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HP Direct Digital Titration Available to Drug Discovery Biologists
Unique Site Payment Solution Streamlines Clinical Payment Process
Greenphire has announced the launch of its Clinical GPS technology, a unique site payment solution that streamlines and automates the clinical payment process for sponsors of all sizes. The system provides the ultimate solution for compliance with the recently passed federal Physician Payment Sunshine Act, enabling clients to make the required disclosures and reports effortlessly. The Physician Payment Sunshine Act requires sponsor companies to record any physician payments that are worth more than $10 in 2012 and report them on March 31st, 2013. The details of payment will be posted in a searchable database starting September 30th, 2013. Failure to include information can lead to significant penalties, with inaccurate reports impacting a company’s ongoing relationship with healthcare providers. The new legislation poses a significant challenge to companies who do not already have a data capture process in place. Technical solutions may need to be devised, implemented and tested well in advance of the upcoming data collection date.
Greenphire’s Clinical GPS solution utilises a proprietary validation engine that is capable of analysing data and triggering payments to a recipient based on customisable terms negotiated within a contract. The system is designed to integrate with EDC, IVRS, CTMS and any other clinical computer system in order to automate the triggering of payments to sites, investigators and vendors involved with a clinical study. By centralising all payment activity through a technology driven system, Clinical GPS is capable of providing detailed reporting at the site, investigator and vendor level for a single study or across a number of studies. The system not only benefits sponsors and ensures compliance with the Sunshine Act, but ultimately facilitates a quicker and more efficient payment process to CROs.
Tecan recently announced the commercial availability of the new HP D300 Digital Dispenser, a simple, standalone instrument for the pharmaceutical sector, which uses HP Direct Digital Dispensing technology to rapidly deliver picolitre to microlitre volumes of drug compounds.
Available exclusively through Tecan, this innovative device can cut titration times from hours or days to just minutes. Based on HP inkjet technology, the Digital Dispenser is the result of an agreement between Tecan and HP to commercialise this new technology for use in drug discovery research.
The HP D300 provides fast and reliable performance across a large dynamic range, eliminating the need for slow, error- prone and wasteful serial dilutions. Using disposable dispenseheads to help avoid the possibility of cross- contamination, the instrument offers non-contact digital
dispensing from 13pl to 5µl, delivering any dose to any well and virtually eliminating waste of valuable compounds.
It combines walk up convenience, ready-to-run performance and flexible, intuitive experiment design software to increase research productivity, reliability of results and the speed of drug discovery workflows.
Wendy Lauber, Head Product Management for Liquid Handling and Consumables at Tecan, commented: “The pharmaceutical industry is recognising a need for change, and there is a growing trend towards benchtop automation solutions.
New technologies such as Direct Digital Titration can offer fresh solutions to entrenched challenges, helping to improve productivity and accelerate the discovery of better drugs.”
The HP D300 Digital Dispenser is available now for delivery in Europe and North America.
Circle no. 433
Approval and Funding Granted for a Phase II Clinical Trial of Inecalcitol in Psoriasis
Hybrigenics announced recently that AFSSAPS, the French drug agency, has granted authorisation for a Phase II clinical trial with oral inecalcitol in patients with moderate-to-severe psoriasis under an Investigational Medicinal Product Dossier (IMPD) procedure. Hybrigenics also announces it has received a zero interest loan of EUR 650,000 from OSEO, the French financial institution supporting innovation, to cover 45% of the overall costs of the study.
The study will be conducted by professor Jean-Paul Ortonne in the Dermatology Department of the University Hospital of Nice, France. It will be a double-blinded and placebo- controlled trial comparing inecalcitol in 40 patients vs. placebo in 20 patients. Inecalcitol will be given orally at four milligrams per day for 16 weeks.
"We are delighted to investigate the full anti-proliferative potential of inecalcitol in psoriasis, a second indication in addition to prostate cancer. This study could extend the therapeutic potential of inecalcitol to non-cancerous proliferative diseases," said Dr Jean-François Dufour- Lamartinie, head of clinical R&D.
"We are also grateful to OSEO for its support to finance nearly half the cost of this Phase II trial. Oral treatment of moderate-to- severe psoriasis by inecalcitol would be a major breakthrough as compared with older oral drugs such as cyclosporin, methotrexate or retinoids which are immunosuppressant or teratogenic. The convenience of oral administration of inecalcitol would also represent an alternative of choice to more recent but injectable biological treatments."
Circle no. 436 Diagnostic Reagents
Founded in 1971 in California, Spectrum Chemical Mfg. Corporation manufactures and distributes 15000 fine chemicals and over 120,000 lab equipment and supplies. Spectrum China Ltd is a subsidiary to provide products and services to Asia Pacific area.
Spectrum has the longest USP/NF, FCC product line. It would be safe to be used in diagnostic field. They have biotech and bio-pharm grade products such as: solvents, surfactants, biological buffers, dyes, Amino acids, sugars, serums, culture media and so on. Spectrum provides a wide variety of choices and high quality products to aid users research.
Circle no. 435 Improved Oligonucleotides for Use in Research and Diagnostics
Link Technologies Ltd recently presented the latest results from its in-house research programme at the Cambridge Symposium on Nucleic Acids Chemistry and Biology, (CSNACB). The new poster describes methods for utilising tocopherol-modified oligos, which improve the targeting of oligonucleotides to cells. In this study, the researchers also took advantage of the high hydrophobicity of tocopherol to improve the purification of thiol-modified oligos. The poster is now available to download from the Link Technologies website. Such efforts are part of the company’s continuing commitment to driving forward the application of oligonucleotides in research, diagnostics and therapeutics.
Link Technologies’ research and development team includes highly qualified chemists and application specialists, whose extensive expertise covers the synthesis, modification and application of oligonucleotides. As well as the research presented at the CSNACB, Link Technologies’ scientists have also been investigating novel ways to improve the internal labelling of oligonucleotides with dyes, haptens and enzymes via thiol-modification. Until now, simple thiol-modification has been limited to the ends of an oligo. However, the researchers are currently optimising the use of a new product that facilitates direct incorporation of the thiol functionality on a dT unit, allowing conjugation of the oligo without further transformation. To allow customers to access this data, as well as that from other projects, Link provides a range of download links and extra information via its website.
Dr Catherine McKeen, Product Manager at Link Technologies, commented: “At Link Technologies we don't just sell reagents for oligonucleotide synthesis; we commit considerable time, resources and expertise to making sure we understand them better than anyone else. This ethos stretches throughout the company and is especially emphasised by the quality of the scientific research we present at meetings such as the CSNACB.” The company’s extensive product catalogue includes reagents for DNA, RNA, PNA & UNA synthesis and modification. In addition, Link offers fully bespoke custom synthesis and contract manufacturing services, all of which utilise an ISO 9001:2008 certified quality management system, rigorous quality control (QC) procedures and pro-active delivery tracking systems to maximise the accuracy and efficiency of the service provided.
Circle no. 437 Spotlight
Samuel Whitaker, CEO at Greenphire, commented: “Currently we are the only company to offer a centralised reporting and auditing tool for clinical trial payments. The strategic release of the Clinical GPS solution to coincide with the passing of the Sunshine Act demonstrates Greenphire’s position as an innovative leader in developing clinical payment solutions and communication technology solutions. Greenphire works to monitor developments within the clinical sector and creates leading technology that anticipates the needs of the customer.”
Circle no. 432 New Approach to Fighting Hospital Superbugs with Bacteria
Trials of a revolutionary, natural and cheap alternative to traditional hygiene practices is likely to spawn a completely new approach to the war against hospital superbugs. The startling results show that harmful bacteria can be completely eliminated by using ‘friendly’ bacteria in a simple cleaning fluid - rather than toxic chemicals. The trials, carried out by UK-based hygiene specialists Chemex International, were unveiled recently at a conference of over 600 members of the Infection Protection Society in Bournemouth.
Sean Derrig, Scientific Director of Chemex International, who presented the results at the Conference said: “Our research has proven that employing ‘friendly’ bacteria in a cleaning product rather than harsh chemicals drove out the bacteria that can be harmful to humans present at the start of the trial. The ‘bad’ bugs were completely eradicated – and the good ones did a very good job of eating dirt and grime as well. “The friendly bacteria chase out germs and form a protective biofilm that is tougher than Teflon and keeps the bad bacteria away permanently. The same principle is used in probiotic drinks that repopulate the gut with ‘good’ bacteria. It’s called competitive exclusion.
“This is a completely new approach to dealing with the pathogens that cause hospital-acquired infections. It is also simple, cheap and highly effective. “We have trialled this approach with a very forward-thinking NHS Trust and we saw more than just a visible improvement in cleanliness; scientific tests clearly demonstrated that harmful bacteria had been totally eliminated. “The ‘friendly’ bacteria are abundant in nature, the strain we use feeds on dirt and produces natural antibiotics which attack and kill the harmful bacteria. It really is using nature’s technology to clean wards and get rid of pathogens once and for all. Its high-level biocides are powerful enough to kill ‘difficult’ organisms such as Clostridium difficile spores and Norovirus against which traditional chemicals are ineffective and are in use in multiple NHS Trusts and other situations where scrupulous hygiene is paramount.
Circle no. 434
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