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Focus on asthma, allergy and COPD
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· Measurement of drug efficacy on the
respiratory tract in man
· Wide range of validated techniques,
including clinical models
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Identification of mechanisms and activity of new molecular entities (NMEs)
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· Profiling and screening anti-inflammatory
activites on human blood
· Use of non-invasive biomarkers,
predicting responders
· Seamless development from laboratory to
clinical application |
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Education and expert panels in asthma,
allergy and COPD
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· Consultancy and Expert panels in asthma
allergy and COPD
· Organisation of meetings
· Full consulting services
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Biomarkers
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· 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.
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Clinical Trials Unit
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Design and management of phase I-III clinical respiratory studies
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· 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
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Strategic advice on drug development for lung disease
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· Proof of concept studies
· Protocol writing
· Ethics committee submissions
· Regulatory submissions
· Data analysis and reporting |
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Due diligence on in-licensing dossiers
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· Review of confidential dossiers
· Preclinical and clinical development
programmes |
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Clinical trial activities include:
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