INC Research Expands Into India

By Stephen DeSantis

Raleigh, N. C.-based CRO, INC Research, has partnered with GVK Biosciences to launch business operations in India using GVK’s facilities in Gurgaon. The new venture will be called INC GVK BIO Private Limited. The plans to open the office were announced to CWWeekly earlier this month during an interview with John Potthoff, Ph.D, president and chief operating officer at INC. Potthoff said that because of increasing demand, INC would be opening up offices in India and Latin America before the end of the year.

“These are mainly driven by where our customers need us to be. And that is where they are leading us at this point,” he said. Given the country’s cost savings and the number of treatment-naïve subjects available, INC sees India as a small but fast growing segment of its current business.

“Our goal in India is really looking at it as an opportunity, a strategic expansion for access to patients and investigators. For us, India also will be a kicking off point for Asia,” said Potthoff.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

Top Stories for the Week of March 26th 2007

Top News

Cetero Adds Phase I Beds, Late Stage with Allied Research Acquisition

Cary, N.C.-based Cetero Research, an early stage contract research organization (CRO), has acquired Allied Research International (ARI), a CRO based in Toronto that has 210 beds and 450 staff. The acquisition will give Cetero 1,600 beds and nearly 1,200 employees along with a foothold in late stage work. Financial details of the deal were not disclosed.

American College of Radiology Spins off New CRO ACR Image Metrix

The American College of Radiology (ACR) has created a new contract research organization (CRO) focusing on clinical trial imaging services, called ACR Image Metrix. The company will be based in ACRs clinical research division office in Philadelphia.

Other breaking news...   

• PRA International signs exclusive agreement with IntrinsiQ Research...
• DecisionView lands multi-year contract with GlaxoSmithKline...

Company Profile: An interview with Robert J. Beall, Ph.D., president and CEO Cystic Fibrosis Foundation Therapeutics.

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!

Recent Industry Personnel Changes

• Premier Research Group, a Philadelphia-based contract research organization (CRO), appointed Troy McCall, Ph.D., as the company's new chief operating officer. He will be responsible for Premier’s global clinical trial operations. McCall is returning to the company after leaving Premier as vice president of business development to become president and chief executive officer of eClinical firm, Advanced Clinical Research Services (ACRS).

• Waltham, Mass.-based CRO Parexel named Matthias Grossmann, M.D. and James Wong, Ph.D., to the company's clinical pharmacology network. Grossmann and Wong have been appointed to vice president of the clinical pharmacology services. Prior to Parexel, Grossman was head of medical affairs at a pharmacology research group in Mannheim, Germany. Before joining Parexel, Wong was the director of clinical pharmacology at The Medicines Company and has held senior positions at AstraZeneca and Schering AG. Grossman will be based in its pharmacology facility in Berlin, while Wong will work out of the company's Baltimore unit.

• Cincinnati-based CRO Kendle has appointed Thomas Smith, M.D., to the position of global medical director. He will be responsible for providing medical expertise to the company's clinical development programs and provide insights for new client proposals. He will have a particular role in CNS related projects. Prior to joining Smith was a senior director of clinical research and development at Akros Pharma. He has also held various positions at Genzyme and Abbott Laboratories.

• Perceptive Informatics, the clinical trials technology subsidiary of Parexel, appointed Sina Adibi to vice president of software development and chief technology officer. Adibi was the former chief technology officer for Thomson Scientific, a division of Thomson Corporation.

A New COG Model In Brazil

Posted by: Sara Gambrill

A new oncology-focused contract research organization (CRO) may have found an ideal way to tap into the large patient population participating in Brazil’s public healthcare system.

Oncopartners, a management-funded U.S. company with a wholly owned Brazilian subsidiary, has entered an exclusive worldwide partnership with Instituto Brasileiro de Pesquisa em Câncer (IBPC), a non-profit entity created to build a network of oncology clinical researchers from 18 public cancer hospitals in Brazil.

Oncopartners has funded and designed the IBPC infrastructure to support international clinical research in each of the public hospitals. Those sites treat more than 30,000 new incidences of cancer annually.

This is a brand-new CRO model for Latin America and an important one. Pharmaceutical and biotechnology companies usually have the option of outsourcing an entire clinical trial, and often do, so the model for a particular country, especially in an emerging region, can be all-important.

Top Stories for the Week of March 19th 2007

Top News

Oncology CRO Oncopartners Launches in Brazil, Offers Different Model

Oncopartners, a new oncology-focused contract research organization (CRO), founded this past autumn, has recently begun work on its first protocol in Brazil. What makes Oncopartners’ business model unique is its exclusive worldwide partnership with Instituto Brasileiro de Pesquisa em Câncer (IBPC), a non-profit entity created to build a clinical research network comprising oncology clinical researchers from 18 public cancer hospitals in Brazil.

HIV/AIDS Microbicide Trial Network Selects 12 Research Centers

The National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) has selected 12 research hubs or clinical trial units [CTUs] in seven countries to operate the agencys new Microbicide Trials Network (MTN). The network was created by the NIAID in 2006 to advance research being conducted to prevent HIV through a woman’s use of topical anti-viral / anti-bacterial agents that may stop the virus from being contracted during intercourse.

Other breaking news... 

• Document Solutions Group (DSG) settles with Datasci...
• Beacon Bioscience changes name to Icon Medical Imaging...   

Company Profile: An interview with Stephen Webb, executive vice president, REGISTRAT

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!

DSG Settles Patent Infringement Suit

Posted by: Stephen DeSantis

Pennsylvania-based Document Solutions Group (DSG) has settled a longstanding, patent infringement suit filed by St. Paul, Minn.-based technology company Datasci. Financial terms were not released.

"We are very pleased that this lawsuit is dismissed, and our current customer base and prospects will be excited to know that this lawsuit is behind us so we can put all our energies toward our customers and products in the life sciences industry,"stated DSG's chief executive officer, Tony Varano.

Datasci filed similar lawsuits against eClinical companies Phase Forward, Datatrak, etrials and DataLabs. Phase Forward settled for $8.5 million in the suit Datasci filed against the company in June 2004. In August 2006, DataLabs, which was acquired by ClinPhone in October 2006, settled its suit for an undisclosed amount and a nonexclusive licensing arrangement.

DataLabs cited the primary reason for its settlement agreement was because of the possibility of its customers getting sued, which Datasci was exploring at the time. DataTrak and etrials have not announced any settlements.

In 2002,the U.S. Federal Patent and Trade Mark Office awarded Mark L. Kozam, founder of Olney, Md.-based MLK Software a patent—6,496,827—for the:

“Methods and apparatus for the centralized collection and validation of geographically distributed clinical study data with verification of input data to the distributed system.”

The patent was filed in January 2000 and patent office records show the company began the process of obtaining the patent by filing a Patent Cooperation Treaty (PCT) in May 1998.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

CenterWatch Monthly: March 2007 Issue

FDA Oversight Doesn’t Cool Device Market

Post-marketing scrutiny of medical devices by regulators has been ratcheted up following safety questions about drug-coated stents and other medical devices. Contract research organizations (CROs) that have strong experience with post-marketing work and with smaller biotech startups have an advantage in the medical device market.

Should Prisoners Be Allowed to Volunteer for Research?

The use of prisoners as research subjects is one of the most controversial areas of human subjects research, and it has a long, complex history. The Institute of Medicine of the National Academies Report, “Ethical Considerations for Research Involving Prisoners,” urges greater oversight and safeguards in human subjects research involving prisoners. It is important to understand the report’s conclusions in their proper context, not as the last word in the discussion but as the latest chapter in an ongoing ethical debate that will likely continue for some time. Given the recent resurgence of discussion on prisoners as research subjects, the time is right to give the issue a thorough review.

Volterys Offers New Patient Recruitment Model in Europe

Volterys is a volunteer recruitment web site recently launched in France and Belgium. It represents a new patient recruitment model in Western Europe, one that circumvents some of the cultural barriers in Western Europe that prohibit recruiting patients for clinical trials over the Internet.

Eye On Hepatitis C

Hepatitis C, a liver inflammation caused by the hepatitis C virus (HCV), affects nearly 170 million people worldwide, making it the most common chronic blood-borne infection in developed countries. Currently, there is no approved vaccine to prevent hepatitis C. CenterWatch has identified a pipeline of 21 drugs in various stages of development for treatment of hepatitis C. Many of these are antiviral agents or compounds related to interferon.

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

• The Association of Clinical Research Organizations (ACRO) has elected new officers to its board. ACRO elected PharmaNet Development Group’s chief executive officer Jeffery McMullen to head the group as its chairman. David Spaight, president of MDS Pharma Services will assist in that role as chair-elect. McMullen replaces Candace Kendle, co-founder and chief executive officer of Kendle International.

• The Sarah Cannon Research Institute, a clinical research network based in Nashville Tenn. has appointed Dr. Gregg Fromell and Jonathan Perlin as new members to its board of governors. Fromell is the executive director of the Office of Human Research at the University of Pennsylvania School of Medicine. Perlin is the chief medical officer and senior vice president of quality for Hospitals Corporation of America (HCA).

• PharmaNet Development Group appointed Jean-Marie Houle, Ph.D. as vice president of clinical operations for the company’s Canadian subsidiary, Anapharm. The division performs bioequivalence and early-stage trials. Just last week PharmaNet replaced Anapharm founder and chief executive officer Mark LeBel with Johane Boucher Champagne, the company’s chief operating officer.

• Kendle named Martha R. Feller, Ph.D., to senior vice president of the company’s global clinical trial development. Feller will oversee Kendle’s phase II/III trial operations in North America, Europe, Asia Pacific, Latin America and Africa. Prior to the promotion, she led the company’s clinical development operations in North America. Before joining Kendle in 2004, Feller held positions at Proctor and Gamble Pharmaceuticals and has worked in the CRO and pharmaceutical industry for more than 30 years.

Top Stories for the Week of March 12th 2007

Top News

eClinical Industry Strong in 2006

Slowed for years by the clinical trials industry's sluggish adoption rates and frustrations about technological integration in an overcrowded marketplace, most companies offering clinical trial software and technology reported banner revenues for 2006 and the signs remain positive in the first quarter of 2007.

INC Research Opens New Switzerland Office,India and Latin America Next

Raleigh, N.C.-based INC Research, contract research organization (CRO), has opened a new office in Zürich, Switzerland. And because of the increasing demand to outsource clinical trials in emerging regions, INC will be opening up new offices in India and Latin America before the end of the year.

Other breaking news...

• Siemens inks agreement with Wyeth...
• PPD in agreement with i-clinics...

Company Profile: An interview with Arif Khan, president, Clinical Trials Reciprocal Insurance Company (CTRIC)

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!

 

Rigorous Clinical Trials Proposed for Generic Biologics

by Steve Zisson

There was encouraging news coming from testimony about legislation proposed for regulating generic biologics before the Senate Health, Education, Labor, and Pensions committee on Thursday.

The committee is beginning to understand the importance of having a full round of rigorous clinical trials for any generic biologic. Manufacturing a biologic isn’t like stamping out a new batch of pills. It is immensely complicated work where inexperienced companies should have to go through stringent clinical trials.

This is good news for patients and their safety and for the biotech companies that have spent millions on developing new biologics.

It is also good news for the pharmaceutical outsourcing industry and contract research organizations such as Parexel, PPD, PRA, ICON, Covance, PharmaNet, Quintiles and others. They will benefit from the projected increase in clinical trials and from their push in the last few years to work with biotech companies. In the short term it could be welcome news for biotech giant Amgen, whose anemia drug Epogen goes off patent in six years...

Siemens Inks Deal With Wyeth For Imaging Agent

By Stephen DeSantis

Siemens Medical Solutions’ molecular imaging division has inked an agreement with Wyeth Pharmaceuticals to use a new Alzheimer’s disease imaging agent in its clinical trials.

The agent, which just recently received approval from the U.S. Food and Drug Administration (FDA), works differently then traditional molecular imaging agents such as PET scans that are less specific. The new agent is the first to specifically identify the accumulation of amyloid plaques and neuronal tangles that cause cell death in the brain.

“Molecular imaging is already revolutionizing the detection and diagnosis of diseases like Alzheimer’s; and now, it is becoming an indispensable component in the development of exciting new drug therapies, improving patient health,” said Michael Reitermann, president, Molecular Imaging, Siemens Medical Solutions.

Stephen DeSantis is the Senior Associate Editor at Thomson CenterWatch.

CROs to Benefit from Pharma Job Cuts

Posted by: Steve Zisson

German pharmaceutical company Bayer AG said recently it plans to cut 6,100 jobs in the wake of its acquisition of Schering AG last year. That’s the latest large layoff by a big pharma company that comes on the heels of a 10,000 employee reduction at Pfizer a month ago.

Both companies are also reworking their research and development strategies. Bayer will reveal its new strategy in June. Pfizer has already said it will improve productivity by consolidating research teams focused on a particular therapeutic area to one of four big sites. Currently, these research teams are at multiple locations around the world.

Who will benefit from these job cuts? It will likely be the companies that provide outsourced clinical research to pharma companies—big global contract research organizations (CROs), such as Quintiles, PPD, Covance, Parexel, PRA , ICON Clinical Research and PharmaNet.

Top Stories for the Week of March 5th 2007

Top News      

PPD Signs Risk-Sharing Deal with Indian Generics Company Ranbaxy

Wilmington, N.C.-based contract research organization (CRO) PPD has licensed investigational statin RBx-10558 from India-based generics company Ranbaxy Laboratories, which recently began developing novel drugs.

inVentiv Health Makes Two More Acquisitions and Reports Strong Revenues

Somerset, N.J.-based inVentiv Health, a life science communications company with a contract research organization (CRO) unit, reported a nearly 40% jump in revenues to $766.2 million in 2006. For its fourth quarter, inVentiv reported revenues jumped 21% to $211.8 million.

Other breaking news...      

• PRA fourth quarter revenues jump...
• RapidTrials launches web-based CME program...

Company Profile: An interview with Jules Mitchel, managing director, ACTN, and president Target Health, Asian Clinical Trial Network (ACTN)

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

PRA Fourth Quarter Revenues Jump

Posted by: Stephen DeSantis

Reston, Va.-based contract research organization (CRO) PRA International reported fourth quarter revenue jumped 18.6% to $82.4 million.Income from operations in the fourth quarter totaled $6.6 million, a 48.4% decrease from $12.8 million in the year-ago quarter.

Net income was $5.7 million, or $0.23 per diluted share, compared with $7.5 million, or $0.31 per diluted share, in the fourth quarter of 2005. On Feb. 28, PRA’s shares fell 13% to $19.93.

PRA reported relatively flat revenue in 2006 and a decrease in operating income compared with last year. PRA reported 2006 service revenue of $303.2 million, compared with $294.7 in 2005.

Operating income in 2006 totaled $33.2 million compared with $51.2 million. The company’s operating margin for 2006 was 10.9%, compared with 17.4% in 2005.

“This is both an exciting and challenging time for PRA, as we are taking immediate actions aimed at getting PRA back on the path to accelerated growth,” said Terry Bieker, chief executive officer of PRA.

The company stated that it will be restructuring into three service areas: early development, product registration, and scientific & medical affairs. PRA also announced it will close its Eaton, N.J., and Ottawa, Canada, facilities. The company stated it does not expect any reduction in staff, and certain project managers and lead CRAs will be able to work remotely.

The cost of the restructuring is expected to be $9 million, with the anticipated annual savings expected to be approximately $4 million.

You can listen to PRA's recent conference call here.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

PharmaNet’s Turnaround Right on Time

Posted by: Steve Zisson

PharmaNet Development Group’s turnaround, from the ashes of the contract research organization (CRO) formerly known as “troubled SFBC,” is right on track as predicted in this space last August.

The latest encouraging news came on March 1 when PharmaNet shares jumped 19% to $24.21 after investors liked what the company reported in its fourth quarter.

PharmaNet CEO Jeff McMullen was talking turnaround in its earnings conference call. He had predicted the company’s turnaround would come just about now and he delivered.

He added a note of caution, however, saying that PharmaNet was still in a “transition” period and could be subject to the ups and down of the CRO business.

McMullen came to SFBC in December 2004 when the company bought PharmaNet as SFBC moved out of early clinical research into phase II-IV. At the time, PharmaNet was an up-and-coming CRO just going global. He took over after SFBC’s leadership resigned amidst a series of scandals reported on by the general media and scrutiny from regulators...

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> For a difference to make a difference it must be a real difference.  Keep this in mind when deciding how much of a difference in safety, efficacy or convenience will be necessary to receive regulatory approval and encourage physicians to use your product.

> FDA based slogans include: Incompetence on your part does not constitute malfeasance on ours.  Also, Failure to plan on your part does not constitute an emergency on ours.

> It is artificial to describe inclusion and exclusion criteria as if they were two separate categories of criteria. The only difference between them is that one set of criteria is expressed in positive terms and the other in negative terms.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of  Bert Spilker & Associates (BS&A).

Cuts That Hurt

Posted by: Sara Gambrill

President Bush’s proposed fiscal 2008 budget includes an increase of less than 1% to the National Institutes of Health (NIH) budget overall, but a decrease of $9 million in the National Cancer Institute’s (NCI’s) budget, to $4.78 billion. The NIH comprises 27 institutes. NCI’s 2008 budget is roughly equal to how much it costs to wage war in Iraq for a fortnight.

As I have cited previously in this forum, NCI had to cut new grant awards by 29% last year. The next round of cuts this year, on top of the previous year’s cuts, will really hurt patients with rare cancers as well as small pharma and biotech companies.

The Coalition of National Cancer Cooperative Groups, founded 10 years ago, is a nonprofit group comprising all 10 of this country’s federally funded cancer cooperative groups, and it will have to make some deep cuts to its clinical research programs. Up to 95—or nearly half of the clinical trials they conduct annually—may have to be shut down or delayed this year. This would eliminate up to 3,000—out of 20,000—patient slots in clinical trials across all cancers, but mainly those for rarer cancers such as sarcoma, some childhood tumors, and head and neck cancers.

Elias Zerhouni, director of the NIH, refers to the current time period as the “post-doubling era” because it comes after the NIH budget doubled between 1998 and 2003.

So why so many cuts?