Pharmacogenomics offers the opportunity to adopt a new paradigm in drug development. The pharmaceutical industry is faced with a number of challenges including relatively low productivity and success in bringing new drugs to market.
The potential of metabolomics, a systems approach to biochemical pathway analysis, to yield scientific and commercial benefits to healthcare and biotechnology enterprises is increasingly recognised.
Clinical drug development is moving into an era where high technology new diagnostics are key to the development of the majority of new drugs.
The current challenges facing drug discovery and development in terms of attrition are well documented. This article discusses how molecular imaging approaches from bench to bedside can not only streamline drug development, but also open up new opportunities in the treatment management of targeted therapies.
The mission at The University of Texas MD Anderson Cancer Center is to eradicate cancer, which remains a major cause of mortality worldwide. It is the second leading cause of death in the United States and globally, claiming more lives than malaria, HIV/AIDs and tuberculosis combined (or ~1 of every 7 deaths) (1-3).
Changing demands in global healthcare over the past 15 years have led to greater complexity and spiralling costs in drug development. The average price tag of taking a new drug from discovery to completion of Phase III clinical trials is now $2.87 billion (1), which means informed decisions need to be made early on about which compounds to pursue.
This article summarises some of the technical and regulatory challenges posed by next-generation sequencing technologies and the efforts being made to address them.
In this article, we consider the symptoms and consequences of a silo culture in drug development, and look at how interdisciplinary integration should be at the heart of every pharma business model.
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 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.
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.
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.
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).
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.
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.
The effort to develop drugs that interact with the human immune system (whether by accident or design) has been dogged by a mismatch between the data derived from animal models (mice in particular) and that found in man.
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.