Biomarkers have become an increasingly hot topic in the pharmaceutical industry. How much of this is hype, how much is reality? In the overwhelming majority of cases, biomarker studies can only provide preliminary data.
Optimal treatment for any disease is one that can cure or prevent spreading with minimal impact on the patient’s quality of life. In the case of cancer, therapeutic agents were initially designed to kill rapidly dividing cells.
Interest in personalised medicine continues to grow, and epigenetic biomarkers are very informative in this respect, giving a clear indication of whether (and how) a patient’s gene expression profile has changed, as well as the rate of disease progression.
To meet the massive challenges of future healthcare, perhaps no two facets hold greater promise than biomarkers for precision medicine and systems biology for personalised patient care.
The progression from health to disease is marked by significant biological changes within an individual (1).
A new collaborative research paper sheds light on the way antibodies distinguish between different but closely related ‘biomarkers’ – in this case protein fragments which reveal information about the condition of the human body. This new understanding could enable pharmaceutical companies to develop new technologies for quickly diagnosing and treating fatal diseases.
The rapidly escalating costs of drug development is causing the biopharmaceutical industry to focus its R&D efforts on identifying new technologies and methods that can predict the safety and efficacy of new compounds as early as possible in the drug development process.
Molecular biomarkers that define a particular state or condition are a powerful tool used to diagnose disease, highlight patients with a pre-disposition towards a given disease and to identify those who would benefit from a given therapy.
With pharmacoproteomic biomarkers being the subject of focus among regulatory agencies as well as research institutions, many pharmaceutical companies are increasing their interest and investment in biomarker strategies.
In today's pharmaceutical research and development environment a major problem is the transition of too many drugs to later stages of development with insufficient and/or inadequate information (eg efficacy, dosing), resulting in high attrition and consumption of resources.
The pharmaceutical industry and the healthcare sector are both confronted with expensive technological innovation, escalating costs and pointed questions about productivity and efficiency. The parallels between the problems of producing new therapeutic agents and treating patients afflicted with poorly understood diseases are compelling.
As the pharmaceutical industry is all too well aware, the genomics and postgenomic sciences have delivered an excessive number of drug targets few of which have been well validated. Indeed, apart from a few rare exceptions, genomics and many millions of dollars in expenditure have yet to greatly impact drug development.
Biomarkers continue to become increasingly relevant in research and healthcare applications, as evidenced by the global market for products involved in their identification, validation, and use estimated at $8.3 billion in 2007 and projected to increase to $15 billion in 2010.
The pharmaceutical industry is striving to develop effective new therapies for diseases, ranging from cancers to cardiovascular and neurodegenerative disorders to a host of metabolic, infectious and genetic conditions, and is placing emphasis on treatments related to the early detection of disease.
Proteins are the machinery that drive most biological processes; however, measuring their concentrations at low levels has been historically impeded by a lack of appropriately sensitive technology.