MD Conference Express ATS 2011 - (Page 14)
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New Collaborations Aim to Speed Drug Development in COPD
Written by Anne Jacobson
Drug 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. One 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—the 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. In this session, presenters described two major research collaborations that are aimed at advancing the discovery and development of new treatments for COPD. The COPD Biomarker Qualification Consortium Biomarkers 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 (FEV1) 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. Qualifying 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. Table 1. COPD Biomarker Qualification Consortium: Example Biomarkers.
Biomarker Candidate Role in COPD A rating scale for health status and disease impact A marker to stratify risk of mortality A marker to stratify risk of mortality and hospitalization
Highlights from the
American Thoracic Society 2011 International Conference
St. George’s Respiratory Questionnaire for COPD (SGRQ-C) 6-minute Walk Distance (6MWD) Plasma Fibrinogen
Biomarker 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
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Table of Contents for the Digital Edition of MD Conference Express ATS 2011
MD Conference Express ATS 2011
Contents
Obesity: Implications for the Clinical Practice of the Pulmonary, Critical Care and Sleep Physician
Asthma Phenotypes: Understanding Distinct Subgroups of Asthma Patients
Evaluation of a Rifapentine-Containing Regimen for Intensive Phase Treatment of Pulmonary Tuberculosis: TBTC Study 29
Asthma Exacerbations During Pregnancy Are Reduced By Inflammatory Guided Asthma Management
TESRA Study Results
Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial
Intensive Care Physician Versus Qualified Nurse Based Critical Care Transport
Chronic Azithromycin Decreases the Frequency of COPD Exacerbations
Drug Development
Sleep Medicine
Critical Care
Advances in NSCLC
Mechanisms and Advances in COPD Therapy
MD Conference Express ATS 2011
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