ONCOLOGY EXPERT SUPPORT
FOR CLINICAL DEVELOPMENT WORLDWIDE
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
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SIMBEC-ORION
RECENT ONCOLOGY EXPERIENCE Solid Tumors
Colorectal
Lung Cancer
Ovarian and Colorectal
Head and Neck Tumors
Ovarian Cancer
Acute Myeloid Lukaemia
Breast Cancer
Metastatic Solid Tumors P HA S E I
Endocrine
Carcinoma
P HA S E II
Prostate Cancer
Melanoma
Head and Neck Tumors
Brain Tumors
Melanoma
Carcinoma Glioblastomas
150
10 0
50
Breast Cancer
Blood and Lymphatic System Disorders Congenital
200
Pancreatic Cancer
Melanoma Prostate Cancer
Carcinoma
Hodgkin’s and Non-Hodgkin’s Lymphoma
B-Cell Lymphoma
T-Cell Lymphoma
Ovarian Cancer P HA S E I/ II
Advanced Cancer Advanced Malignancies
Breast Cancer
P HA S E III
Head and Neck Tumors
Neoplasms
Neoplasms
Lymphomas Non-Hodgkin’s
Lung Cancer
Breast Cancer
Prostate Cancer 0
50
10 0
150
200
0
10 0
200
300
400
50 0
600
70 0
800
900
SIMBEC-ORION
10 0 0
5
EXPERTISE IN ONCOLOGY CLINICAL RESEARCH
23 YEARS OF ONCOLOGY EXPERIENCE
FULL CONTINUUM OF PHASE I – IV SERVICES including, 58 bed Phase I unit, in-house central labs and IMP management
PHASE I – IV
300+ INTERNATIONAL NETWORK OF ONCOLOGY INVESTIGATIVE SITES GLOBAL ONCOLOGY ADVISORY GROUP INTERNATIONAL ONCOLOGY DSMB MANAGEMENT RARE & ORPHAN & PAEDIATRIC EXPERTISE
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SIMBEC-ORION
SIMBEC-ORION IS ONE OF THE MOST EXPERIENCED CLINICAL SERVICE PROVIDERS IN THE WORLD
WORLD–CLASS ONCOLOGY SITE NETWORK Track record of demonstrable success with reputable sites globally
ACCESS TO LEADING ONCOLOGY KOLS Privileged relationships with recognized oncology opinion leaders
RARE & ORPHAN ONCOLOGY & PAEDIATRIC ONCOLOGY Experience from many complex and challenging studies within rare and paediatric indications
RECENT ONCOLOGY EXPERIENCE
OUR ONCOLOGY EXPERIENCE INCLUDES Metastatic Or Unresectable Locally Advanced Platinum-Resistant Ovarian Cancer
AN INTERNATIONAL FULL-SERVICE BOUTIQUE CRO
Simbec-Orion is an international full-service boutique CRO covering first in human Phase I clinical studies through to pivotal Phase III studies and post-marketing studies. Our operations are based in the United Kingdom, France, USA, Germany and Italy. We have operational staff across mainland Europe (Western, Eastern & Central) and throughout North America.
Colorectal Carcinoma After Curative Resection Of Hepatic Metastases Solid Tumour Neoplastic Meningitis With Or Without Brain Metastasis Progressive And/Or Recurrent Glioma (Glioblastoma Multiforme) Non Hodgkin’s Lymphoma And Chronic Lymphocytic Leukemia Progressive Metastatic Castration-Resistant Prostate Cancer
Approximately 47% of Simbec-Orion’s experience has been in oncology. We have delivered studies including > 5,200 patients in the last 5 years alone. As such, the majority of our staff have experience of working in oncology studies, many of which have also been considered rare/orphan conditions.
Metastatic Melanoma With Relapsed Cutaneous Tumors Oral Mucositis In Patients With Head And Neck Cancer Metastatic Castration-Resistant Prostate Cancer Advanced/Metastatic Renal Cell Carcinoma Early Stage HER2 Positive Breast Cancer Advanced Hepatocellular Carcinoma Castrate Resistant Prostate Cancer Advanced Or Metastatic Melanoma Platinum Resistant Ovarian Cancer Waldenstrom Macroglobulinemia Non Small Cell Lung Cancer Non Hodgkins Lymphoma Metastatic Breast Cancer
OPERATIONAL TEAMS WITH IN-DEPTH ONCOLOGY EXPERIENCE AND GLOBAL REACH
Simbec-Orion’s oncology focus means that our project management team have years of experience, to ensure delivery of your all-important oncology study. It also means that our systems and processes have been designed to meet the needs of this challenging therapeutic area.
WE THINK LIKE DRUG DEVELOPERS
Many of our senior leadership team and staff have worked as medics treating cancer or developing drugs within biopharmaceutical companies. Therefore, we think like drug developers, not simply as outsource service providers. We provide real world experience to meet your specific study needs.
Ovarian And Colorecetal Advanced Solid Tumours Head And Neck Cancer Advanced Malignancies Colorectal Cancer Lung Malignancies Advanced Cancer Prostate Cancer Ovarian Cancer Breast Cancer
SIMBEC-ORION
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ONCOLOGY EXPERTISE & GLOBAL NETWORK SIMBEC-ORION PROVIDES STRATEGIC INPUT TO YOUR ONCOLOGY DEVELOPMENT PLAN AND PROTOCOL WE HELP YOU MAKE THE RIGHT DECISION, RIGHT FROM THE START – SAVING YOU VALUABLE TIME AND MONEY
TO SUPPORT ALL YOUR CLINICAL DEVELOPMENT NEEDS
Simbec-Orion will guide and support your oncology clinical development strategy through • In-house oncology clinical development experts: Clinical research specialist medical personnel, regulatory experts and project managers with extensive practical experience in managing the most challanging oncology studies • Established relationships with regulatory and ethics authorities in Europe and the USA • Access to external expert panels of opinion leadeng oncology clinicians, from North America and Europe
DEVELOPMENT STRATEGY Simbec-Orion can help guide your strategic decisions early on by; • Providing therapeutically focused input to your development plan and protocol • Preparing and submitting requests for PreIND and EMA scientific advice / protocol assistance meetings • Writing and submitting the briefing package for the scientific advice meeting • Attending the meetings with regulatory authorities
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SIMBEC-ORION
Access to investigative sites and patients
Meeting timelines and saving money
Extensive experience from complex oncology trials
Oncology experience and expertise within the teams
Established contacts with regulatory and ethics bodies
Rapid study start-up
Oracle e-clinical systems
Real time access to reliable data
Full-service in-house capabilities, including central labs
Continuous control of all critical aspects of your study
FAST & EFFICIENT PHASE I TO III STUDIES UTILISING IN-HOUSE FULL-SERVICE CAPABILITIES
Integrated, full-service capabilities enables Simbec-Orion to rigorously manage critical aspects of your project • In-house IMP management and pharmacy
OUR SYSTEMS AND PROCESSES HAVE BEEN DESIGNED TO ENSURE RAPID AND EFFICIENT START-UP AND CONDUCT OF YOUR ONCOLOGY STUDY
• In-house central laboratories with established methods for analysing a large panel of oncology biomarkers and capability to rapidly develop methods for novel biomarkers • Project Managers, regulatory experts and CRAs with many years’ experience from complex oncology studies to drive your studies forward
ENSURING SPEED AND SUCCESS FOR YOUR EARLY AND LATE PHASE ONCOLOGY STUDIES • Integrated Oracle eClinical solutions
– EDC customised for early phase oncology studies to facilitate and speed up the decision-making process for dose escalation – Seamless delivery to DSMB panels
• Selecting the best investigative sites for your study
• Rapid and efficient study start-up in all territories
– Extensive experience of obtaining clinical trial approvals internationally – Management of ethics approvals/IRB approvals across multiple territories – In-house legal team specialised in negotiating contractual agreements with investigative sites globally
– Network of oncology investigators in Europe and North America, with a • Experienced CRAs with site and track-record of successful oncology investigator knowledge studies – Work with sites to drive recruitment – Data-driven and optimized feasibility – Ensure quality of data as well as speed assessment process of delivery SIMBEC-ORION
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SIMBEC-ORION LABORATORY SERVICES
ON CAMPUS CENTRAL PATHOLOGY & BIOANALYTICAL LABORATORIES
SIMBEC-ORION LABORATORY SERVICES FULL RANGE OF LC-MS & IMMUNOASSAY EQUIPMENT
Is an integrated element of Simbec-Orion based from the Simbec-Orion Clinical Pharmacology campus. Fast efficient reliable delivery for your complex studies
BIOTEK SYNERGY 96-WELL PLATE READER
THE BIOANALYTICAL LABORATORY DELIVERS • Developing and validating complex assays • Highly selective and sensitive methods • Supporting all types of clinical study
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.
API 5500 API 5000’S API 4000 API 365
“37% OF OUR LABORATORY
SERVICES EXPERIENCE HAS BEEN WITH NEW CHEMICAL ENTITIES...
...INCLUDING TRANSFER OF TECHNOLOGY FROM PRECLINICAL TO HUMAN MATRICIES”
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SIMBEC-ORION
SIMBEC-ORION LABORATORY SERVICES
ON CAMPUS CENTRAL PATHOLOGY & BIOANALYTICAL LABORATORIES
PATHOLOGY EXPERTISE THERAPEUTIC AREA EXPERIENCE
Dedicated pathology support for clinical trials. Designed exclusively for the biopharmaceutical industry with over 30 years of consistent, high quality delivery.
REPRODUCTIVE MALE/FEMALE INFECTIOUS DISEASES 7 day per week analyses
ENDOCRINOLOGY
TECHNOLOGY
RHEUMATOLOGY Clinical Chemistry
Urinalysis DERMATOLOGY
Biochemistry, Immunology, Serology, Routine multi-parameter testing with Drugs of Abuse Screening microscopic analysis
Haematology
Full Blood Count with Differential Cytokine Assays Routine and Specialised Haemostasis Markers e.g. Thrombin Generation Assay
Logistics management
IMMUNOLOGY
Multiplex Assays
Flow Cytometry
Laboratory Computer System
Flow Cytometry - Lymphcyte Subset analysis etc.
Clinical Trial LIMS
Microbiology
Freezer Storage
Bacteria Identification and MIC Susceptibility
Rees Scientific System Monitoring Storage Temperatures i.e. 4C, -20C, -80C and Room Temperature
RESPIRATORY METABOLISM CARDIOLOGY ONCOLOGY UROLOGY
SIMBEC-ORION
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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
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@SimbecOrion
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