A regulatory affair

Clinipace Worldwide acquires Regulus Pharmaceutical Consulting

Lori Lesko
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MORRISVILLE, N.C.—Taking a huge step toward bolstering its regulatory and strategic development capabilities and enhancing its in-house regulatory publishing and medical groups, Clinipace Worldwide, a global digital clinical research organization (CRO), has acquired Regulus Pharmaceutical Consulting Inc., a regulatory affairs and quality assurance consultancy based in Boulder, Colo. The financial terms of the deal were not disclosed.

The acquisition expands Clinipace's staff count by 20 percent, with new team members adding an average of 18 years experience in the life sciences industry, the company announced March 1.

"Industry leadership and expertise from Regulus fuels our mission of partnering with our clients in bringing innovative therapies to market through our technology-amplified services in clinical development, regulatory affairs and strategic development," said Christopher Porter, chief operating officer of Clinipace, in a statement announcing the acquisition.

The Regulus team will remain in Boulder with the same management structure and personnel. Operating under the umbrella of Clinipace's corporate structure, Regulus now operates as the Regulatory Affairs, Strategic Development and Quality Assurance consultancy division of Clinipace.

A key piece acquired in this corporate partnership is Brenda Fielding, the founder, chairman of the board and president of Regulus. Now working for Clinipace, Fielding has the position of executive vice president of regulatory affairs, reporting directly to Porter. Fielding is responsible for directing all of Clinipace's regulatory affairs and quality assurance consulting services from the Boulder office.

"Regulus' expertise is a strategic fit for Clinipace Worldwide as they provide a unique resource of experience and skills to meet the requirements of our biopharmaceutical and medical device clients," says Jeff Williams, CEO of Clinipace.

Together, the two companies "can ensure all relevant disciplines are involved in a clinical development project, from initial concept to regulatory strategy and submissions, quality systems implementation, clinical operations, through to the final delivery of the completed project," Fielding says.

Throughout her career, Fielding has held senior management positions at U.S.-based pharmaceuticals and biotechnology companies, including Cortech, Gilead Sciences and Napro BioTherapeutics Inc. (now Tapestry Pharmaceuticals). She has been involved in the clinical development of novel drugs, biologics and drug-delivery systems over a wide range of therapeutic areas including oncology, anti-infectives, immunotherapeutics and ophthalmology.

David Levin, vice president of Clinipace, says the company specializes in fully integrated clinical research services for biopharmaceutical and medical device firms.

"We invented a new way to deliver services called Right-Sized Clinical Research Solutions," Levin tells ddn. "That means you get the right mix of resources at a fixed price to fit your specific trial or registry needs. Not more. Not less. And our contract services are amplified by our proprietary eClinical technology, TEMPO. As a digital CRO, we built, own and use our technology. Our processes and technology are tuned to one another. We are guided by the philosophy that using technology to drive clinical research optimizes project performance while containing costs."

Clinipace and Regulus complement one another, so bringing the companies together makes a lot of sense strategically, Levin says.

The acquisition of Regulus "allows us to get critical mass much more quickly than we could independently," Levin said. "Together, we can make real gains in overcoming the gaps in process that make traditional CROs inefficient."

The Clinipace Worldwide name was adopted in November 2009 after Clinipace acquired fellow U.S.-based CRO Worldwide Clinical Research, building on Clinipace's core expertise in clinical research software and raising its global profile. Clinipace's corporate headquarters are in Research Triangle Park, N.C. As well as the new Boulder office, the company has domestic operations in Overland Park, Kansas, and a South American presence in Sao Paulo, Brazil; Buenos Aires, Argentina; and Lima, Peru.

Clinipace tapped by Plexxikon to manage four clinical trials

MORRISVILLE, N.C.—Clinipace Worldwide also announced last month that Plexxikon Inc. has selected the company to manage all aspects of four clinical trials comprising a Phase I healthy volunteer study, a Phase Ib rheumatoid arthritis (RA) study and two Phase II oncology studies.

"As a digital CRO, we know that successful trials hinge on the transparent exchange of trial and project data among all constituents," says Jeff Williams, CEO of Clinipace. "This platform enables our clients to substantially improve their ability to avoid problems and mitigate risk. As a result, we look forward to a long-lasting and successful partnership with Plexxikon as they continue to bring innovative and effective drugs to market."

Plexxikon announced in January that enrollment started for the first of two Phase I clinical trials with PLX5622, a novel, oral, targeted and highly selective Fms kinase inhibitor for the treatment of autoimmune diseases such as rheumatoid arthritis (RA). The initial Phase I trial is a single-ascending dose (SAD) study in up to 48 healthy volunteers. The second trial is a multiple-ascending dose (MAD) study in approximately 32 RA patients that will begin once the first SAD healthy volunteer cohort has been cleared for safety, with continued enrollment in a staggered fashion following each SAD dose level.

Additionally, Plexxikon has awarded Clinipace two Phase II trials with PLX3397, an orally available compound that selectively co-inhibits three key kinase targets—Fms, Kit and FIt3-ITD—resulting in down-modulation of a number of cell types including macrophages, microglia, osteoclasts and mast cells, as well as cells harboring the Flt3-ITD mutation, a driver in as many as 30 percent of acute myeloid leukemia (AML) cases. These clinical trials are targeted for initiation in 2011 and focus on recurrent glioblastoma multiforme and relapsed or refractory Flt3-ITD+ AML.

"We chose Clinipace Worldwide to manage these important clinical trials for both PLX5622 and PLX3397 based on Clinipace's commitment to customer service. Plexxikon's programs are highly differentiated from its competition, and we needed a highly differentiated CRO to get the job done. The Clinipace team values each working opportunity as a true, strategic partnership," says Dr. Paul Lin, director of business development at Plexxikon. "We believe in Clinipace's dCRO model and the Clinipace team. As our portfolio grows in value, we have confidence that Clinipace has the experience and expertise to handle additional, mission-critical trials with high visibility and efficiency."

Based in Berkeley, Calif., Plexxikon develops structure-guided discovery and development of novel small-molecule pharmaceuticals to treat human disease. The company was recently acquired by Daiichi Sankyo Co. Ltd. of Tokyo.

Lori Lesko

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