With a typical production and maintenance lifetime measured in decades, the decision to devote capital resources to build a development or manufacturing facility is a significant investment that carries long reaching implications for any business. In our industry, facilities have to be built out well in advance of proof of clinical efficacy and commercialization, which further magnifies the risk to an organization’s potential to be successful.

Let’s look at the elements that should factor in any strategic discussion that takes place prior to a decision to build. Today, we find the complexity of the equation escalating as we incorporate the support of overseas organizations for key steps within the drug development lifecycle. As the industry struggles to integrate the principles of ICH Q8, Q9, and Q10 as part of our routine product development process, the demands on the facilities we develop can only become greater. I propose a model for expanding the strategic planning effort that contains a clearly defined facilities planning lifecycle to make sure that decisions surrounding the design timing and functionality of a facility maximize its return on investment.

UPDATED REGULATORY GUIDANCE
From the regulatory perspective, the basic characteristics of facility design are well understood. The latest regulatory guidances issued by the FDA and ICH, however, recommend a more focused scientific development approach that integrates risk management more prominently throughout the product development lifecycle. The full potential of these two factors not only impacts our approach to product and process development but may also set the stage for greater flexibility when developing an organization’s strategic and tactical capital plans. As organizations look for new and more effective ways to reduce the investment and overall time to market for new therapies, they turn to the low cost, highly skilled labor force overseas. This has great potential during the early phases of product development, such as formulation and pre-clinical characterization. Outsourcing is a significant opportunity to reduce the overall cost of development and decrease time to market as we move toward parallel processing. Still, with regard to pursuing an outsourcing strategy for any type of development, the question remains: Can we better leverage this business decision by integrating the capability with associated facilities and their operations? The decision to outsource in itself is a significant one for any company; I think it could be made in consideration of the short and long term capabilities and requirements of the capital infrastructure.

STRATEGIC FACILITY PLANNING MODEL
The impact of mitigated or poor decisions in terms of facility design and function will be felt immediately across an organization if a strategic business opportunity cannot be exploited. Best in class operations have long recognized the importance of establishing a process methodology which could provide the decision makers with the best data possible for the best decision possible in terms of facility design and function. The more methodical the strategic planning process the easier it is to integrate the metrics and measurements your business can use to achieve its goals. This model shows the vision and the execution plan, consisting of long and short term analysis coupled with ongoing activities that keep the focus on strategic objectives. The components of the model are shown in Figure 1.

STRATEGIC PLANNING PROCESS—UPSTREAM AND DOWNSTREAM
The business impact of a facility directly relates to overall corporate performance. The strategic planning process upstream is geared to business performance objectives, while business impact analysis is important to allow these goals to percolate downstream. If an organization uses a strategy map or balanced scorecard process to establish overall business objectives it is easy to integrate capital considerations as part of the strategic planning process.

Here are five information sources that support the strategic definition process:

1. Benchmarking
2. Current Economic Conditions Analysis
3. Existing and New Market Analysis
4. Regulatory Strategies
5. Pipeline/Portfolio Analysis