Bio Screening Industry News

Carlsbad, Calif., and Beltsville, Md., May 7, 2008 – In research demonstrating that RNA previously thought to have no biological relevance may be of use for therapeutic and diagnostic targets, Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, and BioServe, the leading provider of clinically annotated tissue samples and provider of molecular marker research services, today announced that their technologies identified noncoding RNAs that were differentially expressed in healthy and diseased tissue. These micro ribonucleic acid (miRNA) sequences were either up or down-regulated between matched samples of RNA isolated from healthy colon and colorectal cancer tissues.  Data was presented in a poster at the annual meeting for the American Association for Cancer Research.

Invitrogen researchers used RNA samples from BioServe’s OncoRNA (http://www.bioserve.com/products/oncoRNA.cfm) product line, a series of RNAs isolated from fresh-frozen, fully annotated tumor and adjacent normal tissues, to probe the Ncode(TM) Human miRNA microarray V3.  Ncode(TM) Profiler software identified miRNAs that were either up- or down-regulated in tumor versus healthy tissue, and researchers used quantitative PCR to validate the findings.

“Using the high quality RNA samples from BioServe, we were able to identify novel microRNA sequences that could potentially be involved in the generation of new tumor tissues, particularly in colorectal cancer,” said Chris Adams, research and development leader of Epigenetics at Invitrogen.  “If more stringently validated, these disease-related microRNAs may eventually serve as targets for diagnostic or therapeutic development.”

MicroRNAs are short RNA sequences that do not code for specific proteins but are extremely important in the regulation of gene expression; they are implicated in several disease states including cancer and heart disease.  Among the activity of miRNAs is the triggering of messenger RNA (mRNA) degradation and the inhibition of protein translation – the process of assembling amino acids into proteins based on the instructions contained in mRNA sequences.  Invitrogen’s Ncode(TM) Human miRNA microarray V3 consists of miRNA content from multiple sources, including the Sanger 10.0 miRNA database and novel miRNAs unavailable in public databases, giving users access to strong content for identification and study of miRNAs.

“MicroRNA is making headlines in drug discovery for its ability to fine tune the activity of genes and its part in the formation of cancer,” said Kevin Krenitsky, chief executive officer, BioServe. “This makes it all the more critical that researchers can be certain they are working with stable, highly annotated samples collected under rigorous ethical and scientific protocols. We created OncoRNA to respond to this need, providing bench-ready RNA for tomorrow’s discoveries.”

About BioServe

BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository(R), a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen’s own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, stem cells, cell therapy and cell biology — placing Invitrogen’s products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.

Rockville, MD, April 23, 2008: Seegene today announced that its Seeplex(R) multi-pathogen tests are now optimized for Lab 901’s ScreenTape(R)  and Caliper LifeSciences’ LC90(R)  automated detection systems. Compatibility with these two leading detection systems opens the way for Seeplex tests to be used throughout a wide spectrum of labs, from small to mid-sized labs to large commercial reference labs.

Seeplex tests are based on a breakthrough multiplexing PCR technology capable of detecting multiple pathogens in a single tube. Seeplex-based tests deliver maximum specificity, reproducibility and sensitivity and can be applied to a broad range of molecular diagnostics, including human, animal, plant and microorganism. Currently, Seegene’s Seeplex multi-pathogen detection tests offer labs worldwide simple, cost-effective and comprehensive screening for STDs, respiratory viruses, human papillomaviruses, sepsis and pneumonia.

“Our broad portfolio of multi-pathogen detection tests being optimized for ScreenTape and the Caliper LC90 systems will make it easier for clinical and research labs of all sizes to take advantage of our technology,” said Dr. Jong-Yoon Chun, Founder and Chief Executive Officer, Seegene. “Both the Lab901 and Caliper LifeSciences systems represent the cutting edge of automated detection. Working in combination with these leading systems provides a powerful high-throughput method for analyzing test results.”

The ScreenTape system is the first fully automated, walk-away solution for gel electrophoresis. ScreenTape will automate the simultaneous analysis of eight or sixteen Seeplex PCR samples. Processing speed for 8 samples is completed within 10 minutes;  16 samples within 15 minutes. ScreenTape displays results using easy to interpret color codes. The ScreenTape system comprises the TapeStation (that carries out liquid handling, electrophoresis and imaging), ScreenTape (a consumable that contains the pre-cast, pre-packaged gel and running buffer) and bespoke software. With no gel or buffer preparation and no system priming, even untrained operators can rapidly generate accurate and reproducible test data.

The LabChip 90 System performs fast, automated, 1-D electrophoretic separations of protein, DNA, and RNA samples directly from a 96 or 384 well plate. The LC90 can load and read 96 Seeplex samples within 45 minutes or 384 Seeplex samples in 4 hours in easy-to-interpret reports.

Seegene is currently working to optimize Seeplex tests for other automated capillary electrophoresis systems. Seeplex’s compatibility with a wide range of automated detection systems will provide end-users with the flexibility to use the platform best suited for their purposes.

About Seeplex(R) System: Frontier of Multi-pathogen Detection

Seeplex(R) is a breakthrough multiplexing PCR technology that enables a new standard in simultaneous multi-pathogen detection. Seeplex works in combination with automatic detection systems such as Capillary Electrophoresis and delivers a benchmark in testing accuracy, efficiency and cost-effectiveness.

About Seegene

Seegene, Inc. is pioneering the field of multi-pathogen testing. Seegene applies its novel and proprietary Seeplex system utilizing “DPO (Dual Priming Oligo)” and “ACP (Annealing Control Primer)” to create multi-pathogen tests delivering maximum specificity, reproducibility and sensitivity. With over 260 citations and several patents and patents pending, Seegene has been offering advanced molecular diagnostics services to over 1,000 major global institutes in more than 25 countries. Seegene is actively working with both the scientific and OEM business community. Seegene’s mission is to integrate Seeplex with disease diagnostics to provide a new guideline for effectively treating patients. Seegene was founded in 2000 and is based in Rockville, MD and Seoul, Korea. For more information please visit www.seegene.com.

Boston, USA — April 29, 2008 — Today at the Bio-IT World Conference & Expo in Boston, USA, CLC bio announced collaboration with Microsoft Corp. on integrating CLC bio’s extensive bioinformatics solutions with Microsoft’s software platform, for the benefit of companies, corporations, and institutions in the biotech, pharmaceutical, and life science sectors. CLC bio has already added support for Microsoft SQL Server in its database solution, CLC Bioinformatics Database, as well as support for Microsoft’s high-performance computing solutions, Windows Compute Cluster Server 2003 and Windows HPC Server 2008.

Dr. Rudy Potenzone, worldwide pharmaceutical industry technology strategist at Microsoft Corp. and director of the Bio IT Alliance, states,
‘We are delighted to work together with CLC bio, a member of the Bio IT Alliance and one of the world’s leading bioinformatics solution providers. This collaboration will ultimately help life sciences firms transition to the Microsoft platform throughout their research and development departments. CLC bio’s tools, fully integrated with the Microsoft Office System, increase ease of use and expand the number of potential users, while reducing administrative overhead and creating a lean workflow. Furthermore, CLC bio’s internationally renowned experts are available for consulting and customized development.’

Jan Lomholdt, Vice President at CLC bio, continues,
‘With our support for Microsoft’s server solutions, the first step in the process has already been taken. The second step is to further advance our collaboration in areas such as Next Generation Sequencing and high-performance computing, which ultimately can help realize the potential of personalized medicine. As a former member of Microsoft’s World Wide Advisory Council, I have first hand experience of the strength and potential Microsoft brings to the table with a collaboration like this, which of course is interesting for a company like ours.’

Windows HPC Server 2008, the successor to Windows Compute Cluster Server 2003, includes a common set of High Performance Computing productivity tools that reaches across desktop and clusters, including a new Parallel Computing Initiative for multicore development. CLC bio’s high-performance computing solution for servers and clusters, CLC Bioinformatics Cell, supports Microsoft’s Message Passing Interface (MPI) in order to run bioinformatics algorithms such as HMMER, ClustalW, and Smith-Waterman on Windows HPC Server 2008 installations.

All CLC bio’s solutions are cross-platform, running on Windows 2000, Windows XP, Windows Vista, as well as Mac OS X and Linux

About CLC bio
CLC bio is the world’s leading full-service bioinformatics solution provider, solely focusing on the development of bioinformatics: software, hardware, data analysis, and custom-designed bioinformatics algorithms.

CLC bio’s mission is to be among the most innovative bioinformatics companies in the 21st century. This is realized through:

Development of bioinformatics software and hardware based on the latest scientific findings
User-friendly, integrated and intuitive cross-platform software solutions
Continuous focus on customer needs and superior customer service
Frequent product updates including the latest IT technologies and bioinformatics algorithms
A flexible IT architecture, enabling customers to buy or develop individualized solutions at a reasonable price

Boston, USA — April 25, 2008 — On Monday, April 28, CLC bio will officially unveil their new Next Generation Sequencing solution, CLC Genomics Workbench, the first comprehensive analysis package which can analyze and visualize data from all the major Next Generation Sequencing (NGS) platforms, such as SOLiD from Applied Biosystems, 454 GS flx from Roche Applied Science, Solexa from Illumina, and HeliScope from Helicos. The World Premiere is at the Bio-IT World Conference & Expo,April 28 - April 30, at the World Trade Center in Boston, USA.

Vice President of CLC bio, Jan Lomholdt, states, Having experienced massive pre-release interest from people within the Next Generation Sequencing segment, we’re confident that our cross-platform NGS solution which includes an intuitive graphical interface, numerous downstream analyses, and support for all the major NGS platforms, will become a hit. Especially when taking into consideration that we have assembled half a million 454 reads against the full E.coli reference genome, in around 2 minutes on a Dual-core laptop with 1 gigabyte RAM. In other words: This is FAST!”

“There is an explosion of interest in the next generation sequencing field right now, and I’m confident that CLC Genomics Workbench will become a valuable tool for the rapidly growing number of users in academia and industry who are using these new instruments for an amazing range of applications,” said Bio-IT World Editor-in-Chief Kevin Davies, PhD. “We’re also delighted that CLC bio has choosen this year’s Bio-IT World Expo in Boston to announce and introduce this product to the scientific and informatics communities.”

CLC Genomics Workbench includes accelerated assembly of Next Generation Sequencing data through use of High Performance Computing technology, making the assembly process very fast. The genomes to be assembled can be of any size, only limited by the number of gigabytes of RAM available on the computer running the assembly.

CLC Genomics Workbench takes full advantage of “paired end” data, and supports a number of features and work-tasks, such as reference assembly of genomes, De Novo assembly of genomes, SNP detection using advanced statistical models, Digital Gene Expression, metagenomics, clustering and assembly of EST and cDNA sequences, large amounts of genomics and transcriptomics downstream analyses, and workflow support. Some of the mentioned features will be implemented in future releases.

CLC Genomics Workbench has already been chosen as Next Generation Sequencing platform for all Danish universities. CLC bio will release CLC Genomics Workbench to the public in late May. To read more about CLC Genomics Workbench go to: www.clcbio.com/genomics

About CLC bio
CLC bio is the world’s leading full-service bioinformatics solution provider, solely focusing on the development of bioinformatics: software, hardware, data analysis, and custom-designed bioinformatics algorithms.

CLC bio’s mission is to be among the most innovative bioinformatics companies in the 21st century. This is realized through:

Development of bioinformatics software and hardware based on the latest scientific findings
User-friendly, integrated and intuitive cross-platform software solutions
Continuous focus on customer needs and superior customer service
Frequent product updates including the latest IT technologies and bioinformatics algorithms
A flexible IT architecture, enabling customers to buy or develop individualized solutions at a reasonable price

CHARLOTTE, N.C., April 8, 2008 (PRIME NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it has acquired full global rights to the I-3D portfolio of orally active, dihydroorotate dehydrogenase (DHODH) inhibiting compounds for the treatment of autoimmune diseases and transplant rejection.

Following a decision to focus its resources on its immunomodulatory compounds, Active Biotech AB has discontinued its participation in the I-3D co-development program and granted Chelsea exclusive global rights to the portfolio in exchange for royalties on future sales. The I-3D portfolio, originally developed by Active Biotech and under joint development by both companies since 2006, consists of an extensive library of therapeutic compounds that have demonstrated, during preclinical testing, potent inhibition of DHODH activity while maintaining PK and safety properties superior to the marketed DHODH inhibitor. Inhibition of DHODH is the rate-limiting step in de novo pyrimidine biosynthesis, which is required for the proliferation of T-cells during clonal expansion. Potential indications for drug candidates in this library include transplant rejection, rheumatoid arthritis, psoriasis and systemic lupus erythematosus (SLE).

“We have greatly enjoyed our collaboration with Active Biotech and respect their decision to focus on their unique quinoline based therapeutic platform,” commented Dr. Simon Pedder, President and CEO of Chelsea. “We continue to believe that the I-3D portfolio of DHODH inhibitors may have value and have identified a cost-effective process for screening molecules in this portfolio which will require only a minimal investment of time and money. The results of this screening will permit us to make more informed decisions regarding our investment in the program for 2009 and beyond.”

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea’s lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea’s antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.

The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

As the agency’s review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products’ lifecycles to keep health care professionals and patients informed of new and emerging safety data.

“Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” said  Bob Rappaport, M.D., director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. “While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug.”

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug’s approval.

Health care professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor.

Vivid, unusual, or strange dreams may occur while taking Chantix.

Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA’s continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency’s continuing reviews and conclusions warrant.

For more information:
http://www.fda.gov/cder/drug/infopage/varenicline/default.htm

As the Intergovernmental Working Group (IGWG) of the WHO prepares to meet and discuss how to best facilitate the expropriation of intellectual property rights (in this case the IPR of pharmaceutical patents) it’s important to consider the unintended consequences — the death of medical innovation.

The global purloiners of patents — led by Jamie Love — are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals — but are far less keen to explain how the fruit tree got there in the first place — or how they are nurtured.

In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.

In other words, the elimination of patent rights doesn’t produce greater access to medicines.

There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive.

Intellectual property rights are the fertile soil that allowed the tree to grow in the first place — and to thrive. To borrow an over-used adjective from the world of global climate change — we must protect “sustainable” innovation.

Jamie Love and Company may very well say, “A world without patents, amen.” And they’re right, because minus pharmaceutical IPR we’d all better start saying our prayers — because that’s the only way we’re going to battle disease and improve the health of our global fraternity.

If the IGWG succeeds, pharmaceutical innovation dies. And that’s a Silent Spring we cannot afford.

Author: Peter Pitts
Source: DrugWonks

The Biotech Industry Organization (”BIO”) spent $6.6 Million on lobbying efforts in 2007, reported the Associated Press.

BIO’s lobbying efforts last year addressed a range of issues from patent reform to generics to FDA-related issues. The Associated Press reported as follows:

[BIO’s] lobbying efforts went toward cloning issues ahead of the Food and Drug Administration’s ruling that cloned meat and milk is safe for consumers. Several members of Congress tried to compel the agency to do more studies before issuing a ruling, but FDA cleared the products for consumption in January.

The biotech industry also lobbied on legislation to allow the Food and Drug Administration to approve generic copies of biotech drugs. Generic drug companies already market cheaper versions of regular, chemical drugs, but the FDA does not have the authority to approve copies of biotech drugs, which are more complicated. Biotech makers opposed a bill that would have made generic biotechs medically interchangeable with the originals. The industry also argued generic biotechs should be classified as similar, but not interchangeable.

They also want biotech medicines to be guaranteed at least 12 years on the market before having to compete with generic copies. Generic drug makers say any protection beyond five years is unreasonable. Senate lawmakers attempted to pass a compromise bill last year, but negotiations broke down over the length of exclusivity.

This report raises some interesting questions about how much various industries spend today on their Washington lobbying efforts. One of the issues that has repeatedly come up in the patent reform debate is how minimal the biotech industry’s lobbying efforts are in contrast with the high tech industry. The argument has been that the proposed patent reform legislation favors the high tech industry, which has traditionally had more of a voice and presence in Washington. However, as this report makes clear, the biotech industry’s expenditures on lobbying–at least BIO’s expenditures on behalf of the industry–are not inconsequential. So, this report begs the question: if biotech’s lobbying efforts pale in comparison to high tech’s lobbying efforts on Washington, just how much is the high technology industry spending on Washington lobbying? What kind of lobbying money is considered adequate to have a voice in Washington?

As reported in today’s Newark Star-Ledger, Schering-Plough’s New Jersey employees will bear the brunt of Fred Hassan’s plan to fire, terminate, let go with extreme prejudice, 5,500 people in S-P’s workforce:

“Schering-Plough’s chief executive said yesterday the budget ax will fall first and hardest in New Jersey as the drugmaker cuts more than $1 billion in spending after the abrupt collapse of its top-selling cholesterol medicines.

“Fred Hassan said the global cost-cutting plan announced late Wednesday was still under development, but workers in the United States — particularly employees at the company’s Kenilworth headquarters — would bear the brunt of the projected 5,500 layoffs.

“‘The way it’s going to fall on the U.S., unfortunately, it’s going to fall on New Jersey,’ Hassan said in a telephone interview. ‘That’s the way the situation has unfolded.’”

“That’s the way the ball bounces, the cookie crumbles! Too bad for you! But, hey, I’m OK!”

A lot of families will be in trouble at the worst possible time as the entire US economy may be heading for a recession (according to Warren Buffet, Ben Bernanke, and other “insiders”).

Not all who are axed will be seeking jobs at other pharmaceutical companies, many of which are cutting back as well, but these are qualified people who can help pharmaceutical vendors work smarter and find potential clients within the drug industry. I propose, therefore, to help these people network with vendors — ad agencies, medical communications companies, solution providers, technology companies, etc — and possibly find at least some leads to a new career.

Source: Pharma Marketing Blog 

Roche has entered into an agreement to provide drug compounds for cardiotoxicity testing using a cell-based platform that could play a major role in the preclinical safety evaluation of drugs and newly developed compounds.

The deal aims to detect any drug-induced changes in the electrical activity of the heart, such as prolongation of the QT interval, which could cause faster, slower, or irregular beating.

Cardiotoxicity has been cited as the reason 30 per cent of all drug compounds fail during testing and with this new deal Roche aim to build predictive models of toxicology to reduce this failure rate.

Under the terms of the deal, Roche will supply Cellular Dynamics International two sets of 25 compounds to test on its platform, that uses human cardiomyocytes derived from human embryonic stem cells. Financial terms of the agreement were not released.

“The validation of the company’s platform through this collaboration is the first step in using these cells in routine toxicology testing,” said Chris Kendrick-Parker, CDI’s vice president of business development.

The late detection of cardiotoxic side effects, such as QT prolongation, caused by pharmacological compounds can impede drug discovery and development projects, and consequently increase their cost.

Drug development can take anywhere between 8 to 16 years, and average cost of developing a drug is now around $500m-$800m with the cost expected to hit the $1bn mark within the next four years.

Market analysis firm Frost & Sullivan has estimated the price of failure at $50m-$70m with approximately 90 per cent of clinical candidates failing at development stage

The launch of new drugs with undetected cardiotoxic side effects could have hazardous consequences and could trigger lethal cardiac dysrhythmias in patients. Testing for the potential cardiotoxic side effects of compounds at an early stage of drug development has therefore been the goal of many pharmaceutical and biotechnology companies.

Electrophysiological test systems and cellular-based fluorometric high-throughput assays are now the test of choice for cloned human cardiac ion channels.

When you consider that every drug nowadays has to undergo testing for hERG block and electrophysiological effects, the potential for this market is huge.

According to Frost and Sullivan, a better understanding of pharmacokinetic properties motivates the use of innovative solutions and early ADME/Tox screening. As a result the European ADME/Tox technologies market is expected to grow from its current size of $384m to $776m by 2011.