The approval of liquid biopsy test for the diagnosis of non-small cell lung cancer (NSCLC) demonstrates how biomarker-based detection tools are becoming important components of precision medicine-based drug treatment regimes.
The recent approval of the first liquid biopsy test for the diagnosis of non-small cell lung cancer (NSCLC) demonstrates how biomarker-based detection tools are becoming important components of precision medicine-based drug treatment regimes.
Magnetic Resonance Imaging (MRI) can be used to provide quantitative measurements in the form of imaging biomarkers. These measurements have a number of attractive characteristics: They are non-invasive, can provide organ and lesion localisation of morphology, physiology and metabolism and can be repeated over time.
The discovery by Yamanaka and Thomson in 2007 that human somatic cells can be reprogrammed to a pluripotent state (ie, induced pluripotent stem cells, iPSCs) has revolutionised cell biology.
The outlook for the drug industry continues to remain bleak in context of productivity and success rates. In spite of ongoing increase in R&D expenses and technology revolutions in the genomics and proteomics area, nearly 95% of drug programmes which enter clinical development fail. This would be expected as serendipity and surprise plays a big role in almost all of the drug successes. What is the probability of the same individual winning the lottery more than once in his/her lifetime?
Gamma scintigraphy is a non-invasive technique with applications in the development of drug products and the assessment of pharmacodynamic effects in humans. It enables the assessment of critical performance parameters that in vitro techniques attempt, but often fail, to predict. Quantification of pharmacodynamic effects (eg gastrointestinal transit; gall bladder emptying; lung mucociliary clearance) provides insights into the mode of action of drug candidates.
The importance of drug delivery as a tool to improve R&D productivity, to provide a pathway for valuable drugs to be successfully commercialised and as an expanding resource to the pharmaceutical and biotech industry, has come a long way since the early work of the University of Kansas. This article explores the advances made in drug delivery technology.
Modelling and simulation in drug development is not new. What is new is the vision for moving from a descriptive role (what happened) to a predictive and therefore decision making role. While seemingly attractive, important hurdles, both scientific and practical, must be overcome.
Over the last 10 years we have seen the introduction of several new ‘ophthalmology only’ pharmaceutical products emerge such as Trusopt (dorzolamide, Merck) and Xalatan (latanoprost, Pharmacia). Innovative products such as these have driven much of the ophthalmic pharmaceutical growth, outpacing the older products that were often developed for ophthalmology via other therapeutic areas.With the ophthalmic pharmaceutical sector currently at around $5 billion worldwide, the continued growth is likely to be driven by even more first-in-class entries in ophthalmology.Two areas that are especially poised for explosive growth are dry eye and retinal disease, in which many new therapeutic approaches are currently in development.
With the high number of sufferers from skin disease around the world, it is astonishing that there are relatively few treatments available and that many of these only serve to relieve symptoms. Can drug development based on a functional genomics approach be the answer in bringing new products to this ‘Cinderella’ market?
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. This article discusses the potential for new efficiencies and cost savings that can be achieved from the utilisation of biomarkers at different stages along the drug development pathway.
The key in vivo drug metabolism and pharmacokinetic studies continue to be undertaken using radiolabelled versions of drug molecules. Traditionally, the preparation of these isotopically labelled compounds was largely the domain of specialist internal radiochemistry groups within large pharmaceutical companies (Big Pharma).
Toxicological safety testing of compounds has not yet advanced to the point where measurement of gene expression is being incorporated in the internal decision process of most companies, much less the FDA approval process. The FDA has asked for voluntary submissions, is preparing guidelines for gene expression data and has identified surrogate biomarker assays as the avenue to escape the dilemma highlighted in the FDA white paper ‘Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products
The completion of the human genome project has focused tremendous interest in determining the structure and function of the tens of thousands of proteins that the genome encodes. Current structural determination techniques are difficult, time-consuming and not generally applicable to all proteins.
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 20101. The accelerating pace of activity in this area is further underlined by a cursory review of the publication space, where the number of relevant scientific articles generated annually has doubled from 20,000 to 40,000 over the past decade (Figure 1).
To have real business impact within preclinical drug development, Enterprise ELNs (Electronic Laboratory Notebooks) must provide a secure, scalable and searchable data management backbone across all disciplines focused on development of both small and large molecules, in compliant and non-compliant environments.
With few exceptions, all compounds being submitted to the Food and Drug Administration (FDA) for approval in the United States will require an assessment of QT prolongation, either by a standard Thorough QT/QTc study, or a similar study modified to fit the safety profile of the compound and indicated patient population.