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Focus on asthma, allergy and COPD
 

Measurement of drug efficacy on the
  respiratory tract in man
Wide range of validated techniques,
  including clinical models

Identification of mechanisms and activity of new molecular entities (NMEs)

Profiling and screening anti-inflammatory
  activites on human blood
Use of non-invasive biomarkers,
  predicting responders
Seamless development from laboratory to
  clinical application

Education and expert panels in asthma,
allergy and COPD

Consultancy and Expert panels in asthma
  allergy and COPD
Organisation of meetings
Full consulting services

Biomarkers

Development of novel biomarkers
  & surrogate markers; induced sputum for
  markers of inflammation, exhaled breath
  analysis, flow cytometry of blood and sputum
  samples, multiple chemokine & cytokine
  measurements in bodily fluids with picomolar
  sensitivity. All methods are performed in
  house using fully validated techniques.

Clinical Trials Unit

Dedicated specialist clinical
  trials unit
CTU located in private independent hospital
 
 
Design and management of phase I-III clinical respiratory studies

 
Drug development for asthma, COPD and allergy
Clinical development plans:
  early drug development strategy
Target profiles and medical needs
Study & protocol design including
  ethics submissions
Providing regulatory submissions to
  the MCA and EMEA
Data handling, full statistical analysis
  and report writing
Clinical studies (all aspects): methodology
  studies, clinical pharmacology through phase 1
  and phase 2 proof of concept studies to larger
  clinical end point studies
Lung function measurements
  (full service available)
Inhaled challenge tests using a variety of
  agents for asthma.
Nasal challenge studies in allergic rhinitis as
  surrogate markers of inflammation
Multi-Slice CT; PET/CT; MRI & Ultrasound
  and imaging facilities
Dedicated specialist Clinical Trials Unit
Expert meetings and consultancy services
 
Strategic advice on drug development for lung disease

 
Proof of concept studies
Protocol writing
Ethics committee submissions
Regulatory submissions
Data analysis and reporting
 
Due diligence on in-licensing dossiers

 
Review of confidential dossiers
Preclinical and clinical development
  programmes
 
Clinical trial activities include:
 

 
Drug development for asthma,
COPD and allergy
Clinical development plans: early drug development strategy
Target profiles and medical needs
Study & protocol design including ethics submissions
Providing regulatory submissions to the MCA and EMEA
Data handling, full statistical analysis and report writing
Lung function measurements (full service available)


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