SFBC International, Inc. (NASDAQ: SFCC), a provider of drug development services to branded pharmaceutical, biotechnology, generic drug and medical device companies, announced today key initiatives implemented by Jeffrey P. McMullen, who was recently appointed chief executive officer of SFBC International. SFBC is relocating its corporate headquarters from its current location in Miami, Florida, to Princeton, New Jersey, the headquarters of PharmaNet, SFBC's late-stage development division. SFBC will continue to provide early stage clinical trial services and operate its clinical laboratory at its research facility in Miami. 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 CFO of SFBC International to John P. Hamill, vice president of finance and CFO of PharmaNet, over a period of the next six to nine months. In addition to Mr. Hamill's future role of CFO of SFBC, he has been promoted to senior vice president and CFO of PharmaNet. After the transition, Mr. Natan will be promoted to senior vice president of financial analysis and reporting. In addition, PharmaNet has promoted four key members of the Executive Committee, including Thomas J. Newman, MD, to executive vice president and chief operating officer of PharmaNet; Robert Reekie, MD, to executive vice president, operations, Europe and Australasia; Dalvir Gill, PhD, to executive vice president, U.S. clinical research; and Sean P. Larkin to executive vice president, late phase development. Additional biographical information about these executives is available on PharmaNet's Website at www.pharmanet.com. Following a preliminary review of SFBC's operations, Mr. McMullen established two internal strategic task forces: -- A Regulatory task force led by Gregory M. Hockel, PhD, PharmaNet's senior vice president of regulatory affairs worldwide, is responding to an open item with regard to an inspection by the U.S. 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. The task force will continue working closely and openly with all parties in an attempt to get these issues resolved. It is important to note that no warning letter has been issued. -- 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 January 18, 2006. In addition, based on SFBC's existing capacity throughout its North American facilities and its previously announced plan to open a new 150-bed Phase I facility in Toronto, Ontario by the end of the second quarter of 2006, the Company is reassessing the need for utilizing SFBC's other Miami site that was previously operated as a Phase I clinic by Clinical Pharmacology Associates (CPA), which was acquired by SFBC in August 2003. In addition, the Company's independent legal counsel will respond to an informal, non-public request from the U.S. Securities and Exchange Commission for records primarily relating to the duties, compensation and expenses of two former employees, Lisa Krinsky and Gerald Seifer. SFBC intends to fully cooperate regarding this request. Jeffrey P. McMullen, chief executive officer of SFBC International, commented, "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 re-instilling confidence in our organization and building shareholder value. Consistent with the recent executive management changes, we believe that it is most effective to relocate the corporate headquarters and consolidate the financial reporting for all SFBC operations to Princeton, where the vast majority of the Executive Committee is located. I look forward to working closely with John and David through the transition of the CFO role and know that both will continue to provide strong support for the future of the company." In addition, the Company announced that it expects the meeting with the staff of the United States Senate Committee on Finance, and Dr. Krinsky and Mr. Seifer to take place on January 11, 2006, as previously requested by Senator Charles Grassley. The Company also believes that Arnold Hantman, as well as the three SFBC employees mentioned in the Independent Counsels' report, will be available to meet with the Finance Committee's staff but no specific meeting date has been set. Mr. McMullen concluded, "I have established teams of experienced professionals to focus on high-priority items, and we will continue working closely and openly with all parties to get these issues resolved. SFBC intends to cooperate fully on all matters and we encourage everyone involved to cooperate as well." About SFBC International, Inc. SFBC International, Inc. provides early and late stage clinical drug development services to branded pharmaceutical, biotechnology, generic drug and medical device companies around the world. SFBC has more than 30 offices located in North America, Europe (including Central and Eastern Europe), South America, Asia, and Australia. In early clinical development services, SFBC specializes primarily in the areas of Phase I and early Phase II clinical trials and bioanalytical laboratory services, including early clinical pharmacology. SFBC also provides late stage clinical development services globally that focus on Phase II through IV clinical trials. SFBC also offers a range of complementary services, including data management and biostatistics, central laboratory services, medical and scientific affairs, regulatory affairs and submissions, and clinical IT solutions. Additional information is available on SFBC's website at www.sfbci.com. Forward-Looking Statements The statements made in this press release relating to the ability to meet the FDA's concerns and completion of the new Toronto facility are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). Additionally words such as "seek," "intend," "believe," "plan," "estimate," "expect," "anticipate" and other similar expressions are forward-looking statements within the meaning of the Act. Some or all of the results anticipated by these forward-looking statements may not occur. Factors that could cause or contribute to such differences include, but are not limited to, the inherent difficulty in predicting how regulators may assess a set of facts and delays in completing improvements or receiving the necessary equipment to operate the new facility.
Sfbc (NASDAQ:SFCC)
Historical Stock Chart
From May 2024 to Jun 2024 Click Here for more Sfbc Charts.
Sfbc (NASDAQ:SFCC)
Historical Stock Chart
From Jun 2023 to Jun 2024 Click Here for more Sfbc Charts.