i3 Pharma Resourcing launched resourcing services in Switzerland and Belgium.

Now active in more than 50 countries, i3 Pharma Resourcing draws on its clinical understanding and global resources to screen and interview each candidate carefully, matching the individual’s skill set, qualifications and competencies with clients’ specific requirements.

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Less than a month after announcing its acquisition of China-based contract research organization (CRO) Excel PharmaStudies and plans to dominate the Asia-Pacific region,PPD, the Wilmington, N.C.-based global CRO has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company. The acquisition of the 660-employee company will expand PPD's drug development capabilities in China.  

Founded in 2005, BioDuro operates a 110,000-square-foot laboratory in Beijing. Most of its employees are based in China, where it provides scientific expertise in medicinal chemistry, biology, pharmacology, drug metabolism, pharmacokinetic and safety services. The company offers integrated scientific resources and services to synthesize novel compounds and optimize those compounds to generate drug development candidates.

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Charging that the Carle Foundation Hospital and Carle Clinic failed to protect cancer patients in their clinical trials, Suzanne Stratton, Ph.D, the former vice president for research at the Carle Foundation Hospital in Urbana, Ill., filed a whistleblower lawsuit in federal court against the hospital’s chief executive officer, the Carle Clinic Association, Kendrith Rowland, M.D., a lead physician at the Carle Clinic, and Bruce Wellman, M.D., the Carle Clinic CEO. 

Stratton alleges she was fired in retaliation on Nov. 18, 2008 for her repeated warnings that the Carle  Foundation Hospital and the Carle Clinic had violated federal regulations intended to protect cancer patients enrolled as subjects in clinical trials. She was hired in early 2007 to help oversee cancer trials there. 

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Whippany, N.J.-based ISI, a provider of software and services for the life sciences industry, has acquired Apyx in an effort to boost ISI’s services business.

The acquisition helps ISI strengthen its capabilities to offer clients a mix of process, technology, data and operational services in a complex regulatory submission environment. ISI’s professional services business already saw a 26% increase in sales from 2007 to 2008.

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Encorium Group, a CRO, reported third quarter revenue decreased 18% to $4.5 million but its loss from continuing operations narrowed to $643,389 or $(0.04) per diluted share for the third quarter of 2009, from a net loss of $2.4 million, or $(0.12) per diluted share, in the third quarter of 2008.

In July, the company sold substantially all of the assets of its U.S. business to Pierrel Research USA. Due to this sale, for the three and nine months ended Sept. 30, 2009 and 2008, the results of the U.S. business have been presented as discontinued operations in the company's consolidated financial statements.

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Datatrak International, a technology and services company focused on eClinical solutions, reported third quarter revenues fell 34% to $1.55 million compared with the prior year quarter but its net loss narrowed.

Compared to the prior year third quarter, combined direct cost and selling, general and administrative expenses decreased approximately $1.8 million, or nearly in half.

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New York-based Medidata Solutions, a provider of hosted clinical development solutions, reported third quarter profits soared on revenues that jumped 27% compared with the year ago quarter.

Non-GAAP net income for the third quarter of 2009 was $3.5 million, or $0.15 per diluted share, compared with a loss of $2.1 million, or $0.32 per diluted share, in the third quarter of 2008.

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Parexel has established The Expert Office, which provides a single point of contact for clients to more quickly access the company’s worldwide clinical research expertise.

The Expert Office aligns the company's leading medical, therapeutic area, regulatory, and clinical operations experts with their counterparts at biopharmaceutical companies. It is designed to deliver a new level of strategic partnering based on program design expertise, operational excellence, and project leadership.

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ICON has signed an extension to its strategic agreement with Eli Lilly and Company to manage the company’s clinical data management outside the U.S. This extension means that ICON will now also manage Lilly’s needs in Japan in addition to those in Europe, Canada, Latin America, Australia and Asia, which was originally agreed to in November 2008.

Lilly also selected ICON to manage clinical trial site set up and monitoring in Europe for Lilly-managed studies in June 2009.

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Premier Research Group, an international pharmaceutical and medical device services company, is expanding its functional sourcing resources to Eastern Europe.

Ajay Sadhwani, vice president of Premier Research’s Functional Sourcing group stated, “These experienced professionals are based in Premier Research’s existing offices in Bulgaria and Slovakia offering a strong presence and capacity to provide low-cost data processing services. This further extends the reach of our group and enhances the flexibility we can offer clients.”

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At the ChinaTrials 2009 conference in Beijing Monday, Dr. Yi Feng, director of Review Management, Center for Drug Evaluation (CDE) in China, laid out plans to implement a new GRP process. GRP is an acronym representing three “R” practices: Good Review Practice, Good Regulatory Practice and Good Registration Practice. It is expected that implementing GRP will greatly contribute to shortening drug review timelines in China. 

“To solve issues surrounding timelines, we need to put ourselves under the magnifying glass,” Feng said. The GRP problem became apparent after China’s regulatory agency, State Food and Drug Administration (SFDA), participated in a survey conducted by UK-based International Institute for Regulatory Science (IIRS) rating 13 emerging markets’ clinical research regulatory systems. China’s participation in the survey reflects the agency’s strong interest in improving the current review and approval system and its desire to know how it stacks up against other countries’ regulatory systems. In addition to answering IIRS’ questionnaire, SFDA has actively studied other Asian countries’ systems as well as those of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. 

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Continuing with its Asian growth plans, Australia-based contract research organization (CRO) Novotech is expanding its operations to include four more Asian countries: Malaysia, Singapore, Thailand and Philippines. 

Novotech has about 130 employees working in its offices in Australia, New Zealand, South Korea and India. Most of its staff work in Australia. The company plans to add 25 employees who will work in the four new countries by the end of 2010. “The way we decided to go forward was to set up a local management hub out of Kuala Lumpur, Malaysia, and from there to then manage the neighboring countries,” said Alek Safarian, CEO of Novotech. 

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Dallas-based Metroplex Clinical Research Center (MCRC) and Rheumatology Associates have opened their new 22,500-square-foot complex featuring rheumatology services and phase I-IV research services under one roof.

Founded in 1984 by rheumatologists Dr. Roy Fleischmann and Dr. Stanley Cohen, both the practice and MCRC have deep roots in North Texas.

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Kendle, a global contract research organization, reported third quarter net income slipped to $8.8 million or $0.59 per diluted share for the third quarter of 2009, compared with net income of $9.4 million or $0.62 per diluted share for the third quarter of 2008.  

The company said execution of cost control initiatives helped it maintain net income. Net revenues for the third quarter were $104.6 million, down slightly from the second quarter and off $20 million from the year ago quarter.

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Pennsylvania-based Omnicare Clinical Research, a global contract research organization (CRO), has opened an office in Seoul, South Korea.

“Since 2006, we have been conducting studies in South Korea with a local partner,” said Benoit Martin, president, International for Omnicare Clinical Research.

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Quintiles has entered into a strategic alliance with AstraZeneca. The contract research organization (CRO)-clinical pharmacology alliance with AstraZeneca was formed to deliver the sponsor’s clinical pharmacology studies across multiple therapy areas and around the globe.

Quintiles will assume the operational responsibilities for the majority of AstraZeneca’s clinical pharmacology delivery. The alliance involves a sole provider for clinical pharmacology delivery, and a simple, standardized pricing model.

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Cincinnati-based Schulman Associates IRB has expanded its institutional review board (IRB) services into Canada. For North American studies, which are conducted in both the U.S. and Canada, Canadian and U.S. board members will review the research together to maintain consistency.

“Our clients have asked us to provide review services in Canada.  Now that our Canadian IRB is operational, Schulman can provide the same high quality review for Canadian research as it has provided in the U.S. for the past 26 years,” said John Isidor, Schulman’s CEO.

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How Investigative Sites Are Making it in Tough Times

During these difficult economic times, a number of investigative sites have been forced out of business or experienced severe cash crunches, squeezed by canceled projects, late payments from sponsors and tight study budgets. But sites are now seeing an uptick in studies as the year winds down, which they hope will continue into 2010.

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Signaling a major strategic shift, PPD is focusing on Asia-Pacific—China in particular. The company has made a big move in the region by entering into an agreement to acquire Excel PharmaStudies, one of the largest contract research organizations (CROs) in China, which will provide PPD additional capacity in China’s rapidly growing pharmaceutical market. PPD also plans to spin off its compound partnering business from its core CRO work and invest $100 million in Celtic Therapeutics.

The Excel PharmaStudies deal significantly increases PPD’s employee and client base in Asia-Pacific, the company said. Excel has about 370 employees and will operate as a wholly-owned subsidiary of PPD.  Financial terms of the deal were not disclosed.

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Waltham, Mass-based Phase Forward, a provider of data management solutions for clinical trials and drug safety, reported third quarter revenues jumped 24% to $53.1 million, compared with the third quarter of 2008, but earnings were cut in half.

For the third quarter, income from operations was $2.4 million, compared with $4.4 million in the third quarter of 2008. Net income for the period was $1.8 million, or $0.04 per diluted share, compared with $0.08 per diluted share in 2008.

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Raleigh, N.C.-based PRA International, a CRO, has opened a new office in Milan, Italy. PRA has operated in Italy since 2003 with home-based PRA staff.

 During the past three years, PRA has participated in more than 80 studies spanning 13 therapeutic areas in Italy.

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Phase Forward, a provider of data management solutions for clinical trials and drug safety, released its DefineValidator tool, Release 1.0, as a free download for Clinical Data Interchange Standards Consortium (CDISC) adopters.

The tool was adapted from a current feature of Phase Forward’s WebSDM product, which was developed under a Cooperative Research and Development Agreement (CRADA) for the U.S. Food and Drug Administration (FDA) to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format. 

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Laboratorio Hidalgo, a central laboratory in Buenos Aires, Argentina, has increased its capacity for its clinical trials division with a new facility five minutes from its headquarters and laboratory.

The two-story, 5,382-square-foot building enables the company to expand capacity for project and data management offices, documentation archive and kits manufacturing and logistics.

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PPD has entered into an agreement to acquire Excel PharmaStudies, one of the largest contract research organizations (CROs) in China, providing PPD additional capacity and expertise in the rapidly growing clinical research market.

The deal also significantly increases its employee and client base in Asia Pacific, the company said. Excel has more than 300 employees. Excel will operate as a wholly-owned subsidiary of PPD.

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Parexel's first quarter consolidated service revenue dipped 1.2% to $259.8 million, compared with $263 million in the prior year period. Net income also slipped to $12.4 million, or $0.21 per diluted share, compared with net income of $13.6 million, or $0.23 per diluted share, for the year ago quarter.

The contract research organization reported operating income of $18.5 million, or 7.1% of consolidated service revenue, in the first quarter of Fiscal Year 2010, compared with operating income of $22 million, or 8.4% of consolidated service revenue, in the comparable quarter of the prior year. Operating income in the prior year quarter would have been $17.2 million, or 6.7% of service revenue, when taking into account the $4.7 million net revenue and cost impact related to the previously described accounting adjustment.

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