We are please to announce that OracleBio’s Chief Scientific Officer, Dr. Lorcan Sherry, will be presenting at the 4th International Definiens Symposium to be held in Boston, 13th – 15th May. Definiens will host more than 20 distinguished speakers at the Symposium, to be held at Joseph B. Martin Conference center on the Harvard Medical [...] Read more »
Image Analysis Insights – OracleBio’s Newsletter
Welcome to the first edition of Image Analysis Insights, OracleBio’s new quarterly newsletter providing informative insights into the application of image analysis in R&D and biomarker research. In this edition, we highlight how image analysis plays a key part in R&D studies and in particular, the increasing application of image analysis in Oncology. You’ll also [...] Read more »
Image Analysis Applications in Drug Discovery
Quantification of histomorphometry and IHC marker staining read outs within cells and tissues is an essential read out across many Pharmaceutical R&D studies. Continued advances in digital image analysis software, in combination with whole slide imaging, now allows for highly accurate, objective and rapid assessment of marker staining across whole tissue sections on a cell [...] Read more »
FDA issues draft guidance on the use of histology in biomarker qualification studies
In recent years there has been a significant increase in the use of histological approaches in the generation of data to support the characterisation, validation and qualification of diagnostic, prognostic and predictive biomarkers, to be used as in both the clinical and pre-clinical setting. In response to this increase, in December 2011 the Food and [...] Read more »
Microscope Slide Scanning – Will Microscope Slide Storage Become a Thing of The Past?
Digitally scanning microscope slides to produce digital histology images is a recent technology which is of interest to both histologists and pathologists. Virtual microscopy is routinely used in various teaching organisations, however its implementation and utilization in everyday histology/pathology laboratories is still in its infancy. There are numerous opinions and preconceptions on the matter and [...] Read more »
Quantification of Beta Amyloid Plaques in Alzheimer’s disease by Definiens image analysis
Detection of Beta-Amyloid (Aβ) plaques in Alzheimer’s Disease (AD) using Immunohistochemistry (IHC) and image analysis was the subject of a recent publication in the Journal of Neuroscience Methods, 2011 (http://www.ncbi.nlm.nih.gov/pubmed/22019329) by Samaroo et al. at Pfizer. They applied a high throughput object-based image analysis methodology using Definiens software and validated it to quantify immunohistochemically stained β-Amyloid [...] Read more »
Xenograft IHC image analysis and getting the most out of R&D studies
Pre-clinical Xenograft Tumor models coupled with immunohistochemistry (IHC) and quantitative image analysis is an established approach within many Oncology focused Pharmaceutical R&D programs to investigate factors involved in malignant transformation, invasion and metastasis, as well as to examine response to therapy. However, achieving robust, detailed and consistent results from study to study depends on a [...] Read more »
Biomarker IHC & image analysis within R&D studies – A gold standard approach.
Traditional Histology and Immunohistochemistry (IHC) techniques are established methods for evaluating tissue parameters from a variety of target validation, efficacy and toxicity studies within pre-clinical drug R&D programs. I spent many of my earlier years within the Pharmaceutical Industry performing Histology and IHC techniques as part of Cardiovascular target validation programs. Coupled with microscopy, these [...] Read more »
So what data should be included in an out-licensing package?
It is certainly important to have a data package that contains compounds showing good in vitro potency and good potency and efficacy in an in vivo model(s). However, if this is the full extent of the licensing data package then the harsh reality is that your program is highly unlikely to achieve a licensing deal [...] Read more »
FDA Issues New Guidelines on Clinical and Nonclinical Genomic Biomarkers
The U.S. Food and Drug Administration (FDA) has issued new guidelines on biomarkers related to drug or biotechnology product development. The guidance was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The objective of the guidance is to create a [...] Read more »