Achievements
Veterinary biologicals and vaccines development & registration
Examples of consultancy work accomplished in the development and registration of veterinary biologicals
Technical regulatory dossier writing
Production of the analytical dossier required for the EU deliberate release authorisation of a recombinant vaccine for poultry
Clinical safety & efficacy study reports review and summary for a new recombinant multivalent poultry vaccine
Analytical technical review and expert reports on new GMO vaccines destined to livestock animals
Technical summaries and expert reports on multiple analytical and clinical variations (pre-2022 and post-2022 systems) covering all aspects of the production, inactivation, potency testing of vaccines destined to most animal species, as well as their safety or efficacy and product claims
Biological products R&D
Expert to the Livestock Vaccines Innovation Fund (LVIF) - an initiative developed by the Bill and Melinda Gates Foundation, Global Affairs Canada and the International Development Research Center (IDRC) based in Ottawa. With a budget of CA$57 millions over seven years, LVIF supports the development, production and commercialisation of innovative vaccines against livestock neglected diseases in low- and middle-income countries (LMICs). Regular technical review of over 30 vaccine development projects submitted by various research Institutes worldwide for funding request. Visits to research and vaccine development sites in Africa for technical discussion and assistance
Expert to the InnoVet AMR (antimicrobial resistance) funding programme. This four-year, CA$30 million partnership between IDRC and the UK Department of Health and Social Care’s (DHSC) Global AMR Innovation Fund (GAMRIF) is funding research to develop new animal biological products and other innovations to tackle AMR in livestock and aquaculture production in LMIC. Critical review of multiple development projects, helping in the decision for funding
Expert to the European Commission HORIZON funding programme, reviewing veterinary vaccine and biological development proposals submitted by Research Institutes and Industry. Assessment of biological product research and development proposals to control emergent diseases in Europe
Antigen manufacturing development and transfer
Identification and management of all the technical and regulatory steps required to transfer the production of an existing recombinant antigen produced in Baculovirus to a new manufacturer, including adaptation to bioreactor and volume scale-up
Conversion of USDA veterinary vaccine dossier to EU part 2 dossier, identifying gaps and remedial activities
Preparation and submission of a regulatory dossier to transfer the EU re-testing activities between two sites
Technical and regulatory compliance
Assessment of technical and regulatory compliance of registered dossiers for entire product portfolios of a large veterinary products manufacturer covering EU, USA, Japan, Canada, Africa, South America and Asia
Produce assessment reports against the new requirements of the European Pharmacopoeia over the risk of extraneous agents contamination of immunological veterinary medicinal product from materials of avian, porcine, ovine, caprine, bovine, equine, feline or canine origin
Acquisitions of animal health biological products
Visit of a veterinary vaccine producer in South America for an extended technical review and reporting on their facilities, products and activities in preparation to a Due Diligence
Technical and regulatory due diligence for the industrial acquisition of porcine vaccines developed by a Spanish University
Vaccine manufacturing and quality development training
Vaccine potency test training for the R&D department of a large veterinary manufacturer in South America covering in vitro and in vivo potency tests for live, recombinant and inactivated vaccines. Emphasis on solutions to move from in vivo to in vitro potency tests
This training resulted in a request from the Company to help devise the potency test of two of their vaccines under development
One health
Since January 2022, responsible of the veterinary regulatory sector in the multidisciplinary team of OneHealth Pharma, contributing to the elaboration of an human health, animal health and environmental integrated approach, key to our planet's future. Various contributions to OneHealth topics discussions and client's requests over medicine unmet needs and minor species importance.
