The Business Case

Campbell, C., "Legal Issues Associated with Pharmacogenomics," In Tadmor, B. and M.H. Tulloch (eds.), The Business Case for Pharmacogenomics, 2nd ed., Wobum, MA AdvanceTech Monitor, pp. 8-23 (2001). 

The business case This provides initial requirements, defining the business problem or opportunity that this project addresses. It typically includes a high-level list of numbered functional and nonfunctional requirements2 (lb), the business reasons and risks for the project (la), the scope of the project in terms of things definitely included or excluded, linked clearly to a business model in terms of business objectives, actions or use cases, and user roles that must be supported (la), known requirements on the architecture, design, and implementation (lc), and constraints on project budget and schedules (Id). 

In the business case of painting disposal costs may reach EUR 0.5/kg and the process efficiency (coating percentage of used paint) may be around 60% of the paint input. This assumption leads to the production of 40% waste related to the input of paint2. Based on the input of 100,000 kg/year in the theoretical example disposal costs of EUR 20,000/yr (40,000 kg a EUR 0.5) occur. An increase of 10% process efficiency means 66% instead of 60% paint used and consequently 34,000 kg waste instead of 40,000 kg. 

The growing use of more complex PAT (vs. the historically used simple univariate sensors such as pressure, temperature, pH, etc.) within manufacturing industries is driven by the increased capabilities of these systems to provide scientific and engineering controls. Increasingly complex chemical and physical analyses can be performed in, on, or immediately at the process stream. Drivers to implement PA include the opportunity for live feedback and process control, cycle time reduction, laboratory test replacement as well as safety mitigation. All of these drivers can potentially have a very immediate impact on the bottom line, since product quality and yield may be increased and labor cost reduced. If these benefits can be exploited by a process analytical application then the business case is typically readily available. 

In either of these cases pursuit of the development may become irrelevant to the business case of one or other partner. Alternatively the asset itself may not perform well in the clinic or may be found to have long-term toxicity problems. This last issue is the most common reason for disengagement of parties in an alliance and is usually dealt with by following the course set down in the contract for that eventuality. 

Thus, even if the business case promises great savings, the scope of those savings must be aligned with an ownership that is empowered to implement the necessary measures to achieve them. 

Finally, the business cases that drive those projects are becoming more conservative. Pay-as-you-go approaches can keep the risks low investment in new projects occurs only if the previous projects cover the costs. Even though CRM projects can become quite lengthy (three to five years), pay-as-you-go ensures budget stability and enhances organizational acceptance and ownership of the implemented solutions. 

Transitioning to this project structure, CR D developed processes to evaluate, activate, staff, track, develop and, if necessary, terminate projects. Growth Council ensures a continued match between the business case and the technical accomplishments of projects. 

Miller, K., Comments at the panel discussion in the session Building the Business Case for Sustainability, AlChE Spring Meeting, Atlanta, 12 April, 2005. 

Of the four critical areas, which can a firm impact the most The commercial team s sales prediction significantly affects the business case, but those predictions are dictated by product efficacy and market forces. Even though the forecast is variable, in most... 

Many computer systems have been implemented on the promise of giving pharmaceutical and healthcare companies a competitive advantage. Claimed benefits in the business case usually include ... 

An Outline Specification is usually required to sanction a project and authorize the allocation of a budget. It typically presents the business case for the computer system, defining key functionality and compliance requirements. This document may be used later on for developing the User Requirements Specification (URS) as discussed in Chapter 7. Where Commercial Off-The-Shelf (COTS) software and systems are being acquired, this document may be used as the URS. Outline Specifications must be reviewed and approved. 

Definition and documentation of the business requirements for LIMS is the first step in the implementation process. These requirements are not system specific and define, at a high level, what LIMS will be expected to do for the business. The business requirements are used in defining the system requirements in the supplier selection process and in the financial justification for the system. The business case will normally be based on the ability of the LIMS to ... 

It must be clearly understood, and covered in the business case, that the implementation and initial validation of LIMS is only one component of the cost of the system through its life. Installation is just the beginning of an ongoing commitment to the maintenance of LIMS in a validated state. This includes the commitment to the ongoing cost of maintenance of the system, infrastructure, and business processes. 

Once the business case has been accepted and investment received, it is necessary to define the process and functional requirements of the development. 

A business case is required to justify the allocation of time, money, and energy needed to make your innovation a successful venture. The business case should be a compelling summary for why the project is necessary and... 

The business case is often based on initial assumptions (customers will buy this innovative offering from us, we will recoup our investment on this project, etc.). Just be sure to test these assumptions for validity as you move through the project. Otherwise, you may find out too late that they weren t sound. 

If you ve completed a Project Charter, you ve established the business case for your innovation. Innovation hnancial management takes over from here and begins with a list of what you know (verihed knowledge), as well as what you need to find out (unverihed assumptions and unknowns). 

The business case for a new product project should include the following ... 

The model invariably involves many iterations before a satisfactory combination of project parameters is assembled it will set the scene for the business case which the investor or the financier will consider prior to committing funds to the project. Further discussion on the financial model is given in the section on risks and critical issues later. 

C. O. Holliday, Jr., S. Schmidheiny and P. Watts. Walking the Talk. The Business Case for... 

A number of other companies, including Dow, BP, and Shell have taken steps in promoting SD initiatives within their firms. This has included developing business cases for the integration of SD into business strategy (Challener, 2001). See Section 8 for the business case presented by several chemical companies. 

IMD (International Institute for Management Development), CSM/WWF Research Project The Business Case of Sustainability, IMD Working Paper Series, IMD, Lausanne, Switzerland, 2003. 

In analyzing the business case for its recommendations, audit teams employ a number of accounting techniques. Because the effects of most corporate responsibility issues cross departmental and divisional lines and because activities drive costs, it is necessary to understand how certain activities and practices impact financially and strategically the entire organization. 

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