Outsourcing Science

Pharmaceutical companies need not be self-sufficient in aU their operations all the time, so they obtain certain goods and services from external suppliers, in a practice known as outsourcing. These goods and services do not merely represent, say, office supplies and corporate advertising remarkably, they also include scientific research. External suppliers furnish to some fipcos the results of chemical and biological drug discovery efforts as well as 

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The extent to which the current trend toward mergers and acquisitions continues in life sciences, and also the extent to which larger pharmaceutical companies outsource research and development to smaller companies. It may become necessary for rapid integration of systems between companies that had previously had no relationship at all, and for the secure integration of particular systems between collaborating companies. 

Facilities and Equipment The technical experts who have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to the product are responsible for defining specific facility and equipment requirements. The equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination and product mix-ups. It is important to remember that the GMPs place as much emphasis on process equipment as on testing equipment while most quality systems focus only on testing equipment. Control Outsourced Operations Quality systems call for contracts with outside suppliers that clearly describe the materials or service, quality specification responsibilities, and communication mechanisms. 

The number of person-hours required for the identification and selection process depends on the size of the research program to be contracted. Normally, a minimum of 1 to 2 person-weeks is necessary to effectively evaluate three to four CSOs for each research study to be outsourced. Many clients use consultants to assist in the CSO selection process. However, these clients need to ensure that the consultant has the necessary expertise and knowledge of how CSOs operate. A common mistake is to hire a consultant with expertise in a disease area but not in the research process, such as toxicology or drug metabolism, or in regulatory compliance but not in the science necessary to characterize a drug candidate successfully. 

The increasing trend to outsource the manufacturing of active ingredients and intermediates in life science companies has led to a drop in the number of chemical engi-... 

Cachon, G. and P. T. Harker. 2002. Competition and outsourcing with scale QConomiQs. Management Science, Vol.48, 1314-1333. 

Mayhew, C. et al. (1997). The Effects of Subcontracting/Outsourcing on Occupational Health and Safety. Survey Evidence from Four Australian Industries. Safety Science, 25(1-3), 163-78. 

Why should we care about a declining number of engineers Services are being outsourced because of a shortage of trained domestic workers. The national interest won t be served. Lack of understanding of basic math/science will eventually come back to haunt ns. The decline in engineers will eventually affect research funding and hence the advances that resnlt from research. 

The development of the auto industry supply chain in India proceeded very rapidly at the level of car makers and their first tier suppUers. Here current standards are close to world class standards and it has led to exports of components and sub assemblies to overseas car makers. Furthermore domestic car makers like Mahindra and Mahindra can outsource more effectively achieving cost reductions while maintaining quality levels. Another strategic choice in a low wage environment is the use of highly qualified anployees for shop floor operations. For example, one car seat maker employs only science graduates for all production line operations. The car producers interact very closely with low technology components such as car seats and exhausts. 

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