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Biomarker and Diagnostic Opportunities in Respiratory Diseases
Decision Resources, Inc, Sep 2011
Although the molecular diagnostics field may not be as robust in respiratory diseases as it is in other therapeutic areas that have a high prevalence and a lively pharmaceutical market, the prospects for growth are certainly present. Exploratory respiratory biomarkers are a part of the pharmaceutical and diagnostic R&D process in several different ways: they help determine treatment choice, monitor disease activity, aid in making differential diagnoses, and stratify patients according to comorbidity (severity). With time and additional research, particularly longitudinal analyses, biomarker and diagnostic opportunities in respiratory diseases are bound to blossom.
Questions answered in this report:
- Diagnosing respiratory diseases poses inherent clinical and functional challenges. What are these challenges, and how are researchers and diagnostics developers working around them to find opportunities for biomarker discovery and diagnostic development? Which disease is more difficult to assess based on these challenges: asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis (CF)?
- Pharmaceutical companies are using biomarkers in several different ways in their clinical trials for the three respiratory diseases we cover in this report. What are some examples of these uses in each indication? How will the use of biomarkers in ongoing clinical trials enhance the understanding of drug safety/dosing/tolerance issues in respiratory diseases? In what ways can biomarkers be used to enhance treatment choice in respiratory disease management?
- When we asked surveyed physicians how biomarkers can help reduce the unmet needs in their patients with respiratory diseases, the highest number of responses was for predicting response to therapy. For each of the three diseases that we cover in the report (asthma, COPD, and CF), what activity is occurring in terms of biomarker development and research, and will this activity address the unmet needs for respiratory diseases that physicians believe biomarkers can help reduce?
Scope:
Indications covered: Asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF).
Primary research: Findings from survey of 105 U.S.-based physicians (54 primary care physicians [PCPs] and 51 pulmonologists) that was fielded by Decision Resources in July 2011.
Insight from clinical trials: Includes data from ongoing clinical trials of biomarkers in the indications covered, as reported in clinicaltrials.gov.
Dealmaking assessment: Brief analysis of 24 biomarkers and diagnostics deals in the three indications covered from January 2005 through August 2011.
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