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Articles

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

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…

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…

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…

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…

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…

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…

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…

Establishing assays and small molecule screening facilities for Drug discovery programs

16 February 2011 | By Sheraz Gul, Vice President & Head of Biology, European ScreeningPort GmbH

Although many of the marketed small molecule drugs have been discovered by research and development efforts within the pharmaceutical industry, there has been a paradigm shift with external sources increasingly being relied upon to fill their pipelines. This trend is likely to increase and the key pre-clinical activities carried out…

Translational science: The future of medicine

16 February 2011 | By Bahija Jallal, Executive Vice President, Research & Development, MedImmune

When the term ‘translational medicine’ first came to prominence at the turn of the century, there were suspicions that this concept was simply a rebranding of conventional medical research, describing the process in which scientific discovery at the laboratory bench eventually translates to an effective therapy at the patient’s bedside.…

Pulmonary inhalation aerosols for targeted antibiotics drug delivery

16 February 2011 | By Chun-Woong Park & Heidi M. Mansour, University of Kentucky, College of Pharmacy and Don Hayes Jr, University of Kentucky, College of Medicine

Targeted pulmonary drug delivery of antibiotics by inhalation aerosols can play significant roles in the treatment of cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD) and in other pulmonary diseases where chronic airway infections exist. Direct administration to the lung as targeted pulmonary inhalation aerosol delivery is uniquely able to…

Article 1 Rapid microbiological methods 2011

16 February 2011 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the first in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2011. Last year, I provided an overview of rapid microbiological methods (RMMs), including validation strategies, regulatory expectations, the technical and quality benefits of RMMs as compared with conventional techniques,…