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Published on 1/10/2006 in the Prospect News Biotech Daily.

SFBC's new CEO relocates headquarters, forms task forces

By E. Janene Geiss

Philadelphia, Jan. 10 - SFBC International, Inc. announced Tuesday key initiatives implemented by new chief executive officer Jeffrey P. McMullen that include relocating its corporate headquarters to Princeton, N.J., from Miami, along with the headquarters of PharmaNet, SFBC's late-stage development division.

SFBC said it will continue to provide early stage clinical trial services and operate its clinical laboratory at its research facility in Miami, according to a company news release.

Concurrent with the relocation of the corporate headquarters, David Natan, vice president of finance and chief financial officer, will transition the role and responsibilities of chief financial officer to John P. Hamill, vice president of finance and chief financial officer of PharmaNet, over the next six to nine months, officials said.

Hamill also has been promoted to senior vice president and chief financial officer of PharmaNet, officials said.

After the transition, Natan will be promoted to senior vice president of financial analysis and reporting, officials said.

PharmaNet also has promoted four key members of the executive committee, including Thomas J. Newman to executive vice president and chief operating officer of PharmaNet, Robert Reekie to executive vice president of operations in Europe and Australia, Dalvir Gill to executive vice president of U.S. clinical research and Sean P. Larkin to executive vice president of late-phase development.

Task forces formed

After reviewing the company's operations, McMullen established two internal strategic task forces, officials said.

A regulatory task force led by Gregory M. Hockel, PharmaNet's senior vice president of regulatory affairs worldwide, is responding to an open item with regard to an inspection by the Food and Drug Administration of SFBC's Miami facility.

SFBC is working with the client and the FDA to clarify information regarding one study. The information addresses concerns raised by the agency's Division of Scientific Investigations regarding the number of evaluators and the timing of the assessments used in the study, officials said. The task force will continue working closely and openly with all parties in an attempt to get these issues resolved, SFBC said in the news release. It is important to note that no warning letter has been issued, officials said.

A building task force is working with Miami-Dade County representatives to address the previously announced concerns about the structural and related issues at its facility and prepare for the upcoming Miami-Dade County Building Department hearing scheduled for Jan. 18.

Based on the company's existing capacity throughout its North American facilities and its previously announced plan to open a new 150-bed phase 1 facility in Toronto by the end of the second quarter of 2006, the company is reassessing the need for using SFBC's other Miami site that was previously operated as a phase 1 clinic by Clinical Pharmacology Associates, which was acquired by SFBC in August 2003, officials said.

The company also said its independent legal counsel will respond to an informal, non-public request from the Securities and Exchange Commission for records primarily relating to the duties, compensation and expenses of two former employees, Lisa Krinsky and Gerald Seifer. SFBC said it intends to fully cooperate regarding this request.

"We are intent on building upon the strong platform of the company, aggressively addressing the issues confronting us and moving the organization forward to achieve our objectives. I am also committed to providing more transparency in our financial reporting and operating activities. These initiatives are important steps in reinstilling confidence in our organization and building shareholder value," McMullen said.

These changes were precipitated by the fallout of Bloomberg Magazine articles that alleged ethics violations and claims that the company was allowing people to be injured or killed at centers conducting clinical trials.

One allegation in the article accused the company of not properly informing poor immigrants participating in trials. The Miami facility was the focus of these allegations.

The company hired an independent counsel to review the ethics allegations, which found the criticisms to be "wholly unsupported."

SFBC, now based in Princeton, provides early and late-stage clinical drug development services to branded pharmaceutical, biotechnology, generic drug and medical device companies around the world.


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