ONCOLOGY EXPERT SUPPORTFOR CLINICAL DEVELOPMENT WORLDWIDE

1 ORION CLINICAL

We are Simbec-Orion. An international, full service, boutique CRO; growing by bringing together the bestpossible 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.

SIMBEC-ORION GROUP MISSION STATEMENT

2ORION CLINICAL

A FULL-SERVICEINTERNATIONAL CRO WITH THE IN-HOUSE CAPABILITIES TO SUPPORT EVERY ASPECT OF YOUR CLINICAL DEVELOPMENTPROGRAM

PHASE III29%

PHASE II48%

PHASE I17%

PHASE IV3%

CONSULTING3%

EXPERTISE IN ONCOLOGY CLINICAL RESEARCH

3 ORION CLINICAL

19 YEARS OF ONCOLOGY EXPERIENCE

PHASE I – IV

SIMBEC-ORION IS ONE OF THE MOSTEXPERIENCED CLINICAL SERVICEPROVIDERS IN THE WORLD

FULL CONTINUUM OF PHASE I – IV SERVICESincluding, 58 bed Phase I unit, in-house central labs and IMP management

WORLD–CLASS ONCOLOGY SITE NETWORKTrack record of demonstrable success with reputable sites globally

ACCESS TO LEADING ONCOLOGY KOLSPrivileged relationships with recognizedoncology opinion leaders

RARE & ORPHAN ONCOLOGY & PAEDIATRIC ONCOLOGY Experience from many complex and challenging studies within rare and paediatric indications

300+ INTERNATIONALNETWORK OF ONCOLOGY INVESTIGATIVE SITES

GLOBAL ONCOLOGYADVISORY GROUP INTERNATIONAL ONCOLOGY DSMB MANAGEMENT

RARE & ORPHAN & PAEDIATRIC EXPERTISE

ORION CLINICAL AN INTERNATIONAL FULL-SERVICE BOUTIQUE CRO

OPERATIONAL TEAMS WITH IN-DEPTH ONCOLOGY EXPERIENCE AND GLOBAL REACHOrion’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 DEVELOPERSMany 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.

Orion Clinical is the clinical development division of Simbec-Orion Group, 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.

Approximately 47% of Orion Clinical’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.

4ORION CLINICAL

Metastatic Or Unresectable Locally Advanced Platinum-Resistant Ovarian Cancer

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

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

Ovarian And Colorecetal

Advanced Solid Tumours

Head And Neck Cancer

Advanced Malignancies

Colorectal Cancer

Lung Malignancies

Advanced Cancer

Prostate Cancer

Ovarian Cancer

Breast Cancer

ONCOLOGY EXPERTISE AND GLOBAL NETWORK TO SUPPORT YOUR CLINICAL DEVELOPMENT NEEDS

5 SIMBEC ORION

ORION CLINICAL 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

Orion Clinical 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

Orion Clinical can help guide your strategic decisions early on by;

• Providing therapeutically focused input to your development plan and protocol

• Preparing and submitting requests for Pre-IND and EMA scientific advice / protocol assistance meetings

• Writing and submitting the briefing package for the scientific advice meeting

• Attending the meetings with regulatory authorities

DEVELOPMENT STRATEGY Access to intenal and external oncology experts

Supporting your strategic direction

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

5 ORION CLINICAL

ONCOLOGY EXPERTISE AND GLOBAL NETWORK TO SUPPORT YOUR CLINICAL DEVELOPMENT NEEDS

6SIMBEC ORION

Integrated, full-service capabilities enables Orion Clinical to rigorously manage critical aspects of your project

• In-house IMP management and pharmacy

• 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

• 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

– Network of oncology investigators in Europe and North America, with a track-record of successful oncology studies

– Data-driven and optimized feasibility assessment process

• 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

• Experienced CRAs with site and investigator knowledge

– Work with sites to drive recruitment

– Ensure quality of data as well as speed of delivery

ENSURING SPEED AND SUCCESS FOR YOUR EARLY AND LATE PHASE ONCOLOGY STUDIES

OUR SYSTEMS AND PROCESSES HAVE BEEN DESIGNED TO ENSURE

RAPID AND EFFICIENT START-UP AND CONDUCT OF YOUR

ONCOLOGY STUDY

6ORION CLINICAL

FAST AND EFFICIENT PHASE I TO III STUDIESUTILISING IN–HOUSE FULL-SERVICE CAPABILITIES

7 SIMBEC ORION

SEIRIAN LABORATORIESSIMBEC-ORION’S CENTRAL PATHOLOGY & BIOANALYTICAL LABORATORIES

SEIRIAN LABORATORIES

“37% OF SEIRIAN’S EXPERIENCE HAS BEEN WITH NEW CHEMICAL ENTITIES...

...INCLUDING TRANSFER OF TECHNOLOGY FROM PRECLINICAL

TO HUMAN MATRICIES”

Is an integrated element of the Simbec-Orion Group based from the Simbec campus. Fast efficient reliable delivery for your complex studies

• Developing and validating complex assays• Highly selective and sensitive methods• Supporting all types of clinical study

THE BIOANALYTICAL LABORATORY DELIVERS

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.

BIOANALYTICAL & PATHOLOGY

API 5000’S

API 5500

API 4000

API 365

FULL RANGE OF LC-MS & IMMUNOASSAY EQUIPMENT

BIOTEK SYNERGY 96-WELL PLATE READER

7 ORION CLINICAL

8SIMBEC ORION

Dedicated pathology support for clinical trials. Designed exclusively for the biopharmaceutical industry with over 30 years of consistent, high quality delivery.

SEIRIAN PATHOLOGY EXPERTISE

INFECTIOUS DISEASES

RESPIRATORY

REPRODUCTIVE MALE/FEMALE

CARDIOLOGY

ENDOCRINOLOGY

DERMATOLOGY

ONCOLOGY

METABOLISM

IMMUNOLOGY

RHEUMATOLOGY

THERAPEUTIC AREAEXPERIENCE

UROLOGY

TECHNOLOGY

Clinical Chemistry Biochemistry, Immunology, Serology, Drugs of Abuse Screening

Urinalysis Routine multi-parameter testing with microscopic analysis

Haematology Full Blood Count with Differential Routine and Specialised Haemostasis Markers e.g. Thrombin Generation Assay

Multiplex Assays Cytokine Assays

Flow Cytometry Flow Cytometry - Lymphcyte Subset analysis etc.

Laboratory Computer System Clinical Trial LIMS

Microbiology Bacteria Identification and MIC Susceptibility

Freezer Storage Rees Scientific System Monitoring Storage Temperatures i.e. 4C, -20C, -80C and Room Temperature

Logistics management

8ORION CLINICAL

7 day per week analyses

www. SimbecOrionCRO.com

ORION CLINICALBUSINESS DEVELOPMENTT +44 1753 578080A 7 Bath Road, Slough SL1 3UA United Kingdom

Info@SimbecOrionCRO.com

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T +44 1753 578 080

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T +33 1 40 83 40 83

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T +49 2241 97398 204

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