Foursome aims to be outsourcing force

Out of the merger of four portfolio companies will arise a new global biopharmaceutical development service organization

Jeffrey Bouley
WASHINGTON, D.C. —With plans to headquarter in northern Virginia, just outside the nation's capital, four small- to mid-sized clinical research service companies—Averion International, Trio Clinical Research, Fulcrum Pharma and ClinResearch/ADDPLAN—are banding together to form a single global biopharmaceutical and medical device development services organization.

Patrick K. Donnelly, formerly the CEO and one of the founders of PRA International—who has been named chairman and CEO of the new group—says that this is indeed a true merger, not simply a joint venture. "The deal is already completed, and we had our first meeting of all the investors and board members yesterday," he told ddn Sept. 24. "We don't have a name yet for the new company, but we have a number of marketing engagements and surveys currently underway and plan to get back to let the market know shortly where we're going with that."

J. Matthew Bond, also formerly of PRA International, will be joining the new company as the chief financial officer. Both men are investors in the new company.

The merger, led by a group of investors that includes the Halifax Group, SV Life Sciences and the Comvest Group, is part of a strategy to address the pressures and challenges currently facing the pharmaceutical, biotech and medical device industries through what the merging companies hope will be a unique and useful service offering.

"We're looking at outsourcing in a new way and looking at drug development using more software and adaptive trial methods, as well as high-end regulatory and consulting talents we possess," Donnelly says. "A lot of changes are taking place in the pharma industry, and the ability to continue to spend a billion dollars to bring a drug to market and the economics associated with that are very difficult. So the combination of regulatory, consulting, software and trial capabilities we offer is something that should assist our clients in making better and faster decisions. The drug and device industry needs to approach development from a different and more dynamic paradigm."

The new financial partnership and the combination of services from each company creates access to hundreds of professionals—essentially a more than 800-strong workforce globally.

Each company brings a specific expertise to the table. Averion International, for example, is a full-service global contract research organization (CRO) with more than 600 trials under its belt, so it can provide services across all phases of development in such areas as oncology, medical devices and cardiovascular trials. Trio Clinical Research, a CRO-staffing company hybrid, provides monitoring and project management services, while U.K.-based Fulcrum Pharma has regulatory expertise spanning research to product approval. For its part, ClinResearch/ADDPLAN provides services and software for developing adaptive clinical trial designs.

"The combined resources of our new company positions us to bring truly novel and innovative solutions to companies developing new drugs and medical devices, which sets us apart from other service providers," says Averion's president, Peter Gonze.

Reinhard Eisebitt, who heads up ClinResearch along with Dr. Michael Fischer and ADDPLAN along with Prof. Dr. Gernot Wassmer, notes that the four-way merger will better position their services for innovative trial designs to be distributed worldwide.

Meanwhile, Betsy Brown, president of Trio Clinical Research, is particularly interested in the chance to offer a "much broader range of innovative and unique services."

"As part of a larger, well-funded, global organization, we'll be able to deliver additional high-value services, to the same exacting standards that our clients have come to expect," echoes Phillip Birch, Fulcrum Pharma's general manager for Europe.

"This is just the beginning for us," Donnelly says. "We will continue to look for other opportunities and perhaps acquisitions in such areas as health economics and outcomes, safety and pharmacovigilance, and expansion of our regulatory services farther into biologics and chemical and molecular entities."

Jeffrey Bouley

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