Anthony Bussiere Email & Phone Number

Geneva, Switzerland

-New pharma products development, including biologics nasal & oral dosage forms-Technical expertise of CMC activities-Management of manufacturing operations, including investigational product-Preparation of development timelines and budget, assessment of CDMO sites-Writing of IMPD / CTD

OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases

Geneva Area, Switzerland

o Pharma Development of oral and injectable dosage forms:-Projects management and CMC with API suppliers (small molecules incl. highly potent drugs & peptides), FP manufacturers (CDMO) and Analytical labs in an international environment-Dev of APIs and FP formulas and manuf. processes acc. regulations (ICH, EU, US) for solid, topical, injectable (incl. prefilled-syringe & highly potent)-Dev strategy definition through writing QTPP/ risk assessm./ request for quote-Preparation of dev timeline and budget, project team coordination, assessment of CDMO sites & technical offers-Writing of tech supportive docs/ protocols/ reports: Galenic, Process scale-up & validation, Tech transfer, Analytical validation & transfer, Stability, Patent research-Technical expertise incl. extraction, chrom. purification, photochemistry, granulation, tableting, coating, spray-drying, filtration, sterility, analytical-Writing of CTD (Modules 2 & 3) + Lifecycle (updates, variations)-Preparation of replies to Health agencies questions-Technical support: change controls, investigations, CAPA-GMP auditoro Management of CMC activities for Consumer Health projects (Food suppl., Medical device)-Dev of herbal extracts, animal protein ingredient, FP formulas (coated/ orodispersible/effervescent tablet, chewing gum, capsule-in-capsule), and of manuf processes acc. regulations for Medical device (EU MDR) or Food supplement (EU, ISO 22 000, FDA cGMP, ANVISA)-Preparation of replies to Health agencies questions (EFSA Novel Food procedure)-Design of in vitro and clinical protocols with CRO, incl. management of investigational supplies-Setting up the initial organization of Consumer Health activity at Stragen from 2011o Tech Responsible of New product development & evaluation:-Coordination of internal committees with Stragen Top Management & Experts-Design and proposals of generics/ hybrids / consumer health products (formula, proof of concepts & mechanisms of action, market positioning)

Gaillard, France

Bayer Healthcare -InternationalTechnicalCenter, Galenic unit-Formulation of liquid forms (solution, emulsion, microemulsion), Optimization and process scale-up

France

Research team « UMR CNRS 8612: Drug targeting and delivery of poorly stable active drugs ». Project: new cyclodextrin-based dosage form.Characterization of the dosage form including dissolution and use of FaSSIF and FeSSIF media

Malta

Pharmacy and Clinical units: medicines dispensation, implementation of a stock inventory

France

- Pediatric intensive care unit: learning of hospital pharmacy activities, medicines stock inventory- Clinical trials units & Pharmacotechny unit: assessment of units coordination and proposals for improvement

Doctor Of Pharmacy (Pharm.D.)

Thesis: "Switch from Drug to Food supplement: Regulations and Galenic reformulation – Examples of Solutions and Emulsions for oral use".

Master'S Degree (Msc, Master Ii), Pharmaceutical

Formulation & Production of Pharmaceutical products Liquid and solid dosage forms. Formulation, Production, Chemistry, Rheology, Scale-up.

Pharmacy Studies

5th year of Pharmacy studies (industry): Drug project: Development of a injectable solution of Diazepam - Chemical synthesis, early.