What is a Biomarker? A biological marker, better known as a biomarker, is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic intervention. Source: Drug Discovery World http://www.ddw-online.com/personalised-medicine/p145613-biomarkers-make-their-mark-on-current-research-and-drug-development-trendssummer-10.html
Worldwide Trends 2014
History of Biomarkers Term biomarker first coined in the 1980s. Biomarkers were developed as a response to understand the relationship between environmental factors and disease. Association or causation? Increase in the use of the term biomarker is a recent one (the last fifty years). Use of the term and the characteristic continues to grow today. Source: The Environment and Disease: Association or Causation? http://www.totalscientific.com/biomarkerblog/?p=55
Worldwide Trends 2014
Biomarker Uses and Applications Biomarkers include tools and technologies that can aid in understanding the Prediction Cause Diagnosis Progression Regression and Outcome of various diseases Source: The Journal of the American Society for Experimental NeuroTherapeutics http:// www.ncbi.nlm.nih.gov/pmc/articles/PMC534923 /
Biomarker Uses and Applications Variety of Biomarkers Each body system has a specific biomarker (i.e.-cardiovascular, respiratory, lymphatic). Each biomarker is relatively easy to measure. Each biomarker forms a piece of routine medical examinations. (i.e.- weight and BMI measurements to predict obesity) Source: News Medical http://www.news-medical.net/health/Biomarker-What-is-a-Biomarker.aspx
Biomarker Uses and Applications Biomarkers can be: Specific cells Molecules Genes Gene products Enzymes Hormones Complex organ functions General characteristic changes in biological structures Source: http://en.wikipedia.org/wiki/Biomarker_(medicine)
Biomarker Uses and Applications Ideal Biomarkers: Safe and easy to measure Create as little discomfort for patient (i.e. blood sample, not invasive biopsy) Cost efficient to follow up Rapid return of results for early initiation of treatment and monitoring effectiveness Modifiable with treatment Consistent across gender and ethnic groups Highly reproducible among various clinical laboratories. Source: Coriell Institute for Medical Research http://www.coriell.org/research-services/biomarkers/characteristics-of-the-ideal-biomarker and News Medical http://www.news-medical.net/health/Biomarker-What-is-a-Biomarker.aspx
Biomarker uses and applications Biomarker identification and validation Applied to a wide variety of therapeutic areas including: Neurological disease Metabolic disorders Immune dysregulation Most predominant field of application lies in oncology. Source: Drug Discovery World http://www.ddw-online.com/personalised-medicine/p145613-biomarkers-make-their-mark-on-current-research-and-drug-development-trendssummer- 10.html
Worldwide Trends 2014
Types of Biomarkers Though many Biomarkers exist, there are two major categories of Biomarkers: Biomarkers of exposure Biomarkers of disease Source: The Journal of the American Society for Experimental NeuroTherapeutics http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923 /
Types of Biomarkers Biomarkers of exposure Used in risk prediction Used in screening Used in diagnostic tests All tests are well established, allowing for a distinct advantage: improves sensitivity and specificity of the measurement of the exposures or risk factors. Source: The Journal of the American Society for Experimental NeuroTherapeutics http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/
Types of Biomarkers Biomarkers of disease Used for screening or diagnosis that represent surrogate manifestations of the disease. Distinct Advantage: Biomarkers depicting prodromal signs enable earlier diagnosis or allow for the outcome of interest to be determined a more primitive stage of disease. Biomarkers of disease are used as an indicator of a biological factor that represents either a subclinical manifestation, stage of the disorder, or a surrogate manifestation of the disease. Source: The Journal of the American Society for Experimental NeuroTherapeutics http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/ e:
Worldwide Trends 2014
Biomarkers and Prostate Cancer Detection Goal of Biomarkers in Prostate Cancer Detection: Avoiding over-diagnosis in patients with indolent (causing little or no pain) prostate tumors. When patients with indolent diseases receive aggressive treatments, negative effects result: Negative side effects occur Reduction in a patients quality of life Little to no benefit to the patient. Source: Prostate Cancer- A Biomarker Perspective http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745 /
Biomarkers and Prostate Cancer Detection One of the current clinical priorities is to develop prognostic biomarkers to identify those with indolent prostate diseases at low risk of progressing Allows patients to better benefit from active surveillance or watchful waiting, thus avoiding: unnecessary treatment (allowing for no unnecessary adverse effects) unnecessary financial burden Source: Prostate Cancer- A Biomarker Perspective http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745
Biomarkers and Prostate Cancer Detection Types of biomarkers in prostate cancer prognosis : therapeutic response drug development Biomarkers can be used to predict: the expected course of a prostate disease (prognosis) help clinicians with making decisions about likelihood to respond to a given drug (predictive) what dose might be most effective for severity and stage of disease (pharmacodynamics ). Source: Prostate Cancer- A Biomarker Perspective http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745
Biomarkers and Prostate Cancer Detection Source: Prostate Cancer- A Biomarker Perspective http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745 Red color denotes types of biomarker Blue color denotes the biomarker-based decision making Green color indicates the exemplary actions or events PSA=prostate- specific antigen DRE=digital rectal examination TRUS= transrectal ultrasound PD= biomarker, pharmacodynamic biomarker.
Biomarkers and Prostate Cancer Detection The previous graph shows the specificity of drug development for prostate cancer in respect to the actual treatment necessary for the cancer. Biomarkers allow for proper treatment of the cancer, dismissing over-diagnosis.
Biomarkers and Prostate Cancer Detection Source: Prostate Cancer- A Biomarker Perspective http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3361745 Black boxes denote conceptual breakthroughs Blue boxes denote biomarker advances Green boxes denote therapeutic and technological outlook. PAP= prostatic acid phosphatase PSA= prostate- specific antigen FDA= US Food and Drug Administration CTC= circulating tumor cells NGS= next- generation sequencing miRNA= microRNA.
Biomarkers and Prostate Cancer Detection The previous timeline depicts the advances of prostate cancer detection and diagnosis. It is clear that biomarkers are leading to technologically therapeutic advances, allowing for the proper prevention and treatment of prostate cancer as the years progress. Personalized cancer prevention will ensue as technological advancements in biomarkers continues.
Worldwide Trends 2014
Key Players Discovery and development of biomarkers is very costly and extremely time consuming. However. application of biomarkers in drug discovery and development reduces overall cost of the entire drug development process Therefore, demand for novel biomarkers is expected to increase in the next five years Source: PR Web http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
Key Players Due to the immense cost and time commitment of the development of biomarkers, many companies are combining forces to ensure that biomarkers are created in the most cost efficient of manners as a main market strategy. Source: PR Web http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm
Key Players Companies such as: Thermo Fisher Scientific, Inc. (U.S.) QIAGEN N.V. (Netherlands) Hologic, Inc. (U.S.) Roche Diagnostics Limited (Switzerland) Johnson & Johnson (U.S.) Siemens Healthcare (Germany) Abbott Laboratories, Inc. (U.S.) and Bio-Rad Laboratories, Inc. (U.S.) are all actively adopting strategies of partnerships and collaborations, to ensure their growth in the biomarkers market. Source: PR Web http://www.prweb.com/releases/global-biomarkers-market/02/prweb11601625.htm and PR News Wire http://www.prnewswire.com/news-releases/biomarkers-market---discovery-technologies--validation-services-applications--diseases---global-trends--forecasts-2013---