RNA-Seq and Microarray Gene Expression Vie for Superiority of Biologic Elucidation Using A Comprehensive Study Design

gene expression

Whole-transcriptome analysis using next-generation sequencing (NGS) technologies, i.e., RNA-Seq, represents a new wave of gene expression analysis. Many publications have presented the advantages of RNA-Seq compared to microarrays, specifically in its wider dynamic range and lower background signal in quantifying gene expression, along with its unique advantage in discovery. Although it seems clear that RNA-Seq rivals microarrays, the reported comparative studies to date have been based on simple study designs and do not address what is perhaps the most important motivation of developing new technologies in the life sciences. That is, to create opportunities to advance the understanding of complex biological systems and to deliver robust biomarkers for use in safety evaluation and clinical applications. (more…)

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Mesothelioma Pipeline Offers Hope for Sufferers of this Rare but Deadly Disease

Mesothelioma

September 26 was first designated as “Mesothelioma Awareness Day” in 2004 (1). In that same year the first FDA-approved treatment for malignant pleural mesothelioma (MPM) was launched, namely chemotherapy with pemetrexed in combination with cisplatin (2).

Sadly, in the intervening decade, no new pharmaceutical treatments for mesothelioma have been approved while the number of deaths from this most aggressive of cancers has continued to rise (3). However, a great deal of research has been undertaken in those ten years and, as this article will show, the future is looking brighter with some promising drugs now progressing through the clinical development pipeline (2, 4). (more…)

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2014 Nobel Laureates Predictions

2014 Nobel

Having accurately forecast 35 Nobel Prize winners since its inception in 2002, the annual Thomson Reuters Citation Laureates study mines scientific research citations to identify the most influential researchers in the fields of chemistry, physics, medicine and economics. Here are some of our top picks: (more…)

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Biocon: India Needs to Focus on Affordable Innovation

biocon

During our recent conference, Pharmavision India, Thomson Reuters had the opportunity to catch up with Kiran Mazumdar-Shaw, Chairman and Managing Director at Biocon, who shared her views on the current state of the pharmaceutical landscape in India. (more…)

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Exoskeleton’s Greatest Hurdles are Value Proposition and Adoption Rates

exoskeleton

Twenty years from now, exoskeletons probably won’t be as advanced as the one depicted in the 2008 movie Iron Man, where actor Robert Downey Jr.’s character Tony Stark dons a suit of armor to fight crime. Ultimately, that’s a fictional account of just what the technology can do and not based in reality at all. What is reality, however, is a growing interest in these devices being used to help patients with spinal cord injuries walk. (more…)

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‘Bugs for Drugs’ – a Microbiome Perspective

microbiome

If the Spanish philosopher Ortega y Gasset had devoted his thoughts to medicine instead of existentialism, his famous aphorism “I am I and my circumstance” might had been replaced by I am I and my microbiome, that is, us and the bugs that thrive on and within us. More technically, the term microbiome refers to a collection of microorganisms, their genomes and their environmental niche. Within the biomedical domain, the microbiome entails the collection of commensal, symbiotic, and pathogenic microorganisms that inhabit our skin, gut and other mucosae. (more…)

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Developments in Alzheimer’s Disease

World Alzheimer's Day

Alzheimer’s disease (AD) affects more than 35 million people worldwide and is the sixth-leading cause of death in the US, where its care costs are predicted to rise from $200 billion in 2012 to $1.1 trillion by 2050. The disease is the only one of the top-ten leading causes of death in the US that cannot currently be treated, prevented or slowed, and while mortality from breast cancer, prostate cancer, heart disease, stroke and HIV declined by between 3 and 29% between 2000 and 2008, AD mortality increased by 66% (see Figure 1). (more…)

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Video: Mersana Scores $792M Partnership with Merck

Mersana

Already partnered with Takeda Pharmaceutical Co. Ltd. and others, Mersana Therapeutics Inc. touts its Fleximer-ADCs as a unique value proposition. Eva Jack, Mersana’s chief business officer, spoke with BioWorld about what specifically gives them superior properties not found with other ADC technologies. (more…)

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A New Era in Risk-Based Monitoring

REUTERS/Caren Firouz

Historically, a feet-on-the-street approach has been the gold standard for risk-based monitoring (RBM) of clinical trials. Sponsors have relied heavily on intensive source data verification (SDV) and on-site monitoring, however, as the cost of drug development rises, this method is beginning to lose its luster. Soaring technology and the draw of big data have given industry food for thought – why not benefit from real time electronic data capture by routing clinical trial information to a centralized repository and conduct monitoring from there? The advantages of off-site monitoring are compelling – a reduction in travel costs and carbon footprint, the ability to assess and prioritize risks for maximum safety and data quality, and source data errors caught before they sully the trial. That is not to say that centralized statistical monitoring (CSM) is without its limitations – industry experts agree that the best approach is a personalized one, and will likely include a comprehensive methodology. (more…)

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Merck’s Melanoma Label Perplexes, Disappoints

Keytruda

Merck & Co. Inc.’s FDA clearance, almost two months earlier than expected, of PD-1-targeting Keytruda (pembrolizumab) for melanoma holds the title for gaining the first U.S. approval of a drug in the class, but restrictions in the label have meant “a lot of head-scratching,” said Robert Pierce, director in biologics at Merck and member of the PD-1 development team. (more…)

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