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CWWeekly May 5th 2008 Issue

May 9, 2008 10:18:22 AM

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Top News
      
Bio-Imaging Technologies Acquires Phoenix Data Systems

Newton, Pa.-based contract research organization (CRO) Bio-Imaging Technologies has opened up a new book of business with the acquisition of eClinical company Phoenix Data Systems. Bio-Imaging, which specializes in running trials that require medical imaging management, purchased the King of Prussia, Pa.-based company for $24 million, including $17 million in stock and $7 million in cash.

inVentiv Clinical Moves into Latin America

inVentiv Clinical, the contract research organization (CRO) division of Somerset, N.J.-based marketing, communications and staffing firm inVentiv Health, has expanded its clinical services to Latin America with a new central hub in São Paulo, Brazil. The company stated it plans to bolster its operations in other countries throughout the region as well.

Other breaking news...      

Company Profile: An interview with Patrick Hughes, senior vice president, Exco InTouch

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


 

Gene Therapy Shows Promise for Rare Childhood Blindness

May 6, 2008 4:45:36 PM

By Tracy Trundle

Targeted Genetics reported positive results from a phase I/II trial of its RPE65 gene therapy for the treatment of retinal dystrophy due to Leber’s congenital amaurosis (LCA). LCA is a rare eye disease that causes severe vision loss or blindness. The disease is genetically inherited and usually manifests itself at birth or in early infancy. There are thought to be 3,000 people in the U.S. with the disease; however, the technology has the potential to treat a variety of eye diseases such as macular degeneration which afflicts 1.25 million people in the U.S. alone.

The single-center, open label study enrolled nine young adults, between the ages of 17 and 23 years, with early-onset severe retinal dystrophy due to LCA.

The subjects were administered a single retinal injection of the Adeno-Associated Virus (AAV) vector expressing RPE65. In each subject, the eye with the worse acuity was selected as the study eye and the other was used as a control. After two weeks, data from the first three treated subjects showed that they had improved vision in the injected eye and could read several lines on an eye chart.

They also had less nystagmus (or involuntary eye movement) after six months and one subject showed a significant consistent improvement in visual function and subjective tests of visual mobility.

No adverse events or inflammation were reported. Based on the results the company planned to enroll additional subjects into the trial.

The study, called "Effect of Gene Therapy on Visual Function in Leber's Congenital Amaurosis," by Bainbridge, et al., conducted in collaboration with University College London and Moorfields Hospital, will appear in the May 22nd issue of the New England Journal of Medicine (JAMA). The full results of the trial were also presented at the Association for Research in Vision and Ophthalmology (ARVO) 2008 Annual Meeting in Fort Lauderdale, Fla.

Tracy Trundle is a Research Analyst at CenterWatch.

PharmaNet Sees Profits Sink in Q1 due to Cancellations

May 5, 2008 2:14:22 PM

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By Stephen DeSantis

Princeton, N.J.-based contract research organization (CRO) PharmaNet Development Group dropped out of the black with a reported net loss of $10.1 million for the first quarter of 2008, primarily due to canceled contracts. PharmaNet cut its guidance for 2008 and its stock plunged 28% on May 1 to $17.10, far off its 52-week high of $43.05.

The company reported relatively flat revenue growth, recording a 2.4% increase to $86.8 million in its first quarter of 2008.

Operating margins sank to 8.6% in the first quarter from 10.2% last year as a result of higher expenses in anticipation of a larger volume of projects.

PharmaNet reduced its 2008 guidance to between $390 million and $399 million from its previous estimate of $401 to $409 million. It also slashed its estimated earnings by more than half to 53 cents to 63 cents from $1.42 to $1.57 a share.

Responding to an analyst’s suggestion that the structure of the company may not be well suited to handle sudden swings in project cancellations, Jeffrey McMullen, PharmaNet’s president and chief executive officer, said in the conference call: “I’m not sure this is a particular reflection of our size or the way we are configured. The impact was significant and concentrated. I think for any company that would be difficult to absorb. We have reacted...we’ve started cost saving measures, but they don’t happen overnight.”

To bring the company back to profitability, it is embarking on a series of cost cutting measures to “right-size its later stage business,” including closing offices and reducing staff.

PharmaNet will reduce and reposition its workforce, saving the company $7.1 million in 2008. Part of its strategy is to allow late stage development staff to be home-based to minimize office expansions. In addition, PharmaNet will be closing its offices in Australia and Washington, D.C. Some employees from these offices will become home-based. Closing the offices is expected to cost the company $1.5 million in the second quarter of 2008...

Continue reading... »

CWWeekly April 28th 2008 Issue

May 2, 2008 3:44:06 PM

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Top News

PeerView Acquires Veritas’ Clinical Trial Disclosure Business

Newtown, Pa.-based PeerView, a provider of medical journal publishing technology, acquired the clinical results disclosure platform from Cambridge, Mass.-based Veritas Medicine. The platform, called Veritas Clinical Trial Register (VCTR—or ‘victor’) was one of the last remaining pieces of Veritas’ business offerings after it discontinued its patient recruitment services and laid off a number of employees in February 2008.

Novotech Expanding in Asia-Pac, U.S.

Having opened offices in both Hydera-bad, India, and Seoul, Korea, recently, Novotech shared its plans for an ambitious expansion throughout the Asia-Pacific region. The Korean office has three employees, and India has a slightly different model with a manager and 26 monitors that Novotech has arranged to have through a partner and is therefore able to cover the entire country. Novotech’s plans do not stop with Asia-Pac. The company is also looking at opportunities for creating a bigger presence in North America to get closer to its clients there.

Other breaking news...      

Company Profile: An interview with Dan Ulrey, president and chief executive officer, Midwest Clinical Support, Inc.

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

Veeda Expands Global Capacity with New Oncology CRO

May 1, 2008 4:50:00 PM

By Stephen DeSantis

Ahmedabad-based CRO Veeda Clinical Research, launched a new division, called Global Oncology CRO, to concentrate on cancer research while leveraging Veeda’s operational capacities in the United States, Europe and India. The oncology subsidiary will be led by its president and chief executive officer, Matt Bowman. The new business will be headquartered in Columbus, Ohio. Kathy Squillace was named to the position of vice president of clinical operations and Dave Colborn was made vice president of data management and information technology.

“Since July 1, 2007 we have been establishing the infrastructure for a global oncology CRO and today we are pleased to announce that both the personnel and technical infrastructure are in place, validated and tested,” said Binoy Gardi, Group Managing Director, Veeda Clinical Research. Binoy_gardi_veedacr_big_2

The company stated it expects to expand its global capacity with targeted acquisitions in the coming months. Veeda bought a 40-bed phase I facility in Gorlitz, Germany last May. The facility is located in eastern Germany on the border of Poland and the Czech Republic. The unit was established in 1992 and has 15 staff.

Veeda was created in 2005 from the merger of the 18-year-old UK-based CRO, Phase I Clinical Trials Unit and two-year-old Clinsearch, an India-based phase I unit founded by Binoy Gardi and Apurva Shah.

In December 2006, Veeda acquired DICE, a Brussels-based CRO founded in 1989. The firm focused on data management, biostatistics and medical writing and provided Veeda with a European presence outside the United Kingdom.


New England Research Institutes Partners With Evidence

Apr 28, 2008 10:45:46 AM

Watertown, Mass.-based CRO New England Research Institutes (NERI) established a strategic partnership with Evidence Clinical and Pharmaceutical Research Institute, a CRO which focuses on conducting trials in Russia and Eastern Europe. Evidence is headquartered in Saint-Petersburg, Russia, and has offices in Los Altos, Calif., and Swampscott, Mass. The companies stated that both Eastern Europe and Russia are becoming increasingly popular regions for conducting clinical trials, and sponsors are creating an ever larger presence there.

“In addition to our North American depth, we have established a consortium of strategic CRO partners in emerging locations. The Evidence team fits well within our mix of employees and partners because they offer excellent data quality, high recruitment rates, well-trained and experienced personnel, and advanced communication technologies,” stated Rebecca Li, Ph.D., NERI’s vice president of clinical research.

CWWeekly April 21st 2008 Issue

Apr 25, 2008 1:52:00 PM

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Top News
      
SpineMark CRO Creates Own Multi-Site Research Network

SpineMark CRO Management
, a contract research organization (CRO) is creating a multi-site network of dedicated research centers, collaborating first with clinical investigators in Los Angeles and Denver. SpineMark CRO plans to have 20 such sites in place by the first quarter of 2009. Eventually, the company wants to have 35 centers across the U.S. and 10 outside the country.

AbCRO Opens Office in Ukraine

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened an office in Kiev, Ukraine. The opening comes just on the heels of the company’s two new offices in Russia—one in St. Petersburg and one in Moscow. The opening comes just on the heels of the company’s two new offices in Russia—one in St. Petersburg and one in Moscow.
    
Other breaking news...      

Company Profile: An interview with James McDermott, corporate development director, Quanticate

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

 

Recent Industry Personnel Changes

Apr 24, 2008 1:48:00 PM

Contract Research

Cincinnati-based CRO Kendle appointed Simon Higginbotham, formerly Kendle’s chief marketing officer, to president, replacing long time president and co-founder Chris Bergen.

Bergen helped start the company Simon_higginbotham_3 in 1981 with current chief executive officer, Candace Kendle.

“As we embark on the next stage of our corporate growth, it is imperative we have the dedicated leadership in place to support our needs as a larger global organization,” saidChris_bergen_6 Kendle. Bergen will remain in his role as chief operations officer.

In addition, the company appointed Alan Boyce to fill the position of chief marketing officer. Boyce held the position of vice president of Kendle’s clinical development in Europe and Africa from 2003 to 2007. He returns to Kendle after serving as chief operating officer at patient recruitment firm Synexus.

Wilmington, N.C.-based PPD appointed Mike Wilkinson, Ph.D, to the position of executive vice president of global clinical development. He will be responsible for all of the company’s phase II through IV trials in worldwide. Prior to PPD, Wilkinson was global head of internal medicine and vice president of project management at Quintiles. Before that, he served 27 years in the United States military, beginning with a career as a Navy Seal.

And after more than 16 years with the CRO, PPD’s Paul Covington, M.D. is retiring from his position Paul_covington_4 of executive vice president and chief medical officer, effective June 30th. He will stay on in an advisory role for special projects through the end of the year and consult for the company thereafter. PPD stated it anticipates having a replacement in place by mid-2008.Covington, who is board certified in internal medicine, was in private practice in Clanton, Alabama from 1985 to 1990. He served as chief of staff and director of critical care and cardiopulmonary disease at a Clanton hospital. "Paul is one of the most talented physicians in our industry, and his leadership and unwavering commitment to excellence have played a significant role in the continued growth and success of our company," said Fred Eshelman, chief executive officer.

Wayne, Pa.-based CRO Encorium Group’s chief financial officer Lawrence Hoffman has resigned his post, effective May 2. Encorium stated Hoffman is leaving his post to pursue other interests. The company saidLarry_hoffmanaspx_2 it will begin the search for a new U.S.-based CFO immediately. "Larry has created a solid financial foundation that will support our ongoing global expansion and business development initiatives. On behalf  of the entire Encorium organization, we wish Larry good luck in his future endeavors and thank him for his  ole in the growth of the Company over the past four years,” said Kai Lindevall, M.D., Ph.D., chief executive officer, and Kenneth Borow, M.D., president and chief medical and strategic development officer,  in a joint statement.

Encorium also appointed Peter Asplund country manager of the company’s Swedish operations. He was formerly the director of marketing and business development at AstraZeneca. His previous posts also include director of business development at GlaxoSmithKline in the UK.

Laboratory Testing

St. Louis-based diagnostic testing company Biomedical Systems named Geert Dewulf, M.D. , managing director of the company's European operations, replacing Rita Jacobs who is set to retire Geert_dewulf_2following 27 years with the company. Dewulf will be based in Burssles, Biomedical System's European headquarters. Prior to joining Biomedical Systems, Dewulf held positions at Agfa Healthcare, where he served as Managing Director for Germany, Austria and Switzerland. Biomedical Systems provides centralized diagnostic testing (including cardiac safety and imaging) for clinical trials.

Technology

Ft. Lauderdale, Fla.-based eClinical provider OmniComm Systems promoted Stephen Johnson to chief operating officer. Prior to this position, Johnson was executive vice president of business development and professional services. He has been with OmniComm Systems since 2006, when he was appointed senior vice president of business development. "We have opened new offices in Bonn, Germany and Tula, Russia to support global clinical trials, we have built dedicated Professional Services and Clinical Services and Support divisions, built a bridge from Oracle Clinical to OmniComm through our OC Connect program and we have implemented our extremely successful CRO Preferred Partnership program. Steve has been the defining influence for all of these programs that were developed to provide quality deliverables to our customers. We look forward to benefiting from Steve's experience and dedication as he leads operations as our new COO," said OmniComm's chief executive officer Cornelis Wit.

Be sure to send Clinical Trials Today your organization's latest personnel news!

Bio's National Investor Conference Plays Matchmaker

Apr 23, 2008 12:21:00 PM

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By Stephen DeSantis

CenterWatch ‘watched’ as more than 60 emerging biotech companies and 125 venture capitalists from across the U.S. converged at the 1st annual BIO National Venture Conference in Boston this week.

The event was hosted by the Biotechnology Industry Organization (BIO), the National Venture Capital Association (NVCA) and the Massachusetts Biotechnology Council (MBC). Boston will now become the Conference’s permanent home.

The conference was designed to bring young, early-stage, startups together with potential investors to fill the coffers of the next wave of biotech hopefuls. These firms often are on the cutting-edge of developing new treatments involving innovative antibiotics, RNA-based therapies, and stem cell and regenerative medicines. The mating game was especially poignant given what many perceive as a severe funding drought in the life science industry.

“This conference is aimed squarely at the seed stage companies of today. We want to help get their footing and grow to become the industry leaders of tomorrow,” said Jim Greenwood, president and chief executive officer of BIO, during his opening remarks.
Greenwood_sd

A recent report by the NVCA found that first quarter 2008 funding for seed and early stage enterprises – especially essential for young biotechs –fell 17% in to $1.7 billion compared with the first quarter of 2007. Overall, venture funding in all sectors was down 5% to $7.1 billion compared with the same period in 2007.

The software industry led the pack with the most venture funding; however, the news wasn’t all bad for life sciences. The biotechnology and medical device sector had the largest number of deals (234) of any industry during this year’s quarter.

Recently, large pharma has been on a biotech buying spree of sorts, paying well for promising companies. Such recent deals include GlaxoSmithKline purchase of Sirtris Pharmaceuticals  for $720 million and last month Takeda Pharmaceutical announced it will pay $8.8 billion for Millennium Pharmaceuticals...

Continue reading... »

CWWeekly April 14th 2008 Issue

Apr 19, 2008 12:07:00 PM

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Top News
      
Coast IRB Receives FDA Warning Letter

Coast IRB, an independent institutional review board (IRB) based in Colorado Springs, Colo., received a Warning Letter from the U.S. Food and Drug Administra-tion (FDA) concerning the company’s improper expedited review of a phase I study being conducted in northern California. In an unusual move, the agency has temporarily suspended the IRB’s ability to do expedited reviews.

LabConnect Gains Centralized Pathology Testing with Bostwick Scientific Deal

LabConnect, a clinical trial–focused central laboratory provider based in Seattle, Wash., has inked an agreement with Bostwick Laboratories, adding one of the top anatomic pathology testing companies to its international list of networked labs.
      
Other breaking news...      

Company Profile: An interview with Paul Bishop, managing partner, and Lyle Camblos, managing partner, Atlantic Research Group

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


 

Magic Johnson—Celebrity Spokesperson for Minority Patient Recruitment?

Apr 18, 2008 12:18:37 PM

By Sara Gambrill

Earvin “Magic” Johnson, NBA champion and chairman and chief executive officer of the Johnson Development Corp., came to IIR’s 17th Annual Partnerships with CROs in Las Vegas, Nevada, with a mission—to urge pharma to increase minority participation in clinical trials. But, he left, quite possibly, with an even bigger mission—to become a celebrity spokesperson for minority patient recruitment.

Johnson began a talk that touched on the personal and professional and made people laugh as well as reflect by pointing out some important statistics.

Magic_johnson_3“Half of America will be minorities in 40 years. We must get them involved. We must do a better job to educate them. They have to take part in what’s going on in medicine,” said Johnson. “I’m going to do my part. I know the reason I’m standing here 16 years [after being diagnosed with HIV] is because someone participated in a clinical trial.”

During his talk, Johnson discussed the anguish of having to tell his wife about his HIV diagnosis and his fears at that time for both her health and their baby’s health. (His wife was pregnant at the time and both his wife and child were healthy.) He discussed the physical and emotional difficulties of receiving an HIV diagnosis in those days.

“When I first announced [in 1991] that I had HIV, we only had one drug—AZT. My doctor started off having me take it 15 times a day because I’m big. It’s the only time I wished I wasn’t tall,” he joked. “Now there are 26 drugs,” Johnson said in gratitude to the hundreds of clinical researchers present at his talk.

Continue reading... »

CenterWatch Monthly April 2008 Issue

Apr 17, 2008 4:14:00 PM

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FDA Debarment Failures a Wake-Up Call for CROs, Drug Sponsors

After Congressional hearings on the antibiotic Ketek, a Congressional committee issued a scathing report on the FDA’s debarment process. The min-ority committee charged that debarment proceedings against individuals are inconsistent and haphazard. Staffers uncovered cases where individuals convicted of a felony related to the development or approval of a drug product were not debarred, while other individuals with similar circumstances or convictions were debarred. In response to Congressional concerns, sponsor companies and CROs should examine their processes and improve investigator selection and training methods to avoid potential debarment or disqualification proceedings.

CROs: The Promise of Biotech and Beyond

CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and others have been working hard to cater to biotech clients for several years. Those efforts should continue to pay off in 2008, which looks to be a good year for biotechs. With large pharmaceutical companies emphasizing biotech products more than ever, large CROs can leverage their expertise in biologics for additional work with existing customers. They can also take advantage of their global infrastructure in emerging markets. But there are some warning signs concerning sustained growth.

Innovative Medicines Initiative Gets Underway During DIA EuroMeeting

The afternoon session on the first day, March 3, of the DIA Euro-Meeting in Barcelona called “Innovative Medicines Initiative: The EU Commission/EFPIA Public-Private Initiative—Up and Running?” answered affirmatively the question it posed in its title.

Eye On: Osteoporosis

In osteoporosis, the density and quality of bone are reduced, with loss of bone mineral density (BMD) and changes to bone structure causing bones to become more porous, brittle and highly susceptible to fracture. Bones at the hip, spine and wrist are particularly vulnerable to osteoporotic fracture. CenterWatch has identified a pipeline of 15 drugs in various stages of development for osteoporosis. Many of these are novel formulations of PTH or target hormonal pathways in other ways, whereas others capitalize on recent advances in understanding of bone metabolism.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

Coast IRB Receives FDA Warning Letter

Apr 15, 2008 11:42:00 AM

By Stephen DeSantis

Coast IRB, an independent institutional review board (IRB) based in Colorado Springs, Colo., received a Warning Letter (to see document click here ) from the U.S. Food and Drug Administration (FDA) concerning the company’s improper expedited review of a phase I study being conducted in northern California. In an unusual move, the agency has temporarily suspended the IRB’s ability to do expedited reviews.

Text from the warning letter:

Fda_9

An FDA Warning Letter is quite rare among independent or central IRBs with perhaps one or two issued in a single year. Warning letters to institutional review boards in hospitals or academic settings are more numerous, with the FDA issuing six per year on average.

Coast’s warning letter stemmed from an FDA audit conducted between July 10 and 18, 2007. IRBs are subject to such standard audits every five years. The FDA subsequently reported its inspection findings to the company in a standard Form FDA 483.

“We were surprised to get it. We thought we had adequately responded to the FDA. Obviously the FDA had a different view on that,” said Gary King, general counsel for Coast.

Although Coast stated it has taken steps to minimize any disruption in its business, by adding review boards and holding more frequent meetings, not having the ability to do expedited reviews will no doubt put stress on the company.

Number_of_irb_warning_letters_4

“That is going to be a tremendous burden because there is a huge amount of work that is done via expedited review. And these can be as minor as a change of a comma to a semicolon on a consent form,” said David Vulcano, vice-chairman, board of trustees of the Association of Clinical Research Professionals (ACRP). Vulcano has researched IRB issues extensively, including warning letters.

Coast’s responses to that inspection letter were submitted in August and November 2007; however, they have not been made publicly available. According to the FDA, the company failed to address its concerns in their responses, prompting the agency’s action.

Continue reading... »

CWWeekly April 7th 2008 Issue

Apr 11, 2008 5:12:44 PM

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Top News

Parexel Buys Larger Stake in India Venture and Expands Phase I Business in U.S., Europe

Waltham, Mass.-based contract research organization (CRO) Parexel has grown its early phase operations with an expansion of three clinical pharmacology units (CPUs), located in Baltimore, London and Berlin.

Progenitor Grows Organically in Latin America, India

The opening of Progenitor International Research’s new office in Buenos Aires, Argentina, a year ago signaled the beginning of a fundamental change to the company’s business model. Previously, Progenitor had worked exclusively as a CRO composed of teams in emerging markets who worked under a coordinated platform to deliver global development services. Progenitor’s office in Argentina represents the first organic growth of the company in an emerging market.

Other breaking news...

Averion’s 2007 net service revenue up...
Baylor College publishes plan for improving clinical trials...

Company Profile: An interview with Janice Sidorick, MPH, managing director, Janix, LLC

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

Parexel's Josef von Rickenbach On Phase I Activity

Apr 8, 2008 6:16:00 AM

Parexel recently expanded its early phase operations in three of its phase I facilities. The move brings the company’s global phase I bed capacity to one of the largest in the industry, at 550.

Parexel also has phase I services in India through a partially owned venture with Synchron Clinical Research’s Ahmedabad-based facility, which has 86 beds. Last month, Parexel increased its ownership stake in that venture from 19.5% to 31% at a cost of $5 million. At the same time, Parexel sold its France-based bioanalytical and biomarker testing laboratory facility—owned since 1999—to a subsidiary of Synchron for approximately $6.7 million. The unit will now be called Synexel Research International and will stay within Synchron’s operational network.

ClinicalTrialsToday recently asked Josef von Rickenbach, Parexel's chairman and chief executive officer, to provide some additional insight into the CRO's recent moves within the burgeoning  phase I market.

Continue reading... »

U.S. Disease Foundation Investment in Biopharmaceutical Industry Continues to Rise

Apr 7, 2008 2:47:58 PM

U.S. disease foundations invested about $75 million last year in biopharmaceutical companies to fund discovery and development of new drugs and therapies for their corresponding diseases, according to CenterWatch estimates published in the August 2007 issue of The CenterWatch Monthly.

Us_disease_foundation_in_biotech__4The 2007 figure represents a 10-fold increase since 2000, and foundations’ investment continues to rise.

The Boston Globe picked up the story about this kind of investment, called “venture philanthropy” when it wrote about the Cystic Fibrosis Foundation’s latest investment in Lexington, Mass.-based Epix Pharmaceutical.

Read today’s Globe article for more.


To read the full article from this issue or for more information on these and other breaking stories, please click here.

EDICT Report Provides Road Map To Comprehensive Patient Enrollment

Apr 7, 2008 6:01:00 AM

A much anticipated report published by Baylor College’s Eliminating Disparities in Clinical Trials [EDICT] project has provided a nine-step action plan for improving the policies surrounding the conduct of clinical trials. The EDICT project set out to create a series of policy proposals designed to help patient recruitment and retention in clinical trials. The four-year project is supported by an unrestricted grant from Genentech.

Among the issues the policies meant to address are minority participation, patient insurance, informed consent, and standards and accreditation.

“Although disparities in clinical trials has been discussed and debated extensively, this problem has generally been under-addressed and, as a result, has received little direct, systematic, or sustained intervention,” said Armin Weinberg, Ph.D., director of Baylor College of Medicine’s Chronic Disease Prevention and Control Research Center and EDICT’s principal investigator.

Continue reading... »

CWWeekly March 31st 2008 Issue

Apr 4, 2008 12:01:29 PM

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Top News     

Bio-Imaging Technologies Acquires Phoenix Data Systems

Newton, Pa.-based contract research organization (CRO) Bio-Imaging Technologies has opened up a new book of business with the acquisition of eClinical company Phoenix Data Systems. Bio-Imaging, which specializes in running trials that require medical imaging management, purchased the King of Prussia, Pa.-based company for $24 million, including $17 million in stock and $7 million in cash.      

inVentiv Clinical Moves into Latin America

inVentiv Clinical, the contract research organization (CRO) division of Somerset, N.J.-based marketing, communications and staffing firm inVentiv Health, has expanded its clinical services to Latin America with a new central hub in São Paulo, Brazil. The company stated it plans to bolster its operations in other countries throughout the region as well.

Other breaking news...      

Quintiles inks agreement with Medca Japan...
Encorium Group inks $2.5 million in new contracts...

Company Profile: An interview with Patrick Hughes, senior vice president, Exco InTouch

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

Parexel Buys Larger Stake in India Venture and Expands Phase I Business in U.S., Europe

Apr 4, 2008 11:09:00 AM

By Stephen DeSantis

Waltham, Mass.-based contract research organization (CRO) Parexel has grown its early phase operations with an expansion of three clinical pharmacology units (CPUs), located in Baltimore, London and Berlin.

The expansion brings the company’s total worldwide phase I bed capacity to 550, one of the largest in the industry, the company stated. Parexel also has CPUs in San Diego and Los Angeles, and two facilities in South Africa. Each of its phase I facilities uses its clinical trial management and electronic data capture (EDC) technology, ClinBase. The company’s early phase services include bioanalytical services, data management, biostatistics, medical writing, pharmacokinetic services and consulting.

Continue reading... »

Averion Sees Fruits of Acquisition

Apr 3, 2008 1:28:24 PM

Southborough, Mass.-based contract research organization (CRO) Averion showed signs that its recent acquisitions and operational changes are paying off. Averion reported that 2007 net service revenue was up an impressive 163% to $34.8 million, due primarily to its acquisition of Swiss-based CRO Hesperion. Averion paid $36.2 million for the company in November. That acquisition doubled the size of Averion’s staff to 400 and expanded its operations into 14 countries.

“With our broader geographic base, expanded client relationships, and added capabilities for managing full-service, large global clinical trials, we are well-positioned to capitalize on the growing trend favoring clinical trial outsourcing,” said Averion’s chief executive officer, Markus Weissbach, M.D., PhD.

And Although Averion’s income from continuing operations was still in the red with a loss from of $3.9 million, it is inching closer to profitability. Its loss is down from $4.6 million in the year prior. The company is getting more efficient as well. Direct expenses during 2007 increased to $20.7 million versus $8.2 million during the prior year; however, those expenses as a percentage of revenues decreased to 59% in 2007 from 62% the year prior.

The company reported a research backlog of $74.7 million last year compared to $35.6 million in 2006. Again, its backlog of business was due to Hesperion’s strong contribution. In October 2007, the company sold its staffing services business to members of that division’s management. That move resulted in a loss from discontinued services of $1.4 million during 2007 compared with $500,000 during the prior year.

Averion went public in July 2006 in a reverse merger with San Diego-based company IT&E International, a regulatory compliance and validation services firm.

NPS Pharmaceutical in Talks with FDA After More Positive Results with Gattex

Apr 2, 2008 7:28:00 AM

By Tracy Trundle

NPS Pharmaceuticals issued positive results from a phase III extension study of Gattex (teduglutide), an injectable glucagon-like peptide-2 (GLP-2) analog, for the treatment of short bowel syndrome (SBS) in subjects who are dependent upon parenteral nutrition (PN).  PN is the practice of feeding a patient intravenously, the cost of which can exceed $100,000 a year.

SBS is a disabling syndrome that can arise after a resection of the small bowel. There are an estimated 10,000 to 15,000 SBS patients in North America who are PN-dependent.

Gattex was granted Orphan Drug status in the U.S. for SBS in August 2000.

This extension study enrolled 65 of the 71 subjects who had completed a 24-week randomized phase III study that evaluated low dose Gattex (0.05 mg/kg/day) and high-dose Gattex (0.10 mg/kg/day) versus placebo. The primary objective of the study was to assess the long-term safety and tolerability of daily Gattex dosing for up to 52 weeks.

Sixty-eight percent of the subjects who had received low-dose Gattex therapy and continued on low-dose Gattex, and 52% of the subjects who had received high-dose Gattex therapy and continued on high-dose Gattex achieved a 20% or greater reduction in PN after a total of 52 weeks of therapy.

Subjects treated with low-dose Gattex showed a mean 51% reduction in PN volume from pretreatment baseline to the end of 52 weeks (p< 0.001) and those treated with high-dose Gattex experienced a mean 24% reduction (p< 0.001).All of the subjects (100%) who had previously received placebo in the phase III study and were randomized to low-dose

Gattex therapy, and two out of seven subjects who had previously received placebo in the phase III study and were randomized to high-dose Gattex therapy, achieved a 20% or greater reduction in PN after a total of 28 weeks of therapy in the extension study.

Treatment was well tolerated in both dose groups with no statistical differences in the rate of adverse events compared with the placebo group.

Based on a series of positive phase III results, NPS is currently meeting with the FDA to discuss the path towards regulatory approval.

Tracy Trundle is a Research Analyst at CenterWatch.

MHRA’s New Phase I Accreditation Scheme in Effect Today

Apr 1, 2008 1:26:20 PM

By Sara Gambrill

The Medicines and Healthcare products Regulatory Agency’s (MHRA) voluntary Phase I Accreditation Scheme went into effect today with the stated goal of formalizing routine inspections and increasing the scope and depth of inspections. Most importantly, the aim of the MHRA’s new scheme is to avoid harm to trial subjects and for handling medical emergencies during first-in-human trials should they arise.

In the wake of the international media attention that TeGenero received in March 2006 after administering TGN1412 to six healthy volunteers who suffered a nearly fatal “cytokine storm,” the UK in particular has intensely scrutinized how first-in-human phase I trials are conducted and how their conduct could be improved. 

In response to the Duff Report, the European Medicines Agency (EMEA) released a new guidance document on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. The guideline went into effect September 2007.

Out of the 22 recommendations made by the Duff Report, three fell under the category of “the clinical environment for first-in-man studies” and two under “developing expertise” on the part of clinical research personnel conducting first-in-human clinical trials.

The final recommendation reads, “The development of a national inspection and accreditation system for clinical centres that undertake first-in-man studies of higher risk agents should be encouraged. The accreditation should be open to all centres that fulfill defined criteria, in both the public and private sectors.”...

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Quintiles to Partner with Japanese Lab Company Medca

Mar 31, 2008 3:31:00 PM

Research Triangle Park, N.C.-based CRO Quintiles inked an agreement with Medca Japan, a laboratory testing and nursing care services company based outside Tokyo in Saitama, to use its lab to support clinical trials in the country. Medca Japan’s facility and staff are College of American Pathologists (CAP)-certified and its data will be available on Quintiles’ QNET database. Quintiles stated that Japanese regulations are changing in a positive way and are now allowing pivotal clinical trials to be conducted outside of Japan into the greater Asia region.

The challenge has been finding laboratories in the region that are “harmonized” with the same standards, the company stated. Quintiles now has central lab coverage in the Asia-Pacific region through a network of CAP-certified labs in Beijing, Singapore, Mumbai and now Japan.

Founded in 1974, Medca reported $340 million in revenue in 2007 and is also a medical supply manufacturer and distributor. It is also a leading pharmaceutical importer and seller in the country. The partnership is headed by Alan Ong, vice president and general manager, Quintiles Labs Asia, and Yoh Narimatsu, president, Quintiles Japan.

“We have established excellent systems for providing high-quality central laboratory services based on Quintiles’ global standard. We are determined to continue to increase clinical trials in Japan and provide superior services for our customers through this strategic business alliance,” said Narimatsu.

CWWeekly March 24th 2008 Issue

Mar 28, 2008 11:04:00 AM

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Top News

Medidata on Fast Track with First Acquisition

New York, N.Y.-based eClinical vendor Medidata Solutions purchased Fast Track Systems, a protocol design and study management software maker based in Pennsylvania. Fast Track’s chief executive officer, Ed Seguine, will become Medidata’s new general manager of trial planning solutions. The company’s chief technology officer, Peter Abramo-witsch, and vice president of operations, Lori Shields, will also join Medidata’s trial planning group. Fast Track’s offices in Conshohocken, Pa., and in Ross, Calif., will continue to operate. The company has 35 employees.

Project to Develop Guidelines for Health Research in Africa Launched

The “Clinical Trials Roundtable” attracted more than 70 participants during the “Science with Africa” conference organized by the United Nations Economic Commission for Africa (UNECA) and the African Union (AU), which is an international organization that promotes cooperation among the independent nations of Africa. The conference was held in Addis Ababa, Ethiopia, and attended by more than 600 stakeholders, including representatives from health and science ministries, universities, non-governmental organizations and international organizations from Africa, Europe and North America.

Other breaking news...      

Company Profile: An interview with Amanda Drake, founder and director, HUNT Services, LLC

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

Progenitor Grows Organically in Latin America, India

Mar 27, 2008 3:36:00 PM

By Sara Gambrill

The opening of the Progenitor International Research’s new office in Buenos Aires, Argentina, a year ago signaled the beginning of a fundamental change to the company’s business model. Previously, Progenitor had worked exclusively as a CRO composed of teams in emerging markets who worked under a coordinated platform to deliver global development services. Progenitor’s office in Argentina represents the first organic growth of the company in an emerging market.

Progenitor International Research is an emerging market contract research organization (CRO) founded in 2005 with headquarters in Deidesheim, Germany. The company’s global management functions reside in Europe, and clinical research is conducted in 12 countries—Argentina, Chile, Peru, India, China, Korea, South Africa and countries in Southeast Asia.

Progenitor conducts clinical research in South Africa and in countries in Southeast Asia through partnerships, but the company is growing organically in the other countries in which it operates. The company has 800 clinical research professionals working together with Progenitor in emerging markets who have experience on more than 500 clinical trials.

CenterWatch caught up with three key members of the operations team at Progenitor International Research at the DIA EuroMeeting in Barcelona to find out how the new model was working and what plans the company had for growth in 2008 and beyond...

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Bio-Imaging Technologies Acquires Phoenix Data Systems

Mar 26, 2008 2:25:47 PM

By Stephen DeSantis

Newton, Pa.-based contract research organization (CRO) Bio-Imaging Technologies has opened up a new book of business with the acquisition of eClinical company Phoenix Data Systems. Bio-Imaging, which specializes in running trials that require medical imaging management, purchased the King of Prussia, Pa.-based company for $24 million, including $17 million in stock and $7 million in cash.

Following the acquisition, Bio-Imaging raised its revenue guidance range from $42 to $45 million to $52 to $55 million. It boosted its earnings guidance from 21 to 23 cents per share to 22 cents to 24 cents per share. The company reported service revenues of $38.2 million last year.

Crosstree Capital Partners acted as financial advisors on the deal.

For the near-term, Bio-Imaging plans to manage the company as a separate entity while it finds ways to leverage its core CRO business.  The company stated it will be looking for sales force, marketing and technology efficiencies. For now, Phoenix Data Systems will remain relatively unchanged. The company will keep its name and continue to be run by its current president, William Claypool, M.D. All 127 of its employees will remain part of the organization. 

“We do see tremendous opportunity, probably in the next year time-frame, to start to look at how we can do things more efficiently and grow more revenues without growing as many people,” said Mark Weinstein, president and chief executive officer at Bio-Imaging stated during a conference call...

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Project to Develop Guidelines for Health Research in Africa Launched

Mar 24, 2008 6:09:00 AM

By Sara Gambrill

The “Clinical Trials Roundtable” attracted more than 70 participants during the “Science with Africa” conference organized by the United Nations Economic Commission for Africa and the African Union, which is an international organization that promotes cooperation among the independent nations of Africa. The conference was held in Addis Ababa, Ethiopia, and attended by more than 600 representatives, including representatives from health and science ministries, universities, non-governmental organizations and international organizations from Africa, Europe and North America.

Two representatives from industry were also in attendance—Dr. Richard C. Hubbard, senior director, External Medical Affairs, International, Office of the Chief Medical Officer, Pfizer, and a representative from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents the global research-based pharmaceutical industry.

Much of the Clinical Trials Roundtable, chaired by Mrs. Avril Doyle, member of European Parliament, focused on identifying the needs of African countries for guidelines in clinical trials and other areas of health research. It also provided an opportunity for leading African and international partners to develop a consensus position on the organization of the project to develop guidelines for health research in Africa.

Francis Crawley, executive director of Brussels, Belgium-based Good Clinical Practice (GCP) Alliance, which he founded in 2005, was approached by organizers of “Science with Africa” in October to participate. Crawley has extensive experience in creating GCP guidelines and model bioethics laws in Eastern European, Asian and African countries. He was also asked to speak briefly at a meeting in the European Parliament in December and subsequently to write an abstract for the roundtable.

More than 70 attended the Clinical Trials Roundtable, which ran for four hours. About 80% of participants were from Africa and the rest were from Europe, the U.S. and Canada, according to Crawley. The industry representatives also participated. At a pre-meeting to the roundtable, African participants made it clear that, despite the existence of many international guidelines, Africa needed its own.

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inVentiv Clinical Moves into Latin America

Mar 24, 2008 5:12:00 AM

By Stephen DeSantis

inVentiv Clinical, the contract research organization (CRO) division of Somerset, N.J.-based marketing, communications and staffing firm inVentiv Health, has expanded its clinical services to Latin America with a new central hub in Sao Paulo, Brazil. The company stated it plans to bolster its operations in other countries throughout the region as well.

inVentiv Clinical has placed Ana Paula Ruenis, Ph.D., in charge as director of clinical operations in Latin America. Ruenis has more than eight years of experience managing trials in Latin America and has worked for top pharmaceutical companies in South America.

"Having already established full off-shore operations in India, the expansion of our clinical operations into Latin America is an important next step in our goals to become a global clinical services provider," said Mike Hlinak, inVentiv Clinical’s chief executive officer.

Latin America has proven to be an emerging market of choice of late. It poses less of a logistical challenge than do more remote regions such as China and India. The six major markets—Argentina, Brazil, Chile, Colombia, Mexico and Peru—have 425 million people, or 80% of the region’s population. That is equal to the population of the entire European Union but less than half the size of India or China.

Continue reading... »

CWWeekly March 17th 2008 Issue

Mar 21, 2008 11:18:34 AM

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Top News
 
Global Research Services Expands in China

Maryland-based Global Research Services (GRS) has expanded its China operations and will now offer full clinical trial services to its clients there. The company, through its subsidiary Global Medical Consulting Services in Shanghai, will provide monitoring, site selection, project management and data management. Prior to the expansion, the office, originally set up in 1996, offered data management.

Clinical Research Advantage Adds 11th Research Site

Phoenix, Ariz.-based site management organization (SMO) Clinical Research Advantage has added Phoenix-based general practice research site Tatum Highlands Medical Associates to its network. Clinical Research Advantage will handle overall study management, regulatory, budgets, business development and ongoing quality assurance. Clinical Research Advantage has 48 employees. In February 2007, a private investment group put money into the company and began an expansion program.

Other breaking news...      

  • etrials’ reports $2.6 M loss...
  • Cato names John Cline as president...

Company Profile: An interview with David Williams, chief executive officer, Clinsys Clinical Research

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

PRA Relocates to Larger India Office

Mar 19, 2008 3:02:00 PM

Raleigh, N.C.,-based PRA International has expanded its Mumbai, India, presence by moving into a larger facility. It is located in a new development in the Andheri East area of Mumbai. The new space can hold more than 20 clinical staff and allow for PRA to bring its total to 50 employees there by the end of the year. The company said this would potentially increase its service capacity by 150%. As the office grows, PRA will increase services in protocol development, medical writing and clinical consultation services in the region.

"This is an exciting time for PRA," said Dr. Sue Stansfield, executive vice president, Product Registration, Europe, Africa and Asia-Pacific. "The Mumbai team is a great example of PRA's global experience and therapeutic expertise.  Their success in earning client trust and delivering service excellence has been key to the growth we are experiencing in India."

eClinical Technology News

Mar 18, 2008 1:55:00 PM

Ft. Lauderdale, Fla.-based OmniComm Systems won a contract from Pleiad Devices, a medical device focused contract research organization. OmniComm will become a preferred vendor for Pleiad. The company will use OmniComm’s electronic data capture (EDC) product TrialMaster, initially for a trial studying an eye treatment. "Over the years, our team has had experience with most of the EDC vendors in the marketplace. TrialMaster is one of the best EDC products that we have seen and we look forward to offering our medical device customers this premier service," stated Stephen Brandao, vice president of business development at Pleiad Devices.

UK-based ClinPhone launched a combination EDC and interactive voice response and interactive web response (IVR/IWR) product to help its clients eliminate costs associated with integrating such technologies separately. The EDC component will be DataLabs – the company’s EDC solution obtained through the acquisition of DataLabs in late 2006 – combined with its IVR/IWR solutions for trial management and electronic patient reported outcomes (ePRO) needs. ClinPhone stated the new product guarantees the data that is shared between the two systems will be accurate via the company’s Connect integration platform.

Waltham, Mass.-based CRF has updated its ePRO software product TrialMax to be used on Tablet PC-based eDiaries running Window’s Vista. While the company stated the use of portable devices has created great benefit to its clients, it also sees the advantages of using Tablet PCs for some studies, and with certain patient populations. All of the company’s TrialMax capabilities -- including TrialManager and TrialStudio -- will be supported by all three device types.

Maryland-based clinical technology company Xceleron launched META-ID, a product designed to help clients comply with the FDA guidelines regarding Safety “Testing of Drug Metabolites”. The guidelines were published in February 2008 and seek to encourage more research into a drug’s metabolic differences between preclinical test species and humans. The company stated the product can be integrated into phase I studies already underway and deliver data within two weeks.

Oracle Clinical unveiled a new version of its EDC solution called Oracle Remote Data Capture Onsite 4.5.3. The enhanced product offers new functions geared toward helping investigative site personnel work more efficiently with upgrades such as new spreadsheet displays of multiple case books and edit check capabilities. The company cites industry experts who believe that investigative sites have not traditionally had their voices heard. 

Waltham, Mass.-based Phase Forward released Empirica Trace, an enhanced version of the company’s current adverse event reporting product Clintrace. The new product will bring together Clintrace’s capabilities with the company’s pharmacovigilance and risk management solutions. The product will be managed by Phase Forward’s Lincoln Safety Group. The product is web-based and will provide clients the ability to collect, analyze and report adverse events as well as handle global report distribution, quick data entry and MedDRA query support.

Cambridge, Mass.-based clinical management software provider PharmaPros unveiled its new product Electronic Data Lifecycle Management (eDLM) designed to manage information gathering during clinical research. The company stated its eDLM uses proprietary data integration technology to provide tracking and reporting functionality easily within client’s own systems. The tool allows clients to “orchestrate” this process from various data repositories and from multiple vendors, a capability that is becoming necessary within the industry.

CenterWatch Monthly March 2008 Issue

Mar 17, 2008 12:18:00 PM

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Unanticipated Problems Reporting Adverse Events to IRBs

FDA regulations governing adverse event reporting and IRBs have become outdated. At a time when clinical research is increasingly being conducted abroad and clinical trials are growing larger and more complex, IRBs are being inundated with single adverse event reports, which they have neither the resources nor the expertise to analyze. In recognition of this growing problem, both OHRP and FDA issued guidance last year. FDA has recognized and more narrowly defined the IRB’s role in clinical research oversight and underscored the necessity for sponsors to send IRBs analyzed reports on the data, in its draft guidance. Sites are caught between IRBs’ own clear reporting guidelines and sponsors taking a conservative position and demanding that sites report all adverse events to the IRB.

Global Growth Story Remains Strong for CROs in 2008, Beyond

Contract research organizations (CROs) report strong growth across all phases of drug development as cancellation rates remain at historic lows. Public CRO shares remain a strong sector in a shaky stock market as CROs report consistent revenue and profit growth. Global CROs are in a strong position in the industry as they solidify their leadership in global clinical trials in emerging regions. CROs such as Covance, ICON, Kendle, Parexel, PRA, PharmaNet, PPD, Quintiles and a few others are well positioned with global infrastructures in place to continue handling global growth.

Addressing the Shortage of Skilled Clinical Researchers in Europe

Difficulties finding and keeping suitably qualified clinical trials personnel have intensified in Europe. Observers agree that the available workforce simply isn’t large enough to meet staffing needs. The result has been spiraling salaries, as experienced professionals—and even relatively new recruits to the industry—capitalize on the staffing shortfalls.

Eye On Prostate Cancer

Second only to skin cancer, prostate cancer is the most common cancer, according to the American Cancer Society. In the United States, it is also the second most frequent cause of cancer-related death in men (after lung cancer), with approximately 30,000 men dying each year from the disease. CenterWatch has identified a pipeline of 23 pharmacotherapeutic agents in various stages of development for prostate cancer. Many of these affect either hormonal or immunological pathways, whereas others are novel formulations of more traditional chemotherapeutic agents.ch year from the disease.

To read the full articles for this issue or for more information on these and other breaking stories, please click here.

Recent Industry Personnel Changes

Mar 17, 2008 6:30:00 AM

Contract Research

Raleigh, N.C.-based contract research organization (CRO) INC Research hired Richard Williams to serve as vice president of the company’s regulatory services. He will help lead the strategic consulting group and all other global regulatory activities. Prior to INC, Williams worked in senior regulatory positions at Merck and Pfizer.

UK-based CRO Premier Research Group hired Sebastien Duval to become the company’s business development director based in France. Prior to joining Premier, Duval was senior business director at the preclinical CRO, CIT. He has also held positions at Chiltern, Parexel and CEREP.

Waltham, Mass.-based CRO Parexel appointed Jacque Fisher to the position of vice president and general manager for its Medical Communications Services division. Fisher will head a group that assists Parexel’s clients to translate scientific information into less complex communications and will advise customers on their communications programs. Prior to joining the company, Fisher was president of Gardiner-Caldwell U.S., a former business unit of Thomson Healthcare. She also held senior-level positions at Page & Moy Marketing in the U.K.

Technology

Waltham-based eClinical company Phase Forward appointed Russ Campanello to senior vice president of human resources and administration. Campanello was the senior vice president at Keane, a worldwide tech consulting firm. Prior to Keane, he held senior roles at NerveWire and Genzyme.

BioPharma Services

Bethesda, Mary.-based United BioSource Corporation expanded its Ann Arbor based regulatory affairs group with the additions of Mark Ammann, Pharm.D., and LaVonne Lang, Dr. PH. Both Ammann and Lang are former regulatory executives at Pfizer.

CWWeekly March 10th 2008 Issue

Mar 14, 2008 10:30:00 AM

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Top News

AbCRO Opens Two Offices in Russia

Sofia, Bulgaria-based, American-owned contract research organization AbCRO opened two offices in Russia. AbCRO currently has 170 employees. AbCRO also has offices in Bucharest and Cluj, Romania; Zagreb, Croatia; and Belgrade, Serbia. In addition, the company opened an office in Warsaw, Poland, last year.

PRA Doubles Kansas Phase I Unit

Raleigh, N.C.-based contract research organization (CRO) PRA International has opened a new clinical pharmacology unit (CPU), adding about 40 beds in Lenexa, Kansas.The facility replaces a smaller nearby phase I unit and doubled PRA’s presence in the area to 80 beds. The 16,000-square-foot facility was built at a cost of about $2 million. According to Tamminga, the new CPU in Kansas will focus on “high-end” complex trials that require a lot of skill and knowledge to perform.

Other breaking news... 

  • GRS launches phase I data management platform...
  • Georgia Institute of Technology develops drug compliance device “necklace”...

Company Profile: An interview with Ron Waife, president, Waife & Associates

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

Japan’s New Regulatory Attitude Evident at DIA EuroMeeting

Mar 12, 2008 11:49:59 AM

By Sara Gambrill

One of the highlights of the DIA EuroMeeting in Barcelona certainly had to be the update from Japan’s regulatory agency, Pharmaceutical and Medical Devices Agency (PMDA). The session was introduced by Yoshiaki Uyama, Ph.D, a review director at PMDA, who  was wearing a PMDA T-shirt, instead of a suit and tie, which admittedly seemed too casual. He explained that his luggage hadn’t arrived at the same time he had, which produced knowing laughter.

What he went on to say was both surprising and refreshing, coming from a representative of PMDA. He said that he had wondered what he would wear if he didn’t get his luggage in time for the session. In the end, even though he had been reunited with his clothing in time, he decided to wear the PMDA T-shirt to foster an informal atmosphere for the session, which he hoped the audience would find acceptable. This last sentiment was met with an enthusiastic round of applause from the hundreds in attendance, many from big pharma.

Clearly the message PMDA wanted to send during its session was that the agency is striving for openness, cooperation and timeliness to promote Japan’s role in global drug development.

Both Uyama and Satoshi Toyoshima, Ph.D., executive director and director, Center for Products Evaluation at PMDA, discussed many objectives and initiatives to accelerate the drug process in Japan, but the initiative that will have the most immediate impact will launch in April. With the new Investigational New Drug Application (IND) Consultation Process, PMDA wants to increase the number of face-to-face meetings with sponsor companies and also meet with them in a more timely manner.

Uyama noted that in 2006 there were 473 sponsor applications for IND consultations with PMDA, with only 295 actually granted. PMDA wants to increase the percentage of consultations granted to those sponsors that apply and has a tentative plan that Uyama shared with the DIA EuroMeeting audience. From April forward, the new IND consultation process should have a predictable schedule of about five months, during which sponsors are able to submit an expression of intention, apply and submit documents to PMDA.

Five weeks prior to the face-to-face meeting, there will be an inquiry and response period between sponsors and PMDA. Four days prior to the face-to-face meeting, PMDA will give its opinion, which will be discussed at the meeting. Draft minutes will be drawn up and then finalized one month after the meeting.

Continue reading... »

RLS Drug Shows Promise in Pivotal Trial

Mar 11, 2008 2:04:08 PM

XenoPort and GlaxoSmithKline reported positive top-line results from a phase III trial of XP13512, a gabapentin pro-drug with enhanced absorption, for the treatment of moderate to severe restless legs syndrome. This 12-week, double-blind, placebo-controlled study, dubbed XP053, enrolled 325 subjects. The endpoints were met with statistical significance in both dose groups when compared to placebo.

The subjects received placebo or 600 mg or1, 200 mg of XP13512, given once per day. The primary endpoints were the change from baseline for the International Restless Legs Syndrome (IRLS) rating scale score at end of treatment and the percentage of subjects showing significant improvement on the Investigator Clinical Global Impression of Improvement (CGI-I) scale at end of treatment.

In the 600 mg dose group, the unadjusted mean reduction in the IRLS scale score was -13.8 (p less than 0.0001). 

At the end of treatment, 73% of subjects treated with 600 mg of XP13512 were reported as “much improved” or “very much improved” on the CGI-I scale (p less than 0.0001 compared with placebo). In the 1,200 mg dose group, the unadjusted mean reduction in the IRLS scale score was -13.0 versus -9.8 for placebo (p=0.0015).

At the end of treatment, 78% of subjects treated with 1,200 mg XP13512 were reported as “much improved” or “very much improved” on the CGI-I scale compared with 45% treated with placebo (p less than 0.0001). Treatment was generally well tolerated, with adverse events mild to moderate.

An New Drug Application (NDA) filing is planned for the third quarter of this year.

In February 2007, GlaxoSmithKline and XenoPort entered into an exclusive development and commercialization collaboration for the drug.

etrials' Reports $2.6M Loss

Mar 10, 2008 12:31:00 PM

Morrisville, N.C.-based etrials’ sales were up 17% during its 2007 fourth quarter. The eClinical company reported net service revenue was $4.9 million compared with $4.2 million in 2006. However, it reported a net loss for the fourth quarter of $2.6 million (or $0.24 per diluted share) compared with a net loss of $46,000 (or $0.00 per diluted share) in the fourth quarter of 2006.

The company stated its business costs rose substantially across the board, signifying it is investing heavily to return the firm to profitability. The fourth quarter included a $1.75 million charge it paid for a litigation settlement for a patent infringement case with software developer Datasci.

Net service revenue for the year was up 18%, with $18.3 million reported in 2007 compared with $15.5 million the prior year. etrials reported a loss of $6.2 million (or $0.57 per share)  compared with a $1.8 million loss (or $0.18 per share) in 2006.

The company stated costs were up significantly in all areas. Its sales and marketing costs also rose, partly due to new sales recrui