Project team approach

The project-team approach features a famous success. In 1972, a team led by organic chemist Robert Ganellin and pharmacologist James Black discovered the antiulcer, Hg-antagonist cimetidine at Smith Kline and French (now SmithKline Beecham). Their scientific and commercial success culminated 15 years of research. During this time, some 20 biologists and 50 chemists tested and made 700 compounds, the first 200 of them in 4 years. (By today s combinatorial chemistry standards, a set of 700 new compounds is minute.) Two of these compounds failed one or more clinical studies be-... 

The QRA project team can select the appropriate technical approach once you specify the study objectives, and together you can define the scope. A variety of modeling techniques and general data sources (discussed in Section 3.2) can be used to produce the desired results. Many computer programs are now available to aid in calculating risk estimates, and many automatically give more answers than you will need. The QRA team must take care to supply appropriate risk characteristics that satisfy your study objectives—and no more. 

Adequate resources are fundamental to any project, but even more so to a well-functioning health and safety program. Many mishaps have been traced to improperly trained workers, lack of adequate tools and equipment, or requirements for personnel to work excessive hours or at unfamiliar jobs because of inadequate staffing or lack of adequate resources. The multidisciplinary team approach can help to identify required resources and can help balance, identify, and coordinate necessary assets. 

The standard requires that if a project management approach is used, a project manager and project team be assigned, that appropriate resources be allocated, and any special responsibilities and organizational interfaces be defined. 

In some respects this requirement is ambiguous as there are no equivalent requirements for when the APQP approach is used. The APQP manual merely offers guidance. With the APQP approach the equivalent of the project manager is the project team leader and the equivalent of the project team is the product quality planning team. 

A multidisciplinary approach is another term for a cross-functional team or a project team. Such teams comprise representatives from each line and staff department so that decisions are taken close to the development work by those who will need to implement the decisions or verify their implementation. Such teams facilitate communication and overcome delays that often occur when reliant upon line-staff relationships. If you have adopted the project management approach this requirement is not additional to that in clause 4.2.4.1. 

Hybrid approaches are generally more difficult to manage as the relationships and division of responsibilities between the PSM project teams and other management varies from element to element. This can lead to confusion within both the PSM teams and among other managers, which can result in misunderstandings and wasted work. 

As with other project teams, those selected for PSM system design need a clear understanding of what your company expects from them. Regardless of which approach you ve chosen, team members need to know ... 

The integration of sensing and other functions in a micro-flow system requires either monolithic, on-chip or hybrid, multi-scale approaches. Concerning the latter, Hessel and Lowe discuss the lack of compatibility of today s fluidic interfaces and report on a German project team developing a standard for micro-reactor interconnection [9, 10]. 

In many respects the fragment approach is ideally suited to projects which have X-ray crystal structures available. The fragments are small and relatively weak binders, but they often only possess one pharmacophoric element that binds to a specific feature on the target. If this interaction is identified by X-ray structure determination, then project teams can propose specific plans which maintain that critical interaction, and ideally optimize binding through other vectors in their fragments. 

Cross [19] advocates a rational approach in the design process. He described in his book the seven steps procedure for the rational method for new design shown in Fig. 12.8-1 and listed in Table 12.8-1. The method covers every aspects of the design process from problem clarification to detailed design. It also facilitates better teamwork and enables better task subdivision. The project team employed this method to guide the design of the indoor air quality control appliance. 

My team approaches these questions with two main projects which are interconnected and open to wider interdisciplinary cooperation. One of these projects focusses on the ethology of art, the other on urban ethology. 

Lastly, every research project presents a unique combination of parameters (target, assay methodology, hit rate, throughput limit, and so forth) and project team requirements for interesting actives (physiochemical properties, novelty, and so forth). This suggests that an optimal selection scheme should be easily tailored to meet these unique needs, which is certainly not true of a simple Top X approach. 

The approach presented here addresses many of the limitations outlined above it gives due consideration to all significant actives, is customizable to the individual needs of the project team, and offers improvements in quality of actives, diversity of actives, and... 

The varying hit rates commonly seen in HTS screens combined with the individual requirements of the project team (stringent or relaxed physiochemical properties, specific scaffolds that represent uninteresting inhibitor classes, and so forth) demand an approach to hit selection that is customizable. This is not true for the Top X method but has been shown clearly here for the current method applied to three very diverse projects with hit rates varying by an order of magnitude (1.3 to 14.6%). 

Figure 2.2. Timeline of fast-track development of an HIV protease inhibitor, indinavir Crixivan) by Merck through a project research team approach. Adapted from Merck s account on Crixivan development.

Step 6 allows us to create a statistical approach for the evaluation of the collected data. Using a statistical test and the statistical parameters selected in Step 6, we will be able to control decision error and make decisions with a certain level of confidence. Decision error, like total error, can only be minimized, but never entirely eliminated. However, we can control this error by setting a tolerable level of risk of an incorrect decision. Conducting Step 6 enables the planning team to specify acceptable probabilities of making an error (the tolerable limits on decision errors). At this step of the DQO process, the project team will address the following issues ... 

Qualified technical personnel should oversee PQ studies however, the execution can be left to specially trained hourly personnel. For larger projects it may be necessary to use a team approach to ensure that the requisite technical skills are available. Evaluation of dose uniformity may require the skills of a quality control analyst, formulation expert, and statistician. In these circumstances, report preparation may have to be split among the team members. 

The plan is now ready to be discussed in all details among the members of the project team or with potential collaborators (if that has not already been done). The strategic plan, as it is now, contains sufficient detail to seriously consider the basic rationale of the approach. Changes to the aim, objectives and some general aspects of the plan will most likely occur at this stage. 

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