CWWeekly March 27th 2008 Issue

Top News

NIH Program to Study Patients with Mystery Diseases

For thousands of frustrated patients with diseases that cannot be explained or diagnosed—even by leading specialists in their field—enrollment in clinical trials has not been an option. Without a definitive diagnosis, they are ineligible to participate. Now, through a pioneering program launched by the National Institutes of Health (NIH), there may be hope. The new trans-NIH initiative, called the Undiagnosed Disease Program, will concentrate its research efforts on patients who suffer from unknown, thus unstudied, illnesses.

CDER’s Woodcock Details Expanded Authority, Sentinel Concept at Post-Approval Summit

Opening the Post-Approval Summit at Harvard, keynote speaker Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.

Other breaking news...

Pharm-Olam opens new office in Russia...
ClinPhone establishes new office in Paris...

Company Profile: An interview with Steve Toon, Ph.D., executive director, Simcyp

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.

Chinese Regulators, Pharma Industry Address Ethics Committee Challenges

By Sara Gambrill

A workshop held recently in Beijing presented an overview of the current ethical considerations and procedures for effectively designing, conducting and registering clinical trials in China. A key focus was clarifying the working procedures and challenges for ethics committees, also called institutional review boards, in China.

eClinical Roundup

San Ramon, Calif.-based clinical software company Nextrials stated its 2007 revenues jumped 80% from an increase in multi-study contracts and its efforts in tapping into the medical device market. The company’s main clinical trial management software (CTMS), called PRISM, was used by various device sponsors including CardioMEMS, EKOS, Z-Tech Medical and Gynesonics.

Malvern, Pa.-based clinical technology provider DSG was chosen by Ovation Pharmaceuticals as its preferred provider of electronic data capture (EDC) solutions, using DSG’s eCaseLink software product to conduct multiple phase I trials. Seven of have already started. The sponsor company has already used eCaseLink for five previous phase I trials and six more are planned for next year. Ovation stated it chose DSG because of its “exceptionally clean data” and user-friendly interface. “This translated directly into significant time and cost-savings for us,” said Robert Anders PharmD, vice president of Ovations’ clinical operations. “DSG supported very tight timelines for our Phase I studies.”

Pittsburg, Pa.-based electronic patient reported outcomes (ePRO) company invivodata reported its electronic diary product, DiaryPRO, was used in Alcon’s phase III pivotal trial for Patanase (olpatadine) in the treatment of allergic rhinitis. The drug was recently approved by the FDA. In a two-week period, patients reported data using DiaryPRO twice per day and recording details of nasal symptoms.

UK-based eClinical company ClinPhone  inked a major contract with Veeda Oncology, a new specialty subsidiary of Veeda Clinical Research for the use of ClinPhone’s clinical trial management system, TrialWorks. TrialWorks provides access to real-time trial data and detailed reports. Veeda Oncology will be using the system at large sites in India, France, Germany and the U.S. Veeda stated it narrowed its selection from 10 vendors before finally choosing ClinPhone because it was “intuitive and easy to use, while still offering robust functionality.” ClinPhone stated it was ultimately TrialWork’s user interface and monitoring module that led to winning the contact. The module allows its client’s monitors to upload data remotely and produce reports in Microsoft Word format. “We’re confident that TrialWorks will not only save time for our monitors and site personnel, but will also provide significant support to our project managers, particularly in areas such as the tracking and management of investigator payments,” said Kathy Squillace, vice president of global clinical operations at Veeda Oncology.

Marlbourgh, Mass.-based Datafarm, an electronic data submission tools provider, has partnered with strategic IT consulting firm Court Square Group. Datafarm provides clients tools to manage electronic clinical trial data (eCTD) submissions for regulatory review. The partnership calls for Court Square to support the installation and management of Datafarm’s S-Cubed eCTD product or host the system if desired.

CWWeekly May 19th 2008 Issue

Top News

i3 Research Acquires Russian CRO and i3 Innovus Creates Late Phase Business

i3 Global is solidifying its presence in Russia through the acquisition of Lege Artis, a Moscow-based contract research organization (CRO). Lege Artis conducts phase I through IV trials in Russia and also has operations in Belarus and Ukraine. The CRO is led by its founder and chief executive officer Tatjana Zwereva, M.D., Ph.D., who will stay on with i3 to run the operation. Alexander Makarkov, M.D., Ph.D., a co-founder, will also be joining i3. Lege Artis will be integrated within i3’s contract research division at i3 Research.

Quintiles Consulting Begins New Path with Eidetics Acquisition

Research Triangle Park, N.C.-based Quintiles took another step in its efforts to expand the CRO’s consulting group through the purchase of biopharma-ceutical consulting firm Eidetics. The firm will be integrated into Quintiles Consulting, a 150-employee company with experts from nearly every segment of the pharmaceutical industry. Eidetics performs health economics, decision-analytics and market research services to help sponsors maximize their products post-launch.

Other breaking news...

• etrials reports drop in net service revenue...
• eRT first quarter revenues soar...

Company Profile: An interview with Kazem Kazempour, Ph.D., Amarex

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.

Pharm-Olam Opens Third Office in Russia

Houston, Texas-based CRO Pharm-Olam International, along with its sister-company MB Quest, opened a new office in St. Petersburg, Russia. The office is Pharm-Olam’s third location in the country to date, after expanding into Moscow and Novosibirsk. The new office is set to house 20 clinical staff by the fourth quarter of 2008. The company stated it has been conducting studies in Russia since 1997, but was using regional employees to monitor trials in St. Petersburg. 

“Because of the concentration of state-approved sites for research and the continued interest from sponsors, it made sense to establish a permanent office there,” said Eugene Barg, president of MBQ.

Like Pharm-Olam, MB Quest is a subsidiary of the POI Group.  It operates in Russia, Ukraine, Georgia, and Belarus. It is also a founding member of the Association of Clinical Trial Organizations in Russia (ACTO). Pharm-Olam International Group now has 25 offices worldwide.

CenterWatch Monthly May 2008 Issue

Eli Lilly, Wyeth, Schering-Plough Rated Top Pharma Companies in Europe

Results of the CenterWatch 2008 Survey of Investigative Sites in Europe found Eli Lilly rated the top sponsor to work with. Also rated highly were Wyeth and Schering-Plough. The 2008 survey had more sites in Central and Eastern Europe reporting, and the survey was also extended to Canada. The number of countries reporting increased by 11 to 37. CenterWatch rated a total of 16 large pharmaceutical and biotech companies.

Cardiac Safety Services Back in Rhythm

Cardiac safety monitoring has developed into a sizable industry sector and the growing demand for these services has led to much activity in the space recently. Cardiac safety effects have become a common cause for drug withdrawals and delays in regulatory approval. Many concerns about serious cardiovascular side effects are related to drugs used for non-cardiac indications, such as the arthritis drug Vioxx.

European Biotech Outsourcing on Steep Learning Curve

Demand for contracted services in the European biotech sector is buoyant. As the industry matures and more biotech drug candidates reach clinical development, business opportunities for contract research organizations (CROs) and other service providers are growing.

Eye On: Muscular Dystrophy

There are nine known types of muscular dystrophy, which is a group of genetically based, degenerative diseases characterized by a progressive wasting and weakening of fibers of voluntary muscles. They are classified based on their pattern of inheritance, age of onset, and typical symptoms; together, they affect more than 110,000 people in the United States alone. In each of these forms, there is a defect in one of several proteins involved in linking the muscle fiber component F-actin to the sheath of tissue surrounding the muscle fiber.

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

CDER’s Woodcock Details Expanded Authority at Post-Approval Summit

By Sara Gambrill

Opening the Post-Approval Summit at Harvard on May 14 and 15, keynote speaker Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.

“FDAAA stipulates many new tasks and authorities for CDER,” said Woodcock.

Another common theme discussed by presenters who spoke later in the day at the conference was that, with the passage of FDAAA into law, the bifurcation of pre-approval and post-approval drug oversight would be eliminated. Woodcock described FDAAA as a “profound change” that would lead to “equal focus and accountability [being] placed on overseeing the safety of marketed drugs as on the evaluation of new drugs.”

Among its new authorities, CDER will be able to require a Risk Evaluation and Mitigation Strategy (REMS), which is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor.

A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS...

CWWeekly May 12th 2008 Issue

Top News
      
ACRO to Join FDA/Duke Clinical Trial Initiative

The Association of Clinical Research Organizations (ACRO) has joined a growing group of research organizations working with the recently formed Clinical Trial Transformation Initiative (CTTI).

Criterium Registers in Canada, Creates New Positions

Saratoga, N.Y.-based contract research organization (CRO) Criterium is planning to open an office in Toronto. The move was client-driven and will be where the company’s newly appointed director of global affairs, Lawrence Reiter, Ph.D., is based.
    
Other breaking news... 

• ICON first quarter revenues up 48%...
• eRT receives ODM certification...

Company Profile: An interview with Enrique Gaubeca, managing director, KLIXAR

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.

eResearch's Profits Soar

Philadephia,Pa.-based eClinical company eResearch Technology (eRT) saw nearly a 60% increase in its first quarter revenues with $33.7 million compared to $21.1 million in the first quarter of 2007. Its net income soared 155.6% to $5.7 million (or $0.11 per share) from $2.2 million (or $0.04) a year earlier.

“Bookings were strong across all phases, but especially in Phase I and Phase III studies. The integration of the CCSS acquisition is proceeding on schedule, and we are meeting with clients to begin the transition process of individual studies,” said Michael McKelvey, eRT’s chief executive officer.

eRT also reported bookings of $50.1 million in new business compared to $29.7 million over the same period last year, including seven new thorough ECG study agreements valued at $1 million each.

Recently eRT received Operational Data Model (ODM) certification from the Clinical Data Interface Standards Consortium (CDISC) for eRT’s electronic data capture product EXPert.

ODM one the industry’s most used standard for using clinical related data. According to the company, eRT was also the first adopter of Health Level Seven (HL7) electrocardiogram standards and the European adverse event reporting standard E2B.

"eRT is a strong proponent of standards to assist the transport and processing of digital clinical data to improve medical research," remarked McKelvey. "eRT was the first adopter of Health Level Seven's electrocardiogram standard, an early adopter of the E2B European standard for adverse event reporting, and now we have a certified product compliant with CDISC's ODM standard."

CenterWatch Monthly May 2008 Issue

Eli Lilly, Wyeth, Schering-Plough Rated Top Pharma Companies in Europe

Results of the CenterWatch 2008 Survey of Investigative Sites in Europe found Eli Lilly rated the top sponsor to work with. Also rated highly were Wyeth and Schering-Plough. The 2008 survey had more sites in Central and Eastern Europe reporting, and the survey was also extended to Canada. The number of countries reporting increased by 11 to 37. CenterWatch rated a total of 16 large pharmaceutical and biotech companies.

Cardiac Safety Services Back in Rhythm

Cardiac safety monitoring has developed into a sizable industry sector and the growing demand for these services has led to much activity in the space recently. Cardiac safety effects have become a common cause for drug withdrawals and delays in regulatory approval. Many concerns about serious cardiovascular side effects are related to drugs used for non-cardiac indications, such as the arthritis drug Vioxx.

European Biotech Outsourcing on Steep Learning Curve

Demand for contracted services in the European biotech sector is buoyant. As the industry matures and more biotech drug candidates reach clinical development, business opportunities for contract research organizations (CROs) and other service providers are growing.

Eye On: Muscular Dystrophy

There are nine known types of muscular dystrophy, which is a group of genetically based, degenerative diseases characterized by a progressive wasting and weakening of fibers of voluntary muscles. They are classified based on their pattern of inheritance, age of onset, and typical symptoms; together, they affect more than 110,000 people in the United States alone. In each of these forms, there is a defect in one of several proteins involved in linking the muscle fiber component F-actin to the sheath of tissue surrounding the muscle fiber.

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

Criterium Registers in Canada, Creates New Positions

By Sara Gambrill

Saratoga, N.Y.-based contract research organization (CRO) Criterium is planning to open an office in Toronto. The move was client-driven and will be where the company’s newly appointed director of global affairs, Lawrence Reiter, Ph.D., is based.

Reiter has worked for Criterium since 2003 and was formerly managing director. All global operations will report into Reiter. He will also be responsible for ensuring that operations in new offices that Criterium opens are standardized.

“We have a new position at the company called director of global affairs. What that means is that for the rest of the world, everything needs to be coordinated, everything codified for every office because we will continue to open offices. [Dr. Reiter] is one of the folks who have been with us for some time, and he’s coming to North America from overseas so that he’ll be in our time zone,” John Hudak, founder and chief executive officer of Criterium, told CWWeekly at IIR’s 17th Annual Partnerships with CROs conference in Las Vegas.

Criterium has three Canadian clients that have studies ongoing in Canada as well as other parts of the world.

Criterium was founded in 1991 and has 117 staff, including full-time equivalent (FTE) and permanent consultant staff. The company began conducting clinical trials globally in 1997. In 2003, the company opened its Johannesburg office; in 2005, it opened offices in Pune, India, and Berghem, The Netherlands; last year, the company opened offices in Boca Raton, Fla., St. Petersburg, Russia, and Gedera, Israel. The company has 21 active clinical trials...

Project Delays Hurt etrials in First Quarter

Morrisville, N.C.-based eClinical company etrials reported another challenging quarter with a drop in net service revenue of $3.7 million for the first quarter of 2008 compared to $4.1 million reported in 2007. Quarter over quarter, the company’s profit losses widen with a $2.0 million net loss for the quarter (or $0.19 per share) compared with a loss of $900,000 during the first quarter of 2007. etrials stated that its drop in revenue was partly due to new project delays, resulting in about $1 million in lost revenue.

"Despite the delayed project starts…we continue to increase studies with existing clients and add new clients. Our qualified pipeline is up nearly 50%; our close rates nearly doubled over last year; and we closed a number of multi-product solution sales with both new and existing clients. The sales metrics we follow are improving and we are where we planned to be at this stage of our sales re-engineering efforts," said etrials chief executive officer, Chip Jennings.

New product bookings for the first were also slightly down compared to the first quarter of 2007, with reportings of $4.8 million and $6.6 million respectively. And etrials booked $7 million during the last quarter of 2007. On a positive note, the company stated it held $20.3 million in backlogged business compared with $19.8 million on March 31, 2007 and $19.2 million on December 31, 2007. The company stated this reflected a trend towards fewer project cancellations and delays.

CWWeekly May 5th 2008 Issue

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.

 

Gene Therapy Shows Promise for Rare Childhood Blindness

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

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...

CWWeekly April 28th 2008 Issue

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...      

• New England Research Institutes in strategic partnership with Evidence Clinical and Pharmaceutical Research Institute...
• Phase Forward reports 26% first quarter revenue increase in 2008...

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

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.

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.