Medicines Evaluation Unit - Capabilities

Phase I-IV Capability

• High-dependency ward in South Manchester University Wythenshawe Hospital, UK

• Full 24-hour emergency cover with access to ITU

• Extensive experience of studies defining pharmacodynamic/pharmacokinetic relationships in healthy volunteers and patients

• All routes of administration, including intravenous, subcutaneous, inhalation and novel drug delivery systems

Quality

• Work to full ICH GCP
• MCA and Independent QA Inspected.
• Internal SOP system

Respiratory Capability

• Whole body plethysmography and impulse oscillometry
• Transfer factor
• Bronchoscopy and bronchial biopsy
• Induced sputum
• Inhalational bronchial challenges of allergens or other mediators (methacholine, histamine, AMP, leukotriene D4)
• Exhaled breath condensate
• Exhaled nitric oxide
• Various Exercise Challenge protocols
• A range of drug delivery capabilities
• Access to an extensive patient database of Asthma, COPD and Healthy volunteers.

Pharmacodynamic Capabilities

• Induced sputum – cell counts, supernatant protein analysis, PCR.

• Exhaled breath measurements (nitric oxide and condensates).

• Whole blood cell culture and flow cytometry.

• Lung cell molecular biology using clinical samples to assess changes in immune function.

Cardiovascular Capability

• Blood pressure and ECG recording and evaluation
• QT interval and dispersion measurement
• 24-hour out-patient blood pressure monitoring
• 24-hour high-dependency monitoring of in-patient studies
• Holter monitoring

Phase II – IV Capability

The staff of the MEU are fully trained and experienced in the conduct of single-site and multi-site patient studies, and have knowledge of a wide range of therapeutic areas. With a dedicated out-patient facility within a major teaching hospital, the MEU is able to offer high quality studies, with recruitment rates and trial completion often well ahead of schedule.

Time

Trial recruitment and delivery to required time-lines
Performance metrics (Time / patient no. dependency etc) produced for each study.

Subject Recruitment

The MEU has a dedicated subject recruitment department of 4 staff whose task is continually recruit subjects to the study database and also attain recruitment targets for individual studies. This is aided by a purpose designed clinical administration database that enables the smooth flow of recruitment data and the documentation involved between the recruitment department, the clinical unit and senior management.

The result of this dedicated function means that the MEU is frequently the top recruiter in the UK in multi-centre studies.

MEU Respiratory Database

Asthma

The subject database includes over 1000 asthmatic subjects of varied severity (from steroid naïve to high dose inhaled steroid patients). Lung function tests (including reversibility) have been performed on all these subjects in addition to a medical and therapeutic history. This enables searches to be made on specific patient groups for individual studies. The asthma database also has a large sub-group of subjects who smoke enabling studies of the effect of smoking in asthma treatments.

COPD

Several hundred characterised patients with COPD/emphysema have been recruited to the database.

Rhinitis

The MEU has recently started to build up a cohort of rhinitis patients for inclusion in studies of seasonal rhinitis.

Healthy Volunteers

A database of healthy volunteers is available for Phase I studies or comparator groups for later phase studies. The database also includes a cohort of "healthy smokers" with small airway disease