Issue 3 2009

Biomarkers in CNS drug discovery and development – focus on molecular blood markers

Issue 3 2009 / 29 May 2009 /

In established economies, mental disorders account for a larger burden of disease than all cancers combined. Yet reliable, measurable, markers of such diseases (biomarkers) are not uniformly known and without them, prediction that a new drug candidate makes contact with its target is poor. This is unfortunate because the attrition rate of new chemical entities (NCEs) in clinical development for CNS disorders is high and primarily driven by failure to show efficacy and often without knowing that the drug reached its intended target for action. Today, several companies have reported efforts towards the discovery of molecular biomarkers for CNS disorders. Confirmation, and ultimately validation of molecular (and other) biomarkers will hopefully foster new drug developments for multiple, currently poorly understood and inadequately treated CNS disorders. (more…)

Tagged with: Biomarkers, Irina Antonijevic, Lundbeck Research USA

Quantitative Proteomics for Systems Biology

Issue 3 2009 / 29 May 2009 /

The pharmaceutical industry continues to experience a high attrition rate during the latter stages of small molecule therapeutic development, most disappointingly during the late, and highly expensive stages of Phase II and Phase III trial1. If left unchecked, it is likely that this late-stage failure in drug development will only increase the already staggering cost of getting pharmaceuticals to market. The failure of drugs at this stage in development occurs primarily because of problems with toxicity and/or failure to produce a significant effect in whole animal models (lack of efficacy)₁. The increasingly popular approach of systems biology is perceived by many as a potential solution for overcoming these problems, enabling the design of effective, safe therapeutics on a realistic R&D budget. (more…)

Tagged with: Claire Eyers, Proteomics, University of Manchester

6th Joint BSPR/EBI Proteomics Meeting – Multiscale Proteomics: From Cells to Organisms

Issue 3 2009 / 29 May 2009 /

This meeting will look at recent advancements of proteomics for analysis across biological scales, i.e. from cells to tissues and organisms. The event aims to overcome the barriers and highlight the interfaces that allow us to take proteomics towards an integrative view of biology. (more…)

Tagged with: BSPR, Show Preview

Article 3: qPCR Assay Design

Issue 3 2009 / 29 May 2009 /

Real-time PCR (qPCR) data are reliable only if they result from a robust qPCR assay that has been carefully designed, validated and optimised. This process requires an extensive assay design procedure aimed at generating an optimum primer/probe/amplicon combination to allow accurate quantification of nucleic acids with minimum need for post-PCR analyses (see Figure 1). (more…)

Tagged with: qPCR, Sigma-Aldrich, Stephen Bustin, Tania Nolan

Frozen Cells and Automated Cell Culture

Issue 3 2009 / 29 May 2009 /

The European Laboratory Robotics Interest Group (ELRIG) is to host a one day conference and exhibition at Hinxton Hall in Cambridge. This will bring together vendor companies and research scientists from all areas of Automated Cell Culture to debate and discuss the progress and issues facing them. (more…)

Tagged with: ELRIG, Show Preview

Cellular reprogramming and its implications for therapeutic applications

Issue 3 2009 / 29 May 2009 /

Nearly fifty years ago, it was hypothesised that terminally differentiated cells such as fibroblasts could be forced to take on a pluripotent state, similar to the embryonic stem cells (ES cells). The basis of the concept is the observation that all cell types, with minor exceptions, have the same genetic code. The only difference is how the code is read. This ability of differentiated cells to acquire a pluripotent state or, more generally, the process of cell fate conversion is termed cellular reprogramming. Reprogramming here means transition between cell fates or dedifferentiation. The classic and earliest change of direction of cell differentiation comes from the research of nuclear transfer. Another milestone showing that the nuclear transfer technology can reverse the cell fate of somatic cells to pluripotent stem cells was the production of the normal adult sheep Dolly. Recent and spectacular advances in this field fell in 2006 when mouse fibroblasts were reprogrammed to induced pluripotent stem (iPS) cells. The next big step was the in vivo reprogramming of adult pancreatic exocrine cells to beta cells. This series of excellent work turns back the clock of somatic cells to create the first (iPS) cells, or stem cells, made without the use of embryos. In this article, we will focus on cellular reprogramming; in particular on transcription factor induced reprogramming as well as its implications for therapeutic use. (more…)

Tagged with: Jens Schwamborn, Lai Wen, Munster University, Stem Cells

Addressing unmet needs

Issue 3 2009 / 29 May 2009 /

Joydeep Goswami from Invitrogen, who provide essential life science technologies for disease research, drug discovery, and commercial bioproduction, talks to us about current and future developments at the company. (more…)

Tagged with: Industry Insight, Invitrogen, Joydeep Goswami

International Society for Stem Cell Research – The world’s premier stem cell research event

Issue 3 2009 / 29 May 2009 /

The ISSCR Annual Meeting has become the preeminent international stem cell meeting, attracting more than 2,500 of the foremost stem cell professionals from public, private, academic and government settings. (more…)

Tagged with: ISSCR, Show Preview

High Content Analysis Roundtable

Issue 3 2009 / 29 May 2009 /

Participants:

Anthony Davies
Director of High Content Research Facility, Department of Clinical Medicine, Trinity College Dublin

Sarah Payne
Product Manager, TTP LabTech Limited

Khuong Truong
European Product Manager, BD Biosciences

Jeremy Simpson
Professor of Cell Biology, University College Dublin (UCD)

Oscar ‘Joe’ Trask
Head of Cellular Imaging Technologies, Duke University

Peter Simpson
Associate Director of Cancer Bioscience, AstraZeneca (more…)

Tagged with: Anthony Davies, AstraZeneca, BD Biosciences, Duke University, HCA (High Content Analysis), Khuong Truong, Oscar Trask, Peter Simpson, Sarah Payne, Trinity College Dublin, TTP LabTech

Concurrent Evaluation of both Compendial and Rapid Methods (ATP Bioluminescence) for Monitoring Water Quality in Pharmaceutical Manufacturing

Issue 3 2009 / 29 May 2009 /

Much has been published elsewhere about the limitations of the compendial microbiological methods and the needs of current Pharmaceutical manufacturing, in particular related to the adoption of PAT as a quality tool_1-4. Rapid Microbiology is seen by many as a tool for addressing a number of these limitations_5,6. Rather less has been published in terms of case histories from users demonstrating how to apply rapid methods to solve specific problems arising from the use of traditional microbiology. This paper addresses this gap by presenting studies based on experience gained from utilising a rapid method based on ATP bioluminescence (the PallchekTM Rapid Microbiology System). (more…)

Tagged with: Bristol-Myers Squibb, Eric Bagur, Microbiology

Applying PAT in Chemical Process Development

Issue 3 2009 / 29 May 2009 /

As the time-to-market of pharmaceutical products has elongated, while its prices are under big pressure, cost saving is currently essential in the pharmaceutical industry.

Therefore, the manufacturing of pharmaceutical products is forced to change to a more efficient and qualitative production. Since the introduction of the PAT guideline in September 2003, even regulatory environment is driving the industry to change their manufacturing from a Quality by Inspection to a Quality by Design state, which has led to quality improvements and cost savings in other industries. Within the concept of Quality by Design, Process Analytical Technology (PAT) is a powerful tool for achieving an optimal manufacturing process. The main goals of PAT are to gain a thorough understanding of the manufacturing processes and to learn how to control them₁. When processes are understood, opportunities for continuous improvement (quality and efficiency), cycle time reduction, cost reduction and QC lab test replacement arise. In this article, the strategy of Johnson & Johnson Pharmaceutical Research & Development (J&J PRD) towards the implementation of PAT in Chemical Process Development is explained and clarified by case studies. (more…)

Tagged with: Johnson & Johnson, Koen De Smet, Mario Hellings, PAT, Tom Van den Kerkhof