DRUG DISCOVERY AND DEVELOPMENT 11
time-to-market speeds that ultimately should help them bring new medicines to patients faster.”
Cancer studies Typically in cancer clinical studies across the industry, the number of low and non-enrolling sites (defined as the enrolment of 0 or 1 patient per site) averages approximately 54 per cent, which can cost a biopharmaceutical company US$50 000 per site.
In a cancer study using Xcellerate methodology and a robust dataset, Covance reduced the low and non-performing sites to under 14 per cent for this single portfolio, resulting in significant time and cost savings for the client.
Xcellerate also significantly contributed to the recent completion of a portfolio study seven months ahead of its recruitment target date.
Additionally, a long Phase III respiratory clinical study with a number of pharmaceutical companies vying for the same patients presented a unique set of challenges to Covance’s client: recruiting patients and retaining investigator and patient interest in the study.
Trough Xcellerate, Covance was able to help the client finish patient enrolment ahead of target and minimise disruption to investigator sites and their regular activities. Tis gave the trial a competitive
Fig. 2. A researcher loads a sample into Lawrence Livermore National Laboratory’s new fast PCR instrument.
multiplex PCR products can be performed with a variety of methods such as agarose gels, capillary sequencers, as well as multicapillary electrophoresis with the QIAxcel Advanced System.
Sub three-minute PCR? Te standard approach to PCR typically takes about an hour, which is a vast improvement over pre-PCR techniques that required days.
edge in investigator uptake and site enrolment. As a single provider, Covance created synergy across multiple data streams from multiple vendors, helping keep this complex trial on track.
Fast reaction times Te latest offering from QIAGEN is the Multiplex PCR Plus Kit, designed for rapid and sensitive multiplex polymerase chain reaction (PCR) that allows researchers to amplify several targets in one PCR run. Te kit provides fast reaction times and comes with a pre-optimised protocol, eliminating the need for optimisation and delivering reliable results on the first attempt (Fig. 1).
Te master mix included with the new kit contains the enzyme
HotStarTaq Plus DNA Polymerase, as well as a balanced combination of salts and additives, which increases multiplex reaction specificity and ensures comparable efficiencies for all primers in the PCR reaction.
Tis proprietary technology allows straightforward assay development for many challenging applications, such as detection of mutations or microsatellites and microbial genotyping.
Te kit also includes CoralLoad, a buffer that contains two dyes that improve pipetting visibility during reaction setup, gel loading, and visualisation of DNA migration. Terefore, it is no longer necessary to use other dyes for gel electrophoresis.
Downstream analysis of the Accelerating computational analytics A
ppistry, a leading developer of cloud solutions for advanced data management, has released Ayrris, an open, scalable solution for data-
intensive applications. Designed specifically for industries with high volumes of data, Ayrris alleviates the technical burdens of analysing big data and accelerating computational analytics. “Organisations today are creating and collecting
massive amounts of data – and the biggest challenge they face is being able to process and analyse these huge data stores into actionable intelligence,” said ceo
Kevin Haar. “Ayrris was designed specifically to provide data-intensive industries the processing capabilities needed to make use of this data. The cloud-based architecture of the product provides our customers with computation analysis capabilities that are over 10 times greater than what’s currently on the market.” The Ayrris line will replace the existing CloudIQ
brand, helping organisations solve big data challenges. Specifically aimed at the life science industry is Ayrris/ BIO. Because of the speed that next generation sequencing technologies produce large volumes of
genome sequence data, research organisations and sequencing service providers face numerous challenges in automating and scaling their bioinformatics solutions to meet the increase in both sequencer output and customer demand. Ayrris/BIO removes the technical burden from the genomics discovery and analysis process, fully automating pipeline execution and data management. The solution includes a pre-built Exome Sequencing and Alignment pipeline, which can be used out of the box, or customised to meet the needs of individual researchers.
However, PCR for point-of-care, emergency-response or widespread monitoring applications needs to be faster still - of the order of a few minutes.
Now, thanks to work by Reginald Beer and his team of scientists and engineers at Lawrence Livermore National Laboratory (LLNL), sub-three-minute amplification of nucleic acids (DNA and RNA) via PCR is possible.
Beer set out to find out just how fast PCR could go. His goal was to develop a device where the limiting factor would be enzyme kinetics or thermodynamics, not mechanical considerations.
He also wanted to use “volumes that are easy to interact with”, not microfluidic-scale, knowing that in a diagnostic setting multiple analyses are often needed and the ability to load samples by hand is vital (Fig. 2).
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