Pharma must be aware that improving trial planning and design

The considerable cost of collecting, analysing and reporting clinical trials to support the submission of a new drug product are well known and it is likely future submissions will go up against more stringent standards.

Speaking at the recent Pabord conference in London, Pharmacutical Clinical Research Projects trade platform(CROlegacy.com),Dr Nicholas Lakin, manager of Accenture's Health and Life Sciences practice in the UK, Construction pharmaceutical directories,spoke about the need for players in the Pharmaceutical sector to maximise the return on their investment.

The need for better exploitation of clinical data is linked directly to the general challenges facing drug development today as development costs for new products have rocketed from $100m (€79m) to $800m.vitamin A, D, and E pharmacutical contract research projects

According to Lakin drug companies are currently following one of two paths to increase the value of their data.

By solving operative issues in conducting, analysing and reporting trials, companies can increase efficiency in obtaining their data faster, saving valuable time and cutting costs.

Clinical business solutions
"Pharma must be aware that improving trial planning and design as well as enabling adaptive trial designs through fast availability of data are key to gaining maximum quality of generated data," said Lakin.

The other method seeks to find new ways to reuse data to obtain more knowledge. This can be achieved by using sophisticated exploration of legacy data to search for new indications or new targets subject groups.

Lakin commented:"In this way companies can apply this knowledge to design better trials, which can also enable patient risk profiling."

According to PhRMA's annual survey 2001, clinical evaluation in Phase I, II and III received 29.1 per cent of US R&D allocation in 1999. Clinical evaluation in Phase IV, by contrast, received 11.7 per cent.

The prospect of going over and revising mountains of data is vastly time-consuming with no guarantees of a successful end result. But Lakin argued that significant revenues might well be obtained by discovering alternative indications for compounds.

He pointed to Evista (Medicis Pharmaceutical Corp. ), which was originally indicated for the treatment of osteoporosis but was found to have efficacy for breast cancer. Evista, which has been approved for osteoporosis, has been shown in studies to help prevent the occurence of breast cancer in high-risk women.

Likewise, Viagra (Sintong Chemical Industrial Co., Ltd) was the result of studies for a hypertension treatment but revisions on the generated data discovered it was better suited as an erectile dysfunction drug.

Wellbutrin (Bupropion) was also a drug originally indicated to treat depression but was marketed as a treatment for smoking cessation.

"By focusing on the exploration of existing data on such synergies, this will make it possible to reuse significant investments in pre-clinical and clinical testing, reducing the cost and effort of bringing the indication to market."

He argued that productivity of statistical programs can be increased by the elimination of manual data cleansing operations. Moreover, time spent on data manipulation and joining for cross-trial analyses can also be reduced using a standardised data model and programs.

Additionally, exploration of a warehouse offers the possibility to identify new potential (clinical research) indications for existing products. It also should aid in the standardisation of study protocol and provide the opportunity for building better study designs based on knowledge of historical data.

"Additionally, this will reduce the risk of project failure as these compounds are often well advanced in the R&D process, or even on the market," he added.

CRO Pharmaceutical Contract Research Outsourcing blog
Lakin pointed to the development of a clinical data warehouse based on a standard data model as the ideal solution to offer both of these benefits.

Clinical research organisations (CROs) should be enlisted to run Phase I oncology drug trials in order to improve efficiencies, delegates heard at Pabord 2006 in London

Traditionally, Phase I trials for oncology drugs are carried out in hospital oncology wards using sick patients so as not to expose healthy patients to the potentially highly toxic effects that many anti-cancer drugs (pharmaceutical) have.

"However, these days, many new cancer drugs, such as monoclonal antibodies, have an acceptable risk/toxicity profile and may be suitable for testing on healthy volunteers," said Kirkpatrick.

"This is opening up a whole new opportunity to improve the running of these trials - by using healthy patients sponsors could recruit a larger and more uniform patient population, with no pre-existing disease or concomitant medication, and could move the trial location from the ward to a specialised clinical pharmacology (pharmaceutical CRO) unit."

Clinical research organisations (CROs) should be enlisted to Services for Drug Discovery run Phase I oncology drug trials in order to improve efficiencies, delegates heard at Pabord 2006 in London.

The new generation of low-toxicity cancer drugs coming through the pharma pipelines is now making this possible, (contract research) said Chris Kirkpatrick, head of the Clinical Pharmacology Unit at Roche Products.

Carrying out clinical trials on hospital wards can be cumbersome and time consuming as it creates a lot of extra work for the already overstretched hospital staff, said Kirkpatrick.

"They have experienced staff who are Tgbaynes able to completely focus on the trial and they are able to reliably produce high quality data through tight sampling, accurate recording and reliable transmission," said Kirkpatrick.

The downside of using healthy volunteers is the inability to demonstrate efficacy or proof of concept, and of course, as the recent (clinical research) Tegenero disaster proved, researchers need to be absolutely certain that the toxicity risks are acceptable.

"It also often takes a long time to recruit patients, and the trial dosing and sampling etc. has to fit in around the other routine ward work," said Kirkpatrick.

"In addition, hospital clinicians and staff are not necessarily experienced in good clinical practice (pharmacutical clinical contract research projects trade platform) and clinical research, and this can cause problems with the collection of data."

On the other hand, Kirkpatrick believes Contract Research CROs are perfectly set up to run clinical trials as efficiently and accurately as possible.

The US-based company provides safety testing and biomarker measurements for clinical trials, mainly phase II and III

The newly redesigned laboratory, located in Dublin, also doubles the size of the operational facilities supporting project management and global logistics services.

The US-based company provides safety testing and biomarker measurements for clinical trials, mainly phase II and III, and the $1.5m (€1.2m) investment to enlarge its Dublin laboratory (CRO) will allow the firm to further develop its flow cytometry technology, particularly useful in the development of oncology therapies. The effect of age on sciatic nerve block duration.

Icon Laboratories, a provider of outsourced services for the biopharma industry, has expanded its central lab facilities in Ireland by 30 per cent to meet growing demand for clinical trial testing services.

There has been a growing demand for such services, particularly due to the host of new oncology, infectious disease and immunology therapies coming through the pipelines.

"Over the last five years, more and more drug makers have been outsourcing these tests to central laboratories such as ours," Robert Scott-Edwards, president of Icon Laboratories, told Labtechnologist.com.

The expanded facilities are also part of a wider capacity development being employed by the global firm who is also planning the launch of a new lab facility in Singapore at the end of the year. clinical research institute in india

"The Asian market is a very important market," said Scott-Edwards.

"We already work in the Asian market in collaboration with partners but we wanted to have our own facilities." CRO Pharmaceutical blog

Icon Laboratories, which had a growth rate of 60 per cent in the past year, provides services for 90 pharma and biotech companies in 52 countries. Indian scientists found that the new genes in microcephalin

"This expansion is part of Icon's efforts to ensure that it can respond to significant global growth in customer base and volume of clinical trials."

Drugs are paired with diseases using sophisticated pattern-matching methods with a high level of resolution and specificity

Despite advances in the understanding of biological systems, drug discovery is still a long process (drugs research contract). Whilst information on the human genome, its sequence and what it encodes has been hailed as the answer to virtually eliminate the bottleneck in therapeutic targets, the full potential is still a long way off.

The tool consists of a search engine that is connected to a giant database. The intention is the two elements work in A new era of dual-use condoms tandem to connect human diseases with potential drugs to treat them, as well as predict how new drugs work in human cells.

Scientists have come up with an innovative tool that may accelerate the drug development process (drugs R&D), which has slowed down considerably despite the investment in new technologies and analytical techniques.

The tool, known as Connectivity (drugs research) Map allows researchers to screen compounds against genome wide disease signatures, rather than a pre-selected set of target genes.

Drugs are paired with diseases using sophisticated pattern-matching methods with a high level of resolution and specificity. CRO blog.

"This is a powerful discovery tool for the scientific community," said Justin Lamb, the lead author of the paper, published in Science.

The Connectivity Map is the work of The Broad Institute, a research collaboration involving faculty, professional staff and students from throughout the Massachusetts Institute of Technology (medical experimental) and Harvard academic and medical communities and is governed jointly by the two universities. Cancer cell membrane protein structure was first discovered.

The Connectivity Map is the subject of three new research papers that are published in the journals Science and Cancer Cell.

"By analysing just a small fraction of available drugs, we have already confirmed several biological connections between drugs and human disease, and made entirely new ones, too," he added.

This research effort aims to generate a detailed map that links gene patterns associated with disease to corresponding patterns produced by drug candidates and a variety of genetic manipulations. JamJaa.com.

That was the view of Karen Maubach, Clinical Development executive at drug development company BTG

That was the view of Karen Maubach, Clinical Development executive at drug development company BTG, who was speaking at the recent Pabord conference in London.

Maubach spoke of 'virtual' companies, which stand in stark contrast to 'traditional' companies, who outsource some functions such as clinical trials, but have invested heavily in headquarters and manufacturing infrastructure. Osteoporosis diagnostic tests.

Several drug development companies are implementing leaner business models, (pharmacutical clinical contract research projects) outsourcing nearly all stages of the drug development process in response to escalating development costs in a move that is proving increasingly popular within the industry.

The virtual model refers to the business practice of outsourcing all stages of drug product life-cycle avoiding huge fixed costs and protecting against booms and busts caused by erratic pipelines.

Maubach spoke of the primary advantage of the virtual drug development model, citing time savings were the result of the flexibility by outsourcing companies to adapt to rapidly changing priorities.

"With the virtual model we are finding that bottle-necks are being worked through, clearing the backlog and further streamlining the overall drug discovery process," she said.

The presentation then focused on the expertise gained from this strategy, commenting on the inherent flexibility the model can incorporate.

"Internally, the model can focus on core competencies whilst maximising use of existing resources. There is no need to prioritise projects based on limited specialised resources," she commented.

"Externally, we can go further as there is scope to expand the skill base and resources. In addition, we can look into gaining the advice of independent experts and therefore gaining access to innovative ideas and exploiting emerging opportunities." Clinical business solutions

"There is also the initial time consuming problem of identifying suitable partnerships and to develop constructive relationships," she said.

Perhaps the most important aspect is in order for the model to be cost-effective the leaders must take into consideration the timely development of good chemical leads and biological data to support the full development of the lead compounds. This too, can be a time-consuming process.

Other advantages include the ability to provide a smoother transition in response to the EU Clinical Trials directive by integrating advisors and experts with the necessary insight to navigate the new regulations. Outsourcing blog

The traditional model of drug development (clinical trial) where the use of an extensive infrastructure with majority of functions in-house has always been the favoured set up. However, with the advent of innovative new technologies the face of pharmaceutical R&D is changing.

By allowing researchers to more effectively identify, select and exploit therapeutic targets, design more efficient drug (clinical) development models and more quickly analyze the economic efficacy of pharmaceuticals, drug developers have realised that drawing on the expertise of the wider scientific community can bring new targets to market more effectively. Research shows that stem cell transplants can improve type I diabetes patients

However, the virtual model is not without its disadvantages. Maubach spoke of the limitiations in some activities being difficult to out-source as well as the inevitable quality/audit/regulatory compliance issues.

new chemical entities approved by the Food and Drug Administration (FDA) have decreased mainly due to safety and toxicity issues

Driving the move is Tandem's ambition to expand its existing services to a new level and offer its clients a more complete laboratory menu and a higher likelihood of success when investigating new chemicals entities (medical social network), the firm said.

In recent years, new chemical entities approved by the Food and Drug Administration (FDA) have decreased mainly due to safety and toxicity issues. Nevertheless, the costs associated with developing and launching a drug to market have increased yearly. Pathological causes of osteoporosis

Targeting the market for drug metabolite identification and biomarker discovery, Tandem Labs has acquired PharmaKD (medicine community), a Massachussets-based division of Linden Technologies.

By acquiring PharmaKD, the contract research organisation (CRO), which provides bioanalytical and immunoanalytical testing for the pharma industry, gains access to proprietary informatics that can reduce time and cost of (medicine social network) drug development.

What PharmaKD brings to the deal is its DMDiscovery platform, a drug-metabolism technology that increases the productivity of drug metabolite identification and quantitation. Also coming to Tandem is the MarkerScan process, a biomarker discovery and screening process that identifies potential biomarkers.

"We have vigorously investigated new technologies and services that will allow our clients to safely and cost-effectively bring new medicines to market," said Denis Lin, (pharmaceutical community) CEO of Tandem Labs.

The newly formed facility, Pharmaceutical Research called Tandem Labs-New England, will bring the number of facilities owned by Tandem within the US to three.

Financial terms of the deal were not disclosed but Tandem said it would retain key employees, intellectual property portfolios, scientific instruments and a 7,000 square-feet of operational space from PharmaKD. Shire company in Japan launched hyperphosphatemia drug therapy

"PharmaKD (medical social network) has strong intellectual property portfolios that improve pharmaceutical research productivity, reduce costs, and increase the success rate of drug candidates."

PharmaKD provides novel PK/PD Services for Drug Discovery technologies to support pharmaceutical and biotechnology industries. These technologies are used for predicting drug efficacy, drug toxicity and monitoring drug progression.

Drug development times, especially the clinical phase

That was the view of Dr Christopher Milne (medicine research blog), associate director of the Tufts Center for the Study of Drug Development (Karnataka Antibiotics & Pharmaceutical Ltd. ) in Boston, who believes that outsourcing is the best option in achieving these objectives.

Drug development times, especially the clinical phase, have almost tripled in the last four decades, pushing up development costs sky high(drugs research blog). Added to the fact the number of new drugs have not significantly increased despite the technology investment, outsourcing is suddenly looking like an attractive proposition.

With the cost of drug development expected to reach $1.9bn (€1.5bn) by 2013, the pressure is on to reduce R&D development time and cost without sacrificing clinical success rate.

Big Pharma clearly agree. According to an earlier Tufts study, during 2003-05, clinical trials for new drug candidates carried out by the ten top selling US drug companies rose by 52 per cent, following a 21 per cent decline from 1993-97 to 1998-02.

Indeed, the adoption of outsourcing certain processes in the R&D process has culminated in statistics, which suggest that of the six specific broad therapeutic categories analysed(clinical research blog), oncology/immunologic and CNS had the greatest shares of new drugs entering clinical testing during the 1993-02 period.

In addition, respiratory, oncology/immunologic, and systemic anti-infective drugs had the highest clinical approval success rates for the 1993-02 period.

However, quantifying the contribution (contract research organization) (CRO) has made to these statistics was the focus for Milne, who pointed towards a pioneering study by Joseph Dimasi.

According to the study to reduce drug development costs by $100m, drug developers must reduce the time taken to develop the drug by 18.9 per cent. To reduce costs by $200m, developers would need to reduce time taken by 41.3 per cent. Propecia|Order Xenical Avodart

The study went further. In order to save $100m, developers would expect a clinical success rate reduction of 25.2 - 25.6 per cent - a massive drop considering the success rates are relatively low even with a generous budget.

A $200m reduction would result in a clinical success rate reduction of 30.4 - 31.7 per cent.

While blockbusters account for over one third of sales worldwide in 2005, Milne pointed to unmet medical needs worldwide, with 5000-8000 rare diseases still without an effective treatment.

Milne also pointed to the 50 per cent non-compliance rate for chronic disease treatments, which represented a future opportunity for new drug development.

"Currently, the average cost to develop and win market approval for a new drug in the US is $802m," said Milne.

"Drug companies need to adopt a new (CROs) paradigm that stresses better, faster, and cheaper. Blockbuster drugs may be a desirable goal, but they require large user populations to generate large revenues."

Contract Research Organisations' (CROs) contribution to drug development has never been more crucial with faster development

That was the view of Dr Christopher Milne, associate director of the Tufts Center for the Study of Drug Development (BioSante Pharmaceuticals ) in Boston, who was making the keynote speech at the Pabord conference in London last week. In it, Milne attempted to quantify and identify key drivers of growth in clinical research outsourcing, particularly since 2000(clinical CRO), as well as quantify the impact of outsourcing on drug development and the role that it has played in public health.

Global drug development spending is expected to top $105bn (€82bn) by 2010 with 40 per cent of this business expected to be dished out in outsourcing contracts.

Contract Research Organisations' (CROs) contribution to drug development has never been more crucial with faster development, earlier decisions on project failures, and higher approval success rates becoming the norm amongst outsourcing partnerships.

Milne pointed towards the escalating cost of new drug development that has been the driving factor towards the switch to outsourcing. Costs have soared from $0.8bn in 1997 to an expected $1.9bn by 2013.

Added to the increase in the time it takes to reach final approval phase from preclinical studies, companies are finding the outsourcing approach is saving huge amounts both in time and cost.

According to a study by the Tufts CSDD in 2005, preclinical phases in the 1960's took approximately five years to complete compared to a figure of 5.8 years for the 2000's.

Likewise, Tufts found the clinical phase period jumped from 1.9 years to a whopping 5.9 years within the same period.(contract research) However, Milne pointed out that approval phase had actually decreased averaging 2.4 years in the 60's to 1.5 years for the present day.

Pharma companies are turning to CROs in an effort to implement these time and financial savings and are carving out a reputation for faster development times.

"We found that high CRO usage projects were submitted more than 30 days closer to the projected submission date," he said.

"High usage projects offered a development speed advantage across all measures, most notably during the close-out phase."

"In an attempt to ease the serious bottlenecks that have formed during the drug development cycle, drug firms see outsourcing as a possible route in easing the congestion." "Bottlenecks are forming at the discovery stage, (clinical research) where targets and biomarkers need to be validated. Also, the clinical stage has become more time consuming with factors such as adaptive CTs, exploratory INDs, dosing and attrition determining trial design."

Milne also pointed to a study carried out by Joseph Dimasi in the journal PharmacoEconomics, which stated that in order to reduce the cost of the clinical trials the amount of time taken for the testing must also be reduced.

The study showed that to reduce (pharmaceutical CRO) drug development costs by $100m, the drug developers must reduce the time taken to develop the drug by 18.9 per cent.

Likewise, to reduce the drug development costs by $200m, the drug developers would need to reduce the time taken to develop the drug by 41.3 per cent.

AstraZeneca has entered into an agreement with two Contract Research Organisations (CROs)

It's another indication of the emerging role CROs are playing in contributing to pharma and the drug pipeline. Indeed, figures from the Tufts Center for the Study of Drug Development (TCSDD) revealed that total global spending on contract clinical services jumped from $3.7bn (€2.9bn) in 2001 to $5.6bn in 2004.

The multi-year collaboration will see scientists from ChemBridge Corporation and ChemBridge Research Laboratories, (CRL) at its Moscow and San Diego research sites working with AstraZeneca scientists to develop small molecule libraries for the drug company. Further details and financial terms were not disclosed.

AstraZeneca has entered into an agreement with two Contract Research Organisations (CROs) with the intention of expanding AstraZeneca's small molecule libraries and enhancing its global drug discovery offerings.

"AstraZeneca has selected ChemBridge and CRL as one of their chemistry partners," said Eugene Vaisberg, chairman and CEO of ChemBridge Corporation and CRL.

"This new agreement serves as yet another confirmation of the capabilities of CRL and ChemBridge in the area of small molecule research," he added.

According to a report by Kalorama Information, publishing division of MarketResearch.com, global drug development spending will top $105bn by 2010 with 40 per cent of this business is expected to be dished out in outsourcing contracts - with contract research organisations (CROs) emerging triumphant. Corporation,dicalcium phosphate

Contract drug development spending reached $19bn in 2005 and will increase at an annual rate of 17 per cent to exceed $42bn by 2010.CRO Pharmaceutical Contract Research Outsourcing blog

AstraZeneca are in the midst of hiring outsourcing companies having also awarded a contract to drug delivery device service provider Bang & Olufsen Medicom to develop a new electronic monitor that can tell whether patients are correctly taking their medication or not.

The firm were not afraid to pull the plug on contracts that were not working, as PDI found out to their cost in March this year. Aspirin may increase the risk of brain hemorrhage older slightly

AstraZeneca pulled the plug on a long-running service contract with the CRO. At the time AstraZeneca was PDI's biggest client, and along with GlaxoSmithKline and Sanofi-Aventis, accounted for 50-60 per cent of the company's revenue.

Speaking at the recent Pabord conference in London, Hammond spoke of the rise in popularity of HCS within the pharmaceutical and biotech industry

That was the view of Dr Stephen Hammond, CEO of Scottish Biomedical(medicine R&D), who believes that HCS' accuracy and speed of data capture are deciding factors when studying cell models.

Speaking at the recent Pabord conference in London, Hammond spoke of the rise in popularity of HCS within the pharmaceutical and biotech industry, with the method currently being applied in drug discovery; instrumentation, live-cell imaging and informatics.

Hammond said that while current methods such as High Content Screening (HTS) showed some advantages, it fell short in crucial areas that would compromise research in both time and cost measures.

According to a senior figure in the outsourcing industry, high content screening (medicine research) is set to overtake current methods as the preferred technique of generating hits with the greatest interest coming from the oncology sector.

"Hits from HTS tend to under perform in that they will often exhibit binding to weak non-specific interactions."

"In addition, there is a noticeably flat Structure Activity Relationship (SAR) in hit to lead activities," he added. Nerve muscle medicine

HCS is the process in which the use of different types of assays enables a number of different considerations of a system to be assessed, in the presence of given lead compounds.

Specifically, HCS refers measurements taken on cells and tissues, which taken together, enable a clearer insight into the lead compound, and therefore enables a more calculated approach to drug development.

According to Hammond, at least 50 per cent of all drug discovery assays performed now are cell-based, with a major marketing push by outsourcing companies suggesting that cell-based HCS as the way to overcome present hurdles(new drugs R&D).

"HCS has many advantages over biochemical assays in that there is no need to purify the target which can affect assay sensitivity," said Hammond.

Additionally, HCS also allows walk away automation of certain targets - a factor not addressable by HTS.

However, Hammond was quick to point out the challenges of this method, which he said would need to be overcome in order for HCS to reach its full potential.

"The disadvantages of HCS (research Organization) are primarily assay development, costs and relative complexity."

While quality of results is higher, researchers have to contend with the fact that HCS requires a different skill set and an altogether different approach, which need to be implemented in order to gain the full benefit from this technique." Chennai Laboratories-Chennai Laboratories

While the survey pointed out that while these were different high content assays, they may not necessarily be high throughput screens.

However, it was clear that large ranges of different research groups were applying HCS today and had expertise in the technology and tools.Pharmacutical Clinical Research Projects trade platform(CROlegacy.com)

According to Drug Discovery World, the mean number of high content screens run in large pharma was estimated to be 6.8 screens per year in 2005.

This is expected to grow to 10.4 screens in 2006. In contrast, small-medium pharma and biotech were estimated to be 5.3 screens in 2005, this is expect to grow to 7.8 screens in 2006.

Outsourcing is expected to emerge as a definitive trend in the bioinformatics industry

Bioinformatics has evolved from being solely a science of comparison and analysis of gene and protein sequences to a more advanced tool that eliminates the need to perform long and sometimes potentially hazardous experimentation.

The use of this exciting technology is expected to become a necessity for life science and biopharma firms as they seek to streamline the drug discovery process and reduce the cost and time required to bring a medicine from research stage to market, at a time when this process is more expensive and complex than ever before. Outsourcing is expected to emerge as a definitive trend in the bioinformatics industry, according to a new report by Frost & Sullivan.

However, "using IT to solve scientific problems is extremely challenging and requires an in-depth knowledge of living systems, an all round understanding of structural, functional and regulatory processes in living systems as well as familiarity with advanced computational power," said Frost & Sullivan research analyst Sumitha Kannan.

"Strategic partnerships and outsourcing will be the business models that will ensure success."

As a result the bioinformatics market is increasingly becoming extremely service driven and is positioned to achieve its maximum potential over the next three to seven years as biotechnology companies with bioinformatics operations, software firms in bioinformatics, as well as core computer hardware, peripherals and IT companies all diversify into this area, said the report.

One of the major challenges in the market then will be to achieve cost competitiveness, while simultaneously providing customised solutions. Golden Crown Chicken Pizza

Introducing new technologies or improving existing products to meet evolving needs and providing more product features will help market participants make competitive gains, said the report, titled: "Opportunities for Outsourcing Bioinformatics (Europe)."

"Constant monitoring of new products entering the market and of changing customer preferences will be central to acquiring a leadership position in the bioinformatics market," said Ms Kannan. Contract Research

"With rising demand for complete solutions encompassing training, installation, maintenance and upgrades, participants should aim at providing clients comprehensive services."

"This (cellular imaging) has been our biggest growth area by a long way over the past year and a half and we know there is a huge market for this out there," Nikon spokesperson Chay Keogh told Multi-service CRO

"Our plans for the next few years will take us down this route quite heavily."
Incidentally, the Bioimaging Facility at the University of Manchester has just announced the purchase of three new Nikon eC1 confocal microscopes, to cope with "increasing demand for its imaging services."

The organisation said that two of the microscopes will be equipped with electron multiplying charge-coupled device (EMCCD) monochrome digital cameras - offering single photon sensitivity - allowing it to add Total Internal Reflectance Fluorescence (drugs research contract) to the array of techniques it makes provides for the Faculty of Life Sciences and external organisations.

Contract drug development spending reached $19bn in 2005 and will increase at an annual rate of 17 per cent to exceed $42bn by 2010

According to remarks made at the recent Pabord conference in London, Dr Arvind Mathur suggested that outsourcing had become so prominent within the pharmaceutical industry that it was, "becoming a strategic function asset."

The comments may come as no surprise to those in both industries as the trend for outsourcing is not new. Pharmaceutical companies have been outsourcing for just over 20 years now, in a process designed to cut down on drug development costs, which can amount to $1.3bn (€1.03bn).

Ironically, Mathur revealed that cost was no longer the dominating factor. Outsourcing has become such a specialised sector that companies are more concerned with hiring the best people for the job.

(drugs R&D) Outsourcing has become so paramount in a pharmaceutical's infrastructure and drug discovery strategy that it can no longer be considered an option, according to a Bristol Myers Squibb (BMS) senior scientist. Buzinee forum

In addition, with tightening regulations and impending legislation that further scrutinise new chemical entities (NCE's) coming through the pipeline, the development of a (drugs research) drug that has gone through the correct channels gains even more importance.

Despite enormous investment in speed, technology and capacity, productivity in drug discovery is not increasing. In addition, current growth trends in R&D expenditure are unsustainable.

While pharma companies have generally responded by restructuring the R&D organisation, investing in technology tools and platforms, and entering into mergers and deals, an alternative and highly effective approach to the innovation deficit - outsourcing - has been gaining momentum. CRO Pharmaceutical

According to a report by Kalorama Information, publishing division of MarketResearch.com, global drug development spending will top $105bn (€81.5bn) by 2010 and 40 per cent of this business is expected to be dished out in outsourcing contracts - with contract research organisations (CROs) emerging triumphant.

Contract drug development spending reached $19bn in 2005 and will increase at an annual rate of 17 per cent to exceed $42bn by 2010.

For pharmaceutical firms, outsourcing enables them tap into a large pool of untapped expertise as well as ultimately proving cost effective.

This balances out with the perceived negatives that may have prevented outsourcing from being even more popular. These include a fear of loss of control over quality, protection of intellectual property, and the distance factor, which can raise shipment-related issues.

Mathur revealed that BMS currently outsource 90 per cent of its scaffold chemical structures.

"We outsource much of the non-critical intermediates, or where the in-house capacity is low," he told CRO Pharmaceutical

The decision by the contract research organisation (CRO) confirms speculation about its intentions for the forthcoming year

The decision by the contract research organisation (CRO) confirms speculation about its intentions for the forthcoming year. In June 2005, Amphora had said the company were investigating ways to cement its future and protect more than $50m invested into the company.

By splitting the company into two, Amphora think that the value of each of the units will increase possibly attracting more additional venture funding as a result. Tony Carita

Drug development company Amphora Discovery has announced it is to split the company into two stand-alone business units - a pharmaceutical development firm in California and a (medical experimental) in Durham.

"The strategic division of the company into two stand-alone business units will enable Amphora to fully realise the value of both its world-leading high throughput drug discovery expertise and its very promising portfolio of drug candidates," said Peter Savas, Amphora CEO and Chairman said of the Business Unit formation. Method of cooperation in the world's largest diabetes genes

"We have constantly been asked to reproduce the demonstrated success of our in-house discovery program in a contract mode by both major Pharma and Biotech companies. This move will enable us to do just that, while at the same time retain focus on the continued development and out-licensing of our drug candidate portfolio." Types of Training

"Amphora's drug discovery efforts have resulted in successful collaborations with industry leaders and the advancement of multiple internal programs into preclinical studies," said C. Nicholas Hodge, CSO and founder of Amphora, who will also head the Amphora Pharma Business Unit.

"Amphora Pharma has a large and growing intellectual property portfolio for drugable small molecules directed toward high-value targets for cancer, inflammation and CNS diseases," he said.

The Amphora Pharma Business Unit is focused on development and out-licensing of the company's selection of lead candidates.

Meanwhile, the Amphora Discovery Business Unit is a provider of integrated contract services for the pharmaceutical (medical outsourcing) industry, employing chemogenomic, systems biology and microfluidics technologies to deliver targeted lead generation and lead optimisation solutions.

the biomedical breakthroughs that are occurring within the industry are transforming medicine and promise to ease the challenges facing an aging population

Sidney Taurel, speaking at the Economic Club of Florida (medical R&D) outlined a future where a wealth of previously unknown information about disease progression and human immune response would lead to the development and delivery of customised treatments, optimised for specific patient populations.

In addition he devoted part of his speech to the aging population and age-related diseases such as Alzheimer's, claiming that the industry "may be right on the edge of a breakthrough."

Nanotechnology applied to medical devices
He added that there was hope pharmaceutical therapies could soon make cancer a chronic disease rather than a fatal one, repair cardiovascular damage and reverse heart disease.

According to the CEO and Chairman of pharmaceutical giant Eli Lilly, the biomedical (medical research) breakthroughs that are occurring within the industry are transforming medicine and promise to ease the challenges facing an aging population.

"When you add up the progress already made in the illnesses that cause much of the disability for seniors and project it forward, you can see major improvement on so many fronts," he added.

"In addition, our scientists foresee new treatments to preserve cognition and mobility and to fight frailty and pain(new drugs R&D) . Old age will take on a new meaning." JamJaa.com

According to the International Monetary Fund (IMF) between 2004 and 2050 will see the number of young persons in the EU (aged 0-14) drop by 18 per cent.

The working-age population (15-64) will fall by 48m, or 16 per cent, whereas the elderly population aged 65+ will rise sharply, by 58m (or 77 per cent), and the fastest-growing segment of the population will be the very old (aged 80+) rising by an astonishing 174 per cent.

Taurel, identified many of the new technologies and (medicine R&D) discoveries arising from the Human Genome Project, citing Florida as "a place for studying the challenges facing an aging population," as well as being 'especially important as a laboratory for the future in health care.'

Among the new technologies are microarrays, RNA (medicine) interference, bioinformatics and biomarkers. Such new information allows scientists to better predict which patients will most benefit from specific therapies. Stéphane Lucchini

With greater understanding of how to target therapies to those most likely to benefit, pharmaceutical companies can provide better care and minimise risk.

"We believe we're CRO in the early stages of a major leap forward in new drug discovery. With all the new ideas and new tools emerging from the biomedical revolution," Taurel said.

"This is the concept behind a tailored therapeutics model (medicine research). The ultimate vision would be to predictably deliver 'the right dose of the right drug to the right patient at the right time.'"

Taurel concluded by stating his optimism for the future of health care. "All of this is possible in terms of science and technology but none of it is guaranteed."

"I'm hopeful our public policies will support the continued innovations that will help us realise this incredible potential." Respiratory medicine

He added that the technological revolution in the development of new drugs and therapies promises better, more effective treatments for a whole range of diseases.

"I believe that treatments that would have been regarded as miraculous ten years ago will be in common use in the future," he said.

Pharmacopeia, earlier this year, continuing GSK's links to biotech companies

The deal marks the second one to have arisen as a result of GSK's drug development partnering unit, the Centre of Excellence for External Drug Discovery (research Organization)

It also reinforces an emerging trend that sees risk-sharing/reward-sharing alliances becoming popular with biotech and smaller pharmaceutical companies.
The hope is that such alliances will help speed up the development time of new in-licensed drugs from target to clinical proof through risk-sharing/reward-sharing alliances with biotech and smaller pharmaceutical companies. Rakesh Kumar

GlaxoSmithKline (GSK) has formed a partnership with ChemoCentryx worth $1.5bn (pharmaceuical R&D)which will provide the company with access to selected targets from one of the broadest pipelines of chemokine-based therapeutics in the biotech industry.

Under the terms of the agreement, GSK will have the right to discover, develop and market the company's novel medicines, targeting four chemokine and chemo-attractant receptors for treating a variety of inflammatory disorders, including Traficet-EN, which is in late-stage development for inflammatory bowel disease (pharmaceutical).

Financial details that were disclosed showed that the licensing deal was worth up to $1.5bn in milestone payments to ChemoCentryx, which will receive an upfront payment of $63.5m, in both cash and equity.

"The ChemoCentryx alliance is a landmark relationship for the CEEDD (pharmaceutical outsourcing). This collaboration clearly demonstrates GSK's commitment to gain access to leading-edge, best-anywhere science and we are excited by the opportunity to work with ChemoCentryx and its world class team," said Maxine Gowan, head of GSK's centre of excellence.

"Accessing its expertise and four advanced chemokine programmes, including Traficet-EN, will allow us to bring novel medicines to patients with high unmet need."

The deal closely follows the $83m deal struck with US pharma company, Pharmacopeia, earlier this year, continuing GSK's links to biotech companies. Antitumor medicine

GSK has previously stated that it wants to make the most of new approaches in targeting diseases by setting up long-term agreements with smaller pharma and biotech companies, which have proven very successful in developing innovative medicines using novel molecules in recent years. Construction pharmaceutical directories

"This important alliance with GSK will provide us with access to significant capital in the near and long term to support the ongoing development in each of these programmes, as well as the ability to continue to discover and bring forward multiple new compounds targeting the chemokine system," said Thomas Schall, chief executive of ChemoCentryx.

GSK's strategy (pharmacutical clinical contract research projects) has resulted in the formation of the CEEDD to create small, independent and accountable R&D teams and the company says it is "virtualising" a portion of its pipeline.

The trend for outsourcing has become more widely accepted by companies

The survey, which looked at 449 responding companies make up a total global R&D investment of almost €30bn - a significant share of European business investment in R&D. The findings revealed that companies expected their global investments in R&D to grow by around 5 per cent p.a. for the next three years. http://crolegacy.com/how-to-buplish-contract-research-projects

These expectations reflect the dominance in the sample of the companies in pharmaceuticals & biotechnology and chemicals, which together accounted for almost 60 per cent of the total R&D investment of all companies in the sample.

A survey has revealed that the pharmaceutical and biotech industry are currently dominating the outsourcing scene in Europe, accounting for a quarter of all sub-contracting activity within the EU. Nano-technology industry risks and benefits

Changes in market demand for new products and services coupled with changes in technological opportunities have moulded Pharmaceutical Contract Research the outsourcing landscape to include services such as chemistry, biology, screening and lead optimisation.

The trend for outsourcing has become more widely accepted by companies, both large and small, needing to supplement their own internal drug discovery efforts and/or utilise technologies they can't afford to do in-house. clinical research institute in india

The survey also confirmed the view that companies continue to prefer to locate R&D in their home country.

Therefore, the top locations for R&D activity in Europe continue to be Germany, the United Kingdom and France. Outside the EU, the US remained by far the most attractive place for locating R&D activity, followed by China and India. Respiratory medicine

The survey also detailed the most important factors when deciding where to locate R&D were market access, high availability of researchers, access to specialised R&D knowledge and results.

Macroeconomic and political stability as well as R&D cooperation opportunities were also mentioned. The labour costs of researchers seemed to be less significant.

The results seem to go against the current thinking, which suggests that advances in the Asian market, where drug discovery services cost only a fraction of what they do in the West could reduce the huge burden of drug discovery and development.

outsourcing has become a necessary means of doing business and shows no sign of slowing

Outsourcing drug discovery services, including chemistry, biology, screening and lead-optimisation are all a part of doing business in today's pharma industry, as the trend for outsourcing becomes more widely accepted by companies, both large and small, needing to supplement their own internal drug discovery efforts and/or utilise technologies they can't afford to do in-house. Bio-pharmaceutical companies refuse to a salesman who cheapens

The growth is also being fuelled in part by impressive advances in the Asian market, where drug discovery services cost only a fraction of what they do in the West - a very attractive prospect for many pharma companies who are seeking outside assistance for traditional in-house services in order to reduce the huge BioScreening.com - Services for Drug Discovery burden of drug discovery and development, which is increasing by nearly 50 per cent every five to seven years.

The rapidly growing market for drug discovery outsourcing services will increase 15 per cent to reach $7bn (€5.5bn) by 2009, fuelled by the advancing Asian market, according to a new study by Kalorama Information, publishing division of MarketResearch.com.

Upon discovering the benefits of outsourcing in Asia, many of the top pharma and contract research organizations (CROs) have opened their own operations there, leading also to improvements in quality of infrastructure and services. http://crolegacy.com/speed-up

"The upgraded quality of CROs and pharma firms in India, China and Eastern Europe makes outsourcing a cost-effective and timely business decision which can translate into drugs coming to market faster and revenues increasing," said Jack Gardner, the report's author.

However, concerns of IP protection, trust, honesty, and transparency, particularly in Asia, still remain large obstacles in the global drug discovery outsourcing marketplace, said the report, titled Outsourcing in Drug Discovery, 2nd Edition. dongmei

India also now adheres to the TRIPS agreement and has enacted the Patent Protection Act in 2005 to protect intellectual property. But at this stage, no one knows how long it will take for the benefits of the new law to take effect and many multinational companies were not completely satisfied with the scope of the law and are continuing to work with the government to address ongoing concerns.

"Despite any of the risks, outsourcing has become a necessary means of doing business and shows no sign of slowing," said Gardner.

Although China has strengthened its commitment to intellectual property by agreeing to adhere to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement as part of its entry into the World Trade Organization (WTO), many drug companies are still weary of how much this adherence will protect them. Respiratory medicine

In particular, a new "one drug, one patent" policy interpretation means that in China patent protection will only apply to the original use of a drug, as stated in the patent. This will be of great disadvantage to multinational companies, which increasingly seek to develop and market new uses for their existing drugs.

More than 70 per cent of pharma executives said that threats to intellectual property pose a business risk in China, with 62 per cent considering patent protection in India an issue, a recent survey by Ernst & Young revealed.

Dalton's analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients

The deal aims to strengthen Dalton's offerings within the outsourcing sector, which already includes cGMP manufacturing and sterile filling services to clients at Phase I, II or III of the regulatory process. Dental Surgical Instrument

The formation of Dalton Medicinal Chemistry Partners is the result of a joint venture with Dr. Judd Berman, a scientist who has held positions at Merrell Dow, Glaxo, GlaxoWellcome, GSK and most recently Affinium Pharmaceuticals. http://crolegacy.com/vitamin-a-d-and-e-pharmacutical-contract-research-projects.html

Dalton Pharma Services has introduced a range of new medicinal chemistry services that are available to companies involved in drug discovery that wish to utilise additional scientific and managerial expertise as well as specialised equipment.Antiparasite medicine

"Judd's broad experience and abilities in drug discovery using medicinal chemistry, as well as his track record in identification and optimisation of high quality lead compounds, combined with Dalton's 20 year history of success in drug development, creates a powerful combination," said Peter Pekos, President and CEO of Dalton Pharma Services.

"Taking full advantage of our state of the art facilities, this new venture makes significant additional scientific and managerial expertise available to our clients and augments Dalton's ability to identify and deliver promising small molecules quickly for our partners' programs," added Pekos.

ON-DEMAND WEBINAR 2009 global anti-cancer cost of up to 305 billion U.S. dollars
Increase your webinar performance with expert tips and advice
Get expert advice and tips from the online marketing solutions team at Decision News Media. After you attend this free web seminar, you will know how to create compelling webinar content, how to sharpen your presentation skills and how to promote your webinars effectively... Click here

Dalton can also carry out sterile fills to produce batches of finished drug product in vials or syringes, either aseptically filled or terminally sterilised, under fully validated conditions.

In addition, Dalton's analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients.CRO Pharmaceutical Contract Research Outsourcing blog

Dalton Pharma Services is a contract pharmaceutical manufacturer that supplies chemistry and analytical services to the biotechnology and pharmaceutical industries in the areas of medicinal chemistry, fine chemical manufacture, custom peptides and antisense oligo production.

Dalton's services include producing active pharmaceutical ingredients (API), at the gram or kilogram scale.

Tripos has launched new software that allows scientists to access

"Instead of wasting valuable time formulating complicated queries or being forced to become Microsoft Excel experts, project teams using Benchware Discovery 360 can now quickly find, analyse and act on the research data they need, no matter where it exists inside their company."

CRO Pharmaceutical Contract Research
The Benchware Discovery 360 enables discovery scientists to access and analyse enterprise wide chemical and biological research data from within a single integrated desktop discovery environment. "Obama medical" cause the United States, "Medicare civil war"

Tripos has launched new software that allows scientists to access and analyse chemical and biological data from a single integrated desktop discovery environment

"Many of today's discovery Hematopoietic system data warehouse solutions require chemists and biologists to become information technology specialists instead of more informed and agile discovery scientists," said Bryan Koontz, senior vice president and general manager of Discovery Informatics for Tripos.

The software becomes the newest member of the Benchware family of applications designed for laboratory scientists, including discovery chemists and biologists.

It is built on Tripos' original SMART-IDEA informatics system that was built in collaboration with Bristol-Myers Squibb. http://crolegacy.com/influence-of-obesity-on-surgical-regional-anesthesia-in-the-ambulatory-setting-an-analysis-of-9038-blocks.html

Tripos said that these capabilities would enable life science organisations to gain better insight into their drug discovery projects, improve scientific collaboration, and allow discovery teams to fully realise the value in the data they are generating. Construction pharmac

The Bristol-Myers Squibb implementation is currently deployed to users throughout the US and Canada allowing scientists and team leaders to access and analyse essential project information on demand.

CNS disorders represent more than 15 per cent of the global cost of disease

The deal sees scientists from both parties pooling their knowledge to identify potent, oral compounds that selectively modulate the specified G-Protein coupled receptor for the target CNS disease. Obama's health reform program into more and more extreme astray opposition

To illustrate just how important GPCR-based drugs are, 12 of the top 20 selling drugs, including Coreg for congestive heart failure, Cozaar for high blood pressure, Zoladex for breast cancer, Buspar for anxiety and Clozaril for schizophrenia, as well as Zantac and Claritin, use this mechanism of action. Together the drug class accounts for $200bn (€159bn) in annual sales.

Drug giant Eli Lilly has joined forces with Suven Life Sciences in a deal that will focus on pre-clinical research of molecules in the therapeutic area of central nervous system (CNS) disorders. http://crolegacy.com/the-effect-of-age-on-sciatic-nerve-block-duration.html

No details were disclosed as to the types of CNS disorders that were being targeted but Suven have a history of R&D in such ailments as Alzheimer's disease, schizophrenia, depression, vascular dementia and Parkinson's disease.

Details that were disclosed include the agreement that Suven will receive milestone payments from Lilly and potentially downstream payments if the identified candidates are selected by Lilly for further pre-clinical research and development.

"This is our first true research collaboration with a global pharmaceutical company thereby helping us realise the next step of our strategic vision," said Venkat Jasti, vice chairman and chief executive officer of Suven.

Suven is no stranger to the market for CNS therapies - currently the second largest therapeutic category worldwide and is one of the fastest growing. CRO Pharmaceutical Contract Research Outsourcing blog

Suven recently presented preclinical data of their 5-HT 6 antagonist compounds being developed for the treatment of Mild Cognitive impairment (MCI) associated with Alzheimer's disease or Schizophrenia, Parkinson and Obesity diseases.

Some of the fastest growing segments are: sleep disorders (+14.8 per cent), attention deficit hyperactivity disorder (+10.8 per cent), Alzheimer's disease (+10.7 per cent) and antipsychotics (+10.2 per cent). All figures are year-on-year.

CNS disorders represent more than 15 per cent of the global cost of disease. For example, costs of over $100bn per annum make Alzheimer's the third most expensive disease in the USA.

Early results suggested that its 5HT 6 antagonists would provide a novel, safe and effective approach of treating these diseases. Synta Pharmaceuticals Corp

According to market research firm Espicom, within the CNS market the largest segments by sales are: antidepressants (23 per cent market share), antipsychotics (22.6 per cent) and anti-epileptics (16.8 per cent).

The choice to use Evotec represents another shift in the formation of alliances as organisations are favouring a biotech approach to finding therapies

The choice to use Evotec represents another shift in the formation of alliances as organisations are favouring a biotech approach to finding therapies. Colombian President Alvaro Uribe infected with influenza A H1N1 influenza virus

In the pharmaceutical industry, small biotech companies are expected to dominate the research agenda over big-pharma, by focusing on ever-tighter niche markets, as well as by discovering disease-oriented drugs based on specific genetic markers. http://crolegacy.com/support

Evotec and CHDI have formed a strategic partnership, which aims to research and develop treatments for Huntington Disease (HD), a genetic disorder that causes programmed degeneration of brain cells and loss of intellectual faculties.

Since March 2006, Evotec and CHDI have signed four agreements covering medicinal chemistry, assay development and medium-throughput screening (MTS), ultra-high-throughput screening (uHTS) and library synthesis and management services.

"As collaborative enablers, CHDI depends on a network of academic and industrial partners to conduct its research efforts," said Robert Pacifici, chief scientific adviser to CHDI.

"We believe we have found the ideal partner in our search for novel treatments that may slow or prevent Huntington Disease," he added.

HD is a familial disease, passed from parent to child through a mutation in a gene. Genetic studies have shown that each child of an HD parent has a 50-50 chance of inheriting the HD gene.

Most people with HD develop the symptoms at midlife but in some people onset occurs in infancy or old age. The average survival time after onset is approximately fifteen to twenty years.

It is estimated that about one in every 10,000 persons has the HD gene. At this time, there is no way to stop or reverse the course of HD. Analgesic medicine CRO project

Under the terms of the agreement, Evotec will apply its biological science know how to develop high content screening assays for use against high priority biological targets thought to be of importance to treating Huntington Disease provided by CHDI and the High Q Foundation.

Evotec will apply its own medicinal chemistry and parallel synthesis skills to synthesise libraries of novel small molecule compounds

Evotec will also use its proprietary platform to screen these compounds and its own library to identify compounds with biological activity.

"We are delighted that CHDI, an organisation dedicated to Huntington Disease research, has chosen us as their partner for drug discovery," said Mark Ashton, executive vice president business development services at Evotec Antiparasite medicine

"We are ideally positioned to add significant value to their programmes up to clinical development and beyond." Clinical Trials Australia

Using Evotec's medicinal chemistry, profiling and ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) facilities active compounds will be further characterised, eventually generating lead molecules for further progression into clinical trials. Financial terms of the deal were not dicussed.

We want other CROs and life-science companies to know the CTP is an attractive destination to grow their business

The new pathology facility will provide biopharmaceutical product and process services and is situated within the 56-acre technology research park, currently home to 30 early- and mid-stage technology-driven companies. Why has the U.S. medical reform so difficult?

It fosters the belief that outsourcing within the industry is on the up as it meets a large, unmet need that demands improved R&D productivity, in the face of declining New Chemical Entity (NCE) introduction and increasing R&D expenses. PDR Partners

Charles River Laboratories becomes the ninth contract research organisation (CRO) to open up a new pathology facility within the Chicago Technology Park (CTP), reinforcing the emerging outsourcing trend in pharmaceutical discovery and development.

Charles River, a company that supplies research models and laboratory animal support services, preclinical services, and clinical services to the biomedical market, has been at the forefront of this upsurge.

The company recently announced the expansion of its California research models production site. Anti-infective medicine CRO project

The expansion is expected to double existing production capacity and provide a dedicated barrier room for Preconditioning Services, which include feed and aging studies as well as model characterisation.

The Chicago Technology Park is a 56-acre research park that fosters the commercialisation of innovative technologies through state-of-the-art facilities and critical support services.

CRO Pharmaceutical Contract Research Outsourcing blog
The CTP is administered by the Illinois Medical District in partnership with the University Of Illinois and Rush University Medical Center. The CTP Research Center was one of the first biotechnology incubators in the US and is still one of the largest.

Speaking about this latest venture Samuel Pruett, CTP executive director commented: "Charles River's decision to locate one of its research facilities to the CTP is a testament to our resources, facilities and people."

"We want other CROs and life-science companies to know the CTP is an attractive destination to grow their business." http://crolegacy.com/contact-us

Pharmaceutical companies are spending big on market research during the early stages of drug discovery

Regardless of whether they are promoting a future blockbuster drug or a small, niche brand, all drug companies tend to spend heavily on market research in early drug development up until Phase II, according to a recent study published by pharmaceutical business intelligence firm Cutting Edge Information.

This is because in the early stages of a drug's development, it is difficult to assess whether the majority of marketing resources should be allocated until a drug's benefits become clearer and a clinical profile is established. Chennai Laboratories">Chennai Laboratories

Pharmaceutical companies are spending big on market research during the early stages of drug discovery. Biocompatibility of the Advisory

Therefore, a brand team relies heavily on market research during the early stages to identify unmet treatment needs and outline the drug's competitive environment in order to spot potential problem areas that could affect commercial development in the years ahead.

This allows any potential challenges to be tackled by the drug company as early as possible and also allows them to guide the R&D process more effectively towards desired clinical endpoints.

American public health reform Obama-style dissatisfaction rate has risen to 52%
"The project team members we interviewed report that it's nearly impossible, especially in early phase development, to recognise and address key commercial challenges without market research," said Jon Hess, project team leader at Cutting Edge Information. Antibiotic medicine

Between pre-clinical and phase II, niche brand teams allocated 53 per cent of their total commercialisation budget to market research, while mid level brands spent 42 per cent and blockbusters only spent 38.5 per cent, according to the report "Pharmaceutical Product Commercialization: Pre-Clinical to Phase III Resource Allocation".

Because of this, niche and mid-level brands allocate higher percentages of their total commercialisation budget to market research in comparison to blockbusters, as they tend to have fewer overall resources to play around with.

http://crolegacy.com/ceftizoxime-sodium-for-injection-pharmaceutical-outsourcing-project-find-cro-contract-research-organization.html
Blockbusters, while still spending as heavily on market research, will usually also spread their resources out and spend more on other categories in early development as well, such as advertising or awareness campaigns, and establishing a connection with the medical community, in order to address potential problem areas.

The Laboratory Primate Advocacy Group has used these figures to estimate that 23-25m animals are used in research each year in America

The use of live animals in laboratories for the testing of drugs has become normal practice for outsourcing firms that are involved in managing clinical trials. However, Covance's stance on their use has attracted condemnation from animal rights organisations concerned with how the animals are treated. Covance's purchase of a 38-acre site in Chandler, Arizona, is with the specific intention of building a 600,000-square-foot medical research and animal-testing campus that will employ up to 1,200 people. Blood medicine CRO project

Since those plans were made public last year, Covance has had to deal with a storm of protest from organisations such as the Physicians Committee for Responsible Medicine and Citizens Against Covance based in Chandler. http://crolegacy.com/pharmaceutical-references-contract-research-organizations

On July 14 of this year, Covance filed a rezoning request with Chandler, a move that will start a lengthy public process that has pushed the firm into the media spotlight and fan the flames of a very emotive issue.

Just last week, Covance received official backing from the Chandler Chamber of Commerce.

This was less than a week after a city planner requested more information about the companies planned "pathological waste thermal destruction unit:" an incinerator that could be used for animal carcasses.

Barack Obama ridiculed the Congress to promote medical reform has been severely reprimanded highlight the differences
Protestors, which also include the People for the Ethical Treatment of Animals (PETA), an international animal rights group, have vehemently objected to these incinerator plans.

They have objected to the potential for these animals to carry diseases and to the possibility that Covance would build an incinerator to dispose of animal carcasses.

Covance has hit back, saying that animal testing is part of developing drugs to cure diseases and that the company treats animals humanely.

Covance, the world's largest provider of drug-development services, is bracing itself for the onslaught of protests by animal rights activists who are demonstrating against the building of a $100m (€78.6) laboratory in the US.

They deny that there would be health risks posed by laboratory animals.

This has not been the first time the parties have crossed paths. In October 2005 Covance settled a lawsuit against PETA, in which PETA agreed to a ban on conducting any infiltration of Covance for five years. disease-resistant poison

In addition, PETA operative, Lisa Leitten, accepted a three-year ban on infiltrating any commercial animal research facility worldwide. PETA and Leitten also agreed to provide all video footage and written notes taken from Covance.

According to the US Department of Agriculture, the total number of animals used in that country in 2002 was 1,137,718, not counting birds, mice, and rats, which make up around 85 per cent of research animals.

Other sources estimate the percentage of all lab animals that are rats, mice, or birds at 85-90 per cent, or 95 per cent. Tgbaynes

The Laboratory Primate Advocacy Group has used these figures to estimate that 23-25m animals are used in research each year in America.

At the time James Lovett, senior vice president and general counsel at Covance, said: "This resolution achieves our key goals of the lawsuit: to obtain a ban on infiltration and to demonstrate that Covance will not tolerate such unlawful acts by those who seek to block important biomedical research." CRO Pharmaceutical Contract Research Outsourcing blog "Our business is devoted to helping develop new medicines for diseases such as breast cancer, diabetes, leukaemia, Alzheimer's, heart disease and HIV/AIDS. The research we perform is essential to ensuring that these medicines are safe and effective before they are made available to patients."