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Opportunities for rapid methods discussions: where the experts are meeting!

3 September 2012 | By Michael J. Miller, President, Microbiology Consultants, LLC

This is the fourth paper in our continuing series on Rapid Microbiological Methods (RMM) that will appear in European Pharmaceutical Review during 2012. Over the past few years, a number of professional meetings have focused on strategies and case studies for the validation and application of rapid microbiological methods (RMM).…

Figure 2: The number of targets addressed for a specific cancer patient. There are 90 currently approved anti-neoplastic drugs, including 9 biologicals2; a patient often receives a chemotherapy regimen comprising three to six chemotherapy agents and a targeted monoclonal antibody (left). A tumour has ~50 immunogenic antigens from protein-changing cancer mutations18,19 and 20-150 gene isoforms with tumour-enhanced expression that, assuming at least one immunogenic epitope per gene, suggests ~50 addressable expression and differentiation antigens (right)
Figure 2: The number of targets addressed for a specific cancer patient. There are 90 currently approved anti-neoplastic drugs, including 9 biologicals2; a patient often receives a chemotherapy regimen comprising three to six chemotherapy agents and a targeted monoclonal antibody (left). A tumour has ~50 immunogenic antigens from protein-changing cancer mutations18,19 and 20-150 gene isoforms with tumour-enhanced expression that, assuming at least one immunogenic epitope per gene, suggests ~50 addressable expression and differentiation antigens (right)

The T cell druggable genome

3 September 2012 | By Jan Diekmann, Martin Löwer, John C. Castle, Sebastian Kreiter, Özlem Türeci and Ugur Sahin, Translational Oncology, Johannes Gutenberg Medical University of Mainz

The ‘druggable genome’ has been defined as those genes that can be pharmaceutically modulated; when intersected with disease-associated genes, the resultant set represents therapeutic targets for developing drugs to prevent and treat diseases. Historically, druggable therapeutic target genes have been defined by two features; (i) their significant contribution to the…

Figure 5: VHP can stratify CVD status. The profile computationally combines EPC and MP measures. In the upper panel, the vertical axis represents a measure of a subpopulation of endothelial microparticles and the horizontal axis a measure of EPCs
Figure 5: VHP can stratify CVD status. The profile computationally combines EPC and MP measures. In the upper panel, the vertical axis represents a measure of a subpopulation of endothelial microparticles and the horizontal axis a measure of EPCs

High dimensional flow cytometry comes of age

3 September 2012 | By Jonni Moore, Professor of Pathology and Laboratory Medicine, Director, Clinical Flow Cytometry, Hospital of University of Pennsylvania, Director, Abramson Cancer Center Flow Cytometry and Cell Sorting Shared Resource – Perelman School of Medicine of the University of Pennsylvania and Pascal Yvon, CEO, CytoVas

Technologies for single cell analysis have recently become prominent in the emerging life science sectors. The last few decades have seen an explosion in advancements in cytometric technologies encompassing instrumentation, probes and data analysis. In particular, flow cytometry has become a well-established and routine method in clinical laboratories. Recent developments…

Figure 1: Schematic representation of body compartments in physiologically based pharmacokinetic modelling. Abbreviations: Qorgan: Blood flow to organ
Figure 1: Schematic representation of body compartments in physiologically based pharmacokinetic modelling. Abbreviations: Qorgan: Blood flow to organ

Physiologicaly based pharmacokinetic modelling of transporters in drug discovery and development

3 September 2012 | By Pradeep Sharma and Katherine Fenner, Global DMPK, AstraZeneca R&D

Physiologically based pharmacokinetic (PBPK) models describe the different compartments (tissues) in the body linked via arterial and venous blood flow (Figure 1). The volume of each tissue and blood flows are available from literature data1-5 and PBPK models have been developed for many species including rat, mouse, dog, pig and…

Figure 1: Classification Scheme of GPCRs. R (Rhodopsin-like), S (Secretin-like), G (Glutamate-like), Others (Adhesion, Frizzled, Taste type-2, unclassified)
Figure 1: Classification Scheme of GPCRs. R (Rhodopsin-like), S (Secretin-like), G (Glutamate-like), Others (Adhesion, Frizzled, Taste type-2, unclassified)

G protein coupled receptors – exploiting flexible conformations

3 September 2012 | By Kathryn L. Chapman, Imperial Drug Discovery Centre, Imperial College London and John B.C. Findlay & Gemma K. Kinsella, Department of Biology, National University of Ireland Maynooth

G-protein coupled receptors (GPCRs) are a diverse super-family of proteins located within the plasma membrane of eukaryotic cells which have a common architecture consisting of seven-transmembrane (7-TM) segments, connected by extracellular (ECL) and intracellular (ICL) loops. They differ from other 7-TM proteins in their ability to activate guanine-nucleotide binding proteins…

Transforming-a-paper-based-trial-master-file-to-a-streamlined-electronic-document-management-solution-at-Sanofi
Transforming-a-paper-based-trial-master-file-to-a-streamlined-electronic-document-management-solution-at-Sanofi

Ensuring patient safety during clinical trials; translation to preclinical drug discovery

3 September 2012 | By David Cook & James Milligan, AstraZeneca

Ensuring patient safety during clinical trials is of paramount consideration with stringent monitoring built into trials (and beyond) and the design and interpretation of safety outcomes subject to a large amount of regulation. As a result, it is rare for clinical trials to produce extreme adverse drug reactions but it…

Man on a phone analysing data and charts on computer screen
Man on a phone analysing data and charts on computer screen

Integrating preclinical data into early clinical development

3 September 2012 | By Vikash Sinha, Clinical Pharmacology Leader, Janssen Research and Development

One of the important goals in preclinical and early clinical drug development is to reduce attrition rates and to improve our ability to pick winners and drop potential loser drug candidates. By being able to efficiently translate preclinical data and observations into possible clinical outcomes, one can make the drug…

Under the microscope: Graeme Lowe, Catalent

3 September 2012 | By Helen Bahia, Editor, European Pharmaceutical Review

Graeme Lowe, Director of Development and Analytical Solutions at Catalent, discusses outsourcing pharmaceutical development and analytical solutions.

Figure 2: Showing 96 and 384 well micro-plates which have has gel based bioreactor system incorporated within the body of the plate in regions in between and surrounding the wells
Figure 2: Showing 96 and 384 well micro-plates which have has gel based bioreactor system incorporated within the body of the plate in regions in between and surrounding the wells

A reduction to practise for siRNA screening utilising high conent analysis (HCA) technologies

10 July 2012 | By Anthony Mitchell Davies & Anne Marie Byrne, Department of Clinical Medicine Trinity College Dublin; Holger Erfle, BIOQUANT-Zentrum Ruprecht-Karls-Universität Heidelberg; Graham Donnelly, Rita Murray & Peadar MacGabhann, Biocroi Ltd

One of the major limitations of performing large-scale High Content Analysis (HCA) screens is reagent cost, indeed this fact has been a key driver in the development of assay size reduction strategies here at The Irish National Centre for High Content Screening and Analysis at Trinity College’s Department of Medicine.…

Pills Powder
Pills Powder

Evolution of drug metabolism and pharmacokinetics in drug discovery and development

10 July 2012 | By Dr. Dermot McGinnity, Innovative Medicines, AstraZeneca R&D

Drug Metabolism and Pharmacokinetics (DMPK) is a scientific discipline once primarily associated with safety evaluation in drug development that has, in the last two decades, become a core discipline within drug discovery, development and even post-marketing. Approximately 20 years ago, sub-optimal DMPK properties were recognised as a contributor to the…

Breaking old habits: Moving away from commonly used buffers in pharmaceuticals

10 July 2012 | By David Sek, Research Scientist, Pfizer

One of the key factors in stabilising proteins is determining the optimal pH and buffer system to provide adequate solubility and stability. Currently, three buffers, citrate, phosphate and acetate, make up the majority of buffers used in parenteral pharmaceuticals approved by the FDA, but less precedented excipients are certainly available…

Figure 3: The global TSC spectrum of caffeine Form I
Figure 3: The global TSC spectrum of caffeine Form I

Applications of thermally stimulated current spectroscopy in pharmaceutical research

10 July 2012 | By Milan Antonijević, School of Science, University of Greenwich

Thermally Stimulated Current Spectroscopy (TSC) is a new tool that can be used to analyse pharmaceutically important molecules. TSC studies are usually conducted to provide additional information about molecular mobility in the solid state, and as a result characterise phase transitions that are related to thermal transitions in the crystalline…

FIGURE 1 Parties involved in the biomarker discovery and validation process. Medical Science is responsible for sample collection, pre-classification and storage in biobanks. Analytical Chemistry is responsible for developing sample preparation protocols and analytical platforms both for comprehensive biomarker discovery on low numbers of samples as well as for the targeted validation in large sample cohorts. Bioinformatics is responsible for performing the data pre-processing and statistical analysis as well as the validation of data and clinical information provided by the analytical and medical partners. A close collaboration and information exchange is essential for the success of biomarker research
FIGURE 1 Parties involved in the biomarker discovery and validation process. Medical Science is responsible for sample collection, pre-classification and storage in biobanks. Analytical Chemistry is responsible for developing sample preparation protocols and analytical platforms both for comprehensive biomarker discovery on low numbers of samples as well as for the targeted validation in large sample cohorts. Bioinformatics is responsible for performing the data pre-processing and statistical analysis as well as the validation of data and clinical information provided by the analytical and medical partners. A close collaboration and information exchange is essential for the success of biomarker research

Discovery and validation of protein biomarkers

10 July 2012 | By Péter Horvatovich & Rainer Bischoff, Analytical Biochemistry, Department of Pharmacy, University of Groningen

Biomarkers are biological characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic intervention. Biomarkers can be used to determine disease onset, progression, efficacy of drug treatment, patient susceptibility to develop a certain type of disease or predict efficacy…