InVentiv Health Acquires Addison Whitney

By Steve Zisson

CenterWatch has been watching for years the goings on at Somerset, N.J.-based inVentiv Health. The billion-dollar company is on another buying spree and we’ve been interested in what it continues to do in the contract research space. In March 2006, inVentiv bought Synergos, a clinical services provider with expertise in clinical trial management services, including project management and monitoring as well as investigator and patient recruitment. Synergos, which was purchased for $5.75 million in cash and stock plus earn-outs, operates under inVentiv’s clinical division.

inVentiv’s latest acquisition on May 31 is Addison Whitney, a global branding consultancy that focuses on creating unique corporate and product brands. Addison Whitney will operate within the inVentiv communications division, which provides integrated healthcare marketing and communications solutions. Financial terms of the transaction were not disclosed.

Founded in 1991, Addison Whitney offers a range of capabilities to create, renew and strengthen brands, including an expertise in generating names that reflect the brand's identity and meet regulatory requirements. Addison Whitney Healthcare, the company's healthcare division, works with clients including Bristol-Myers Squibb, Novartis, sanofi-aventis, Eli Lilly and Co., Pfizer, Takeda, Boehringer Ingelheim, Wyeth, and Cephalon. The company also supports branding strategies for consumer goods and high technology companies in its non-healthcare division.

Blane Walter, president of inVentiv Health said, "Addison Whitney Healthcare is an industry leader in partnering with pharmaceutical and biotech companies to create strong, recognizable identities for their products. Their expertise in developing brand names, along with their long-standing customer relationships and their ability to serve clients very early in the product lifecycle will directly complement and broaden the suite of offerings within inVentiv Communications."

Upon the close of the transaction, Addison Whitney will become a wholly-owned subsidiary of inVentiv Health. The Addison Whitney brand will remain and the business will operate within the inVentiv Communications division under the leadership of William O'Donnell, who was recently named president and chief operating officer of inVentiv Communications.

Steve Zisson is managing editor at Thomson CenterWatch.

Cost of Compliance Rising for AHCs

By Stephen DeSantis

The Association of Academic Health Centers (AAHC), a non-profit organization supports the nation's academic health centers, has released a paper reporting that its members are allocating higher amounts of funds towards increasingly burdensome clinical trial compliance requirements. The AAHC placed investing in compliance as its top priority and called the requirements essential for ensuring safe and effective trials. However, the AAHC stated the cost of compliance is a national issue facing the entire academic health center (AHC) enterprise. The report said that for a one-year period, some AHCs reported compliance costs increased as much as 70%. The paper is called Investing in Clinical Trial Compliance.

“The AAHC is actively pursing solutions to the complex cost issues through its Forum on Regulation,” said AAHC president and chief executive officer Steven Wartman, M.D.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Recent Industry Personnel News

• MDS Pharma Services, a contract research organization (CRO) based in King of Prussia, Pa. has named James Pusey as the company’s vice president and general manager of its global clinical development business. The group manages MDS’ late stage trials. Prior to MDS, Pusey was chief executive officer at the biotech company OrthoLogic. He also served as executive vice president for neurology at Serono and a vice president of marketing at AstraZeneca’s CNS, Pain and Infection group.

• UK-based eClinical company ClinPhone appointed Michael Smyth to the position of vice president of product management for the company’s Trial Management Solutions Group. He will be based at ClinPhone’s East Windsor, N.J. office. Prior to joining ClinPhone, Smyth was director of business development at Premier Research and more recently the head of global strategic accounts at VivoMetrics.

• Wilmington, N.C.-based CRO PPD named William Sharbaugh as the company’s new chief operations officer. Prior to joining PPD, Sharbaugh was vice president of global development at Bristol-Myers-Squibb and held various positions at Merck & Co. more than 10 years. Recently, the company’s chief financial and accounting officer Linda Baddour announced her resignation. She was with the company for 11 years. Until a replacement can be found, PPD has promoted Peter Wilkinson to vice president of finance and chief accounting officer and Brian Tuttle to vice president of finance and corporate controller.

• Clinsys Clinical Research, a Berkeley Heights, N.J.-based CRO, has hired three new executives for the company’s management team. Clinsys appointed Anthony Abruzzini, Ph.D., as vice president of global regulatory services. Prior to Clinsys, Abruzzini was senior vice president of regulatory services at INC Research and held various positions at Quintiles and Encelle. Clinsys named Linda Patricia Miller, M.D., as the company’s chief medical officer. Miller previously held positions of director of clinical research at Eisai and associate director of clinical development at Organon. The company also named John Hogan, MPM, to the position of CNS project director. He has held similar positions at Sepracor and INC Research.

• Boston, Mass.-based CRO Parexel International appointed Joe Avellone, M.D., to the position of corporate vice president of clinical research operations in both North and Latin America. Avellone was formerly the chief executive officer at Veritas Medicine. He also served as chief operating officer for BlueCross BlueShield of Massachusetts.

Top Stories for the Week of May 21st 2007

Top News

i3 Acquires Outcomes Firm European Health Economics

Medford, Mass.-based i3 Innovus, the health economics and outcomes research division of i3, has acquired Stockholm-based firm European Health Economics (EHE). Financial details were not disclosed.

DSG Partners With Japanese CRO ACRONET

Malvern, Pa.-based eClinical company DSG has established a partnership with Japanese contract research organization (CRO) ACRONET. The move allows DSG to enter the electronic data capture (EDC) market in Japan in partnership with a large CRO that has established clients.

Other breaking news...      

• etrials first quarter revenues jump...
• Encorium reports strong first quarter...

Company Profile: An interview with Dr. Nadia Cheaib, General Manager, ClinServ

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

Quintiles Cuts Ribbon On New Research Facility

By Stephen DeSantis

North Carolina-based CRO Quintiles has opened a new four-story, 236,000-square-foot clinical research facility in Overland Park, Kan. The facility will replace the company’s Clinical Development Services and Clinical Pharmacology units located in Kansas City, Mo., as well a an early phase unit in Lenexa, Kan. The new phase I facility will be three times the space, consisting of 150 beds and room for up to 200 more staff. Quintiles already employs about 750 employees in the Kansas City area.

The unit was dedicated in a ceremony by company founder and chief executive officer Dennis Gillings and David Kerr, Secretary of the Kansas Department of Commerce. Also in attendance were Thomas Thornton, president and chief executive officer of the Kansas Bioscience Authority, and Carl Gerlach, mayor of Overland Park.

"Ultimately, however, this building is about even more than the creation of jobs in Overland Park and the growth of Quintiles," Gillings said. "It is about improving healthcare -- for people in Kansas, across the United States and around the world." 

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Innovex Signs Agreement With ForceLogix For Sales Coaching Software

By Steve Zisson

Innovex, the Quintiles unit that provides commercialization services to the pharmaceutical, biotechnology and medical device industries, signed an agreement with software company ForceLogix to provide on-demand global access to Innsight, Innovex's custom-designed sales coaching tool.

When using ForceLogix's "SalesForceOptimizer" application, Innovex managers on six continents will be able to securely and rapidly share information to better coach their field teams.

"ForceLogix's technology allows us to deliver a multilingual coaching process that can be easily and rapidly configured and deployed globally," said Jim Kendall, senior director of Innovex Business Solutions. "This promotes the consistent execution of our coaching and enhances our ability to capture, evaluate and rank sales representative performance.”

Patrick Stakenas, president and chief executive officer of ForceLogix, added, ‘Our on-demand delivery model allows ForceLogix to quickly provide value to companies such as Innovex without the time, expense and added risks of having to buy hardware, software and implementation services.”

CenterWatch Monthly: May 2007 Issue

U.S. Sites Rate Novo Nordisk, Novartis and Roche as Top Sponsors in 2007

Results of the Thomson CenterWatch 2007 Survey of Investigative Sites in the U.S.  have been tabulated. Sites have rated Novo Nordisk the top sponsor to work with. It is the first time the company has ever been rated in the survey. Novartis and Roche were ranked second and third, respectively. Asked in which areas sponsors have generally become better or worse in the last three years, effectiveness of communications with investigators, case report form (CRF) design, medical staff quality, and monitor quality were the top areas showing general improvement. Monitor turnover, feasibility of project timelines, and contract and budget negotiations are the three areas sites said have suffered. Electronic data capture technologies was listed by 43% of sites as most likely to prevent future delays.

Medical Imaging Creating a Special Effect

Medical imaging in clinical trials has gained momentum since the FDA began allowing imaging as part of the evidence in support of a new drug application. The FDA, in an effort to increase new drug approvals, has identified imaging as an important technology for assessing new therapeutics and accelerating drug development in the future. There has been a big increase in demand for imaging services in the past 18 months with players ranging from Parexel to GE Medical Systems ramping up their efforts.

Increasing Interest in Small Population Trials in EU

While distinct definitions exist for orphan drugs and orphan populations, small population studies are more of a gray area, as there is no exact definition of what constitutes one, either in patient numbers or study design. The new European Medicines Agency (EMEA) Guideline on Clinical Trials in Small Populations due to have become operational in February aims to deal with problems associated with limited patient numbers available for study.

Eye On Vaccines

Despite the advent of antibiotics, infectious diseases continue to plague mankind, especially those caused by viruses that do not respond to traditional antibiotics. The likelihood of prevention therefore far outweighs that of cure, mandating development of new vaccines designed to prevent infection with such deadly viral diseases as AIDS, smallpox and hepatitis. CenterWatch has identified a pipeline of 19 vaccines in various phases of development for infectious diseases and cancer, as well as for certain autoimmune conditions including allergies and multiple sclerosis.

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

John Cline Resigns from etrials

By Stephen DeSantis

Morrisville, N.C.-based eClinical company etrials  reported that John Cline, founder and long time chief executive officer of the company, has resigned his post effective immediately in order to pursue other "entrepreneurial endeavors." He will, however, remain a member of the board of directors.

In 1999, Cline began the electronic paper diaries company Expidata, which was soon acquired by etrials (then PharmaCentric). The company -- along with most other eClinical companies in the space -- struggled through the early days of the electronic data capture marketplace.

As a thought leader in the clinical trials industry, Cline championed the value of paperless trials and helped usher in the modern EDC landscape we see today. In February 2006, etrials merged with CEA Acquisition Corp., a specified purpose acquisition company, changed its name to etrials Worldwide and began trading on the Nasdaq National Market. The merger gave the company a total of $20.5 million in cash.

"I am extremely proud and honored to have led our great employees from a small North Carolina start-up software firm to a top-tier, publicly-held global eClinical solutions company. As I move on to other entrepreneurial endeavors, I remain committed to etrials and support this change in management as a step forward in building a leading eClinical software solutions company," said Cline.

Last week ,etrials reported first quarter net services revenue jumped 51% to $4.1 million, compared with the same quarter a year ago. The company reported a loss of $0.9 million. In the first quarter of 2006, etrials reported a similar loss of $1 million. The company reported its gross margins improved to 47% compared with 40% the previous year.

It also reported a backlog of business of $19.8 million compared with $17.7 million at the end of 2006 and $24.8 million at the end of the first quarter of 2006. etrials reiterated that it expects new project bookings in 2007 will be up 40% to 50% over last year to $25 to $28 million.

“Our balance sheet remains strong, and we are well positioned to capitalize on the accelerating move towards electronic clinical software and services. We continue to believe 2007 will be a year of significant growth in new project bookings for etrials,” said Cline.

etrials has named Eugene "Chip" Jennings as the company's new president and CEO. Just prior to this position, Jennings was the senior corporate vice president of SHPS, a private healthcare management tools and resources company based in Kentucky.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Top Stories for the Week of May 14th 2007

Top News

BIO 2007 Draws Clinical Trial Industry Hopefuls

Among the nearly 2,000 companies that exhibited at last week's Biotechnology Industry Organization (BIO) annual meeting in Boston, Mass., a small but focused contingent of clinical trial industry firms set up shop.

Australia Unveils Research Tax Incentive at BIO 2007

The Australian government has launched a new tax incentive to boost the level of outside research and development conducted by foreign sponsors. The announcement came during the BIO 2007 biotech convention last week in Boston, Mass. Regardless of where sponsors are based, companies will be eligible for a tax concession of 175%, essentially subsidizing all levels and areas of research, including clinical trials.

Other breaking news...      

• Datatrak reports drop in revenue...
• ClinPhone in contract with Kendle...

Company Profile: An interview with Roger Wallhouse, chairman, and Martin Ryan, director InferMed

Senate Okays PDUFA

By Stephen DeSantis

In a 93-to-1 vote, the U.S. Senate has approved a bill re-authorizing the U.S. Food and Drug Administration (FDA) to collect fees from drug companies to review investigational new drugs. The bill would also require that all phase II and later stage trials for both drugs and devices be listed on the government’s web site, www.clinicaltrials.gov.

Currently, the listing of trials beyond those for serious and life-threatening conditions is voluntary from a regulatory perspective. In addition to listings, the bill requires trial results to be added to the database after a product has been approved for marketing. The trial results will be provided by the FDA, the National Institutes of Health and peer reviewed journals. Sponsors who violate the new laws will be subject to monetary penalties.

The Prescription Drug User Fee Act (PDUFA), which was originally enacted in 1992 and was set to expire on Sept. 30, increases the amount collected through PDUFA by $138 million a year. The bill was sponsored by Sen. Edward Kennedy, D-Mass., chairman of the Health, Education, Labor and Pensions Committee and Sen. Michael Enzi, R-Wyoming, a ranking member of the Senate Health, Education, Labor and Pensions Committee.

Although the bill would mean higher costs per drug submissions and force transparency on the pharmaceutical industry, it had the support of its largest lobbing group. The Pharmaceutical Research and Manufacturers of America’s (PhRMA) president and chief executive officer, Billy Tauzin, said in a statement:

“Swift reauthorization of the Prescription Drug User Fee Act (PDUFA) is essential to ensure that the Food and Drug Administration (FDA) has the resources necessary to protect and promote the public health. To this end, PhRMA applauds the Senate’s quick passage of the PDUFA legislation.”

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Top Stories for the Week of May 7th 2007

Top News

Reliance Life Sciences Launches U.S.Clinical Research Subsidiary

Mumbai, India-based Reliance Life Sciences has opened a U.S. subsidiary of its four-year old contract research organization (CRO) Reliance Clinical Research Services (RCRS). The U.S. unit will be based in Newtown, Pa., and will offer clinical research and molecular diagnostic services to sponsors.

Changing Regulatory and Economic Standards Boost Evidence Market

Bethesda, Md.-based United BioSource Corporation (UBC), global investment management firm Goldman Sachs and former high ranking federal regulators discussed evidence or post-approval outcomes research and its impact on clinical trials and future medical treatments at a a recent summit in New York. The event was called: “The New Evidence Landscape: The Impact of Changing Regulatory and Economic Standards on Clinical Innovation and Product Commercialization.”

Other Breaking News...

• PharmaNet reports first quarter revenue increase...
• Nextrials partners with Raining Data...

Company Profile: An interview with Doug Kurschinski, vice president market development, AtCor Medical

PharmaNet On The Road To Recovery

By Stephen DeSantis

Princeton, N.J.-based PharmaNet Development Group reported first quarter revenue of $84.8 million compared with $74.4 million in the first quarter of 2006, a 13.9% increase. Total revenue, after out-of-pocket expenses, reached $107 million for the period.

Operating margins rose to 11.2% for the quarter from 10.2% in the year ago period. The company reported non-GAAP operating earnings of $9.5 million compared with $7.6 million in the same quarter a year ago.

Last year PharmaNet’s first quarter bottom line results were quite different. The company's net earnings for the first quarter of 2007 were $6.6 million or $0.35 per share, compared to a net loss of $4.1 million or $0.23 per share in the first quarter a year ago. The lion share of the loss was due to discontinued operations associated with its reorganization after its acquirer SFBC International was dissolved.

PharmaNet’s revenue increased in both its early and late stage business groups. Although PharmaNet sold off its Miami phase I assets, its early stage work in Canada is still strong. The company stated its backlog of business in early stage work increased to $54.4 million from $42.3 million reported at the end of last year. The company announced that its new Quebec City, Canada clinic and laboratory facility is open and has a capacity of 200 beds.

Jeffrey McMullen, president and chief executive officer at PharmaNet stated the company is now beginning to reap the benefits of last years major restructuring.

"With the improvement in the operating performance of the early stage segment, record direct revenues in the late stage segment and significant backlog growth, we are continuing to see the results of our organizational and operational improvements, business development initiatives and capacity expansions,” he said.

PharmaNet will maintain -- for 30 days -- an archived webcast of its earnings call on its investor relations website.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Striving For Diversity In Clinical Trials

By Sara Gambrill

AstraZeneca has launched a new initiative to address the lack of diversity in U.S. clinical trial participants. The big pharma company will provide significant grants to the National Medical Association (NMA), which represents more than 30,000 African American physicians, and the Interamerican College of Physicians and Surgeons (ICPS), a network of more than 39,000 physicians throughout the U.S. and Puerto Rico.

AstraZeneca expects that its ongoing partnership with NMA and ICPS will ensure that physicians of diverse backgrounds receive the education and tools they need to participate as investigators in clinical trials.

Several top-20 pharmaceutical companies have approached the challeng getting racial and ethnic diversity in their study groups by trying to engage a more racially diverse group of investigators or those with access to diverse patient populations. These have mostly been internal initiatives. AstraZeneca’s decision to partner with these well-established organizations is a new approach to gaining access to African American and Hispanic patient populations and one that could lead to some real success.

Alfonso Alanis, M.D., chairman and chief executive officer of Anaclim, a minority-focused contract research organization (CRO), said, “One of the key reasons minorities do not participate in clinical trials is that they are not invited. Their physicians do not participate.”