Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Endocrinology
Gastroenterology
Healthy Volunteers
Hematology
Immunology
Infections and Infectious Diseases
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Ophthalmology
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma (Emergency, Injury, Surgery)
Urology

Center Overview

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 Research Experience

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)

Facility Description

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

Investigator Experience

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
Medical Director

• 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
Senior Clinical Research Physician/Principal Investigator

• 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
Senior Research Physician

• Diploma in Pharmaceutical Medicine
• Advanced Life Support Provider
• Principal Investigator: 10 studies
• Co-Investigator: >500 studies

Dr Karen BengEe So
Clinical Research Physician/Sub-Investigator

• 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

Patient Demographics

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

Other Information

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.