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Cantum Biosciences
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Veterinary vaccine technical development consultant


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

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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 to market


Documentation and training


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 technical development and regulatory topics


Regulatory Affairs


Focused technical development leads to adequately documented and validated vaccines, which translates into successful product licences. We select together the best regulatory approach and offer a regulatory support of your veterinary vaccine dossier before and during entire procedures.


Consult the Recent work section which shows some of Cantum Biosciences' track records

[ ABOUT ]


Cantum Biosciences Ltd
Veterinary vaccine technical development consultant
Independent consultant providing technical veterinary vaccine development and regulatory support

Dr Thierry Biot launched Cantum Biosciences 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.

Cantum Biosciences contributes to various vaccine developmental 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 various grant application and site visits to report projects progresses.

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 perfects.

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[ SERVICES ]


Technical and regulatory support for veterinary vaccine development

REGULATORY AFFAIRS

Selection of the optimal regulatory procedure, organisation of pre-submission meeting with regulatory authorities



Full support during the entire procedure, including responses to querries within the deadline



Gap analysis and compliance; pharmacovigilance expert reports



TECHNICAL DEVELOPMENT

Safety and efficacy clinical study designed for the intended product claims.

Associated clinical validations


Method of production and validations fitted for regulatory dossiers; manufacturing site transfers


Master & Working Seeds and Cells Banks; potency test and validations


DOCUMENTATION/ TRAINING

Preparation, QC and QA review of all technical, scientific or regulatory documents required, including expert reports




Write analytical, safety and efficacy dossier parts with their summaries




Vaccine technical development and regulatory trainings




[ CONTACT ME ]


If you have any question or wanted to investigate anything, please fill the form below or phone me

Info request


Contact me to know more about the services I provide

Vaccine development help

[ BIOGRAPHY ]



Veterinary vaccine development consultant



Dr Thierry Biot BSc, MSc, PhD

Since 2011, Thierry provides independent veterinary vaccines regulatory and technical development assistance to research labs, start-ups and established animal health companies. He also frequently acts as an 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 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 BSc in Biomedical Sciences, all granted by the 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.
Provided and commented full technical development plans for in house R&D biological products for various animal species, maintained existing products through variations.
Initiated and managed various 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 various 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
Veterinary vaccine development consultant
Why choose Cantum Biosciences?
Veterinary vaccine technical development and registration is a specialised field, much different from the non-biological medicinal development. Regulatory agencies in France, Germany, UK, US and other countries have dedicated veterinary vaccine expert teams. Only trust veterinary vaccine development experts to help you!
© Cantum Biosciences Ltd - 2019
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