2. 2
Company
• Independent contract research organization (CRO) for
animal health and human pharmaceutical industries,
based in VetAgro Sup campus (F – Lyon area).
Operates since 1981, acquisition of 100% of shares
by Phatobio SAS end of 2014
Social Capital: 268 000 € (Phatobio SAS)
Sales (TO): ~ 0,8 – 1 M€ / year
Employees: 11 people (DVM, Study directors, QA
manager, Analysts) + trainees
Member of LyonBiopole and AFSSI network
Good Laboratory Practice accredited
Partners
IClB, PIGASE et BCL (experimental farms)
HISTALIM, AVEPHARM, LABOVET, VOXCAN, BACTUP,
NEOBIOSYS, CHARLES RIVER…
VetAgro Sup campus laboratories
Services
Advice & Expertise / Study Design
Project Management in biological or pharmaceutical
product development
Analysis of pharmaceutical and biological products
(R&D and Quality Control)
Preclinical (In-vivo) and clinical veterinary studies
Bioanalyses
Regulatory affairs
Quality Assurance
Customers Customers
PHArmacology TOxicology PHYsiology
3. 3
Sandrine COMBEAU
Part II Regulatory Affairs Manager
Céline SALVI
Biopharmaceutical Unit Manager
11 years of pro. exp.
Diploma: Master Analyses Physico-
chimiques et contrôle
Dr Jérôme THEVENON
Managing Director
Directeur d’Installation d’Essai
27 years of pro. exp. in AH industry
Docteur Veterinary Medicine, Microbiology &
Immunology Pasteur Inst., CESAM
Magalie CHAPEL
Preclinical & Clinical Unit
Manager
11 years of pro. exp.
Diploma: Master 2 Bio expérimentation
animale
Aud FROGER
Quality Assurance Manager
13 years of pro. exp.
Diploma: BTS Biological Analysis &
Biotechnology
A PROFESSIONAL AND EXPERIENCED TEAM
Sandrine COMBEAU
Bioanalysis/Pharma Study Director
16 years of pro. exp.
Diploma: DEA de Chimie Analytique
Jerome THEVENON
Regulatory Affairs Manager
Study Directors
Chemical engineers:
Emilie VENCK
Laetitial BESIN
Analysts:
Julien TRACOL
Melinda DOUCET
Julien TRACOL
Metrology
PC Study Director / Monitor
Emilie QUATRESOUS
Emilie VENCK
Archivist
Deputy Study Director
Trainees
Emilie QUATRESOUS
Part III & IV Reg. Affairs Manager
5 years of pro. exp.
Diploma: Master 2 Bio expérimentation
animale
Jerome THEVENON
Statistician
4. JEROME THEVENON EXPERIENCE
DVM, SPECIALIST R&D in Biopharmaceutical Industry
Development of new drugs in Animal Health for 22 years
CEVA SANTE ANIMALE (2004 - 2014) : Director of R&D Biological Projects (7
years) and Director of the Bacteriological and Immunological Development (3
years)
MERIAL (1997 - 2004): Biological Project Leader – Veterinary Senior Clinician
(Bio and Pharma Projects)
RHÔNE-MERIEUX (1992 - 1997): Research Associate and Head of Laboratory
Diagnostic Laboratory and Veterinarians Analysis (1987 - 1992)
Animal Health (autopsies, immunology, bacteriology, virology, epidemiological
investigations..., cattle, pigs, poultry, rabbits ...)
Food safety (microbiological analyses)
Veterinary practice – Production & Companion animals (1985-1987 and 1992)
Dr J Thevenon 4
5. Consulting / Expertise & Regulatory Affairs
Consulting in biological and pharmaceutical
product development:
Product specifications
Development plan (roadmap)
Regulatory strategy (gap analysis)
Project management:
Manufacturing process, active ingredient and
product control definition according to project
specifications
Budget definition and monitoring
Time schedule definition and monitoring
Writing of variation / update dossier: Gap
analysis of existing product dossier versus
new regulatory guidelines or requirement.
Writing of M. A. dossiers of party I (expertise), II
(Quality), III (Safety) and IV (efficacy) for National,
Decentralized or MR Procedures.
Export dossier writing (outside EU).
Meeting with Regulatory Agencies in EU for new
product development plan validation or existing
product renewal/variation strategy, Responses to
Questions of MA dossier submission.
5
6. Pharmaceutical Analyses
Pharmaceutical Development
Active ingredient and finished product dosage:
oral powders, drinking solutions, injectable solutions,
tablets, aerosols, feed…
Setting and validation of analytical methods,
transfer
Manufacturing in process control
HPLC chemical analysis and physical-chemical
tests:
pH, density, viscosity, melting point, Karl Fisher,
colorimetric tests...
Dosages: HPLC, CPG, potentiometric titration
(active ingredients, preservatives, impurities)
Pharmaceutical-technical tests: dissolution,
disaggregation, friability, rupture resistance,
compaction volume, density, viscosity, etc.
Quality control:
Batch to batch quality control. Analytical support of in process
control validation and of cleaning validation.
Microbiological Tests (with partners)
Microbiological quality of pharmaceutical
preparations
Antimicrobial preservative efficacy
Microbiological antibiotic dosage
Bacterial endotoxin quantification
Sterility test
Stability studies:
Preliminary stability to select best formula
Regulatory stability studies, in-use, on-going,
photostability in various climatic chambers
Storage and management of samples in
ICH/VICH conditions with different temperature /
hygrometry levels: 6, 12, 24, 36, 48 and 60
months storage for all product and packaging
types (bags, jars, bottles, pipettes, boxes, vials,
aerosols, etc...).
6
7. Bioanalysis
A team of Study Directors with a solid background in
biological matrix analysis development and validation for
pharmacokinetic studies, residue depletion injection sites
and/or tissues (milk, eggs, blood, plasma, urine…)
analyses.
Pharmacokinetics, bioequivalence
KINETICA software, possible modeling with
Winonlin,
ADME for all species, biodisponibility,
bioequivalence.
Residue and metabolite studies
Feasibility, development and remanence studies
7
8. Quality Assurance
Independent Quality Assurance
Department:
Review of all study plans, raw data
and final reports of GLP studies (Good
Laboratory Practices).
Critical phase audits.
Yearly quality assurance program
including SOP review.
Equipment qualification and IT
validation.
Study Director validates the study by
signing a Declaration of Conformity
attached to the study report.
GLP accreditation by ANSES
Independent Assurance Quality Department
Internal metrology services
Archiving System
8
10. Liquid Chromatography HPLC systems with different sensor modes: UV
(diode array), fluorescence, refractometer, electrochemistry,
Acquisition software of liquid chromatography validated (Empower),
Analytical balances and safety hood
Dissolution device, tablet disintegration device, titrators (including Karl
Fisher), sifter, density meter, UV-visible spectrophotometer, viscosimeter
and many other laboratory equipment ...; appropriate equipment to
pharmacopoeia tests
10
Technical laboratory equipment
11. 11
Under the terms guidelines ICH / VICH: 7 climatic chambers from 1300
to 2000 liters, qualified and with GSM alarm 24 / 24h:
25°C / 60% HR
30°C / 65% HR
40°C / 75% HR
Other conditions on request
Photostability (ex: 25°C / 60% HR, visible light 1.2 million
lux.hours)
Technical and storage equipment
12. Preclinical and clinical studies
A team of Study Directors / Monitors to organize, experiment and perform studies on all target species with the
most convenient partner site
Pharmacokinetic studies after treatment by different routes for ADME, bioavailability, dose determination,
bio-equivalence, PK/PD analysis, etc.
Systemic and local safety studies with clinical examination, blood-biochemistry, examination of injection
sites, gross examination, sampling for histo-pathology but also medical imaging by scan, IRM, echography.
Residue depletion studies in foodstuffs of animal origin with validated analytical methods and in compliance
with MRLs and regulatory guidelines
Palatability tests for any product (tablet, solution, mix the food), single administrations or long duration.
Efficacy tests and challenge tests for antibiotics, vaccines, anti-parasitic, but also for additives or products
that do not need regulatory studies
Pilot and proof of concept studies on target species
Clinical trials field of Veterinary Medicinal Products compliant to GCP
12
13. 13
Preclinical and clinical studies
Efficacy and challenge tests:
For antibiotics, vaccines, additives,…
Various species : pig, poultry, ovine, bovine…
Experimental infection or tested in naturally but
qualified infected animals
Network of microbiological laboratories for
challenge suspension preparation and
quantification
Clinical study – veterinary field trials
A team of Study Directors (monitor/investigators) entitled to experiment and perform
studies on all target species
