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Top Stories for the Week of June 25th 2007

Jun 29, 2007 10:48:58 AM

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Top News

AbCRO to Expand into Poland and Russia

Sofia, Bulgaria-based, American-owned contract research organization AbCRO announced its expansion plans into Central and Eastern Europe (CEE) at the Drug Information Association (DIA) 43rd Annual Meeting in Atlanta, Georgia. The company will open an office in Warsaw, Poland, next month and then an office in Moscow, Russia by December.

Aptuit to Invest $100 Million in India's Laurus Labs

Greenwich, Conn.-based Aptuit, and Hyderabad, India-based Laurus Labs Limited formed a joint venture for a new contract drug development company called Aptuit Laurus.

Other breaking news...      

Company Profile: An interview with Miganush Stepanians, chief executive officer, Prometrika

Past weekly article summaries for the year can be found in the CW Weekly Issue archives. To read the full articles for this issue or for more information on these and other breaking stories, please click here!

AAHRPP Accredits 16 New Research Organizations

Jun 28, 2007 5:58:48 PM

By Stephen DeSantis

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited its largest group of institutions at one time in its six-year history. In total, 16 organizations gained AAHRPP approval. The certification is valid for three years. The AAHRPP is a non-profit organization that offers accreditation to organizations that conduct or review research with humans.

“This is the largest number of accreditations we have awarded at one time and we expect the numbers to continue to grow as we see an ever-expanding list of applicants, said Marjorie Speers, Ph.D., executive director of AAHRPP.

The list of hospitals or health systems that received full accreditation includes the Cincinnati Children’s Hospital, The MetroHealth System in Cleveland, Ohio and the University Hospitals Case Medical Center in Cleveland. Among the list of universities were: University of Cincinnati, University of Kentucky, University of Utah, University of Rochester, University of Southern California, and the Virginia Commonwealth University.

Three Veterans Administration facilities were granted full accreditation, including Cincinnati Department of Veterans Affairs Medical Center, the Department of Veterans Affairs Salt Lake City Health Care System, the Veterans Affairs Pacific Islands Health Care System in Honolulu; VA Palo Alto Health Care System and  Veterans Affairs Healthcare Network Upstate New York at Albany. Austin, Texas-based IntegReview Ethical Review Board also received full certification.

Lexington VA Medical Center received qualified accreditation, which means it met the standards with only a few minor deficiencies in administrative processes, not involving patient care. It will still be accredited for three years and if these deficiencies are corrected within that time, the institution will receive full accreditation status.

“This is a very exciting time for these organizations and for AAHRPP. Not only is it a significant achievement for these institutions, but accreditation is critical for the public’s trust in research,” added Speers.

AAHRPP has accredited 68 organizations since 2001 and is currently working on nearly 400 new accreditation assessments.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Trio Offers Webinar Training Series on Adaptive Trials

Jun 27, 2007 12:13:20 PM

By Stephen DeSantis

Maryland-based CRO United BioSource Corporation (UBC), in conjunction with eClinical firm Medidata Solutions, and the adaptive trials tools and modeling company Tessella, have joined together to educate the industry on the use of adaptive clinical trials in drug development. The companies are producing a series of free webinars—six in total—that will feature expertise from industry professionals and regulatory authorities on how to overcome some of the challenges of these studies.

The first webinar, entitled “Operational Challenges and Strategic Planning,” will be held on July 11th and can be viewed online at www.enablingadaptivetrials.com. “Even with the right regulatory environment and the right technology, sponsors who are looking to execute adaptive clinical trials need to devote time to planning for this change to the clinical process,” said Michael Borkowski, general manager of clinical technologies at UBC.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

NovaCardia Sees Positive Results with treatment for heart failure

Jun 25, 2007 11:04:15 AM

By Tracy Trundle

NovaCardia reported positive preliminary results from a phase III trial of KW-3902 for the treatment of acute congestive heart failure (CHF). This double-blind, randomized trial enrolled 304 subjects with CHF and renal impairment. Subjects received placebo or 10, 20 or 30 milligram doses of intravenous KW- 3902, administered daily for up to three days. All subjects received intravenous furosemide.

The primary endpoint was the proportion of subjects in the categories of treatment success, treatment failure or no change. The 30 mg dose of KW-3902 appeared to be the most efficacious, with higher rates of treatment success and lower rates of treatment failure compared to placebo.

Twenty-four hours post-treatment, self-reported marked or moderate improvement in dyspnea was reported in 66% of the KW-3902 (30 mg) group compared to 51% of the placebo group. No statistically significant differences in adverse events were reported between the groups. The 30 mg dose of KW-3902 was determined to be the optimal dose for NovaCardia’s two 600-subject phase III trials, dubbed PROTECT-1 and PROTECT-2.

Both trials are enrolling subjects in the U.S., Canada, Europe, Israel and Russia.

Tracy Trundle is a Research Analyst at Thomson CenterWatch.

ICON Taps Ovation for New Lifecycle Sciences Business Group

Jun 25, 2007 10:56:42 AM

By Stephen DeSantis

Dublin-based ICON Clinical has established a new business unit called its lifecycle sciences group, focusing specifically on outcomes research and economic analysis services. The news was announced during the Drug Information Association (DIA) 43rd Annual Meeting in Atlanta. The group will work with stakeholders across the client organization in area such as clinical development, but also with sales and marketing, medical affairs and strategic development groups—units where most contract research organizations (CROs) have less interaction with.

The core of the group will be Illinois-based Ovation, which ICON acquired in July 2006. The company, now a part of ICON’s clinical research division, conducts prospective pharmacoeconomic and quality-of-life analysis, disease and product registries, and health outcomes research.

Originally dubbed Ovation Healthcare Research, the company was founded in 1990. Ovation’s founder and former president Jeff Trotter, has been promoted to senior vice president of ICON's new lifecycle sciences group.

“This time last year, [Ovation] became pretty much the corner stone of ICON’s late stage business, but one of the things that we’ve done in evolving to this lifecycle sciences group is help everyone recognize that what we do isn’t just in the post approval realm. A lot of what we do starts as early as phase II up to through approval and beyond. That is kind of where the concept of lifecycle sciences came from,” said Trotter.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Read our full coverage of the news in an upcoming CWWeekly article or for any other CenterWatch stories visit our publications area.

Parexel Expands Global Reach with New Hub in India

Jun 22, 2007 7:45:00 AM

By Stephen DeSantis

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Waltham, Mass.-based contract research organization (CRO) Parexel International has opened a major clinical operations and data management office in Hyderabad, India. The office will serve as the company’s main hub in the region and will expand its presence in the emerging Indian clinical trials market. Although Parexel already operates an 86-bed phase I unit in Ahmedabad, through a joint venture with the CRO Synchron, this would be the company’s first late phase clinical operations office in the region.

During the Drug Information Association (DIA) 43rd Annual Meeting in Atlanta, Mark Goldberg, M.D., president of clinical research services and Perceptive Informatics at Parexel, discussed the company’s news with CWWeekly.

“One of the biggest challenges in running clinical trials today is patient recruitment and retention,” said Goldberg. “India provides a great opportunity to work with a vast population of patients, many of whom are interested in participating in clinical trials. Parexel will also be able to leverage its global footprint to perform appropriate tasks within a lower cost structure, such as data management.”

The phase I sector in India remains comparatively soft due to regulatory requirements on first-in-man studies. Goldberg stated he didn’t see that changing anytime soon but added that India will be a key later phase market for the company. About 7% of Parexel’s revenue comes from trials in Asia. And that business is projected to grow rapidly over the next few years. The U.S.-based consulting firm McKinsey has estimated that biopharmaceutical sponsors will spend $1.5 billion per year on clinical trials in India by 2010.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Read our full coverage of the news in an upcoming CWWeekly article or for any other CenterWatch stories visit our publications area.

Top Stories for the Week of June 18th 2007

Jun 22, 2007 7:15:00 AM

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Top News

Quintiles Continues Central Lab Expansion with New Facility in Scotland

Quintiles Transnational is building a new 132,000-square-foot facility in Livingston, Scotland, that will become mainly laboratory space. The new facility is being constructed in part to further Quintiles' global central laboratory expansion plans.

Omnicomm Systems Expands into Europe

Ft. Lauderdale, Fla.-based eClinical firm Omnicomm Systems has made its first international expansion by opening a European hub in Bonn, Germany. The company plans to have a staff of 10 to 15 employees there in the next year, ranging from sales, help desk support, project management teams to technical consulting personnel.

Other breaking news... 

  • BBK creates new division...
  • Parexel launches global recruitment team...

Company Profile: An interview with Gary Zammit, chief executive officer, Clinilabs

Past weekly article summaries for the year can be found in the CW Weekly Issue archives. To read the full articles for this issue or for more information on these and other breaking stories, please click here!

Aptuit to Invest More Than $100 Million in Laurus Labs in India

Jun 19, 2007 7:48:00 PM

By Steve Zisson

India continues to be a country where investment in contract research is hot. A deal announced Monday is a big one.

Greenwich, Conn.-based Aptuit, and Hyderabad, India-based Laurus Labs Limited formed a joint venture for a new contract drug development company called Aptuit Laurus.

The new venture will combine Aptuit’s global offerings in drug development with Laurus’ research and development and manufacturing expertise, and newly built facilities. The combined company will provide pharmaceutical companies with integrated services, technologies and manufacturing capabilities that span the entire drug development continuum.

The new entity, Aptuit Laurus Private Limited, will use the trade name Aptuit Laurus, and will be based in Hyderabad with additional facilities in Vishakhapatnam and Bangalore.

Aptuit Laurus will initially provide services to clients in early-stage drug discovery, medicinal chemistry, lead optimization, process development, scale-up and process optimization, safety and hazard assessment, formulation development and analytical chemistry. Aptuit Laurus will comprise Laurus’ newly-established 160,000 square foot research and development facility in Hyderabad, which already employs 200 scientific personnel. It will also include Laurus’ large-scale manufacturing plant, which is currently under construction on 34 acres of land in Pharma City, Vishakhapatnam and Aptuit’s existing informatics development and support group of 100 employees in Bangalore.

Aptuit has committed to invest $100 million in the next four years to build upon Aptuit Laurus’ development, manufacturing and informatics capabilities with the addition of a complete suite of development services including: medicinal chemistry, preclinical, solid-state chemistry, consulting, clinical packaging and logistics, phase I/IIa research and large-scale dosage form manufacturing.

When these investments are completed, Aptuit Laurus will mirror the full suite of services offered by Aptuit in North America and Europe. In addition, the new company will further extend those development services to offer expanded services in discovery and clinical research and access to larger-scale manufacturing at the back-end of the product development lifecycle. Aptuit, founded in late 2004, has been in growth mode following a number of acquisitions and now has more than 2,000 employees.

“Laurus Labs shares our strategic vision to build an end-to-end drug development services partner with high service levels and an emphasis on technology, and their offerings align neatly with ours,” said Michael A. Griffith, founder and chief executive officer of Aptuit.

In late 2005, Dr. Satyanarayana Chava founded Laurus Labs along with two colleagues. Dr. Satyanarayana was most recently chief operating officer of Matrix Laboratories Limited. At Matrix, he played a key role in transforming that company into one of the major pharmaceutical companies in India.  “Aptuit is the ideal strategic partner for Laurus,” he said. “Our strengths are complementary, and we are very focused on the value and efficiencies to be gained for our customers in having access to a full range of research, development and manufacturing capabilities and services on a truly global scale. We see this as a very powerful combination, one that benefits our customers quite uniquely.”

Dr. Satyanarayana, who was named to Aptuit’s board, and his co-founders will remain with Aptuit Laurus and have invested in the company.

Steve Zisson is managing editor at Thomson CenterWatch.

BBK Creates New Global Mobilization Team Division

Jun 19, 2007 8:34:00 AM

By Stephen DeSantis

Newton, Mass.-based patient recruitment company BBK Worldwide has created a new company division called the global mobilization team. The company stated that this division will help address the challenges of planning and deploying of resources for large-scale, global trials. BBK stated the division will include in-country staff with expertise in local patient recruitment, a web-based communication structure and real-time access to data essential for making changes in recruitment operations mid-trial.

"At one time, site support specialists were perceived as 'nice-to-haves,' until the industry realized that they made a big difference in enrollment, and then site support became standard practice. With the number of multinational trials on the rise, creating a sub-specialty in global mobilization is not just a nice thing to do - it's an industry imperative," stated Bonnie Brescia, co-founder and principal at BBK.

Waltham, Mass.-based CRO Parexel made a similar announcement about launching a global recruitment team called START – or Start-up and Accelerated Recruitment Team – which will use the company’s planning and recruitment tool called SPARC – or Scenario Planning and Recruitment Calculator.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.


Wellquest Opens New Research Facility in Hyderabad

Jun 18, 2007 7:56:00 AM

By Stephen DeSantis

Mumbai-based Wellquest CRO, the clinical outsourcing division of India pharmaceutical company Nicholas Piramal, opened a 30,000 square foot research facility in Hyderabad. The 112-bed center boasts separate wards for female and pediatric subjects. The unit will be Wellquest’s second facility in India, which runs a 20,000 square foot center at the Wellspring Hospital in Mumbai. The Mumbai facility consists of a 60-bed ward, six-bed ICU, pharmacy, phlebotomy stations, bioanalytical laboratory and an accredited central pathology laboratory. Wellquest was established in 2000 by Nicholas Piramal and has conducted about 100 pivotal trials and 40 pilot studies. Both facilities are complaint with Good Clinical Practice and Good Laboratory Practice guidelines.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.


Top Stories for the Week of June 11th 2007

Jun 15, 2007 7:44:00 AM

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Top News
      
Private Equity Group Acquires Radiant Research to Grow the SMO Globally

Bellevue, Wash.-based Radiant Research, the largest owned-model site management organization (SMO) with 26 sites, has completed a sale of the business to an ownership group led by India-based ICICI Venture, a private equity company with $2 billion under management.

Veeda Clinical Research Acquires Phase I Unit in Germany

Veeda Clinical Research, an early phase contract research organization (CRO) with headquarters in both Plymouth, UK, and Ahmedabad, India, has bought a 40-bed phase I facility in Gorlitz, Germany. Financial and other details of the transaction were not disclosed; however, according to public records, the last company to own the unit was Medifacts International.

Other breaking news...      

Company Profile: An interview with Gary Velasquez, president and chief executive officer, Synarc.

CenterWatch Monthly: June 2007 Issue

Jun 14, 2007 5:36:56 PM

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U.S. Sites Rate Kendle, Covance, Omnicare as Top CROs in 2007

The Thomson CenterWatch 2007 Survey of Investigative Sites in the U.S. finds that sites have rated Kendle as the top CRO to work with. It is the first time that Kendle has been rated number one. Being organized and prepared for a study was the attribute rated most important for CRO performance with more than 86% of sites listing it as of the highest importance. Three other attributes had more than four out of five sites giving them highest ratings for importance: responsiveness to inquiries, CRAs/managers being knowledgeable and maintaining open communications.

Beyond Study Brokers

During the past five years, the study broker space has changed as new companies have entered the market and a variety of business models have emerged. And many organizations that perform study brokering have added services, changed the direction of their businesses and grown. The emergence of alliances and small site networks has also been a trend. In this model, independent sites band together and hire a full-time business development person to conduct marketing and business development duties on their behalf. Some of these alliances or networks focus a particular therapeutic area, while others represent multi-specialty investigative sites.

European CRO Federation Has Ambitious Plans

The European Contract Research Organization Federation (EUCROF) was formally established 18 months ago, and it has ambitious plans that members have wasted no time embarking on.

Eye On: Obesity

Obesity, defined as body mass index (BMI) of greater than 30, is currently the leading nutritional disorder in the Western world. According to a European study by the World Health Organization, more than 70% of men and nearly 70% of women 55 to 64 years of age are clinically obese or overweight. CenterWatch has identified a pipeline of 19 drugs in various phases of development for obesity.

To read the full articles for this issue or for more information on these and other breaking stories, please click here or contact us at cw.sales@thomson.com.

Sanofi Aventis and Taiho Report Positive Results In Stomach Cancer Drug

Jun 14, 2007 5:32:55 PM

By Tracy Trundle

Sanofi Aventis and Taiho Pharmaceutical reported positive results from a phase III trial of S-1 for the treatment of gastric cancer, at the 43rd Annual Meeting of the American Society of Clinical Oncology. This randomized trial, dubbed SPIRTS, enrolled 305 subjects in Japan. Subjects were randomized to receive either oral S-1 (40 mg/m2) twice daily for 28 days followed by a 14-day rest period, or oral S-1(40 mg/m2) twice daily for 21 days plus IV cisplatin on the eighth day of treatment, followed by the 14-day rest period.

The primary endpoint was overall survival (OS). Secondary endpoints included Response Rate, Time to Treatment Failure (TTF) and toxicity. Results revealed overall survival with a two-year follow-up was significantly higher in the S-1/cisplatin combination arm compared to the S-1 alone arm, with a median rate of 13 months versus 11 months, respectively (p=0.036).

The overall response rate was also significantly higher in the combination arm, with 54% of subjects in the S-1/cisplatin arm showing response to treatment compared with 31.1% with S-1 alone, p=0.001). In addition, S-1 with cisplatin significantly reduced the risk of death by 22.6% (HR: 0.774; 95% CI [0.608-0.985]) over S-1 alone.

Several phase III trials of S-1 are underway in the United States.

MDS Reports Strong Growth in Late Stage Business

Jun 12, 2007 6:10:00 AM

MDS had a big second quarter following the sale of its diagnostic business and the life sciences company is also encouraged by signs of a turnaround in its MDS Pharma Services unit’s late stage business.

The Toronto-based company reported net income ballooned to $736 million or $5.34 a share compared with $14 million or 10 cents in the second quarter a year ago. Earnings included a gain of $792 million from its diagnostics unit sale. The overall company’s revenue jumped 13% to $273 million compared with $242 million in the year ago quarter.

In its second quarter, MDS’ revenues from the company’s late stage segment grew 22% to $55 million. The company’s early-stage segment was down 12% compared with the year ago quarter, partly due to U.S. Food and Drug Administration (FDA) issues at its Montreal site. MDS stated it expected to have the majority its independent audits completed by the end of the year, at a cost of $61 million to the company.

Second quarter revenues from the company’s analytical technologies division rose 54%, compared with the same period last year. Those earnings included results of its Molecular Devices acquisition in March 2007.

“I am pleased that we continued to make solid progress executing our strategy,” said Stephen DeFalco, president and chief executive officer of MDS. “I am encouraged by the steady improvement.

In February 2005, MDS agreed to conduct a review of all it bioequivalence studies done at its Ville St. Laurent, Quebec site. The review covered a five-year period from January 2000 through December 2004. This was done in response to FDA concerns about the company’s bioanalytical testing operations after a routine inspection in 2003.

MDS Pharma Services also recorded a $26 million charge to restructure and streamline its business. It will use these funds to “optimize” its global network through site consolidations, workforce reductions, and operational enhancements.

Private Equity Group Acquires Radiant Research to Grow the SMO Globally

Jun 11, 2007 10:20:22 AM

By Steve Zisson

Bellevue, Wash.-based Radiant Research, the largest owned-model site management organization (SMO) with 26 sites, has completed a sale of the business to an ownership group led by ICICI Venture, a private equity company with $2 billion under management. Company officials said June 8th that Radiant will continue to provide development, study conduct and centralized patient recruitment services.

Radiant Research has undergone many changes lately. In May 2006, Radiant Research sold its eight phase I units to Covance for $65 million. Those phase I units generated $25 million in annual revenue. Founder and former chief executive officer Mike Lester left the company in August 2006.

“After the sale of our phase I business unit, we refocused our attention to our core business units, which consist of Radiant Research for phase II-IV study conduct services, Radiant Development for CRO services and Radiant Recruitment, which offers centralized recruitment services for the biopharmaceutical industry,” said Spaniac.

Spaniac and the management team at Radiant will remain at the company. Radiant has 400 employees and an estimated $70 million in annual revenues.

Steve Zisson is managing editor at Thomson CenterWatch.

Top Stories for the Week of June 4th 2007

Jun 8, 2007 8:13:00 AM

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Top News

Quintiles and Thermo Fisher Create New eClinical Company in Joint Venture

North Carolina-based contract research organization (CRO) Quintiles and global laboratory supply giant Thermo Fisher have teamed up to form a new eClinical company called Cenduit. The new firm will have an alliance management team comprising executives from both companies. The joint venture has been in the works for nearly six months.

Perceptive Informatics Collaborates with University of Chicago on Cancer Imaging

Waltham, Mass.-based Perceptive Informatics, the technology subsidiary of Parexel, has formed a collaboration with the University of Chicago's Department of Medicine to commercialize a breakthrough magnetic resonance imaging (MRI) technique called the double reference tissue method (DRTM).

Other breaking news...   

Company Profile: An interview with Jodi Andrews, co-founder and chief executive officer, Protrials Research

CFOs in Demand at CROs

Jun 7, 2007 11:06:01 AM

By Steve Zisson

On April 30 when PPD announced that Linda Baddour, chief financial and accounting officer, was resigning effective May 31, the contract research organization (CRO) added that Baddour would be providing consulting services to the company for the next six months to assist with the transition of her responsibilities to other members of senior management.

Well, that six months of consulting won’t be happening.

Just a few days after her resignation became effective, Baddour took a new job at competitor, PRA. That CRO named Baddour as executive vice president and chief financial officer. Baddour, who worked at PPD for 11 years,  replaced Matt Bond who resigned to pursue other opportunities.

"We are very excited to have Linda join us," said Terrance Bieker, chief executive officer of PRA. "She has the financial acumen and the proven track record we need to take PRA to the next level. This includes experience managing the financial systems of a fast-growing global firm, evaluating and integrating acquisitions and working well with investors. She has a background in our industry, having worked her way up to the CFO position for a leading, global contract research organization. We are looking forward to the perspective Linda offers and the contributions she will make.”

In this era of heightened financial regulations, CFOs are certainly in demand. Bond—Matt Bond—should have plenty of opportunities to pick from.

The chief financial officer at AstraZeneca showed there are plenty of options. On Wednesday, AstraZeneca said its CFO Jon Symonds plans to leave the company at the end of July to take a position with investment bank Goldman Sachs.

Symonds was reportedly passed over for the top spot at AstraZeneca and was expected to leave.

Steve Zisson is managing editor at Thomson CenterWatch.

Recent Industry Personnel News

Jun 6, 2007 2:39:12 PM

Inclinix, a patient enrollment CRO based in Wilmington, N.C., has announced a series of personnel changes to the company’s executive management team. Inclinix promoted Robert Bernosky to executive vice president, strategic activities. Bernosky was formerly chief financial officer. That role will be filled by Jeffery Reiniche. Prior to Inclinix, Reiniche served in various roles at Click Commerce, Health Alliance and PriceWaterhouseCoopers. Bill Gwinn, formerly of Thomson MedStat and IMS Health, has joined the company in the newly created role of vice president, product marketing. And Robert Welch has joined the company as director, strategic accounts. Retiring from the Inclinix is senior vice president Bryan McIntyre.

Reston, Va.-based contract research organization (CRO) PRA International appointed Linda Baddour as executive vice president and chief financial officer. Prior to joining the company, Baddour was chief financial officer at the Wilmington, N.C.-based CRO Pharmaceutical Product Development (PPD). Baddour replaces Matt Bond who resigned to pursue other interests. Bond was appointed to the executive vice president role in 2006 after four years as the company’s senior vice president and CFO. Just last month PRA appointed interim chief executive officer Terrance Bieker to the position permanently. Colin Shannon was named president and chief operating officer.

London, U.K.-based clinical trials software firm InferMed appointed Duane Lawrence to the role of chief executive officer. Prior to InferMed, Lawrence was General Manager at MISYS Healthcare Systems, with responsibilities of operations in markets outside North America.

Dallas-based MedTrials reorganized its operational structure into four key divisions. Ivana Waller will continue will lead its business operations division. Barbara Richardson was appointed vice president of compliance and regulatory affairs, Bill Sams will serve as vice president of clinical operations and Kathy Labowitz will oversee the company’s biostatistics, data management and data services division.

Cincinnati, Ohio-based clinical services company Hill Top Research hired Paul Briggs as vice president and general manager of CRO services. Previously Briggs held positions at Fast Track Systems, Sentrx, Parexel and SCIREX.

WorldCare Clinical, a Cambridge, Mass.-based imaging CRO, hired Darlene Moscone as the company’s director of quality assurance and regulatory affairs. Prior to joining WorldCare, Moscone served as senior regulatory operations associate at Bristol-Myers Squibb Medical Imaging and senior regulatory operations specialist at Shire Pharmaceuticals.

Bilcare To Create Research Academy in India and Asia

Jun 5, 2007 6:45:00 AM

By Stephen DeSantis

India-based Bilcare Limited, a pharmaceutical packaging and clinical technology firm, together with the Association of Clinical Research Professionals (ACRP), have created the Bilcare Research Academy. The company will open 25 educational centers in India and Asia by 2010, investing $4.8 million. The first centers to open in India and Singapore, followed later by Thailand, Pakistan, Bangladesh, Sri Lanka, Indonesia and China.

Bilcare Research Academy will offer a one-year postgraduate diploma, accredited by ACRP, in clinical trials management to graduates of pharmacy, life sciences and medicine. The academy will also provide continuing medical education course for current industry professionals. Students also receive a year of free membership to ACRP.

ACRP and Bilcare have a common interest to enhance the capability, competency and expertise of the professionals engaged in developing, monitoring, conducting and supervising clinical trials in India and other Asian countries by way of specialized training programs," said Thomas Adams, chief executive officer of ACRP.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Novartis And Vanda See Positive Results With iloperidone

Jun 4, 2007 3:53:08 PM

By Tracy Trundle

Novartis and Vanda Pharmaceuticals reported positive results from a phase III trial of iloperidone for the treatment of akathisia in schizophrenia. This randomized, double-blind, placebo controlled trial enrolled 706 subjects who were placed into one of four treatment groups: iloperidone 12.16 mg/d or 20.24 mg/d, risperidone 6.8 mg/d or placebo for 6 weeks. Changes in akathisia were measured weekly by the Barnes Akathisia Scale (BAS) and the Extrapyramidal Symptom Rating Scale (ESRS) from baseline to the six-week end point.

Both iloperidone groups had fewer subjects whose total akathisia score worsened (12%, p=0.04; 8%, p=0.004, respectively), compared to placebo and risperidone (20%, p=1.00). In addition, anticholinergic medication was needed for extrapyramidal symptoms in 5% and 7% of the two iloperidone dose groups respectively, compared with 22% for risperidone and 7% for placebo. The results were presented at the 2007 American Psychiatric Association annual meeting.

Vanda licensed iloperidone in 2004 from Novartis Pharma AG and is completing the phase III program. Based on the results, the Vanda  expect to file a NDA in Q4 of 2007.




Top Stories for the Week of May 28th 2007

Jun 1, 2007 11:15:00 AM

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Top News

AAIPharma Acquires Instituto de Pesquisa Clinica de Sao Paulo

Wilmington, N.C.-based contract research organization (CRO) AAIPharma acquired Brazilian CRO Instituto de Pesquisa Clinica de Sao Paulo (IPCSP). Financial details were not disclosed.

Chinese Firms Form CRO Alliance

Three Chinese-owned companies have joined forces to create a contract research organization service alliance (CROSA) in Shanghai's Zhangjiang HiTech Park. The companies, Sundia MediTech, United PharmaTech, and HD BioSciences, will operate as one entity in the pharmaceutical research market.

Other breaking news...      

Company Profile: An interview with Paul Gilbert, chief executive officer, MedAvante

Past weekly article summaries for the year can be found in the CW Weekly Issue archives. To read the full articles for this issue or for more information on these and other breaking stories, please click here!

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