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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EDrug discovery and development is a complex and expensive process. Clinical trials are major investments for industry and for academic researchers but also for patients, many of whom could undergo repeated clinical, radiographic, and laboratory assessments without the promise of therapeutic benefit.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EChronic Obstructive Pulmonary Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Genomics\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EDrug discovery and development is a complex and expensive process. Clinical trials are major investments for industry and for academic researchers but also for patients, many of whom could undergo repeated clinical, radiographic, and laboratory assessments without the promise of therapeutic benefit.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EOne option for streamlining drug development includes ending the development of less effective drugs earlier in the development process. This requires the use of surrogate markers that better predict clinical efficacy and safety. Novel biomarkers, for example, may serve as intermediate outcome measures in patients with chronic obstructive pulmonary disease (COPD). Another option involves identifying the specific population of patients who are most likely to benefit from a particular drug\u2014the right drug for the right patient at the right time. Specific patient populations could be determined by patient profile (phenotype), including factors, such as age, gender, x-ray CT findings, blood biomarkers, and genetic or clinical profile. Target populations could also be restricted to certain disease stages, such as early versus late disease or previously untreated versus treatment-refractory COPD.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn this session, presenters described two major research collaborations that are aimed at advancing the discovery and development of new treatments for COPD.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EThe COPD Biomarker Qualification Consortium\u003C\/h2\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EBiomarkers play a prominent role in every stage of drug development. In preclinical studies, biomarkers can be used to determine whether therapeutic targets are relevant in disease pathology. In Phase 1 studies (healthy volunteers), biomarkers can be used to explore mechanism of action, pharmacology, and optimal dosing. In Phase 2 and 3 studies (patients with disease), biomarkers are essential for assessing clinical outcomes. As an example of biomarkers in COPD, the forced expiratory volume in 1 second (FEV\u003Csub\u003E1\u003C\/sub\u003E) has been instrumental in characterizing airflow obstruction and determining efficacy of bronchodilator-based therapies. However, COPD is a heterogeneous disease, and a single biomarker is not sufficient to evaluate the potential efficacy of promising drug candidates across diverse patient phenotypes.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EQualifying a novel biomarker requires a large volume of preclinical and clinical data, which is difficult for individual research programs to amass. The COPD Foundation launched the COPD Biomarkers Qualification Consortium (CBQC), a new collaboration of government agencies, academic medical centers, and pharmaceutical companies that will share data on the identification and validation of COPD biomarkers. Ruth Tal-Singer, PhD, GlaxoSmithKline, King of Prussia, Pennsylvania, USA, and Industry Chair for the CBQC, described the goals of the new initiative.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EBiomarker qualification is the process of evaluating the clinical utility of biomarkers. According to the United States Food and Drug Administration (FDA), a biomarker is qualified when the scientific, medical, and regulatory communities agree that its measurement is analytically valid. In addition, when a qualified biomarker is evaluated, the test result can be relied upon to provide specific physiological, toxicological, pharmacological, or clinical meaning. Early candidates for biomarker qualification in COPD are listed in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\u003C\/p\u003E\n         \u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/12274\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/12274\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12274\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003ECOPD Biomarker Qualification Consortium: Example Biomarkers.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EThe CBQC was launched in October 2010, with three specific goals. The first is to qualify biomarkers through the FDA and European Medicines Agency (EMA) to facilitate the development of new treatments for COPD. Second, the CBQC aims to identify biomarkers for which sufficient data already exist in industry, academic, and government databases to warrant consideration for qualification. The third mission of the CBQC is to identify and fill any additional gaps in biomarker development by facilitating collaborations within the international research community.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EThe SPIROMICS Collaborative Study\u003C\/h2\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EThe Subpopulation and Intermediate Outcome Measures in COPD Study (SPIROMICS) is an ongoing collaboration that is led by the National Heart, Lung, and Blood Institute (NHLBI) to evaluate the heterogeneity of COPD. Tom Croxton, PhD, MD, NHLBI, Bethesda, Maryland, USA, described the background, design, and goals of the SPIROMICS initiative.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003ESmoking is the primary risk factor for the development and progression of COPD. However, in the COPD Genetic Epidemiology (COPDGene) Study, smoking history correlated only weakly with lung function in patients with COPD [\u003Ca href=\u0022http:\/\/www.COPDGene.org\u0022\u003Ewww.COPDGene.org\u003C\/a\u003E]. The lack of a dose-response relationship between pack-years of smoking and FEV\u003Csub\u003E1\u003C\/sub\u003E was a surprising finding that underscores the complexity of COPD. Indeed, other recent studies have revealed many diverse factors that influence the natural history of COPD, including systemic inflammation, infectious colonization, and immune dysregulation. At the cellular level, mucous metaplasia, apoptosis, and matrix degradation also contribute to COPD.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EAccording to Dr. Croxton, the SPIROMICS collaborative study arose from the recognition that developing effective pharmacotherapies for COPD requires a comprehensive understanding of the disease process, which can only be realized through the analysis of a wide spectrum of characteristics, including phenotypic, biomarker, genetic, genomic, and clinical data.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003ESPIROMICS has two main objectives. The first objective is to identify subpopulations of COPD patients who are pathogenetically and mechanistically homogenous, based on clinical characteristics, biomarkers, genotypes, and imaging studies. The second objective is to identify practical surrogate markers of COPD severity that can be incorporated into future clinical trials, including early-phase proof-of-principle and dose-ranging studies. The goal is to accelerate the development of new COPD therapies by identifying potential intermediate outcome measures for use in COPD research.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003ESPIROMICS will recruit approximately 3200 individuals across a range of age groups and ethnic backgrounds, comprising 2400 patients with COPD, 600 smokers with normal lung function, and 200 never-smokers. To maximize the applicability of study findings to the COPD patient population, there will be few restrictions on study eligibility. Patients will undergo annual assessment of lung function and biochemical measures for at least 3 years (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E). In addition to the core longitudinal study, SPIROMICS will also include substudies that are related to bronchoscopy, COPD exacerbations, and mucus clearance.\u003C\/p\u003E\n         \u003Cdiv id=\u0022T2\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/12275\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/12275\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/12275\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-15\u0022 class=\u0022first-child\u0022\u003ESPIROMICS: Patient Assessment Measures.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EThe SPIROMICS initiative also represents a new model for prospective collaboration in COPD research. Through SPIROMICS, participating medical centers will build a rich repository of biochemical specimens for ongoing research projects. SPIROMICS will also develop bioinformatics resources that will facilitate the sharing of clinical, biomarker, radiographic, and genetic data across participating sites and external investigators. Medical centers that are currently involved in the SPIROMICS project include Columbia University, Johns Hopkins University, University of California at Los Angeles, University of California at San Francisco, University of North Carolina at Chapel Hill, University of Utah, Wake Forest University, and University of Michigan.\u003C\/p\u003E\n         \u003Cp id=\u0022p-17\u0022\u003EThrough unprecedented collaborative efforts, the CBQC, SPIROMICS, and similar global public-private partnerships have the potential to discover new biomarkers and therapeutic agents that can improve the diagnosis, monitoring, and treatment of COPD while expediting the development of novel therapies. Preliminary reports from these research groups may have clinical implications on COPD management in the near future.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/11\/4\/14.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn2pe\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzn2pe\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}