Pierre-Louis Bardonnet. Pharm.D., Ph.D. Email & Phone Number

Bagsværd, Dk

Principal Scientist:• Subject matter expert for oral formulation of macromolecules (proteins, peptides, nanobodies, affibodies, semaglutide, insulin, GLP-1 analogue) containing or not permeation enhancers, with focus on diabetes, obesity, and haemophilia.• Participate in projects progression with a highly business strategic fit, global mindset and cross-functional focus.• Design, execute and conclude on experiments in alignment with project plans and results.• Collaborate with and supervise laboratory Technicians.Project Manager of Oral Formulation project for delivery of macromolecules:• Direct management of 10 team members and transversal management of numerous FTE trough Analytical, Characterization, Pharmacology, Large animals, Histopathology, Screening and Bioassay departments.• Responsible for Initiating, Planning, Executing, Monitoring and Organising the project. • Responsible for Resources, Budget and Coordination with stakeholders (internal & external).Drug Product Coordinator for Oral Formulation project (biologics and small molecules):• Secure and coordinate project activities to progress in agreement with the Project and alignment with Line of Business.• Coordinate biophysical screening to ensure early assessment of molecular formats and developability potential of lead candidate.• Evaluate need for biophysical characterisation of tool molecules to ensure high quality API.• Secure development of fit-for-purpose formulation.• Communicate regarding the project within and across the department, as well as with Line of Business.• Bring forward technical issues and recommendations to the Project and relevant Line of Business.• Ensure CMC DP transfer and participate in CMC transfer teams.• Ensure fit-for-purpose documentation supporting IP & Regulatory strategy.

Brentford, Middlesex, Gb

• Lead complex global projects across multiple areas for the “Pain Relief” products, from product conception to commercialisation (End-to-End process). Accountable for Analytical, Formulation, Manufacturing, Environment Health & Safety, Medical Affair, Microbiology, Packaging, Regulatory, Quality and Toxicology deliverables. • Lead a team of R&D Scientists as well as Regulatory, CMC, Medical Affair, Clinical and Safety. Manage overall work priorities and ensure team activities are in accordance with company standards and regulations, taking into account scientific, budgetary and timing objectives. Key achievements:• Managed a world-wide team (13 people in 5 countries) for the launch of a fixed-dose combination of oral solid dosage form, across multiple functions. • Led a team of experts, including external partner (7 people in 4 countries) to develop a fast disintegrating direct compressible paracetamol tablet (Panadol Advance®) aiming to save up to 40% of manufacturing cost. Established a successful proof of concept at pilot scale with 6 months stability data meeting both quality attributes and manufacturing constraints (e.g. supply chain, COGs).• Supported and coached less experienced team members, both in their day to day operations and development plans. Gave more than 10 courses on pharmaceutical technologies.

St. Gallen, Switzerland, Ch

Besides formulation scientist activities: • Lead project teams for technical projects; interact and coordinate project activities with internal and external stakeholders; schedule timelines and project development activities according to the company goals. • Provide support to regulatory, CMC, quality, production and process validation according to current regulatory requirements.Key achievements:• Successfully led the scale-up (4 & 5 times increase) and technical transfer for freeze-drying and sizing processes of 2 biological products (Uro-Vaxom® & Broncho-Vaxom®). • Developed and registered (in Switzerland & Turkey) a tablet obtained by direct compression (Doxium 1000®).• Led a 5 years project involving 3 sites and 7 departments, allowing the company to secure critical business with climatic zone IVb countries.

Meyrin, Geneva, Ch

- In charge of formulation for various pharmaceutical dosage forms.- Responsible of pre-formulation, formulation, development and optimization of the manufacturing process. - Primary packaging selection.- Preparation and reviewing of SOPs, protocols, CTD and scientific reports.- Preparation and monitoring of stability protocols according to ICH guidelines.- Evaluation of the stability results of formulation prototypes and industrial scale batches.

Villeurbanne, Fr

- Lecturer and teacher for the pharmaceutical technology practical labs for undergraduates. - Ph.D. Thesis : "Formulation and characterization of synthetic glycolipids-loaded liposomes to target Helicobacter pylori”.- Liposomes formulation.- Physico-chemical characterization of synthetic glycolipids-loaded liposomes. - Helicobacter pylori characterization, growth, and interaction with glycolipids-loaded liposomes.International oral communications:P.L. Bardonnet, 1ère Journée de l’arc alpin, Pharmapeptides, Archamps (France), 24th of November 2006. Oral communication.P.L. Bardonnet, V. Faivre, F. Pirot, P. Boullanger, F. Falson, 5th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology in Geneva (Switzerland), March 27-30, 2006. Poster session.P.L. Bardonnet, V. Faivre, F. Pirot, P. Boullanger, F. Falson, 18th Annual Meeting of the G.T.R.V. in Lille (France), December 11-12, 2003. Poster session.

Villeurbanne, Fr

Ph.D.Thesis

Leading Digital Business Transformation

Ph.D., Pharmacy

Ph.D., Pharmacy

Dea/Master, Pharmacotechnie Et Biopharmacie

Pharm.D., Pharmacy

Master'S Degree, Biomedical & Medical Science