UPDATE Wednesday 6:00 p.m.:
A new name and the returning familiar faces are two big changes employees at Cetero Research are relieved to hear about.
It's been a long, bumpy road for them. Dr. Alan Copa, President of the Fargo building, says, "When the Houston information came out, it was guilty by association for everyone involved."
Questions about the results of test studies in Houston, Texas between April 2005 and June 2009, layoffs and filing for bankruptcy caused employees to not know what each day would bring. Dr. Copa says, "It was an uneasiness. Am I still gonna have a job? What's gonna happen with the outcome of this? Morale was low."
But a couple of familiar faces are easing the pain. Dr. James Carlson, who co-founded and served as CEO of Cetero Research in Fargo from 1983 to 2006 has returned as the new CEO. Dr. Carlson says, "I'm envious of those people that can retire and enjoy it. It didn't work for me. I was bored after two weeks."
Dr. Carlson brings a very hands-on approach. He is staff-oriented and participant oriented and believes the new changes will allow the company to optimize better than in the past.
There's also soon to be a change of logos on the building. That's because the new company name is a familiar and returning one, PRACS Institute.
Dr. Carlson says, It's a name well-known with the FDA, the generic and innovator pharmaceutical industries." It also has a good standing with the community and those who work at PRACS.
Dr. Carlson will be visiting all of the sites PRACS owns, including the one in Fargo, and will work directly with the employees.
After that he'll work with all clients and hash out any issues they had with the old company.
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Editor's Note: The following is a news release from the company.
Cetero research announced the completion of a major milestone in an effort to reorganize. Following the company filing for reorganization under Chapter 11 and the U.S. District Bankruptcy Court's approval of the sale of Cetero to its investor group, the sale was finalized Wednesday.
Over recent months, Cetero has engaged with lenders and stakeholders to plan a growth-filled future for the company. As a first step in this process, the board of directors has named three executive appointments to lead operational, financial and new business initiatives.
James Carlson, Pharm.D, has been named Chief Executive Officer, based on his extensive background in the Phase I research space and reputation for entrepreneurial leadership. Dr. Carlson is a life science industry veteran with more than 30 years of experience in early phase research. He co-founded and served as CEO of a legacy operation of Cetero Research, based in Fargo, ND, from 1983 to 2006, where he oversaw the conduct of more than 450 studies per year across a wide range of therapeutic indications and study types. A 250,000 square-foot clinical pharmacology unit with specialization in cardiac safety and healthy participants for bioavailability, bioequivalence, preclinical and clinical dermatology studies, this facility is the largest Phase I unit in the world. As part of the new ownership structure, the company's headquarters will move from Cary, NC, to Fargo, ND, and the company has been renamed PRACS Institute.
Mark Ubert, CPA, MBA, has been named Chief Financial Officer. Mr. Ubert joined Cetero in 2009 as corporate controller, bringing extensive experience in financial leadership, corporate treasury, mergers and acquisitions, accounting and operational performance improvement within the life science and healthcare industries. In his new position, Mr. Ubert is responsible for the overall financial operations of the company, including corporate finance, treasury, financial planning and analysis, tax, accounting internal audit and risk management.
John Pottier has been named Executive Vice President, Business Development. With more than 20 years of industry experience, Mr. Pottier brings significant expertise in early phase clinical knowledge and R&D business requirements. Joining PRACS from Worldwide Clinical Trials, Mr. Pottier previously served in business development roles at Novum Research, Cetero Research and PRACS Institute, Ltd., after beginning his career at the Clinical Research Foundation, now part of Quintiles Transnational.
"This is an exciting time for our new company. We have a lot of work ahead of us, and we look forward to strengthening our organization and integrating service offerings," said Dr. Carlson. "We will continue to uphold the company's commitment to the delivery of reliable, quality data and on-time study results, as well as the safety of our study participants," he added.
As biopharmaceutical companies seek new ways to help manage drug costs and navigate the rising complexity of early phase development, sponsors are starting to rely more heavily on niche providers like PRACS, who is well positioned to serve the generic, innovator and dermatology markets. PRACS has the flexibility and capacity to accommodate the expected increase of bioavailability and bioequivalence studies following near-term patent expirations.
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