Research Center Profile:
Cardiology/Vascular Diseases
ICON’s hospital-based Clinical Pharmacology Unit in Manchester, UK has conducted clinical pharmacology studies for over 27 years. The newly constructed, state-of-the-art 52-bed facility on the Central Manchester University Hospital Foundation Trust (CMFT) campus and fully integrated into the Manchester Royal Infirmary (MRI) is suited to conduct studies in all major therapeutic areas. ICON has new dedicated ward in the Manchester Royal Infirmary Hospital that enables ICON to conduct a wide range of validated early-phase metabolic techniquesincluding Glucose Clamp Procedures, Graded Glucose Infusion, Glucose Tolerance Testing, Insulin Tolerance Testing, Maximum Stimulation Testing, as well as safety assessments of diabetic molecules, including Flow Mediated Dilation, Electrophysiology, Contractility and Platelet Aggregation.
ICON will be further expanding on the same hospital campus into a 40,000 square foot facility at Citylabs, a newly developed biomedical centre of excellence scheduled to open Q2 2014.
ICON’s partnership with the MRI provides full access to critical care facilities, including hospital emergency services, resuscitation team response, critical care beds and designated consultant level referral making this unit ideal for conducting first-in-human studies. Our collaborative relationship with the CMFT and the Manchester Academic Health Science Centre unrivalled access to the expertise, specialist procedures and patient populations.
Clinical Trials Experience
First in human studies including 15 FTIH recent mAbs in both healthy volunteer and patient populations
Single and multiple dose escalation, safety and tolerability studies
Combined SAD/MAD food effect studies
Combined healthy volunteer/patient protocols
Drug-Drug Interaction (DDI) and Food-Drug Interaction studies
Bioavailability and Bioequivalence studies
Biosimilar studies
Pharmacodynamic and Pharmacokinetic studies
Biomarkers, Imaging studies
ICON Development Solutions has a wealth of experience of clinical pharmacodynamics. Current models at our Manchester facility include:
Diabetes (Glucose Clamp)
Euglycemic Camp, where the glucose concentrations are maintained at their basal value
Hyperinsulinemic Euglycemic Clamp, where a priming dose of insulin is administered prior to the administration of the test insulin/drug whilst maintaining glucose concentrations at their basal value
Hyperglycemic Clamp, where glucose concentrations are raised and maintained at an elevated concentration
Hypoglycemic Clamp, where glucose concentrations are reduced in a controlled environment
Anxiety (Aversive autonomic conditioning, Simulated public speaking, CO2 - induced panic)
Pain Models
Acute Pain, (Cold Pain Model, Heat Pain Detection Thresholds, Heat Pain Tolerance, Brief Thermal Stimulation)
Chronic Pain (Intradermal Capsaicin Model, (Hyperalgesia, Allodynia, Pain VAS, Flare Measurement, Heat Hyperalgesia), Topical Capsaicin Model, Heat Capsaicin Model)
Quantitative Sensory Testing (QST), Perception Thresholds, Heat detection, Cold detection, Wind up ratio, Mechanical pain threshold/sensitivity, Pressure pain threshold
UVB/C Burn Model
Menthol Model
Inflammatory Response (Cantharidin Blister Model)
Appetite Models
Test Meal Model (Universal Eating Monitor, Validated Questionnaires, Bioelectrical Impedance, Food Diaries)
Sexual Dysfunction (Ejaculatory Latency Model)
Cognition
Scopolamine Model
Computerised and “pencil & paper” Cognitive Testing
Specialist Techniques
Saccadic Eye Movements
Critical Flicker Fusion
Body Sway
Laser Doppler
Pupillometry, (Static / Dynamic Measurements, Crossed-pupillary Response)
Respiratory (Peak Flow Rate, Flow Loops)
Electroencephalography, (Clinical EEG, Pharmaco-EEG, Evoked Potentials)
Audiometry
Actigraphy
Exercise Physiology
Physiological Measurements
Temperature (Continuous Core Body Temperature Monitoring (Ingestible Capsule), Continuous Skin Temperature Monitoring (Dermal Patch), Infra-Red Skin Temperature)
pH Monitoring, (Continuous Measurement (Bravo Capsule), Peripheral)
Skin Conductance Measurement
Imaging (Formal collaborations with local PET and fMRI centres including the delivery of integrated pharmacodynamic and PET ligand recepetor occupancy studies)
The Manchester unit is located at the Central Manchester University Hospital Foundation Trust (CMFT) campus and is fully integrated into the Manchester Royal Infirmary (MRI). The partnership with the MRI provides full access to critical care facilities making this unit ideal for conducting first-in-human studies.
Summary
52 beds available (a mixture of 4/6 bed bay, a number of single rooms, some with en-suite facilities & 4 light-controlled PD testing rooms)
Additional 20 beds within the MRI are available if increased capacity required
24-channel Mortara telemetry system
Hospital-based clinical research facilities on the Central Manchester University Hospital Foundation Trust (CMFT) campus
Extensive and fully validated pharmacodynamic models in cardiovascular, CNS and metabolic diseases
ICON GMP pharmacy
On-site PK processing laboratory and local bioanalytical laboratory
Human performance and tissue handling laboratories
The Manchester CPU medical team includes licensed physicians, nurses and phlebotomists. ICON enhances the medical expertise of its staff by providing regular training for medical and emergency care, and all medical staff maintains the necessary continuing education for compliance with their licensure and/or registration requirements.
Manchester employs 3 dedicated full-time Principal Investigators:
Peter Dewland, BSc, MA, MBBS, FFPM, DCPSA
Over 33 years experience in Pharmaceutical Medicine
Fellow of Faculty of Pharmaceutical Medicine (FFPM)
Lecturer, Masters in Clinical Research, Welsh School of Pharmacy
Member of the South East Wales Research Ethics Committee
Principal Investigator on >100 First in Human Studies
Dr Simon Singer
Honorary Clinical Fellow in Emergency Medicine, Central Manchester University Hospitals NHS Foundation NHS Trust
Pharmaceutical Medicine Specialty Training (currently ST2)
Diploma in Human Pharmacology
Advanced Life Support Provider
Principal Investigator: 20 studies
Sub-Investigator: 40-50 studies
Dr. Pui Man “Paul” Leung
Diploma in Pharmaceutical Medicine
Advanced Life Support Provider
Principal Investigator: 10 studies
Co-Investigator: >500 studies
Dr Karen BengEe So
MD research in the treatment of scarring from University of Manchester 2011
Advanced Life Support Provider
6 years experience in pharmaceutical industry
Phase II and Phase III clinical trials
Principal investigator in Phase III clinical trial
Manchester Leadership Team includes:
Dr Cyril Clarke, Vice President Translational Medicine
Clinical Pharmacologist with over 21 years’ experience in clinical research
Principal Investigator for over 300 Phase I studies
Chair of the ABPI Experimental Medicines Committee
Honorary Senior Lecturer in Translational Medicine
University of Manchester
Dr John Connell, Vice President Pharmacodynamics
Extensive experience in developing PD markers and human disease models
20+ years Clinical Research Experience
250+ Phase I/II clinical trials
Gwen Aston, Site Head & General Manager
Registered Nurse with over 26 years’ experience in clinical research
6 years Pharmacovigilance& Medical Affairs experience
Experience in excess of 500 Phase I/II clinical trials
ICON Development Solutions’ Manchester Clinical Unit maintains an active database of over 10,000 volunteers which includes healthy male and female volunteers, non-child bearing females, genotyped males and females, “healthy elderlies” and patients with COPD and asthma. The main demographic is healthy, male, Caucasian aged 18-55, BMI 18 - 28, non smokers. The database is considered active (defined as having joined, screened or taken part in a study in the last 2 years) and clean, as the volunteers are contacted regularly (generally monthly) to ensure their interest is current.
Manchester
Volunteer database
9500+ Healthy males & Females
250+ Asthmatic
100 + Diabetic
150+ Post-Menopausal
500+ Older – age 55+
Metropolitan population of 2.6 million
25 colleges/universities in Greater Manchester
85% Caucasian, 4% Asian, 2% Afro-Caribbean, 9% other
Manchester Clinical Pharmacology Unit IDSinfo@iconplc.com
Division Headquarters IDSinfo@iconplc.com
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