march 08 update

A high-profile biomedicine research institute is under construction in Tianjin, and several projects are expected to be developed there. Most of the construction work will be completed by the end of this year in the rising North China economic power-house.

Developed at a cost of 1 billion yuan (US$140 million), the Tianjin International Biomedicine Research Institute has already recruited two deputy directors to manage the operation. The two are from multinational pharmaceutical companies and have been tasked with bringing the very latest biomedical technologies and projects to Tianjin.

The institution is designed to research and convert biotechnology into usable drugs and, more importantly, integrate biomedicine resources within the coastal city of Tianjin.

The research center will differentiate itself from Beijing's Zhongguancun and Daxing institutes by focusing on the commercialization of biomedical research.

Rao Zihe, president of Nankai University in Tianjin and director of the research institute, said the top priority for the lab is to commercialize biomedical technologies.

Although the main focus for projects has yet to be decided, research into cancer treatments and the development of stem cell bio-drugs are two promising options

Members of the research institute will also seek to broaden the scope of existing research, he said.

Nycomed Gets Raw Material from India

Mid-sized European pharma company Nycomed has struck a deal to offshore the vast majority of its raw materials sourcing to India, in a move which could affect around 200 jobs.

An existing agreement between Nycomed and Cadila Healthcare is to be amended, moving the responsibility for chemical production of active pharmaceutical ingredients (APIs) to the joint venture company Zydus Nycomed in India.

The two European production facilities affected by the deal are located in Singen (Germany) and Linz (Austria), which employ a combined total of 1,390 people.

In January Nycomed announced its intention to find a partner to help relocate its API production as the pharmaceutical industry shifts towards countries with lower production costs.

The global contract manufacturing market is forecast to reach a value of $26bn by 2011.

Production costs in India are widely believed to be 30-40 per cent lower than in developed markets and the companies also have the skills and experience gained through over a decade of API production and establishing scale manufacturing operations.

GlaxoSmithkline Cuts Production in Cumbria

GlaxoSmithKline (GSK) announced it would be cutting production at its plant in Ulverston, Cumbria, resulting in a reduction in the workforce from 540 to 210 over the next two years.

The move is part of GSKs attempt to achieve savings of $1bn by 2010, a cut of 40 per cent, which CEO Dr JP Garnier says will be achieved through, "standardization, consolidation, outsourcing and offshoring".

AstraZeneca has Established a TB Research Institute in Bangalore

AstraZeneca has established a tuberculosis research institute in Bangalore, India and increasing numbers of company's are looking at the savings of conducting clinical trials abroad, which can be as significant as 60 percent.

Teva Expands in Hungary and India

Israeli generics maker Teva will spend $100m to double its manufacturing capacity in Hungary, as the pharma global spread continues.

The money will be used to extend the capacity of a tableting plant that the company runs in Debrecen, eastern Hungary, after the government granted it a $12m incentive.
The expansion will create 415 new jobs after its planned completion in 2010, at which point the factory's output will grow to 15bn tablets per year.

Hungary, where manufacturing cost base is relatively low, is the centre of Teva's European operations. The firm runs three manufacturing facilities there and sits in the top five pharmaceutical companies that are active in the country, where it has invested $630m in its operations since 1995.

At its Hungarian sites Teva makes active pharmaceutical ingredients (API) and finished dosages in forms including tablets, capsules, injections, infusions, ophthalmics, soft gelatin capsules and ointments.

However, Hungary is not the only region that the world's generics titan has an eye on - in January Teva said it has earmarked over $1bn to fuel an ambitious plan to broaden its presence in India.

Over the next two years the firm is intending to use $250 million to $300million to build new generic ingredients manufacturing facilities in the country.

The first of these planned constructions is imminent, with company preparing to build a large API manufacturing facility on over 100 acres of land near Gwalior, Madhya Pradesh. Production capacity will be in line with Teva's large Indian competitors.

Meanwhile, the remainder of the money will be used by Teva to fund the hopeful takeover of some Indian pharma businesses.

Teva already has a presence in India through its Indian subsidiary, Teva India, in addition to a two year old R&D centre in New Delhi, however, the company is intent on broadening its activities in the country.

Those in the business of generics market find India's low cost base a particular beacon, as margins in the industry become tighter and tighter and rock bottom production costs are key to remaining competitive.

Meanwhile, in January Teva also made a significant investment in the biopharmaceuticals arena, buying up Human Genome Sciences' biotech spin-off, CoGenesys, for $400m to get its hands on the firm's broad-based biotech platform and innovative pipeline, with the aim of becoming a leading player in the biogenerics market.

Rensselaer Polytechnic Institute Expands and Upgrades

Troy, New York. There will also be a new initiative beginning in the fall to replace, expand and upgrade the existing Jonsson-Rowland Science Center. The new expansion and upgrades will include a new laboratory and wetland facility for biology and physics, and provide space for new labs for undergraduate and graduate research. The existing building will be renovated for office, academic, teaching and conference use, and will incorporate deferred maintenance. Although an exact budget has not be calculated, Jackson expected around a $75 million cost for total construction.

SAFC Builds Bio-CMO Capacity

In May 2007, Sigma Aldrich Fine Chemicals (SAFC) acquired Molecular Medicine BioServices, Inc. (MMB), a Carlsbad, CA-based bio-CMO with a focus on vaccines and gene therapy products. Earlier this year, SAFC announced a $12 million expansion of that site, adding 8,000 sq. ft. of manufacturing space and providing 100 L batch production in stirred tank bioreactors and 1,000 L batch manufacturing in disposable bioreactors.

Pharmaceutics International has Expansion, an Acquisition and New Partnership

The US-based contract manufacturer has recently opened a new 30,000 sq. ft development, aseptic filling, and good manufacturing practice (cGMP) production plant near Baltimore, Maryland in the U.S.

The company specializes in the formulation development and manufacturing of solid and semi-solid dosage forms of both clinical trial and commercial drug products. The expansion, which was 18 months in the planning phase, now allows the firm to fulfil its customer demands for the aseptic filling of vials. Further investments were being planned by the company.

Initially the aseptic filling line will fill containment and high potency small molecules for clinical trials and the commercial supply of niche products. The firm also has a lyophilised product manufacturing capability on site.

In addition, the company's existing development work has been moved to a dedicated space in the new building, where there are multiple manufacturing and containment suites to support development projects for products before they are moved on to the manufacturing phase.

In addition to the new site, Pharmaceutics International already has two facilities in the US and one in the UK. The UK site was gained through an acquisition made in January of preformulation and formulation development services firm Pharmaterials for an undisclosed amount.

The purchase was made to extend the development capabilities and service offerings of Pharmaceutics International's business, adding prefomulation, polymorphism, salt screening and co-crystal services to the company's repertoire.

Meanwhile, the company has also just formed a new partnership with another UK firm Bio-Images Research, which develops imaging technology for clinical trials that allows researchers to see how effective treatments are to specific areas of the body.

Through the alliance, Bio-Images Research will be able to bring its technology to the North America market.

St. Louis Community College Expands and Renovates Science Labs

Some 6,700 students annually will benefit from renovations to science laboratories at three St. Louis Community College campuses as a result of funds received through the Lewis and Clark Discovery Initiative (LCDI).

LCDI is a partnership between the state of Missouri and the Missouri Higher Education Loan Authority (MOHELA), authorized through legislation and lawmaker support. It reinvests a state asset to generate more than $350 million for capital improvement projects at Missouri higher education institutions.

St. Louis Community College has received approximately $4.05 million through the LCDI, and will use the funds to enhance, modernize and standardize selected biology and chemistry labs at the Florissant Valley, Forest Park and Meramec campuses. The college is providing matching funds to support the $5 million project. Construction is slated to begin simultaneously in April and will be completed in mid-September.

"The labs selected for renovation serve thousands of students annually who enroll in the science courses that are the foundation of our transfer education program as well as our innovative science, biotechnology, engineering, technology and allied health programs," said Zelema Harris, STLCC chancellor. "The Lewis and Clark Discovery Initiative is a positive investment in higher education throughout the state and in the future of the St. Louis region."

The project involves renovation of 15 science labs and 12 lab support spaces. These labs have not had extensive renovations since the campuses were constructed in the 1960s. Renovations will include new finishes for walls, floors and ceilings in the labs; new casework, counters and storage cabinets; whiteboards, projects screens and audio/visual additions. All associated mechanical, plumbing and electrical updates will be addressed, including new fume hoods, sinks, gas and electrical outlets.

Christner Inc. will serve as the architectural consultant for the project. S.M. Wilson will serve as the construction management consultant.

Established in 1962, St. Louis Community College is the largest community college district in Missouri and one of the largest in the United States. STLCC has four campuses - Florissant Valley, Forest Park, Meramec and Wildwood - that annually serve more than 120,000 students through credit, non-credit and continuing education courses.

Arch Pharmalab Opens Plants

India's Arch Pharmalabs has opened its expanded operations at its Gurgaon site, which are now ready for production.

The new facilities entail four manufacturing plants, with enhanced utilities and effluent treatment amenities, in addition to a new pilot plant that will address the company's contract manufacturing ambitions, producing compounds for both preclinical and clinical requirements of pharma firms.

The facility will be dedicated to the manufacture of active pharmaceutical ingredients (APIs). In particular, the site will focus on APIs for cardiovascular and immunologic indications.

Azopharma Opens New Facility in Florida

Azopharma Product Development Group, Inc. announced the opening of a new facility in South Florida. The new 22,000 sq. ft. facility is home to Azopharma's formulation development services, small-scale manufacturing, development services and specialized analytical services. The expanded facility allows for small scale manufacturing from 30 Kg to 50 Kg. The new facility also houses Azopharma's new drug delivery company, ApiCross Drug Delivery Technologies which was launched at the 2007 AAPS Meeting & Exposition.

Portugal's Hovione Invest Further in China

The contract manufacturer has purchased 75 percent of Hisyn Pharmaceutical for a price of $20m and the new joint venture is already approved and operational.

Along with 180 staff, it includes development laboratories in Shanghai and an active pharmaceutical ingredient (API) plant in nearby in Zheijiang.

Prior to the purchase Hisyn has been supplying Hovione with intermediates, but this factory will now instead be used to produce Hovione's two largest volume products.

Hovione has been active in China for 20 years, and has a plant in Macau from which it has been processing raw materials bought in the country, as well as in its facility in Portugal.

The firm is planning to invest further over the course of this year to effectively double Hisyn's current manufacturing capacity.

Hovione offers custom synthesis of APIs and regulated intermediates for oral, topical, inhalation and injectable grades, including sterile bulk.

The Portuguese pharmaceutical market is the tenth largest in the EU-15, valued at $5.3bn at retail prices in 2006. Market growth has decreased to around 5 per cent, with the government keen to contain reimbursement and increase generic consumption.

The country's manufacturers have a lot of catching up to do since Portuguese pharmaceutical production was estimated at €1.56bn in 2003, only one per cent of the total combined production from the EU-15 and Switzerland.

University of Queensland Expands School of Pharmacy

The $120 million first stage of a new UQ centre will ease a chronic shortage of pharmacists and help to improve health care nationally and globally.

Queensland Premier Anna Bligh inspected the 1.7ha site of the Pharmacy Australia Centre of Excellence (PACE) on March 7, saying Queensland was about to realise a plan to lead the nation in bringing pharmacy education, research and industry together in one location.

"The University of Queensland will be the first cab off the rank with the relocation of its internationally-recognised School of Pharmacy to the precinct and a ramping up of its research into the Quality Use of Medicines," she said.

A first for the Asia-Pacific, PACE will combine Australia's leading pharmacy educators and researchers with key pharmacy professional organizations and commercial research and development groups.

UQ's Deputy Vice-Chancellor (International and Development), Professor Trevor Grigg, said the Queensland Government made PACE possible by donating the land - which adjoins the Princess Alexandra Hospital in Brisbane in 2001. Construction follows an agreement between UQ and Alba Capital Partners.

“The location has risen in strategic importance since the Government donated the land. It is now part of what will become a concentrated health and pharmaceutical version of Silicon Valley.

“PACE will be a stone's throw from the planned Translational Research Institute, which will house UQ's Diamantina Institute for Cancer, Immunology and Metabolic Medicine and scientists from the Mater Medical Research Institute, Queensland University of Technology and the Princess Alexandra Hospital,” Professor Grigg said.

UQ’s School of Pharmacy will move into Stage One, which is scheduled for completion in 2010. In anticipation of PACE's extra capacity, UQ has increased new pharmacy student enrolments from 185 in 2006 to 246 in 2008. Numbers will continue growing in order to ease a widespread shortage of pharmacists that is estimated to reach 3000 nationally in 2010.

PACE will complement and enhance UQ's established strengths in biotechnology, nanotechnology and molecular bioscience.

The researchers attracted to it will include top Australian and international postgraduate students who want to develop new and improved pharmaceuticals as well as better results for consumers.

Stage one will cover 10,155 square meters (109,267 sq. ft.) including lab space, a 360 seat lecture theatre, other teaching facilities, offices, and basement parking.

Subsequent stages are envisaged to include up to 30,000 square meters (322,800 sq. ft.) to accommodate entities involved in health and pharmaceutical research and development and services.

Other confirmed PACE partners and future tenants include The Pharmaceutical Society of Australia, the Society of Hospital Pharmacists of Australia and the Australian Institute of Pharmacy Management.

McMaster University in Canada Has Plans for Science Park

McMaster plans to transform vacant brownfields and warehouses into a premiere research park, building on the University’s existing reputation as a research centre of excellence.

The McMaster Innovation Park will house laboratory, office, teaching, training, and conference facilities, in support of research and development in a number of key industrial areas: advanced manufacturing and materials, nanotechnology, biotechnology, and other areas in which McMaster University has recognized research strengths.

These facilities will accelerate the commercialization of research into new and marketable products and services, and create new companies that will provide high-paying, highly skilled jobs in Hamilton.

Biotage and McMaster University have agreed to extend their molecular imaging development agreement for another two years. The next research phase will expand microwave synthesis to a broader range of radionuclides and probes used in PET imaging and as therapeutic agents.

McMaster University researchers successfully completed the first year of the research agreement using the Biotage Initiator^™ microwave synthesis system to prepare a range of carborane cage structures labeled with rhenium and technetium (Tc99c). They reported an 85 percent reduction in synthesis time and 26 percent gain in decay-corrected yield when compared to the traditional synthesis methods.

As a result of its previous success, McMaster University has created the Biotage Molecular Imaging demonstration laboratory, which will offer other researchers the opportunity to see the technology working in a real radiochemistry environment and have first-hand experience with the tools that Biotage offers.

Adnavance Technologies Opens Lab in San Diego, CA

Adnavance Technologies has opened a 2,400 sq. ft. laboratory in San Diego. The space will be used for R&D of its M-DNA^™ (metalized-DNA) platform on which the company is developing molecular diagnostics.

Adnavance believes that the M-DNA technology could eliminate the need for target and/or signal amplification that standard molecular diagnostics require. The platform is based on the conducting properties of hybridized DNA. Under strict reaction conditions, certain metal ions can enter the central core of hybridized DNA and displace the hydrogen bonds. This forms the equivalent of a metal wire in the center of the DNA, making it highly conductive.

Adnavance uses a microarray of 10-micron electrodes to detect the M-DNA through the differential change in conductivity between hybridized and metalized DNA. This change in conductivity is so large that it may obviate the need for target amplification used in current molecular-based tests, the firm explains.

The company is initially developing molecular diagnostic tests using M-DNA™ for the U.S. market. It believes its technology will open the market to approximately 30,000 new customers who are not licensed to perform molecular diagnostic tests.

Due to cost involved with target-amplification devices, Adnavance says that only about 10 percent of hospital laboratories and 35 percent of independent laboratories in the U.S. perform molecular diagnostic testing. The M-DNA technology will offer advantages over existing DNA testing methods, including ease of use, time to result, and lower cost, according to the company.

“Our medical device platform is being engineered and developed at the Vancouver, BC, facility, while the DNA chemistry to run on that platform will be developed in San Diego,” says Randy White, CEO.

Under the three-year lease, Adnavance can at any time during this period exercise a no-penalty option to expand by 50 percent into another suitable facility managed by Asset Management Group

Metrics Doubles Lab Space

Labs are part of $18 million expansion that will double Metrics' physical footprint in 2008. Metrics Inc. has opened its newest analytical lab space, nearly doubling its service capabilities to clients.

Metrics' four new analytical labs, which came on line last week, boost Metrics' capacity for service by 40 percent. The labs will be fully operational, validated and ready to handle projects by second quarter 2008.

In addition to including four new analytical labs, the addition to Metrics' existing 44,000-square-foot pharmaceutical development laboratories includes larger scale manufacturing (Phase III to commercial), stability storage, a dedicated laboratory for cytotoxic and potent compounds, and a microbiology laboratory.

The new lab space is part of an $18-million, 47,000-square-foot facility addition at Metrics that will allow clients to keep development and commercial manufacturing projects under the same roof.

University-based Technology Park Growing

A University-based information technology park, deemed the first of its kind in Metro Manila, is fast rising on an idle property of the University of the Philippines in Diliman, Quezon City.

The P6-billion UP North Science & Technology Park is now drawing attention because of not only the brisk pace of its construction but its myriad potential benefits for the academe and the IT industry.

When it starts operations at the end of 2009, the park is expected to become the hub of IT and BPO (business process outsourcing) multinational companies.

The prospective locators include HSBC, IBM, Convergys, Manulife and Pointwest Technologies Corp., among other outsourcing and software development firms, said Prof. Ruperto Alonzo, UP vice president for development, who is in charge of the project.

Ayala Land Inc. (ALI) is developing the IT park on a 37.5-hectare site on Commonwealth Avenue near the corner of Elliptical Road under a 25-year lease agreement with UP.

The partnership is also the first of its kind.

The site is part of the sprawling 98.5-hectare UP property on that busy thoroughfare, which includes the lush 12-hectare Arboretum that will be left untouched by the project.

The IT park is one of the university's centennial projects under UP president Emerlinda Roman.

Apart from saving the idle property from the creeping intrusion of informal settlers and generating more income for UP's academic programs, the park is seen to boost the premier state university's goal of becoming the center of education, research and training excellence.

And the UP administration is projected to earn some P4.236 billion at the end of the lease agreement.

Chief among the expected benefits are the industry-academe collaboration in research and development, employment, and, in the long run, further development of the IT industry.

And that's on top of the business opportunities that the park will create for the city and the IT industry, Alonzo said, pointing out that the mere presence of the multinational firms would "attract more innovation from IT service providers."

HSBC Electronic Data Processing (Philippines) Inc. will set up its regional BPO operations at the park. The others will be offering outsourced IT engagements from the Philippines, as well as software development, Alonzo said.

As it has been doing in the smaller UP South Science & Technology Park on C.P. Garcia Street, Ayala Foundation Inc. will run an "incubation facility" for start-up IT companies in the park's S&T office.

The S&T building, to be called Techno Portal, will house conference rooms, restaurants, cafés, specialty stores, convenience stores and banks, among others, that will cater to the locators' executives and staff, and UP faculty and students.

Also in the pipeline is the construction of low-rise residential buildings for the park employees and UP faculty and students, and a three-star hotel for businessmen.

There will be 10 office buildings for the locators, plus the S&T office. The construction of six buildings is in full swing.

Because its design evolved from UP's conceptual framework plan, the IT hub will function "like a campus," in which green spaces will be integrated whenever possible, Ignacio said.

The IT park is only the first of a three-phase development plan of the UP administration. Now on the drawing board are plans to build biotechnology and education-energy system parks on the sprawling property.

Covance Gets OK for Animal Tesing Lab

Covance has emerged triumphant in the latest episode of a long-lasting saga over a new US animal testing lab that it is building in Chandler, AZ.

At the request of the plaintiffs, a judge has this week thrown out a lawsuit that the contract research organisation (CRO) has been embroiled in mid last year after a bid was launched to stunt its lab development plans.

The plaintiffs were seven local residents who live within a mile of the construction site and the Physicians Committee for Responsible Medicine (PCRM) - one of the groups that have been campaigning to shoo Covance away from Chandler since those plans were made public over two years ago.

The decision will have left Covance breathing a sigh of relief over the controversial project, the future of which had been somewhat in limbo.

The company broke ground on the 300,000-square-foot site in June last year but the lawsuit jeopardized the smooth continuation of the site construction as the lawsuit asked the court to void the building permit and the zoning for the facility.

This week a judge dismissed the final part of a five-part suit, the other four aspects had been dismissed in late January.

Specifically, the lawsuit alleged that Chandler city officials violated the Arizona Open Meeting Act and city ordinances in allowing Covance to build in the Chandler Airpark.

The lawsuit also alleged that city officials took part in non-public meetings about Covance in which they discussed the company's plan to build its new facility on the rezoned Airpark property instead of the initial building site.

The dismissal of the last part of the lawsuit, which pertained to the non-public meetings, now closes the door on the saga for Covance and opens the door for the firm to begin operating the 300,000-square-foot laboratory early next year.

Meanwhile, the battle may have been won but it seems the war is not over. PCRM is still adamant that the Chandler City Council violated the open meeting law and has requested that the state Attorney General's Office reopen its investigation into the matter. An earlier inquiry into the issue by the office was planned but halted when PCRM decided to file the lawsuit.

Charles River Laboratories Steps Up its China Plans

In an analyst call related to its fourth quarter results, Jim Foster, company president, chairman and CEO said that it is now speeding up its facility expansion program in China, where it is constructing a new 50,000 square foot laboratory, and is expecting to begin offering good laboratory practice (GLP) preclinical services from the country by the middle of this year instead of the first quarter of 2009.

Charles River has been operating in China since mid 2007 when it forged a joint venture with a local firm Shanghai BioExplorer, which it later actually acquired.

Interestingly, Foster insists that to date, the company is not seeing its business in China coming from international customers who are offshoring the work to them in a bid to save money.

Meanwhile, for the fourth quarter of 2007, the contract research organization's (CRO's) sales increased 17 per cent to $318.0m from $271.7m in the comparable 2006 period.

Operating income grew to $52.1 million, up from 45.2 million in the previous year, as did pre-tax profit which came in at $51.1 million compared to $44.5 million. Charles River attributed the profit gains primarily to the higher sales.

Sales for the Research Models and Services (RMS) segment were $145.2 million in the fourth quarter of 2007, an increase of 13.7 percent from the fourth quarter of 2006. At the same time the segment's operating margin increased 1.5 percentage points to 27.1 percent.

Looking forward, Charles River said it plans to boost its workforce by around 800 employees during the year - equivalent to an increase of around 10 per cent.

Dextra Works from New GMP Lab

Dextra Laboratories, the specialist carbohydrate chemistry subsidiary business of UK biotech firm Summit Corporation, has just signed service contracts with four undisclosed biotechnology companies.

The contracts total an initial £500,000, however, the firm said that the value of these deals could rise to over £1m within the next six months.

For its new clients, Dextra will develop efficient routes of compound synthesis and good manufacturing practice (GMP) product supply for their drug development programs

Dextra will conduct the work from its GMP facility in Reading, UK, which was completed in June last year. The company said the deals represented the first significant return on its investment in the new GMP plant.

Metrics Expand in North Carolina

Meanwhile, US Lab services firm Metrics is in the midst of an $18 million expansion plan that will involve a 47,000-square-foot facility addition, increase its potent and cytotoxic drug handling capabilities and double the capacity of its facility in Greeneville, North Carolina.

The site existing site currently holds 44,000 square feet of drug R&D, large scale manufacturing (Phase III to commercial) and stability storage space, as well as a microbiology lab and a lab for potent compound work. The expansion will allow its clients to keep development and commercial manufacturing projects under the same roof.

As part of this, the company recently opened four new analytical labs, increasing the site's lab capacity by 40 percent. Metrics said it expects to begin accepting contract work in the new facilities during the second quarter of this year once they receives validation.

To assist with the expansion, Metrics received a $150,000 One North Carolina Fund grant and said it plans to create 77 new jobs.

Two CROs Merge to take on Eastern Europe

A Polish and a Czech firm have merged together in a bid to strengthen their position in the Central and Eastern Europe's (CEE's) budding clinical research scene.

KCR (formerly called Kiecana Clinical Research), a contract research organisation (CRO) based in Warsaw, has bought DUX Consuling, the largest Czech company handling this type of research in the Czech Republic and Slovakia. Financial details were not disclosed.

KCR specialises in Phase II-IV research. It already has branches in the Ukraine and the Baltic countries and coordinates research in Central Europe, Russia and Western Europe.

The firm indicated that the acquisition will now bring it greater access to new clients in the geographies of the Czech Republic and Slovakia, where DUX currently operates.

The US is still dominant in the clinical trials arena, carrying out 53 per cent of the world's 59,000 Phase I-III studies, however, US investigator groups are continuously underperforming with patient recruitment, with 50 per cent of sites recruiting less than 5 per cent of patients and 30 per cent recruiting 50 per cent of patients.

Despite notorious issues with recruitment, this is no longer the country's number one cause for trial delay either, with contract and budget delays taking over the number one spot of woe and 94 per cent of all US trials are now delayed over a month.

Meanwhile in Europe, ethics committee review and application; patient recruitment;
legal review, contract and budget negotiations; and protocol amendment are the biggest trial headaches The CEE region is one of several offshore locations that has been gaining in popularity for running clinical trials to speed up the recruitment and study turnaround times and cut costs.

Adding Russia and the Ukraine to the mix makes the region even more lucrative, with 200m treatment naïve patients - greater than in all 12 Western European countries combined - and a recruitment rate between two and ten times faster as well as a cash saving of up to 50 per cent compared to the west. As a result trials from the US have more than tripled here in the past few years and both the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) are now approving drugs with trial data from Russian sites.

PRA International Expands Its Capabilities Opening New Facility in Kansas, U.S.

The $2 million expansion doubles the capacity of PRA's existing Clinical Pharmacology Center in the region to 80 beds. Eighteen new staff have also been added.

Over the next year, PRA indicated that it is also planning to hire 50 more people, 13 nurses and clinical staff for the new pharmacology facility and the reminder to work in its other local operations that run studies in other phases of the clinical development chain.

Meanwhile, a number of other contract research organizations (CROs) have been making moves on the Phase I scene of late. Earlier this month, Ireland's Icon bought itself a Phase I base in the U.S. with the acquisition of Healthcare Discoveries.

Healthcare Discoveries operates an 85 bed clinical pharmacology unit in San Antonio, TX, and Icon's CEO Peter Gray said at the time that the new US facility will complement its existing European Phase I operations, which include an existing 80 bed clinical pharmacology unit based in Manchester, England.

Around the same time, Chiltern added to its Phase I cache with the purchase of a Scottish business called Drug Development Solutions (DDS).

Via the acquisition, the UK-based CRO gained a Phase I unit with 42 high intensity care beds located at Ninewells Hospital and Medical School, Dundee - one of the UK's major teaching hospitals.

According to Chiltern, the unit has expertise in first-in-man studies and in systemic drug phototoxicity studies in humans. It is also one of only a "small number" of Phase I units in the UK that is located within a major hospital that can provide emergency medical services if required.

Moreover, at the end of January MDS Pharma Services also opened its new Phase I clinic in Arizona - the largest of its kind on the US west coast.

Built to the tune of $25 million, the new 300-bed facility more than triples the capacity of the firm's Phase I presence in Phoenix, which combined with a nearby existing unit, totals 420 beds.

One of the therapeutic focus areas at the new clinic is ophthalmology, and there is an on-site centre dedicated to this specialty area. The facility also has a cardiac safety testing centre with 65 beds.

The $2 million expansion doubles the capacity of PRA's existing Clinical Pharmacology Center in the region to 80 beds. 18 new staff have also been added.

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