WORLD CLASS LABORATORY SERVICES BIOANALYSIS & PATHOLOGY A NEW BREED WITH A LONG PEDIGREE
MISSION STATEMENT We are Simbec-Orion. An international, full service, boutique CRO; growing by bringing together the best possible people, healthcare professionals and drug developers, from all areas of clinical development. We focus on a defined series of core therapeutic areas, where we can make best use of our skills elegantly to design, execute and deliver our clients’ clinical development needs. We are making Simbec-Orion a highly respected and profitable boutique CRO. We do this by working for our clients with excellence, commitment and passion for our trade. We provide an environment in which our colleagues can continue to grow and develop. We will always remember that our work leads to the improvement of patients’ lives.
OUR THERAPEUTIC EXPERIENCE
4
SIMBEC-ORION
BIOANALYTICAL & PATHOLOGY SIMBEC-ORION LABORATORY SERVICES, A NEW NAME WITH 3 DECADES OF EXPERIENCE, IS AN INTEGRATED ELEMENT OF SIMBEC-ORION - A TRULY FULL SERVICE, GLOBAL CRO WITH IN-HOUSE CAPABILITIES TO SUPPORT EVERY ASPECT OF YOUR CLINICAL DEVELOPMENT PROGRAM
SIMBEC-ORION LABORATORY SERVICES SUPPORTS: • SIMBEC-ORION • BIOTECH AND PHARMA COMPANIES • OTHER CROs
TYPES OF CUSTOMER
6%
13%
32% Large Pharma Biotech & Mid Cap Pharma
“115,000 CLINICAL CHEMISTRY TESTS PER WEEK, FROM 5,000 SAMPLES”
49%
Academic Institutions CRO/Other SIMBEC-ORION
5
BIO LABORATORY
BIOANALYTICAL SERVICES Simbec-Orion Laboratory Services is experienced in: • Developing and validating complex assays • Highly selective and sensitive methods • Supporting all types of clinical studies We continually: • Invest in the state of the art equipment to ensure we can deliver on our customer’s needs • Ensure that we apply the most appropriate analytical methods • Produce the highest quality data sets for your studies
STUDY MANAGEMENT Our dedicated project management staff coordinate the bioanalytical phases of your study and: • Logistics • Data management • Statistics We can coordinate either with your existing CRO or as part of an integrated study run by Simbec-Orion. All bioanalysis conducted in support of a study is directly managed by a highly experienced Principal Scientist, liaising with your clinical, pharmacokinetic or bioanalytical teams. 6
SIMBEC-ORION
FULL RANGE OF LC-MS & IMMUNOASSAY EQUIPMENT BIOTEK SYNERGY 96-WELL PLATE READER
API 5500 API 5000’S API 4000 API 365
RADIOISOTOPES LABORATORY Our Radioisotopes Laboratory performs radioactivity measurements for human ADME and mass balance studies. Radio-HPLC and LC-MS/MS techniques are then used to investigate metabolite profiles and to assist the identification of putative metabolites. SIMBEC-ORION
7
PATHOLOGY LABORATORY
PATHOLOGY EXPERTISE Dedicated pathology support for international clinical trials. Designed exclusively for the biopharmaceutical industry with over 30 years of consistent, high quality delivery.
COMMITMENT OUR SERVICE OFFERING: • Extensive range of analytical capabilities • 7 Day per week Analyses • ClinAxys LIMS 21 CFR part 11 compliance • State-of-the-art fridge/freezer temperature monitoring system
Our combined expertise, experience and investment in infrastructure Simbec-Orion Laboratory Services provide a: • Rapid • Responsive • Reliable service Committed to ensuring the prompt analysis and electronic transfer of results, helping our customers make critical decisions in a timely manner.
• Rapid turnaround times • Biomarker Services • Internal QA support • Pharmacokinetic and Pharmacodynamic analyses • Logistics Management • Visit-specific sample collection kits • Protocol-specific pathology manual • Project Management • Data Management 8
SIMBEC-ORION
“37% OF SIMBEC-ORION
LABORATORY SERVICES EXPERIENCE HAS BEEN WITH NEW CHEMICAL ENTITIES...
THERAPEUTIC AREA EXPERIENCE
“15,000 BLOOD COUNT
SAMPLES PER WEEK”
REPRODUCTIVE MALE/FEMALE INFECTIOUS DISEASES ENDOCRINOLOGY RHEUMATOLOGY DERMATOLOGY IMMUNOLOGY RESPIRATORY METABOLISM CARDIOLOGY ONCOLOGY
...INCLUDING TRANSFER OF TECHNOLOGY FROM PRECLINICAL TO HUMAN MATRICIES”
TECHNOLOGY Clinical Chemistry Biochemistry, Immunology, Serology, Drugs of Abuse Screening Haematology Full Blood Count with Differential Routine and Specialised Haemostasis Markers e.g. Thrombin Generation Assay Flow Cytometry Flow Cytometry - Lymphocyte Subset analysis etc.
Urinalysis Routine multi-parameter testing with microscopic analysis Multiplex Assays Cytokine Assays Laboratory Computer System Clinical Trial LIMS Freezer Storage Rees Scientific System Monitoring Storage Temperatures i.e. 4C, -20C, -80C and Room Temperature
Microbiology Bacteria Identification and MIC Susceptibility
SIMBEC-ORION
9
www.SimbecOrion.com i n fo r m at i o n @ S i m b e c O r i o n .c o m SimbecOrionCRO
100 Overlook Center 2nd Floor Princeton NJ 08540 USA
Simbec House Merthyr Tydfil Industrial Park Merthyr Tydfil CF48 4DR United Kingdom
@SimbecOrion
7 Bath Road Slough SL1 3UA United Kingdom
Centre d’Affaires La Boursidière Bâtiment le Jura, BP 141 92357 Le Plessis-Robinson Cedex France