Development within the Company

This is by far the most common route for exploitation of the results from R D as, rather obviously, the majority of its work is targeted towards achieving objectives set by the current business. 

The document listing the R D target will have laid down criteria that a new product or process must meet if it is to go forward to commercialisation. Typically the following questions must be answered about projects. 

It is unlikely that all the criteria set in the target document will be met and the decision is often made as a balance of several factors. This aspect of the R D methodology is covered in greater detail in Section D. 

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Having developed some intellectual property to the level where it is open to exploitation a decision must be made about how this should be done. R D and marketing personnel will be involved in an evaluation of the product or process to see if it is suitable for development within the company. If, for a variety of reasons, the answer is no, exploitation by other means will be considered. One way could be in a joint venture with an appropriate partner. Alternatively, it is possible to license or sell the intellectual property to another company, if this fits in with the company strategy. The final option is to abandon the project at this stage and to leave the data in the company secret files, for reconsideration at some future date. These options are shown in Figure C9. 

The opportunities for exploitation, described above, arise from developments within the company and any transfer of technology would be outward. There are also those opportunities which arise from outside the company, but that could be developed within the company, if there was an inward transfer of technology. The transfer of technology is an increasingly common way of exploiting the opportunities from... 

Eastman Kodak has identified 10 core competencies and developed a process for their management and utilization within the company (29). Similarly, Eaton Corporation selected seven core technical competencies, ranked them in importance, assessed their importance vs the known state-of-the-art for the industry, and developed action plans to extend the life of each (30). Eaton subsequently found the company could bring to market products designed with proven building blocks, thus minimizing risk and the need for additional capital equipment. In addition, the competencies were found to be reservoirs of proprietary advantage that had not previously been put to work. 

Ideally, data bases will have been developed within a company such that predetermined PIFs are associated with particular categories of task. If this is not the case, the analyst decides on a suitable set of PIFs. In this example, it is assumed that the main PIFs which determine the likelihood of error are time stress, level of experience, level of distractions, and quality of procedures. (See Section 5.3.2.6.)... 

Moving into the commercial world, he accepted a position with a new telephone company in Budapest, where he developed a telephone repeater system, which formed the basis for the modern loudspeaker. Tesla was promoted within the company to a position in Paris. His potential was now clear to the manager of the plant, who recommended that he move to the United States to work with Thomas Edison, then considered the premier engineering genius of the age. 

Are there skills within the company or organization that can develop a cost-effective program specifically for the respective department, or would it be more economical in terms of costs and the proposed timetable for implementation of the program to purchase an off-the-shelf package Caution on which route should be taken must be exercised in that in-house staff may be available in the initial programming stages but as the system becomes more developed, they may not be free due to other priorities discussed above. 

The Hydrocarbon Processing Industry (HPI), has traditionally been reluctant to invest capital where an immediate direct return on the investment to the company is not obvious, as would any business enterprise. Additionally financial fire losses in the petroleum and related industries were relatively small up to about the 1950 s. This was due to the small size of facilities and the relatively low value of oil and gas to the volume of production. Until 1950, a fire or explosion loss of more than 5 million U. S. Dollars had not occurred in the refining industry in the USA. Also in this period, the capital intensive offshore oil exploration and production industry were only just beginning. The use of gas was also limited early in the century. Consequentially its value was also very low. Typically production gas was immediately flared or the well was capped and considered as an uneconomical reservoir. Since gas development was limited, large vapor explosions were relatively rare and catastrophic destruction from petroleum incidents was essentially unheard of. The outlays for petroleum industry safety features were traditionally the absolute minimum required by governmental regulations. The development of loss prevention philosophies and practices were therefore not effectively developed within the industry. 

The treatment for most of these attitudes is the developement of an effective loss prevention team culture within the company, (i.e., led by senior management, with employee involvement), that demostrates the mutual benefits of an accident free environment. 

Method development and optimization are started with review of the currently available methods within the company or in literature. Available methods are used as a starting point and evaluated against the method requirements set in the method definition. If necessary the method is optimized or redeveloped in order to fulfill the requirements. DOE tools (response surface design) are preferentially applied to obtain the best optimal conditions in terms of robustness. Application of DOE methodology is not new in chromatography and DOE is frequently applied also for enantiomeric separations in Especially in... 

One approach in beginning the development of a fire protection strategy is to define the level of risk that the company is able or willing to accept. Acceptable loss is defined as the cost of a loss event (repair/replacement, including demolition and debris removal, plus consequential business loss) that is within the capability of the company, business unit, or division to absorb financially and culturally. This loss can be retained within the company or partially transferred to others through insurance. 

Most (if not all) companies within the pharmaceutical industry have recognised that such requirements are now a permanent part of doing business, and are developing internal health economics expertise, both on a global (corporate) and on a country-specific level. It should be noted that because of the multidisciplinary nature of this area of research, pharmaceutical company-based health economists cannot operate in isolation from the other disciplines within the company. It is therefore vital that pharmaceutical physicians understand the basic principles of health economic evaluations in order to work with the health economists in the development of high-quality analyses. 

Feike Sijbesma has been a member of the managing board of directors at DSM since 2000. In 1987, he joined the Industrial Pharmaceuticals division of Gist-brocades, with responsibility for strategic planning and business development. After several jobs within the company he joined its executive committee in 1995. Gist-brocades became part of DSM in 1998. Feike Sijbesma studied medical biology at the University of Utrecht and business administration at Erasmus University in Rotterdam. 

Once the goals of the company have been determined and the corporation has made a decision as to where to dedicate its resources, actual position descriptions should be developed. It is important to note that the company s size and cultural objectives can determine the importance a pharmacist has within the company. For example, if the pharmacy department in an organization represents 70 percent of the company s total gross profit, this company would be more sensitive to recognizing and developing its pharmacists compared with an organization in which pharmacy represents only 10 percent of the company s total gross profit. The actual description of a position is called a... 

DSM Venturing Business Development was set up to enable the company to focus on future high growth markets. Whilst it is business oriented it is also concerned with two-way licensing technology both within the company and also venturing activities across the company (See also Section C, 3.2 - 3.4). 

The main component of this type of developmental work is a detailed evaluation of the manufacturing processes used to make the company s products. The targets are therefore derived from discussions within the company after considering the economic climate in which the derived products and business must perform and, importantly, how customers view the current product line or ranges. The benefits that are being sought from process development work are ... 

Internal written policies and procedures must be developed to define the scope of QA activities within the company. These policies and procedures should encompass those areas within the company that, after an assessment of risk, provide the most assurance that safety and integrity are designed into the drug development process. 

The first risk assessment that needs to be done when implementing a new system is one that may often be skipped because the result often seems quite obvious this is the decision as to whether or not the computer system requires validation. However, leaving this assessment out can lead to regulatory liability in regard to systems that a firm decides do not need validation, so it is advisable to make this assessment a standard expectation within the company s system development methodology. It is not an onerous expectation, as it usually takes only a few minutes to document the decision properly. 

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