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Cantum Biosciences
Cantum Biosciences
Cantum Biosciences
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Veterinary vaccine technical development consultant


Converting veterinary vaccine research into innovative commercial products, increasing vaccines availability in Europe, Africa, South America and South-East Asia

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Regulatory Affairs


Focused and validated vaccine technical development translates into successful product licences. We select together the regulatory approach adapted to your vaccine marketing needs. I help you with the entire regulatory procedure of your veterinary vaccine, from craddle to grave


Technical development


Start on the right technical development path. Avoid unnecessary studies and expenses. I help you define the technical development studies required for the intended purpose, guiding your veterinary vaccine technical development path to maximise your speed and effort to market


Documentation


I provide assistance in the redaction or the review of vaccine technical development protocols, reports or validations and in the production of dossier summaries or regulatory expert reports. I train your work force on various vaccine technical development and regulatory topics


Consult the Recent technical development projects section which shows examples of my recent work in vaccine technical development projects

[ ABOUT ]


Cantum Biosciences Ltd
Veterinary vaccine technical development consultant

Independent consultant in veterinary vaccine technical development


Dr Thierry Biot launched Cantum Biosciences Ltd in 2011 after over 20 years’ broad experience of veterinary vaccine development and registration gained from various positions in R&D and EU regulatory affairs of major international Animal Health companies.

As a consultant, Thierry contributes to the technical developmental of veterinary vaccine projects from university research laboratories, start-ups or established pharmaceutical companies located on various continents. Thierry also helps government bodies funding veterinary vaccine development in Africa and South East Asia with technical reviews of grant applications and site visits to report and help projects progresses. Have a look on his recent technical development projects contributions.

Thierry works remotely or from any client's based office, in English or in French; he also has solid notions of Spanish and Portuguese languages, which he actively continues to perfect.

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[ SERVICES ]


Technical and regulatory support for veterinary vaccine development

DOCUMENTATION/ TRAINING
Preparation and QC review of all technical, scientific or regulatory documents required, including expert review


Write analytical, safety and efficacy dossier parts with their summaries. Expert reports

Training in veterinary vaccine technical development and regulatory affairs
REGULATORY AFFAIRS
Selection of the optimal regulatory procedure adapted to marketing needs, pre-submission meeting with regulatory authorities


Full support during entire regulatory procedures, responses to queries within their deadline


Gap analysis and compliance; pharmacovigilance expert reports
TECHNICAL DEVELOPMENT
Safety and efficacy clinical studies designed for the intended product claims;
Associated clinical validations

Method of production, product testing and validations fit for regulatory dossiers. For new vaccine or manufacturing site transfers


Establishing Seeds and Cells Banks, potency test and validations




[ CONTACT ME ]







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Vaccine development help


[ BIOGRAPHY ]



Veterinary vaccine development consultant



Dr Thierry Biot BSc, MSc, PhD

Since 2011, Thierry provides independent veterinary vaccines technical development and regulatory assistance to research labs, start-ups and established animal health companies. He also acts as a technical expert to advisory panels of government bodies funding veterinary vaccine development in Africa and South East Asia.

Before being a consultant, Thierry worked for over 20 years in the veterinary vaccine industry for major international Companies in Belgium and UK holding various technical R&D and regulatory roles, providing full technical development guidance for vaccines destined for most animal species, writing expert reports and regulatory dossiers, managing regulatory procedures and answering their technical list of questions.

During 16 years, Thierry was also appointed at the Biologicals Working Party of the International Federation of Animal Health Industries (IFAH, now Health for Animals), directly influencing and contributing to the EU and international veterinary vaccines technical and regulatory legislation.

Thierry works remotely or from any client's site - he is fluent in English & French and actively perfects his Spanish and Portuguese languages skills.

Thierry holds a PhD in Medical Sciences, a Master Degree in Biomedical Technologies and a Bachelor degree in Biomedical Sciences, all granted by the Faculty of Medicine, University of Louvain (UCL), Belgium.

Past employments

Pfizer Animal Health, Sandwich, UK, 1995-2011
Associate Director, Biological Regulatory Affairs
Started the biological regulatory affairs group of the Company in UK.
Wrote and reviewed full technical development plans for in house R&D biological products destined to various animal species. Initiated and managed multiple EU registration procedures for full product licences.
Lead and contributed to due diligences and manufacturing/technical transfers of 20+ biologicals acquired through purchase of CSL and Fort-Dodge AH businesses and manufacturing plants (Melbourne, (Australia), Omaha and Charles City (USA), Olot, (Spain) and Weesp, (Netherlands)) and through products divested by Schering Plough and Intervet following their merger.
Active member of the Biologicals Working Party of the International Federation of Animal Health Industries (IFAH, now Health For Animals), developing and challenging the veterinary biologicals regulatory and technical legal frameworks with the EU regulators.

SmithKline Beecham Animal Health, Louvain-la-Neuve, Belgium, 1993-1995
Regulatory Manager, Biological Regulatory Affairs
Initiated the development and registration of new vaccines in compliance with the newly published EU Directive 92/18 and accompanying Guidelines.

International Institute of Cellular and Molecular Pathology, de Duve Institute, Belgium, 1989-1993
Research Scientist, work funded and managed by Solvay, Upjohn, Eurogentec, Innogenetics and the Belgian Government to engineer, characterise and test Yersinia enterocolitica as live recombinant expression vector vaccines for diverse veterinary antigens. Various publications.
Veterinary vaccine development consultant
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