James J. Kramer, Ph.D., has been appointed vice president, Global Biologics Operations, a newly created position at BioReliance Corp. Dr. Kramer joined the company in December 2007 as vice president, operations, U.S. Biologics. In his new position, his responsibilities will be expanded to include all operations at the company’s three facilities in Scotland, located in Glasgow, Stirling and Edinburgh, Scotland. He will continue to report to president, chief executive officer and chairman David A. Dodd, and will be based at the company’s headquarters in Rockville, MD.

“Jim is an excellent choice to lead our global biologics operations as we aggressively proceed in developing our organization to more effectively serve our clients. His leadership will ensure that BioReliance remains highly competitive as we develop and expand our customer base globally,” said Mr. Dodd. “Since joining the organization, Jim has consistently demonstrated expertise in creating and leading a highly customer-oriented management team. Our focus is to provide the highest levels of client support and service through operational excellence, and I am confident that under Jim’s direction we will achieve that goal.”

Prior to joining BioReliance, Dr. Kramer served as senior vice president/general manager, Talecris Plasma Resources, Talecris Biotherapeutics. Previously, he served as vice president, Global Manufacturing Operations at Serologicals Corporation, and held management positions at Ortho-Clinical Diagnostics, Inc. (a Johnson & Johnson Company), and Pacific Hemostasis Division of Curtin Matheson Scientific.

BioReliance provides biologics safety testing, toxicology, viral manufacturing and laboratory animal diagnostic services.

Morphotek, Inc., a subsidiary of Eisai Corp. of North America, has opened clinical sites in the EU as part of its Phase II study of MORAb-009. A monoclonal antibody to mesothelin, MORAb-009 is being studied as a first-line treatment for patients with pancreatic cancer. The randomized, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine.

Morphotek has currently qualified 33 clinical sites in the U.S. and Canada to conduct its Phase II study that started earlier this year. The company has opened four clinical sites in Spain and received regulatory approval in Spain, Belgium and Germany and 17 sites have been qualified in these countries. Regulatory approval for this study is also pending in Argentina. These approvals expand the ability to evaluate the efficacy of this compound in patients outside of the U.S.

“We are extremely pleased to receive approval for the MORAb-009 Phase II trial sites in the EU,” said Martin D. Phillips, M.D., chief medical officer of Morphotek. “A distinguished group of clinical investigators treating pancreatic cancer patients throughout the EU have expressed an interest in novel biologic therapies for this typically fatal disease. We look forward to the possible involvement of additional European clinical sites for this compound as well as others in our pipeline.”

MORAb-009 is an IgG1 antibody that recognizes a cell surface glycoprotein called mesothelin, which is over-expressed on a number of epithelial-derived cancers. The antibody has been found to elicit anti-tumor effects via blockade of mesothelin to bind to its ligand present on neighboring cells and immune-effector responses. Phase I studies of the antibody in patients found the molecule to be well tolerated at, or below, the maximum tolerated dose and clinical observations from those studies suggested anti-tumor responses in a number of patients.

Algorithme Pharma has acquired Simbec Research in Merthyr Tydfil, Wales. The move gives the Laval, Quebec-based clinical research and bioanalysis provider, a foothold in Europe, and comes six weeks after the company's acquisition of a Baltimore, MD-based CRO.

Simbec has provided contract clinical research services to large pharmaceutical R&D companies for more than 30 years. The staff of the new Algorithme Pharma division in the UK is composed of a core team of approximately 100 employees who will join those already working at company locations in Montreal, Laval and Baltimore.

"Given the considerable growth of our 'international' clientele, it became necessary to acquire a location in Europe in order to better serve our fast-growing market once we had expanded to the U.S. The acquisition of this strategically-located and highly-respected clinical research centre is the first step in our European expansion strategy and provides us with an important base for future growth in the European market," explained Algorithme president and chief executive officer, Louis Caillé.

The Phase I and IIa UK location for clinical research includes a 38,000-sq.-ft. facility with 48 beds, all used by the Intensive Monitoring Unit. With this addition, Algorithme will increase its production capacity in Phase I and IIa drug development clinical trials.

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