DIA Biosimilars 2013

Articles Published in 2007

2006 Is Strong Year For Averion Despite Merger Costs

Monday, April 9, 2007 01:11 PM

Boston-based CRO Averion International reported a 48% increase in revenue for 2006 to $27.3 million. However, the company reported a loss in net operating income of $9.2 million, primarily due to costs associated with a merger in 2005 with Millennix and a 2006 reverse merger with IT&E International. The company’s chief executive officer Philip Lavin stated the Averion has had a “solid start” during the first quarter of 2007 and its goal is to reach profitability by the second of half of the year. Averion's backlog of business within clinical research was $35.6 million as of December 31, 2006. Cash and equivalents were roughly  $8.1 million, an increase of $1.7 million from 2005.

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Cenduit: Now with Patient Reminders

Diagnostic Lab CRO Venture Created

Thursday, April 5, 2007 12:20 PM

Houston-based Power3 Medical, a developer of protein biomarkers and diagnostic technology research, has formed a new joint venture contracted research organization (CRO) with Fort Myers, Fla.-based NeoGenomics, a clinical diagnostic laboratory specializing in cancer genetics testing. Power3 Medical, which owns a minority stake in the yet unnamed CRO, will use the firm to advance its proteomics and genomics diagnostic testing technology. The companies stated they will take the next six months to develop the new firm’s business model and begin operations thereafter.

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CRF Health – eCOA Forum

Top Stories for the Week of April 2nd 2007

Tuesday, April 3, 2007 03:11 PM

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EMEA Tightens Phase I Guidelines

Tuesday, April 3, 2007 12:13 PM

The European Medicines Agency (EMEA) has drafted guidelines to help ensure the safety of subjects enrolling in first-in-man studies. The guidelines come on the heels of TeGenero’s trial, which caused six otherwise healthy phase I subjects to suffer severe adverse reactions after being administered an immunological agent at a hospital in the United Kingdom. Following the incident, reviews were performed on how the study was conducted and concluded it satisfied current regulatory requirements. Among the many items cited in the report, the EMEA recommends that the Minimal Anticipated Biological Effect Level—or MABEL—be used when testing “high risk products” such as monoclonal antibodies in phase I trials.

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INC Research Expands Into India

Thursday, March 29, 2007 03:02 PM

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.

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Top Stories for the Week of March 26th 2007

Wednesday, March 28, 2007 09:11 AM

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Recent Industry Personnel Changes

Monday, March 26, 2007 02:02 PM
  • 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).

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A New COG Model In Brazil

Friday, March 23, 2007 04:03 PM

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.

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Top Stories for the Week of March 19th 2007

Tuesday, March 20, 2007 06:38 AM

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DSG Settles Patent Infringement Suit

Monday, March 19, 2007 10:08 AM

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.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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