Outsourcing

The author analyzes the study design, participation, and data pooling from a recent benchmarking study on pharmaceutical manufacturing and raises concerns about the process used and data collected in evaluating the performance of contract manufacturers.

Ricerca Biosciences LLC a contract drug-development company, is embarking on a growth strategy upon which it hopes to double its revenues by 2009. The company recently completed a financial restructuring that includes new equity and term facilities totaling nearly $50 million. That financing will enable Ricerca to implement a multiyear business plan, which includes a $15-million investment to add chemistry and biological laboratories to its site in Concord, Ohio.

Interphex2007, New York, NY (Apr. 24)-Effective project management is critical for successful outsourcing between a pharmaceutical company or sponsor and a contract manufacturing organization (CMO), and the strategies for such success was highlighted at the Interphex2007 Conference and Exhibition.

Interphex, New York, NY (Apr. 24, 2007)-Summarizing the current state of the outsourcing industry, Jim Miller, president of PharmSource Information Services said "It's the best it's ever been and seems to be getting better."

Forty years ago, investors and business speculators shuddered at the prospect of working with India's pharmaceutical industry. The industry was plagued by archaic patent laws and insufficient infrastructure, and only multinational companies (MNCs) were able to exploit its crude resources and monopolistic legal framework. Struggling in the shadows of these MNCs were the Indian pharmaceutical entrepreneurs and a handful of producers. Because more than 70% of the pharmaceutical market value was in the hands of MNCs, India's indigenous pharmaceutical industry was floundering. Its amount of exports was negligible, and the domestic market outlook was bleak because of onerous government regulation.

Strong demand is straining service providers' project-management capabilities; Patheon receives a much-needed cash infusion.

Liability issues are often controversial, but much depends on the nature of the agreement.

As big pharmaceutical companies restructure and reevaluate the way they do business, contract research and manufacturing organizations could reap greater financial rewards.

The low-volume pharmaceutical industry must adapt Lean Manufacturing tools invented for high-volume, single product industries.

As big pharmaceutical companies restructure and reevaluate the way they do business, contract research and manufacturing organizations could reap greater financial rewards.

While the Gulf region has already become well-known for its globally accepted infrastructure, and large projects in tourism and other service areas, major investments in healthcare or pharmaceuticals have failed to develop as well.

Finding a CMO partner will take time and an incorrect choice that leads to changing the CMO is financially very painful.

Although the CRO may not wish to draw attention to weaknesses in the intended trial, failing to do so is a great disservice.

Sixty deals were completed in 2006, with a total value of $2 billion.

The latest pacts from the pharmaceutical supply chain.

The latest regulatory and association news for pharmaceutical manufacturers and contract manufacturing organizations.

People on the move in February 2007.

A roundup of manufacturing and service expansions for February 2007.

A roundup of company moves and positioning from the pharmaceutical and biotechnology industries and contract service providers.

Continuing an ambitious growth strategy, SAFC eyes CGMP manufacturing capacity in India for its custom-synthesis business and seeks to gain large-scale organics manufacturing capacity in China for raw-materials supply. And, its biosciences segment seeks opportunity in single-use disposable manufacturing.

As the supply-chain strategies of the pharmaceutical industry evolve, managing risks in outsourcing takes on greater importance. A recent program by the Drug, Chemical, and Associated Technologies Association examined approaches to mitigating risk and improving the pricing-and-cost model in the outsourced relationship.

InformexUSA, San Francisco (Feb. 14?16)-Several contract manufacturing organizations (CMOs) and technology providers used InformexUSA to announce plans to expand manufacturing capabilities, increase service offerings, and ramp up other investments.

InformexUSA, San Francisco (Feb. 12?Feb. 14)-Custom manufacturers of active pharmaceutical ingredients and intermediates are gathered at InformexUSA this week, with companies announcing investment plans and unveiling new technology

InformexUSA, San Francisco (Feb. 14)-The Synthetic Organic Chemical Manufacturers Association is launching a new sustainable chemistry initiative, the International Center for Sustainable Chemistry.

InformexUSA, San Francisco (Feb. 14)-NPIL Pharma unveiled a $100-million investment program in formulation development and manufacturing services.