Improving the Quality of Allergy and Respiratory Clinical Research Using Induced Sputum Biomarkers

Both asthma and COPD are highly heterogenic, chronic inflammatory airway diseases. Current treatments such as inhaled corticosteroids, often combined with long-acting bronchodilators, represent the gold standard pharmacotherapy in milder disease; they are much less effective in severe persistent asthma and in COPD. Therefore, as part of a precision approach to drug targeting, inflammatory phenotyping (as one example) may help to identify key inflammatory components within a disease subset both as targets and for monitoring of existing and innovative therapies.

Induced sputum is increasingly being implemented in all phases of drug development both for phenotyping and as a read-out of drug efficacy. The involvement of hundreds of patients undergoing sputum induction requires a multicenter collaboration often spanning countries and continents. The selection of collaborating sites for such large studies poses several methodological, technical and logistical challenges. Standardization and are some of key elements to reduce variability and data loss which if accomplished, can translate into successfully captured outcome measures.

The presenters, experts in the industry, will discuss the Quintiles Biospit Initiative, a global effort with collaborating centers aimed at harmonizing methodologies for sputum biomarker collection and testing while also improving site selection and monitoring performance in these trials.

The Quintiles team aims to give you insights into delivering more robust data to enable critical go-no go decisions earlier and with greater confidence in your asthma, COPD, CF, ICF, or other studies.

Speakers

Graham Clarke, PhD, Senior Director and Head of Respiratory & Inflammation, Quintiles Early Clinical Development

Graham Clarke, PhD, is the senior director and head of the respiratory and inflammation unit in Early Clinical Development. He leads the development and execution of inhaler generics and inhaler characterization studies in broncho-protection and broncho-dilation bioequivalence programs. He also leads Quintiles’ biomarker identification efforts and the development of challenge models of inflammation.

Dr. Clarke joined Quintiles in 2008 as the therapeutic area head for respiratory responsible for developing patient strategy and biomarker development initiatives. In that role, he contributed to new integrated approaches for drug development across Quintiles — including patient recruitment strategy, protocol design and optimizing biomarker read-outs.

After training as a clinical physiologist at the Royal Brompton Hospital, London, Dr. Clarke served in a variety of respiratory clinical research environments. He is the former editor of Inspire, the journal of the Association for Respiratory Technology and Physiology, and he is a senior research fellow in cardiothoracic pharmacology at Imperial College London’s National Heart and Lung Institute, where he contributes to the research and medical degree teaching programs. Dr. Clarke completed a PhD in respiratory pharmacology and physiology with focus on airway and vascular hyper-responsiveness in asthma at King’s College, London.

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Neil Alexis, Professor, Department of Pediatrics, Division of Immunology and Infectious Disease, University of North Carolina at Chapel Hill

Professor Neil Alexis, Director of the Applied Airway Immunobiology Laboratory at the CEMALB, where he leads the processing of human samples (sputum, blood, BAL, nasal lavage) and the execution of all lab-based measurements/assays on those study samples. These include measurement of markers of inflammation and flow cytometric-based assays for markers of innate immune activation.

As PI of the CEMALB Sample Repository, Neil is responsible for the proper storage, electronic documentation and access to all archived samples generated by the CEMALB. As a past Core Director of a SCCOR Grant (Sample Acquisition, Analysis, and Repository Core), and current Core Director of a TCORS (Tobacco Centers of Regulatory Science) grant he is responsible for sample acquisition and repository functions, as well as executing assays for proteomics, inflammation and innate immune endpoints.

Neil is a Professor at the Department of Pediatrics, Division of Immunology and Infectious Disease, UNC School of Medicine, University of North Carolina at Chapel Hill, NC. Professor Alexis is also a QA/QC Officer, Center for Environmental Medicine Asthma and Lung Biology.

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