Current Molecular Medicine - Volume 5, Issue 1, 2005

What will drug development look like in 10, 20 or 40 years? Opinions abound on this interesting question, ranging from totally personalized development of medicines, (visions of Scotty in Star Trek using his scanner to diagnose and treat Captain Kirk on the spot!) to multifunctional drug targets that can be used across a wide range of disease indications. As the landscape in drug development is rapidly evolving, there are Read More

Peripheral blood may be the most feasible tissue source in clinical assessment of differences in gene expression between diseases and drug treatments due to accessibility. Yet, gene expression profiling from blood remains a challenge. Blood is a complicated biological system consisting of a variety of cell types at different stages of development. In addition, blood is also one of the most variable tissue types for gene expr Read More

The increasing use of gene expression profiling offers great promise in clinical research into disease biology and its treatment. Along with the ability to measure changing expression levels in thousands of genes at once, comes the challenge of analyzing and interpreting the vast sets of data generated. Analysis tools are evolving rapidly to meet such challenges. The next step is to interpret observed changes in terms of the bi Read More

Many ethical and legal issues surround genomic technologies, some of which are present for other kinds of medical data, but some of which are specific to genomic data. Specifically the global nature of genomic data and the life-long implications of genetic defects on the health of the individual subject produce challenges in the ethical and legal handling of this data. In general, data derived from transcriptome analysis, Read More

Traditional biomarkers have played an important role in drug development as well as patient care. A single traditional biomarker or surrogate endpoint is unlikely to either characterize the complete pathophysiology of a complex disease or capture all the therapeutic benefits or potential adverse effects that a drug will have in a diverse patient population. Transciptome analysis, on the other hand, can provide a large-scale Read More

Over the last decade we have witnessed a fundamental change in how biomedical research is carried out and we can now assess the impact of the Human Genome Project on drug discovery and development. Advances in “omics” technologies (genomics, transcriptomics, proteomics and metabonomics) were touted as having the potential to revolutionise our approach to disease diagnosis, prognostication and developmen Read More

A major benefit of the genomics revolution in biomedical research has been the establishment of transcriptome analysis as an enabling technology in the drug development process. Nowhere in the realm of drug development has the expectation of the impact of transcriptome analysis been greater than in the area of pre-clinical toxicology. Transcriptome analysis, along with other new high-content data generating technologi Read More

Clinical pharmacology is the investigation of drug effects in humans. This review discusses the basic tenets of clinical pharmacology research, including pharmacokinetic and pharmacodynamic analysis, therapeutic window, and clinical trial design, and the issues that may arise in the application of transcriptome analysis to clinical pharmacology studies. Examples of how transcriptome analysis can be applied to clinical Read More

Microarray-based expression profiling studies in the field of oncology have demonstrated encouraging correlations between tumor transcriptional profiles and eventual patient outcomes. These findings have fueled great interest in the application of transcriptional profiling to samples available from real-time clinical trials, and clinical pharmacogenomic objectives utilizing transcriptional profiling strategies are becoming increasin Read More

Transcriptional profiling of a tumor's entire genomic complement has become a key tool in the analysis of human cancers and identification of novel markers to predict disease state, outcome, and response to therapy. At present, this technology provides the most comprehensive approach for the analysis of somatic changes altering critical pathways during transformation of stable diploid cells into unstable tumor cells. Such Read More

The recent sequencing of the human genome, coupled with advances in biotechnology, is enabling the comprehensive molecular “profiling” of human tissues. In particular, DNA microarrays are powerful tools for obtaining global views of human tumor gene expression. Complex information from tumor “expression profiling” studies can, in turn, be used to create novel molecular cancer diagnostics. We discuss the utility of DN Read More