Schering-Plough has continued the overhaul of its business practices started prompted by chief executive Fred Hassan with a revamp of its clinical research structure, but says no reduction in headcount is planned.
The aim of the restructuring is to create a centralized, overarching management structure for the company’s clinical functions, remove redundancies and make the clinical process - from Phase I to Phase IV studies – more efficient, according to a company spokesman.
“When fully implemented, the new model we are adopting is designed to result in a global, standardized approach to how we conduct clinical trials,” said Brent Saunders, senior vice president, Global Compliance and Business Practices.
The spokesman told PharmaTimes that one key element of the new strategy is the formation of a Global Clinical Operations (GCO) division that will operate as part of the Schering-Plough Research Institute.
At the moment, he said, clinical trials intended to support the registration of new drugs are run by the SPRI’s clinical teams, while post-marketing studies come under the remit of Global Medical Affairs. Meanwhile, the structure is complicated further by the national clinical divisions operated by S-P’s subsidiaries around the world.
S-P declined to speculate on the level of cost-savings that could be achieved through the programme, and stressed that the announcement is more of a statement of intent, with the finer details of the initiative yet to be mapped out by the GCO.
The company still has to appoint an executive to lead the new group, and the incumbent will report to Tom Koestler, executive vice president of global development at the SPRI.
“We looked at best practices throughout the industry and identified several approaches that could be adapted to serve S-P’s needs, said the spokesman. No timetable has been set for arriving at the new set of standards, but the aim is to develop a single model – dubbed Global Clinical Harmonisation - that will be applicable to all the company’s trials ‘regardless of trial type, phase or geography’.
S-P did stress that there would be no change in headcount as a result of the revamp, but noted that one change would be a change in the way it interacts with contract clinical research organisations (CROs).
The new structure would allow it to ‘leverage purchasing power’ with its outsourcing partners, a move that ties in with an emerging trend for pharmaceutical companies to establish preferred provider contracts with larger CROs that can offer a broader range of services. This in turn is driving consolidation in the sector.
Hassan is credited with orchestrating a major restructuring initiative at S-P, and has already out surgery on the group’s manufacturing and marketing operations. The so-called Action Agenda was spurred by declining sales and earnings at the company, as well as serious legal and regulatory issues, when he took over in 2003.
For example, earlier this month the company announced a job cull of 1,100 at its manufacturing plants in Puerto Rico and New Jersey, in a move designed to streamline operational efficacy and boost the company's competitiveness. In 2002, Schering-Plough paid the Food and Drug Administration $500 million to settle a series of investigations into repeated quality control problems and its failure to improve its manufacturing processes. The company expects the plan to cost it between $235 million and $260 million.