinical development plans (toxicology studies in the relevant species (rodent and/or primate)).
• Supervision of the Non Clinical Safety project leader.
• Schedule of regular team meetings to monitor project progress and solve potential problems.
• Supervision of the allocation of resources in line with strategic objectives and schedule of work with team managers and experts, prioritizing tasks in order to meet expectations, budget and timelines.
• Management of the human resources of the Department in accordance with internal procedures and regulations (recruitment, absence management, annual and professional interviews). Training and development of staff skills, implementation of technical performance improvement strategies to ensure maximum efficiency.
• Management of analytical and bioanalytical subcontractors: sourcing, requesting quotes, monitoring work, quality control, invoicing.
• Constant technological monitoring to keep up to date on new approaches and improve efficiency by proposing innovative and appropriate solutions. Participation in international conferences in the analytical and bioanalytical fields.
• Establishment of good team cohesion and a collaborative mindset through cross-functional work within the Department and with the other company's Departments, to improve efficiency, responsiveness and fluidity.

• Responsible for the production of monoclonal antibodies in ascites (mice) and their purification.
• Production of cleaved forms of antibodies (F(ab)'2 or Fab fragments) and their purification.
• Responsible for: coupling antibodies to various fluorophores (Phycoerythrin (PE), Fluorescein (FITC)), biotinylation and tetramerisation of antibodies.
• Responsible for quality control of the proteins produced: Analytical liquid chromatography, Electrophoresis, Western blot, IEF, UV, Endotoxin assay.
• Development of immunoanalysis methods for monitoring pharmacokinetics (PK) in animals and humans.
• Training and supervision of technicians.