Outsourcing

As FDA tries to bring pharmaceutical manufacturing into the 21st century, competitive dynamics in contract manufacturing are likely to change in favor of companies that have greater manufacturing expertise and the means to invest in new technologies.

Outsourcing is part of the public debate as politicians seek to explain the lag in job growth despite a recovering economy, and as the Bush administration presses its initiative to "competitively source" more agency activities.

CROs and contract manufacturers had a decent second quarter, but they are hoping that Big Pharma comes through with a burst of trial start-ups in the second half of 2003.

The Biotechnology Industry Organization lends insight into the trends of biopharmaceutical contract manufacturing.

This second annual survey tracks teh growth of the outsourcing services sector in the past year.

The DSM investment puts biomanufacturing capacity in the spotlight. Contract biomanufacturers are adding new capacity and sponsors are marketing their excess capacity.

Gene Logic acquires TherImmune Research Corp. as part of its plan to create a new business model; First quarter results are a mixed bag for contract services companies.

The successful auction of Quintiles raises questions for the company's new owners, Pharma Services Holdings, Inc., and the entire pharmaceutical industry with regard to strategic investments, assets to be sold, and other concerns.

As demand for contract services slows down, contractors restructure themselves and the industry.

CROs and CMOs project strong business operation in 2003, and contract sterile manufacturing companies invest millions to increase capacity.

A column covering the outsourcing industry.

Developments in 2002 such as acquisitions, excess manufacturing capacity, and less funding for biotechnology will continue to affect the industry long into the new year.

December's Contract Services articles include "Using Virtual Private Networks to Gain Competitive Advantage," by Mark Tuomenoska and "Outsourcing Outlook," by Jim Miller.

November's Contract Services articles include "Outsourcing Xbox Manufacturing," by Heather Hayes, "Outsourcing Outlook," by Jim Miller, and "Quality in Pharmacovigilance," by Brian Edwards and Jeffrey Priem.

The European Union is attempting to reform its current business environment in hopes of restoring its role in the lobal R&D sector.

The author discusses the potential effect on CROs of pending major-pharma mergers and consolidations.

When choosing a CRO, take the time to conduct an in-depth evaluation of each department, paying special attention to the quality and training of its personnel.

The author examines the concept of evaluating CRO operating performance in today's pharmaceutical industry.

The results of this 2002 survey of contract services decision makers reviews and forecasts the state of the outsourcing industry.

Carefully crafted outsourcing arrangements allow companies to become powerful partners in the quest for market share.

The author discusses the Japanese cabinet's approval of a measure that lifts manufacturing restrictions on domestic pharmaceutical companies.

The author discusses the upcoming human research congressional debate and CROs' preparations to respond.

Treating a cross-organizational team as a full-fledged partnership helps complete a project on time and on budget.

A profile about how a provider with a solid reputation in niche areas of contract manufacturing became a full-service operation.

A knowledgeable and experienced contract service provider can help in the development and success of an inhalation drug product.

The author discusses recent acquisition activity in the chemistry, manufacturing, and controls (CMC) outsourcing industry.

The use of on-line auctions can provide increased business and new sellling opportunitites for suppliers.

The author discusses the current soft demand and excess capacity in the contract-manufacturing market of small molecule actives and intermediates.

Reverse auctions can benefit both buyers and suppliers of goods and services, but extensive preparation and careful management are required to obtain those benefits.

The author discusses three current examples of new ideas in formulating outsourcing arrangments.