phase i brochure
DESCRIPTION
All your Early Phase Research Needs from a Single Research Campus.TRANSCRIPT
EARLY PHASE RESEARCH
ALL YOUR EARLY PHASE RESEARCH NEEDSFROM A SINGLE RESEARCH CAMPUS
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.
> 1,500 PHASE I/IIa STUDIES SUCCESSFULLY COMPLETED
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SIMBEC RESEARCH HAS UNPRECEDENTED ACCESS TO A POPULATION POOL OF 2-3 MILLION POTENTIAL HEALTHY VOLUNTEERS AND PATIENTS
32%
49%
6%13%
Large Pharma
Biotech & Mid Cap Pharma
Academic Institutions
CRO/Other
TYPES OF CUSTOMER
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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
CLINICAL PHARMACOLOGY UNIT
With 40 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
Simbec Research
Volunteer Recruitment immediate sphere of influence
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SIMBEC RESEARCH’S FULL SERVICE RESEARCH CAMPUS
“SIMBEC RESEARCH CONTINUALLY PERFORMS >20% OF THE FIH STUDIES
APPROVED IN THE UK.” SOURCE MHRA STATISTICS
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ACCREDITED TO THE HIGHEST STANDARDSSimbec 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.
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.
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
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.
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.
SIMBEC RESEARCH CAMPUS BENEFITSTO SPONSORS
Experienced medical teams Subject Safety
Access to >2m healthy volunteers and patients
Meeting timelines cost effective
40 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
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KEY THERAPEUTIC AREAS
RESPIRATORY
DERMATOLOGY
OPHTHALMOLOGY
PAIN
ENDOCRINE
CARDIOVASCULAR
NEUROLOGICAL
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.
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.
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PHARMACY / IMP MANAGEMENT
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OUR PHARMACY HANDLES A WIDE RANGE OF IMP DOSAGE FORMS FOR ALL EARLY PHASE CLINICAL STUDIES
OUR GOAL IS TO MAKE YOUR STUDY AS EASY AS POSSIBLE FOR YOU, NO MATTER WHAT DOSAGE FORM YOU USE
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.
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
We are
• GMP and GCP compliant
• Annex 13 compliant IMP Label Design
• Controlled Drug (CD) license holder
BIOMETRICS AND PK ANALYSIS
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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
Data Management
• Case Report Form (CRF) review
• Data Management Plan
• Annotation of CRFs and Data Specification
• Database design
• Data Entry, Verification, Comparison, Query Resolution
• MedDRA and WHO Drug dictionaries
• 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
Statistical Analysis
• Set up activities include protocol review and generation of randomisation scheme
• 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
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.
SEIRIAN LABORATORIESON CAMPUS 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
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
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7 day per week analyses
HEALTHY VOLUNTEER & PATIENT RECRUITMENT
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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!”
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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 40 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
The biggest problem facing Phase I studies is getting the right volunteers at the right time in a cost efficient manner
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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”
• 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
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
WHY CHOOSE THE UK FOR YOUR CRITICAL FiH STUDIES?
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
ONLY 1 IN 10 DRUGS ENTERING PHASE 1 WILL RECEIVE AN NDA
ONLY 60% OF ALL MOLECULES ENTERING INTO PHASE I MAKE IT TO PHASE II
With these facts in mind, strategically for your business, where isthe best place for you to conduct your early phase clinical studies?
Probability Of Drug (All Molecules) Progressing Between Clinical Development Phases*
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* Hay M et al. Clinical development success rates for investigational drugs. Nature Biotechnology 2014
10 6 <2 Drugs
No. of Products in Development Phase
Phase I Phase II Phase III
1 NDA
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
FOR FIH STUDIES IN THE UK YOU NEED A CTA ONLY BEFORE YOUENTER THE CLINIC – 2 MONTHS TO PREPARE & SUBMIT.
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“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.”
“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
Regulatory Costs Prior to First Phase I Study Per Molecule
USA
INDPreparation/Submission
Cost Saving to Reach NDA $900,000
$120,000
Cost Saving $90,000
CTA Preparation/Submission
$30,000
UK
Regulatory Time Prior to First Phase I Study Per Molecule
Extra Revenue Generated* Up to $83,000,000
Time Saving 2 – 4 Months
USA
INDPreparation/Submission
~ 4 – 6 Months
CTA Preparation/Submission
~ 2 Months
UK
*assuming drug gets to market with sales of $1b / year
www. SimbecOrionCRO.com
SIMBEC RESEARCH LIMITED BUSINESS DEVELOPMENTT: +44 1443 690977A: Simbec House Merthyr Tydfil Industrial Park, Merthyr Tydfil CF48 4DR United Kingdom
ACCREDITATIONS
UK GLP/GCP COMPLIANCEMHRA PHASE 1 CLINICAL TRIALS
SUPPLEMENTARY ACCREDITATIONCLINICAL PATHOLOGY ACCREDITATION UK
EXTERNAL QUALITY ASSESSMENT SCHEME
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T +44 1753 578 080
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