April 2007

Recent Industry Personnel Changes

Monday, April 30, 2007

  • Cambridge, Mass.-based CRO PROMETRIKA has hired Gretchen Richards to the role of director of clinical operations. In her new role, Richards will oversee the company’s new clinical management services group. The group will offer study assessment and planning, site selection, trial and regulatory management, and monitoring. Prior to joining the company, Richards served as director of clinical research at NUCRYST Pharmaceuticals and has held various roles at Parexel International, MacroChem, Hydridon, and Millennium Pharmaceuticals.

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Cancer Biomarkers Collaborative Formed

Friday, April 27, 2007

The American Association for Cancer Research (AACR) has formed a collaborative group with the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI) called the Cancer Biomarkers Collaborative (CBC). The purpose of the CBC is to champion the use of validated biomarkers in clinical trials.  Its mission is to develop a set of guidelines for effectively integrating predictive biomarkers into oncology trials.

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CMS Seeks To Revise Clinical Trial Coverage Rules

Tuesday, April 24, 2007

The Centers for Medicare and Medicaid Services (CMS) has proposed new coverage rules for payments to Medicare recipients involved in clinical trials. The rules would revise the agency’s Clinical Trial Policy’s national coverage determination (NCD) system and push additional transparency requirements on trial sponsors.

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Russia’s Growth Potential

Wednesday, April 18, 2007

The growth of Russia’s clinical research market in the past five years has been impressive. Nearly double the number of clinical trials were approved in 2006 as were in 2000, and the number of patients participating in global clinical trials conducted in Russia more than tripled between 2002 and 2006. In addition, between 2001 and 2006, Form FDA 1572s were filed by more than three times the number of investigators in Russia.

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Recent Industry Personnel Changes

Monday, April 16, 2007

  • New York-based eClinical firm Medidata Solutionshas appointed Hugh Levaux to the position of vice president of product strategy. Levaux is the former chief executive officer of Ninaza, an electronic data capture company formerly based in San Mateo, Calif. Ninaza was acquired just this month by Octagon Research Solutions. Prior to Ninaza, Levaux held various positions at Quintiles, CareScience, and the RAND Corp. Levaux also worked as vice presient of Operations at the Lewin Group, a division of Quintiles, where he managed consulting projects on health economics, quality of life, and reimbursement.

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Paved With Good Intentions

Friday, April 13, 2007

The financial model of the Center for the Study of Neurodegenerative Diseases at the University of Virginia leaves much to be desired. Facing shortfalls during a clinical trial studying a drug to treat amyotrophic lateral sclerosis (ALS), James P. Bennett, Jr., director of the center and the physician sponsor of the clinical trial, solicited trial subjects for money to continue to study the drug’s effects on them, according to an article in the Wall Street Journal.

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