2016

PRECLINICAL & CLINICAL TRIALS SOLUTION IN MUSCULOSKELETAL

DISEASES

WHO WE ARE

CRO SPECIALIZED IN MUSCULOSKELETAL DISEASES OFFERING PERSONALIZED SOLUTIONS FOR PRECLINICAL STUDIES AND CLINICAL TRIALS…

… BRIDGING THE GAP BETWEEN PRECLINICAL AND CLINICAL DATA WITH INNOVATIVE TOOLS OF VALIDATION

… PROVIDING SCIENTIFIC EXPERTISE AND OUTSTANDING RESEARCH SERVICES…

WHO WE ARE

Founded in 2010 as a spin-off of the University of Liège, Belgium

Customers include large and mid-size pharmas, biotech, medical device and academic research organizations

Portfolio preclinical studies and clinical trials in drug/complement development (phase I/II, II, IV) and medical device (class II, III)

Phase IV

Phase II

Phase I/II

Preclinical

Portfolio of studies

Drug Medical device Food complement

ADDED VALUES

SCIENTIFIC EXPERTISE

REGULATORY SERVICES

CERTIFICATIONS

INNOVATIVE TOOLS

PRECLINICAL STUDIES

TAILOR-MADE 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 EXPERIMEN

TS•Macroscopy•Histology

ANALYSE AND

STATISTICS

REPORT

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PRECLINICAL STUDIES IN OSTEOARTHRITIS

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

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FACILITIES

Visit the Novalis Science Center

Technical accesses outside the area Hermetic and decontaminable area HVAC-Pressions Airlock H202

SPF animal facilities High capacity of accomodation (mice, rats, guinea pigs, rabbits)

CLINICAL TRIALS

PROTOCOL WRITINGREGULATORY ACTIVITIESKOL EXPERTISE

INNOVATIVE TOOLS

SITE SELECTION & MONITORINGDATA MANAGEMENT & STATISTICSFINAL REPORT

TAILOR-MADE SOLUTION

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Disease/Structure modifying product

Symptom-modifying product

CLINICAL TRIALS IN OSTEOARTHRITIS

CLINICAL OUTCOMES IN OA EMA guidelines on clinical trial in OA (CPMP/EWP/784/97 Rev.1.2010)

Biomarkers

Imaging

Soluble biomarkers

Pain & Function

WOMAC, KOOS, VAS

A DEDICATED TEAM

CRO TEAM

1 Clinical Manager

3 Clinical Research Associates

Network ofFlying Nurses

2 Technicians

2 Clinical Project Leaders

1 Imaging Leader

OUR NETWORK OF INVESTIGATORS

More than 30 centres in France and Belgium (University) hospitals and private practice Rheumatologists, orthopedic surgeons, physiotherapists

IMAGING BIOMARKERS

Biochemical composition of cartilage (dGEMRIC, delayed Gadolinium enhanced MRI of cartilage): information about the content of proteoglycans in cartilage knee.

WORMS (Whole-Organ Magnetic Resonance Imaging Score) assigns a multiple scores to each structure of the joint.

Examples of evaluation

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BIOMARKERS TESTING

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)

BIOMARKERS TESTING

ARTIALIS OFFERS A COMPLETE PORTFOLIO OF VALIDATED ASSAYS AVAILABLE FOR TESTING

BONE

OsteocalcinNTXI

CARTILAGE

Coll2-1CTXIIFibulin-3COMP

INFLAMMATION

Coll2-1NO2PGE2usCRPMPOHA

METALLOPROTEASES

MMP1MMP3

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WHERE WE ARE

ARTIALIS IS LOCATED INSIDE THE UNIVERSITY HOSPITAL OF LIÈGE

+32 4 242 77 27

contact@artialis.com

ARTIALIS s.a11, Avenue de l'HôpitalTour GIGA +34000 Liège (Sart-Tilman)Belgium