Page 1

EARLY PHASE RESEARCH

ALL YOUR EARLY PHASE RESEARCH NEEDS FROM A SINGLE RESEARCH CAMPUS


QUALITY ASSURANCE

PHASE I - IV

INTERNATIONAL MEDICAL MONITORING

DATA MANAGEMENT

INTERNATIONAL SITE MONITORING

REGULATORY AFFAIRS

MEDICAL & TECHNICAL WRITING

IMP MANAGEMENT

STRATEGIC SUPPORT

BIOSTATISTICS INTERNATIONAL PROJECT MANAGEMENT

PHARMACOVIGILANCE SAMPLE MANAGEMENT

PHASE I RESEARCH CAMPUS

BIOANALYTICAL LAB

PHASE I - IIa BIOMARKERS

PATHOLOGY LAB

MEDICAL SUPPORT

ASSAY DEVELOPMENT

SCIENTIFIC SUPPORT CLINICAL PHARMACOLOGY PROJECT MANAGEMENT

SCINTIGRAPHY & ADME STUDIES


> 1,500 PHASE I/IIa STUDIES SUCCESSFULLY COMPLETED Simbec Research’s 58 bed clinical pharmacology unit, is one of the largest in the UK. A fully MHRA accredited facility able to carry out all types of studies (including FiH) and offering client focused project management, experienced medical teams, on site pathology & bioanalytical laboratories (with ɣ-scintigraphy imaging services), integrated data management and biostatistics, medical writing, pharmacy and Qualified Person (QP). A full service facility all on a SINGLE dedicated research campus in South Wales. Mass Balance/ ADME

3%

Scintigraphy

SAD / MAD / PT

5%

SAD / MAD / PD / FE SAD / MAD / FE SAD / MAD SAD / FORMULATION SAD

35%

57% MAD / PT MAD / PD MAD / FE MAD

PK studies

0 Combination Protocols

2

4

6

8

10

12

14


CLINICAL PHARMACOLOGY UNIT

58 BED PHASE I CLINICAL UNIT WITH FULL SERVICE SUPPORT ALL ON A SINGLE CAMPUS SIMBEC RESEARCH’S FiH EXPERIENCED TEAM HAS DELIVERED >1,500 CLINICAL STUDIES

SIMBEC RESEARCH With 42 years of experience, Simbec Research is one of the oldest and most experienced First in Human (FiH) Phase I organisations, having successfully delivered >1,500 clinical studies. As well as expertise in FiH studies including single and multi-dose tolerability Simbec has significant expertise in: • Drug-drug interactions • BioAvailability/BioEquivalence studies • PK/PD studies • Food/Gender effect • Gamma Scintigraphy • PoC Phase IIa studies • Mass Balance/ADME/Microdosing studies • Genotyping • Phenotyping studies • QTc studies

Located in South Wales, near Cardiff, and with easy access to Heathrow, Simbec commands almost exclusive, efficient access to a volunteer and patient population of 2-3 million people. Simbec Research Volunteer Recruitment immediate sphere of influence 4

SIMBEC RESEARCH


SIMBEC RESEARCH’S FULL SERVICE RESEARCH CAMPUS

With a campus combining a 58 bed Phase I clinical unit, central pathology & bioanalytical laboratories (Seirian Laboratories), ɣ-scintigraphy imaging services, IMP management via pharmacy and our Qualified Person team, integrated data management & statistics, project management & medical writing, Simbec provides unprecedented service and delivery.

ACCREDITED TO THE HIGHEST STANDARDS Simbec Research has been successfully inspected by MHRA-GMP, MHRA-GLP, MHRA-GCP, MHRA-GCP for Laboratories, MHRA-Phase 1 Accreditation, US FDA and UK Clinical Pathology Accreditation.

“SIMBEC RESEARCH CONTINUALLY PERFORMS >20% OF THE FiH STUDIES APPROVED IN THE UK.” SOURCE MHRA STATISTICS

SIMBEC RESEARCH

5


PROJECT MANAGEMENT

BY HAVING THE FULL SERVICE SUPPORT IN A SINGLE CAMPUS ENVIRONMENT, DRIVEN BY EXPERIENCED PROJECT MANAGERS, SIMBEC RESEARCH CAN PROVIDE YOU WITH SIGNIFICANT BENEFITS: SPEED, RELIABILITY OF DATA AND COST EFFECTIVENESS

Project Management group is located on campus – allowing direct/ face to face lines of communication and ensuring a hands on approach with the study team.

SIMBEC RESEARCH CAMPUS BENEFITS TO SPONSORS

To speed studies along smoothly we have: • Established procedures and templates for management of dose escalation trials • Established trial management SOPs/ templates with a flexible approach to sponsor requirements • Direct liaison with analytical laboratory to ensure timely reporting of drug concentration/pharmacodynamic/biomarker data Quality and scientific integrity are assured because all protocols are reviewed alongside current guidelines to ensure appropriate design and to minimise regulatory risk.

6

SIMBEC RESEARCH

Experienced medical teams

Subject Safety

Access to >2m healthy volunteers and patients

Meeting timelines cost effective

42 year history of safe and efficient delivery

Experience and expertise within the teams

On site Labs & MHRA GMP Pharmacy

Controlled environment for handling samples and IMP

E-clinical systems & LIMS

Real time access to better quality data

Full service phase I on a dedicated campus

Data (samples and CRFs) do not leave this site

Innovative and simple pricing model/structure

Efficient service delivery


KEY THERAPEUTIC AREAS The Project Management Team is highly experienced at managing early phase clinical trials. To ensure deadlines are achieved Project Management work in close cooperation with on campus support departments including Volunteer Recruitment, IMP Management (Pharmacy), Central Laboratories and Biometrics. A risk management plan is put in place for each study. Simbec has established procedures for capture and tracking of non-compliances, CAPA and project issue escalation.

RESPIRATORY DERMATOLOGY OPHTHALMOLOGY PAIN ENDOCRINE CARDIOVASCULAR NEUROLOGICAL

RESEARCH ETHICS COMMITTEE (REC) SUBMISSIONS Established relationships of nearly 15 years with Wales REC and their administration office - providing a fast turnaround and minimising risk of delays. The use of established templates for Informed Consent, Participation Information Sheet, GP letters etc. speeds approvals.

SIMBEC RESEARCH

7


PHARMACY / IMP MANAGEMENT

OUR PHARMACY HANDLES A WIDE RANGE OF IMP DOSAGE FORMS FOR ALL EARLY PHASE CLINICAL STUDIES

As active pharmaceutical ingredients are increasing in value, it is imperative that they can be managed effectively and efficiently. Simbec Research offers an effective, GMP & GCP compliant, in-house solution.

OUR GOAL IS TO MAKE YOUR STUDY AS EASY AS POSSIBLE FOR YOU, NO MATTER WHAT DOSAGE FORM YOU USE

Simbec’s Research specialist clinical trials pharmacy team are solely focused on the efficient management of your drug product. With 5 Qualified Persons named on Manufacturing Authorisation, Pharmacist & dedicated Clinical Trials Supplies Technicians, the team can manage your needs. We can manage • Sterile Products

• Grade A Isolator for aseptic production

• Non-Sterile Products

• Oral solutions, suspensions, topicals hand filling capsules, radiopharmaceuticals, solutions for inhalation/nebulisation

• Importation of IMP from outside EU

• MIA(IMP) No. 4757 manufacture,

primary and secondary packaging, IMPD

writing and review

• Double-blind Randomisation and Code break Envelope Production • IMPD writing and review 8

SIMBEC RESEARCH

We are • GMP and GCP compliant • Annex 13 compliant IMP Label Design • Controlled Drug (CD) license holder


BIOMETRICS AND PK ANALYSIS

At Simbec our in-house experts can work with you to ensure the data you want to collect can answer the questions you need answering. From development of the electronic Case Report Form (eCRF) through to PK analysis. Data Management

Statistical Analysis

• Case Report Form (CRF) review

• Set up activities include protocol review and generation of randomisation scheme

• Data Management Plan • Annotation of CRFs and Data Specification • Database design • Data Entry,Verification, Comparison, Query Resolution • MedDRA and WHO Drug dictionaries

WE WORK WITH YOU FROM GETTING THE VOLUNTEER THROUGH THE DOOR TO DELIVERING THE ANSWERS TO YOUR STUDIES QUESTIONS. ALL WITHIN THE ONE RESEARCH CAMPUS

• Statistical Analysis Plan agreed with sponsor, prior to database lock • Statistical Analysis & TFLs • All PK output for the Clinical Study Report (tables, figures and listings) listed in the SAP will be produced by the Statistician using SAS

• CDISC experience

PK analysis is a core skill within Simbec - performed by our in-house scientists • Non compartmental PK analysis will be performed using validated WinNonLin Phoenix 32 software • PK analysis will be independently verified by second analyst and QC checked before issue • Rapid turnaround of PK analysis for dose escalation decisions • Routine PK analysis for demonstrating bioequivalence • Final PK analysis for the report QA audited prior to issue to Statisticians for further analysis SIMBEC RESEARCH

9


SEIRIAN LABORATORIES

ON CAMPUS CENTRAL PATHOLOGY & BIOANALYTICAL LABORATORIES

FULL RANGE OF LC-MS & IMMUNOASSAY EQUIPMENT 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

API 5500 API 5000’S API 4000 API 365

“37% OF SEIRIAN’S

EXPERIENCE HAS BEEN WITH NEW CHEMICAL ENTITIES...

10

SIMBEC RESEARCH

...INCLUDING TRANSFER OF TECHNOLOGY FROM PRECLINICAL TO HUMAN MATRICIES”


SEIRIAN 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

TECHNOLOGY Clinical Chemistry

ENDOCRINOLOGY RHEUMATOLOGY

Urinalysis

Biochemistry, Immunology, Serology, Routine multi-parameter testing with Drugs of Abuse Screening microscopic analysis

Haematology

Multiplex Assays

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

Logistics management

DERMATOLOGY

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

IMMUNOLOGY RESPIRATORY METABOLISM CARDIOLOGY ONCOLOGY UROLOGY

SIMBEC RESEARCH

11


HEALTHY VOLUNTEER & PATIENT RECRUITMENT

KEY QUESTION FOR YOUR EARLY PHASE STUDIES IS “CAN YOU GET ENOUGH APPROPRIATE VOLUNTEERS FOR YOUR TRIAL FAST ENOUGH AND IN A COST EFFICIENT MANNER?” SIMBEC RESEARH HAS THE TEAMS, PROCESSES, AND AN ALMOST EXCLUSIVE VOLUNTEER POOL TO ANSWER “YES!”

12

SIMBEC RESEARCH

The biggest problem facing Phase I studies is getting the right volunteers at the right time in a cost efficient manner Some other Phase I units center themselves like clusters in cities hoping to trawl enough volunteers from large transient populations, competing with each other for the finite number of potential volunteers.

At Simbec Research we’ve taken a different approach. For the last 42 years we have been based in an area of the country with no competing Phase I operators. Within our catchment area there are 2-3 million potential healthy volunteers and patients. With cities, large population centres, universities and a steady stream of young healthy participants our outreach programmes have a enthusiastic and engaged audience.


• Dedicated Volunteer Recruitment group comprising of clinical and marketing staff • Driving both study specific and general volunteer engagement and recruitment activities

— Focus of healthy volunteer recruitment via social media and digital channels, to increase engagement and drive down recruitment costs

— Significant links with both hospital centres of excellence and General practitioners to reach patient populations

DEDICATED ENROLMENT SERVICES TEAM FOCUSED ON ENSURING TIMELY AND EFFICIENT VOLUNTEER RECRUITMENT AND SCREENING

“Our current % rate of scheduled FSFD is 99.3% and our current average screening ratio is 2:1” ONLINE & SOCIAL MEDIA • Twitter posts • Facebook ads and posts • Google Adwords • Simbec Research Website - post with links to sign-up. TRADITIONAL MEDIA ADVERTS – PRINT & ONLINE • Local and regional newspapers MEDIA – BROADCAST • Radio adverts DIRECT MARKETING • Phone calls • Emails SITE SPECIFIC • Rail stations and trains • Bus Terminus and buses SIMBEC RESEARCH

13


WHY CHOOSE THE UK FOR YOUR CRITICAL FiH STUDIES? ONLY 1 IN 10 DRUGS ENTERING PHASE 1 WILL RECEIVE AN NDA

POSITIVE REGULATORY ENVIRONMENT, STRONG SAFETY GUIDELINES, EXPERIENCED RESEARCH PERSONNEL AND AN ACTIVE VOLUNTEER POOL, ALL COMBINE TO HELP FIRST IN HUMAN PHASE I STUDIES BE MORE EFFICIENT IN SOUTH WALES THAN THE USA

Probability Of Drug (All Molecules) Progressing Between Clinical Development Phases*

No. of Products in Development Phase

Phase I

Phase II

10

6

Phase III

<2 Drugs 1 NDA

* Hay M et al. Clinical development success rates for investigational drugs. Nature Biotechnology 2014

ONLY 60% OF ALL MOLECULES ENTERING INTO PHASE I MAKE IT TO PHASE II With these facts in mind, strategically for your business, where is the best place for you to conduct your early phase clinical studies? 14

SIMBEC RESEARCH


TOP QUALITY RESEARCHERS, SPEED TO GETTING DATA & COST EFFICIENT FOR FiH STUDIES IN THE US YOU MUST HAVE THE IND WRITTEN BEFORE YOU ENTER THE CLINIC – UP TO 6 MONTHS TO PREPARE & SUBMIT

“WITHOUT THE NEED FOR EXPENSIVE IND APPLICATIONS, AT SIMBEC YOU CAN HAVE DATA COMING BACK FROM THE CLINIC BEFORE YOU’VE EVEN STARTED ENROLLING VOLUNTEERS IN THE USA.”

Regulatory Costs Prior to First Phase I Study Per Molecule USA

UK

IND Preparation/Submission

CTA Preparation/Submission

$120,000

$30,000

Regulatory Time Prior to First Phase I Study Per Molecule USA

UK

Cost Saving

$90,000

IND Preparation/Submission

CTA Preparation/Submission

Cost Saving to Reach NDA

$900,000

~ 4 – 6 Months

~ 2 Months

FOR FiH STUDIES IN THE UK YOU NEED A CTA ONLY BEFORE YOU ENTER THE CLINIC – 2 MONTHS TO PREPARE & SUBMIT.

Time Saving

2 – 4 Months

Extra Revenue Generated*

Up to $83,000,000

*assuming drug gets to market with sales of $1b / year

“Having been the CEO of several biotech companies, I see now the huge upside in running early phase clinical studies at Simbec, without the expense or delays of the IND process before the studies start. Upfront fees, earlier milestones, more sales value in the patent life. I wish I’d known this then...” Ronald Openshaw former biotech CEO now CEO Simbec-Orion Group SIMBEC RESEARCH

15


SIMBEC RESEARCH LIMITED BUSINESS DEVELOPMENT T A

ACCREDITATIONS UK GLP/GCP COMPLIANCE MHRA PHASE 1 CLINICAL TRIALS SUPPLEMENTARY ACCREDITATION CLINICAL PATHOLOGY ACCREDITATION UK EXTERNAL QUALITY ASSESSMENT SCHEME

+44 1443 690977 Simbec House Merthyr Tydfil Industrial Park, Merthyr Tydfil CF48 4DR United Kingdom

Info@SimbecOrionCRO.com

www. SimbecOrionCRO.com

100 Overlook Center 2nd Floor Princeton NJ 08540 USA

Simbec House Merthyr Tydfil Industrial Park Merthyr Tydfil CF48 4DR United Kingdom

7 Bath Road Slough SL1 3UA United Kingdom

Centre d’Affaires La Boursidière Bâtiment le Jura, BP 141 92357 Le Plessis-Robinson Cedex France

Via Boezio, 6 Cap 00193 Roma Italy

T +1 215 345 5004

T +44 1443 690977

T +44 1753 578080

T +33 1 40 83 40 83

T +39 328 03494

Phase I Brochure  

All your Early Phase Research Needs from a Single Research Campus.

Phase I Brochure  

All your Early Phase Research Needs from a Single Research Campus.