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APRIL 2015
YOUR PARTNER FOR INNOVATION IN
MUSCULOSKELETAL DISEASE
WHO WE ARE
Our vision
To be a leader of the joint health market offering personalized innovative solutions to address unmet
needs in the musculoskeletal field
Our mission
To develop personalized solutions based on specific and innovative biomarkers for the research
and management of musculoskeletal disorders
Our values
Professionalism, dynamism, creativity, and ethics
Our strength
A diversity of talents working together: 15 people with complementarity expertise in musculoskeletal field
WHAT WE DO
IN THE FIELD OF
MUSCULOSKELETAL
DISEASES
ELISA KITS
RUO & CE-IVD
CLINICAL
TRIAL
PRECLINICAL
STUDIES
DESIGN &
DEVELOPMENT
OF
BIOMARKERS
INNOVATIVE
BIOMARKERS
BIOMARKER IS CLASSICALLY DEFINED AS A CHARACTERISTIC THAT IS OBJECTIVELY MEASURED AND
EVALUATED AS AN INDICATOR OF NORMAL BIOLOGIC PROCESSES, PATHOGENIC PROCESSES, OR
PHARMACOLOGICAL RESPONSES TO A THERAPEUTIC INTERVENTION.
(BIOMARKERS DEFINITIONS WORKING GROUP, CLIN PHARMACOL THER 2001;69:89-95)
THE CORE OF OUR ACTIVITIES
CARTILAGE METABOLISM
INFLAMMATION
BONE REMODELING
MATRIX DISORGANIZATION
CUSTOMIZED TO DRUG:
COMPANION KIT
INNOVATIVE BIOMARKERS
HIGHLIGHT ON CARTILAGE METABOLISM: COLL2-1
Coll2-1 is a specific fragment of type II collagen
Type II collagen is the main component of the articular cartilage
Coll2-1 immunoassay is available in blood and urine samples
INNOVATIVE BIOMARKERS
FOR THE DIAGNOSIS, THE
PROGNOSIS, AND THE FOLLOW-UP
OF OSTEOARTHRITIS
INNOVATIVE BIOMARKERS
BUT ALSO…
ARTIALIS OFFERS A COMPLETE PORTFOLIO OF VALIDATED BIOMARKERS EITHER AS ELISA KIT OR THROUGH
BIOMARKER TESTING SERVICE
BONE
Osteocalcin
NTXI
CARTILAGE
Coll2-1
CTXII
Aggrecan
Fibulin-3
COMP
INFLAMMATION
Coll2-1NO2
PGE2
usCRP
MPO
HA
METALLOPROTEASES
MMP1
MMP3
PRECLINICAL STUDIES
ONE-STOP SOLUTION
ANALYSIS OF
YOUR NEEDS
FIRST, WE MEET!
STUDY DESIGN
•Animal model
•Time line
•Treatment
administration
•Biomarkers
IN-LIFE PHASE
•Clinical follow-up
•Blood sampling
•Surgery
•Imaging
•Treatment
administration
EX-VIVO
EXPERIMENTS
•Macroscopy
•Histology
ANALYSE
AND
STATISTICS
REPORT
PRECLINICAL STUDIES
ANIMAL MODELS
• Rat, rabbit, guinea pig,…
• Induced OA model
• Spontaneous OA model
STUDY ENDPOINTS
• Gold standard endpoints
• Macroscopy
• Histology
INNOVATIVE TOOLS
• Biomarkers
• CatWalk
• Mach 1
CLINICAL TRIALS
WE CAN OFFER AN ALL-IN-ONE COST-EFFECTIVE CLINICAL TRIAL INCLUDING BIOMARKERS, X-RAY AND
MAGNETIC RESONANCE IMAGING (MRI) ANALYSES
ONE-STOP SOLUTION
• SAFETY
• EFFICACY
• FOOD COMPLEMENT
• VISCOSUPPLEMENTATION
• BIOMARKERS QUALIFICATION
• BIOLOGICAL VARIABILITY
• …
FROM
EXPLORATORY
TO
POST-MARKETING
CLINICAL TRIALS
CLINICAL CRO
(FULL SET OF
SERVICES)
STUDY
DESIGN
PROTOCOL
WRITING
KOL
EXPERTISE
TRIAL
ESSENTIAL
DOC
REGULATORY
ACTIVITIES
SITE
SELECTION
MONITORING
BIOMARKERS
TESTING
IMAGING OA
MARKERS
DATA
MANAGEMENT
STATISTICS
FINAL
REPORT
 Evaluation of the Prognostic Value of Biological Markers, Coll2-
1 and Coll2-1NO2 in Patients With Symptomatic Knee
Osteoarthritis (PRODIGE) NCT02070224
 Biological Variability in Cartilage Specific Biomarkers in Healthy
Volunteers (COVAR) NCT02348944
IMAGE READING
- WORMS
- T2 MAPPING
- VOLUME
TRANSFER
QUALITY
CONTROL
Protocol design
Site selection
- Multi-site imaging coordination
- Imaging parameters standardization
- Site training
Transfer to central
reading
Quality assurance
Selection, training validation
and monitoring of expert
radiologists specialized in
osteo-articular disease
Highlight on clinical imaging: MRI
CLINICAL TRIALS
IN SILICO ANALYSIS
• Review of literature
• Bioinformatics'
analysis
• Peptide design
• IP assessment
• Immunoassay type
TOOLS PRODUCTION
& SELECTION
• Immunogen
• Animals
• Hybridoma
• Cloning steps
• Production and
purification Abs
• Qualification of Ab
(titer, specificity)
IMMUNOASSAY
DEVELOPMENT &
VALIDATION
• Assay protocol
• Dynamic range
• Analytical
performances
BIOMARKER
QUALIFICATION
• Preclinical studies
• Artialis’ proprietary
cohorts (COVAR,
PRODIGE)
• Collaborative
cohorts
• New clinical trial
specifically designed
COMPANION
KIT
• Industrialization
• Scale-up
SUPPORT TO DESIGN & DEVELOPMENT
TAILOR-MADE SOLUTION
FROM DESIGN TO COMPANION KIT, YOUR PARTNER AT EACH STEP FOR THE DEVELOPMENT OF YOUR
CUSTOMIZED BIOMARKER
WHERE WE ARE
ARTIALIS IS LOCATED INSIDE THE UNIVERSITY HOSPITAL OF LIÈGE
+32 4 242 77 27
contact@artialis.com
ARTIALIS s.a
11, Avenue de l'Hôpital
Tour GIGA +3
4000 Liège (Sart-Tilman)
Belgium

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Corporate presentation 2015

  • 1. APRIL 2015 YOUR PARTNER FOR INNOVATION IN MUSCULOSKELETAL DISEASE
  • 2. WHO WE ARE Our vision To be a leader of the joint health market offering personalized innovative solutions to address unmet needs in the musculoskeletal field Our mission To develop personalized solutions based on specific and innovative biomarkers for the research and management of musculoskeletal disorders Our values Professionalism, dynamism, creativity, and ethics Our strength A diversity of talents working together: 15 people with complementarity expertise in musculoskeletal field
  • 3. WHAT WE DO IN THE FIELD OF MUSCULOSKELETAL DISEASES ELISA KITS RUO & CE-IVD CLINICAL TRIAL PRECLINICAL STUDIES DESIGN & DEVELOPMENT OF BIOMARKERS INNOVATIVE BIOMARKERS
  • 4. BIOMARKER IS CLASSICALLY DEFINED AS A CHARACTERISTIC THAT IS OBJECTIVELY MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGIC PROCESSES, PATHOGENIC PROCESSES, OR PHARMACOLOGICAL RESPONSES TO A THERAPEUTIC INTERVENTION. (BIOMARKERS DEFINITIONS WORKING GROUP, CLIN PHARMACOL THER 2001;69:89-95) THE CORE OF OUR ACTIVITIES CARTILAGE METABOLISM INFLAMMATION BONE REMODELING MATRIX DISORGANIZATION CUSTOMIZED TO DRUG: COMPANION KIT INNOVATIVE BIOMARKERS
  • 5. HIGHLIGHT ON CARTILAGE METABOLISM: COLL2-1 Coll2-1 is a specific fragment of type II collagen Type II collagen is the main component of the articular cartilage Coll2-1 immunoassay is available in blood and urine samples INNOVATIVE BIOMARKERS
  • 6. FOR THE DIAGNOSIS, THE PROGNOSIS, AND THE FOLLOW-UP OF OSTEOARTHRITIS INNOVATIVE BIOMARKERS
  • 7. BUT ALSO… ARTIALIS OFFERS A COMPLETE PORTFOLIO OF VALIDATED BIOMARKERS EITHER AS ELISA KIT OR THROUGH BIOMARKER TESTING SERVICE BONE Osteocalcin NTXI CARTILAGE Coll2-1 CTXII Aggrecan Fibulin-3 COMP INFLAMMATION Coll2-1NO2 PGE2 usCRP MPO HA METALLOPROTEASES MMP1 MMP3
  • 8. PRECLINICAL STUDIES ONE-STOP SOLUTION ANALYSIS OF YOUR NEEDS FIRST, WE MEET! STUDY DESIGN •Animal model •Time line •Treatment administration •Biomarkers IN-LIFE PHASE •Clinical follow-up •Blood sampling •Surgery •Imaging •Treatment administration EX-VIVO EXPERIMENTS •Macroscopy •Histology ANALYSE AND STATISTICS REPORT
  • 9. PRECLINICAL STUDIES ANIMAL MODELS • Rat, rabbit, guinea pig,… • Induced OA model • Spontaneous OA model STUDY ENDPOINTS • Gold standard endpoints • Macroscopy • Histology INNOVATIVE TOOLS • Biomarkers • CatWalk • Mach 1
  • 10. CLINICAL TRIALS WE CAN OFFER AN ALL-IN-ONE COST-EFFECTIVE CLINICAL TRIAL INCLUDING BIOMARKERS, X-RAY AND MAGNETIC RESONANCE IMAGING (MRI) ANALYSES ONE-STOP SOLUTION • SAFETY • EFFICACY • FOOD COMPLEMENT • VISCOSUPPLEMENTATION • BIOMARKERS QUALIFICATION • BIOLOGICAL VARIABILITY • … FROM EXPLORATORY TO POST-MARKETING
  • 11. CLINICAL TRIALS CLINICAL CRO (FULL SET OF SERVICES) STUDY DESIGN PROTOCOL WRITING KOL EXPERTISE TRIAL ESSENTIAL DOC REGULATORY ACTIVITIES SITE SELECTION MONITORING BIOMARKERS TESTING IMAGING OA MARKERS DATA MANAGEMENT STATISTICS FINAL REPORT  Evaluation of the Prognostic Value of Biological Markers, Coll2- 1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis (PRODIGE) NCT02070224  Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers (COVAR) NCT02348944
  • 12. IMAGE READING - WORMS - T2 MAPPING - VOLUME TRANSFER QUALITY CONTROL Protocol design Site selection - Multi-site imaging coordination - Imaging parameters standardization - Site training Transfer to central reading Quality assurance Selection, training validation and monitoring of expert radiologists specialized in osteo-articular disease Highlight on clinical imaging: MRI CLINICAL TRIALS
  • 13. IN SILICO ANALYSIS • Review of literature • Bioinformatics' analysis • Peptide design • IP assessment • Immunoassay type TOOLS PRODUCTION & SELECTION • Immunogen • Animals • Hybridoma • Cloning steps • Production and purification Abs • Qualification of Ab (titer, specificity) IMMUNOASSAY DEVELOPMENT & VALIDATION • Assay protocol • Dynamic range • Analytical performances BIOMARKER QUALIFICATION • Preclinical studies • Artialis’ proprietary cohorts (COVAR, PRODIGE) • Collaborative cohorts • New clinical trial specifically designed COMPANION KIT • Industrialization • Scale-up SUPPORT TO DESIGN & DEVELOPMENT TAILOR-MADE SOLUTION FROM DESIGN TO COMPANION KIT, YOUR PARTNER AT EACH STEP FOR THE DEVELOPMENT OF YOUR CUSTOMIZED BIOMARKER
  • 14. WHERE WE ARE ARTIALIS IS LOCATED INSIDE THE UNIVERSITY HOSPITAL OF LIÈGE +32 4 242 77 27 contact@artialis.com ARTIALIS s.a 11, Avenue de l'Hôpital Tour GIGA +3 4000 Liège (Sart-Tilman) Belgium