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Articles

Flow Cytometry
Flow Cytometry

Implementation of flow cytometric biomarker assays in clinical development

20 June 2011 | By Dianna Y. Wu & Russell Weiner, Clinical Biomarkers and Diagnostics, Merck & Co

Biomarker research has become one of the integral aspects in drug discovery and development. It is broadly utilised to confirm drug mechanism of action (MOA), explore PK/PD correlation, support dose selection and predict response to treatment. Therefore, biomarker data provide valuable information to guide clinical decisions, support drug filings with…

Sheraz Gul
Sheraz Gul

Reducing attrition in drug discovery: The role of biomarkers

20 June 2011 | By Sheraz Gul, Vice President & Head of Biology, European ScreeningPort GmbH

The development of most diseases is often attributed to the dysfunction of the activities of key proteins involved in biological processes and their modulation by a therapeutic agent is considered to offer the potential to alleviate the disease state.

Under the Microscope: Fredrik Sundberg, GE Healthcare

20 June 2011 | By Fredrik Sundberg, Global Director, Strategic Market Development, GE Healthcare

As a company whose expertise includes medical imaging and information technologies, performance improvement and biopharmaceutical manufacturing, GE Healthcare is well placed to support drug discovery innovation and productivity. With the Pharma industry moving away from blockbuster discoveries and focusing more on orphan drugs and rare diseases in the hopes of…

Figure 1. Engineering the Stem Cell Niche. The ability to assembly natural and manmade components into idealized biosynthetic 3D architectures requires a detailed understanding of the environment, along with the technology and expertise to manipulate them. This multiscale and multi-expertise approach is expected to lead to unprecedented breakthroughs in tissue engineering and biofabrication that benefit human health for an improved quality of life.
Figure 1. Engineering the Stem Cell Niche. The ability to assembly natural and manmade components into idealized biosynthetic 3D architectures requires a detailed understanding of the environment, along with the technology and expertise to manipulate them. This multiscale and multi-expertise approach is expected to lead to unprecedented breakthroughs in tissue engineering and biofabrication that benefit human health for an improved quality of life.

In search of the Holy Grail: Engineering the stem cell niche

19 April 2011 | By Janet L. Paluh, Associate Professor Nanobioscience, College of Nanoscale Science and Engineering, University at Albany SUNY and Guohao Dai and Douglas B. Chrisey, Biomedical Engineering, Rensselaer Polytechnic Institute

There is no other biomedical frontier that offers the stunning potential of human pluripotent stem cells and their progenitors in therapeutic applications to ease human suffering or in their ability to provide insights into development and diseases. Cell plasticity for reprogramming has revealed new opportunities in cell-based therapies and informed…

AstraZeneca announces collaborations to use CRISPR technology for genome editing across its drug discovery platform
AstraZeneca announces collaborations to use CRISPR technology for genome editing across its drug discovery platform

Using translational pharmacology biomarkers to drive earlier decision making

19 April 2011 | By Magnus Ivarsson, Head of Physiological Biomarkers, Pfizer and Mark Fidock, Head of Quantitative Biomarkers, Research Enabling Group, Pfizer

The current high rate of attrition during drug development is unsustainable. An increasing amount of the cost of developing a new drug is made up of the investment in molecules that fail at some point during the process and the later that failure occurs, the more costly it will be.…

The increasing role of toxicology in early decision making processes
The increasing role of toxicology in early decision making processes

The increasing role of toxicology in early decision making processes

19 April 2011 | By Eckhard von Keutz, Senior Vice President, Head Global Early Development, Bayer HealthCare

Clinical development costs are rising at an alarming rate. There is a decreasing success rate for new drug candidate approval and the duration of development is increasing. In other words, industry is spending more and getting less from current drug development efforts. In 2010, 21 new drugs were approved in…

is it ever right to sue a client?

19 April 2011 | By Jim Kinnier Wilson, Partner, Manches

Imagine that you are part of a small biotech company, BiotechCo, whose business is the development of delivery systems for pharmaceutical products. One of your team, who is in charge of developing sales with a large pharmaceutical company, Pharma Co, came to you three months ago with the possibility of…

Figure 1 Process to obtain UV Scans of standards and assay samples. Solid compound samples are weighed
Figure 1 Process to obtain UV Scans of standards and assay samples. Solid compound samples are weighed

UV-Vis scan-based quality control of assay-ready plates for improved data integrity

19 April 2011 | By Gary K Smith, M Anthony Leesnitzer, Lois L Wright, Iona Popa-Burke, Trevor Casserly, Luke Miller, Melissa Gomez & Iris Scherer, GlaxoSmithKline

Quality biological data requires both a high quality assay and a high quality compound. While assay quality is very closely monitored and has been intensively studied in the past, the quality of the final compound solutions being tested in an assay has received little attention. Quality of these samples is…

Figure 1The autophagy pathway. Autophagy proceeds in three steps: initiation by protein kinase complexes
Figure 1The autophagy pathway. Autophagy proceeds in three steps: initiation by protein kinase complexes

Molecular drug targets in autophagy

19 April 2011 | By Robin Ketteler, MRC LMCB, University College London

Autophagy is a cellular stress response to diverse stimuli such as starvation, infection and DNA damage. Autophagy plays important roles in the progression of various diseases including cancer, neurodegenerative diseases and Crohn’s disease. Despite recent advances in our understanding of the autophagy machinery, surprisingly little effort has been undertaken towards…

DiscoveRx Interview

19 April 2011 | By Sailaja Kuchibhatla, Senior Vice President Business Development DiscoveRx Corporation

“The goal of DiscoveRx has always been centred on creating technologies that enable the highest levels of innovation and development to enrich drug discovery,” Sailaja Kuchibhatla, Senior Vice President Business Development, asserts. Founded in 2000, DiscoveRx solved an unmet need within the GPCR industry by commercialising a functional, naturally coupled…

Reducing microbial contamination via sterile risk assessment
Reducing microbial contamination via sterile risk assessment

Overview of rapid microbiological methods evaluated, validated and implemented for microbiological quality control

19 April 2011 | By Oliver Gordon, Jennifer C. Gray, Hans-Joachim Anders, Alexandra Staerk & Oliver Schlaefli, Novartis Pharma Stein AG and Gunther Neuhaus, University of Freiburg

The risk for patients through spoiled or otherwise adulterated pharmaceuticals has been acknowledged for many centuries and led to the establishment of Good Manufacturing Practice (GMP) and pharmacopoeial guidelines. Besides chemical purity, pharmaceuticals also have to meet microbiological standards, the latter primarily depending on the administration route. Drug products which…

Flow Cytometry
Flow Cytometry

Article 2: Direct detection of microorganisms using viability-based technologies

19 April 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the second in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. In my last article, I provided an overview of growth-based rapid microbiological methods (RMMs). This was a good place to start my review of RMM technologies, as most…

Figure 1Translational and integrative proteomics for the identification of new therapeutic targets in oncology
Figure 1Translational and integrative proteomics for the identification of new therapeutic targets in oncology

Proteomics and target identification in oncology

16 February 2011 | By Hubert Hondermarck, Professor and head of U908 INSERM research unit – Growth factor signalling in breast cancer – functional proteomics, University of Lille

The recent progresses in the field of proteomics now enable large scale, high throughput, sensitive and quantitative protein analysis. Therefore, applying proteomics in clinical oncology becomes realistic. From the analysis of cell cultures to biological fluids and tumour biopsies, proteomic investigations of cancers are flourishing and new candidate biomarkers and…

Figure 1 High Content Imaging Technology. The leading fluorescent high content imaging platforms established within the pharmaceutical and biotechnology industry. Represented are; A. Fully automated high throughput high content imaging systems (ImageXpress, InCell, BD Pathway, ScanR, Opera and the Arrayscan). B. Live cell kinetic imaging systems (IncuCyteFLR and Cell-IQ) and C. Fluorescent tissue slide imaging platform (Scanscope FL)
Figure 1 High Content Imaging Technology. The leading fluorescent high content imaging platforms established within the pharmaceutical and biotechnology industry. Represented are; A. Fully automated high throughput high content imaging systems (ImageXpress, InCell, BD Pathway, ScanR, Opera and the Arrayscan). B. Live cell kinetic imaging systems (IncuCyteFLR and Cell-IQ) and C. Fluorescent tissue slide imaging platform (Scanscope FL)

Advancing high content analysis towards improving clinical efficacy

16 February 2011 | By Neil Carragher, Edinburgh Cancer Research UK Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh

High-content analysis is primed to play a prominent role in a new era of drug discovery research that places greater emphasis on clinical translation at all stages of the discovery process from target identification to proof-of-concept testing. High content analysis provides a technical bridge between reductionist targetdirected drug discovery approaches…

Pharmaceutical materials science and disorder: The next steps

16 February 2011 | By John Murphy, Senior Scientist, Materials Science, Pfizer

Over the past decade, the pursuit of materials science within the pharmaceutical industry has largely focused on determining the crystal structure of our drug molecules and ensuring that the most stable polymorphic form is carried forward and maintained through development, as the manufacturing issues and regulatory impact arising from the…