Volume 28 Issue 5, May 2010

Argentina has blazed a trail as one of the leading genetically modified (GM) crop producers. Can other developing countries import the seeds of its success? Lucas Laursen investigates.

Social media represent a new way for drug companies to interact with consumers. But transitioning medical communication and marketing campaigns to the internet poses several thorny legal and regulatory issues. Sarah Webb investigates.

A survey of entrepreneurial collaborations among health biotech firms in developing countries reveals a surprisingly high level of collaboration but a lack of emphasis on new or improved health biotech products and processes.

Open biotechnology may be the ideal solution to ensure scientific progress and the realization of the common good, but it has yet to deliver on its promises.

New methods for analyzing RNA-Seq data enable de novo reconstruction of the transcriptome.

An engineered centromere-specific histone could enable homozygous diploid lines to be generated at high frequency, simplifying crop breeding.

Multiparametric imaging of siRNA screening data sheds light on endocytosis.

Advances in sequencing platforms promise to make this technology more accessible.

A consortium of industry, nonprofit institutions and regulators outlines a rolling biomarker qualification process, providing the first clear path for translation of such markers from discovery to preclinical and clinical practice.

There is a paucity of biomarkers that reliably detect nephrotoxicity. The Predictive Safety Testing Consortium (PSTC) faced several challenges in identifying novel safety biomarkers in the renal setting.

By streamlining the qualification process for biomarkers, coordinated protocols recently implemented at the different regulatory agencies can facilitate progress and provide impetus to novel biomarker discovery and validation.

A collaborative effort between pharmaceutical companies, regulatory agencies and academia to qualify biomarkers for kidney toxicity provides a model for investigating and identifying reliable safety markers for preclinical applications.

Current biomarkers for detecting kidney damage, such as serum creatinine (SCr) and blood urea nitrogen (BUN), lack the sensitivity needed for use in drug development. Urinary clusterin outperforms SCr and BUN in detecting proximal tubular injury, and urinary total protein, cystatin C and β2-microglobulin each outperform either SCr or BUN in detecting glomerular injury.

Exposure of rats to kidney toxicants reduces levels of urinary trefoil factor 3 (TFF3) and increases levels of urinary albumin. Whereas urinary albumin outperforms either serum creatinine (SCr) or blood urea nitrogen (BUN) for detecting kidney tubule damage, urinary TFF3 abundance complements the capacity of combined SCr and BUN levels to detect renal injury.

Urinary kidney injury-1 (Kim-1) outperforms serum creatinine, blood urea nitrogen and urinary N-acetyl-β-D-glucosaminidase in detecting kidney damage induced in rats by a range of nephrotoxicants. Earlier detection of renal injury, enabled by monitoring levels of urinary Kim-1, should enable elimination of nephrotoxic candidates sooner in the drug development pipeline.

A panel of urinary biomarkers enables the progression of renal injury and subsequent repair and recovery to be monitored after exposure of rats to either carbapenem A or gentamicin. The authors complement this study by demonstrating that serum cystatin C is more sensitive and specific than serum creatinine and blood urea nitrogen in monitoring generalized renal function after exposure to nephrotoxicants.

ChIP-Seq data are usually analyzed with approaches developed for microarrays, which only consider binding events within a few kilobases of a gene. McLean et al. present an algorithm that takes into account more distant events, thereby improving functional annotation of regulatory regions.

High-throughput sequencing of total cellular RNA by RNA-Seq promises rapid reconstruction of spliced transcripts in a cell population. Guttman et al. accomplish this using only paired-end RNA-seq data and an unannotated genome sequence, and apply the method to better define many new, conserved long intergenic noncoding RNAs (lincRNAs).

RNA-Seq enables rapid sequencing of total cellular RNA and should allow the reconstruction of spliced transcripts in a cell population. Trapnell et al. achieve this and transcript quantification using only paired-end RNA-Seq data and an unannotated genome sequence, and apply the approach to characterize isoform switching over a developmental time course.

Insects are biotechnologically important producers of recombinant proteins and materials, and their biology as crop pests has substantial economic consequences. Xiang et al. map cytosine methylation genome-wide at single-base resolution in the silkworm, opening the door for global studies of epigenetic DNA modification in insects.

Smith et al. use time-lapse imaging to study the conversion of mouse embryonic fibroblasts to induced pluripotent stem cells. By reconstructing movies of single cells over a two-week period, they identify an early phenotypic change characteristic of cells that are successfully reprogrammed.

The first formal results of the Predictive Testing Safety Consortium, a community-wide effort involving over 190 scientists from industry, non-profit institutions and regulators that set out to qualify nephrotoxicity biomarkers in the preclinical and clinical settings.