Pharmatech Delivers a Unique Life Sciences Focus to Project Cost and Schedule Management
The benefits of project schedule and cost management for both capital and expense projects have been deeply entrenched in competitive business sectors for over 50 years. Public utilities, such as power and water processing facilities, have long applied cost management tools to ensure compliance wherever oversight (public or private) constitutes an integral requirement for project success.
Unfortunately, due to many historical factors, the regulated life sciences industry has not been cost-driven and therefore slow to adopt this analytic approach. Now, in a much more competitive global world, biotech and pharmaceutical organizations are asked to do more with less. The flow of capital demands greater oversight and the metrics for success in terms of dollars escalates as rapidly as the complexity and sophistication of new drug therapies. Consequently, costs are rising for new facilities and for more intensely integrated operations, all with an increased level of scrutiny by the investment and regulatory communities.
Supported by proven methodologies, Pharmatech’s consultants grasp:
- The unique complexities of operating in a sophisticated and highly regulated environment
- The challenges faced with defining and measuring project cost, schedule, and resource management with disparate internal and external entities.
Pharmatech recognizes it is paramount that organizations perfect a plan and then perform to that plan if they are to be successful. Our tools for capturing and controlling projects provide unprecedented visibility to project and program performance over time to anticipate future resource, fiscal and scheduling roadblocks early within the execution process. This integrated forecasting allows organizations to quickly and effectively measure risks, adjust and/or mitigate project deviations before jeopardizing a program’s potential for success.
Unlike cost control organizations outside the life sciences sector that are uninitiated in the intricacies of plant licensure, NDA, ANDA, and PMA submissions, Pharmatech’s specialists base the flows of the critical path(s) around these elements. The result is a management system capable of integrating process, product, capital improvement and GMP operations all within the context of regulatory oversight. Pharmatech’s clients include multiple Fortune 50 pharmaceutical and biotechnology clients from around the world totaling current capital project execution in excess of 1 billion (USD).
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Project Earned Value
The core output of this project cost methodology is establishing an earned value (EV) assessment for each critical step in the process. The earned value calculation evaluates the amount of time, money and resources required to execute against the planned schedule and budget. Although these three interdependent factors are critical to determining EV, unfortunately one of these components is frequently left out or discounted. Too often time and money are the focus of today’s capital project world, while company resources are often considered to be a fully elastic and assumed available commodity. Although this use of already committed resources may provide a tempting cost savings for the project and may appear to meet the corporation’s short-term needs, this over allocation of resources actually adds risk to both current operations and the overall project success. Fortunately, Pharmatech’s methodology has the power to forecast both a project’s and operational group’s resourcing needs as early as the 30 percent completion level of either a capital project or development project enabling management to provide additional resources as or where needed to ensure the most efficient path to project success. This project snapshot provides an effective early warning system so that corrective measures can be applied to keep the project on target.
True and effective cost management calls for a detailed understanding of the specific project under consideration as well as the client’s wider business cost drivers.
Pharmatech’s in-house expertise spans architecture, mechanical, civil, electrical, automation and controls engineering; structural and construction management; value management; and environmental engineering. This multi-disciplinary approach ensures a better coordinated, more comprehensive solution to cost management needs. Applying this approach to the capital project management presents the following benefits:
- Coordinate budget scope with both quality and regulatory expectations
- Monitor and analyze costs at every stage of development
- Generate accurate, timely reports
- Forecast future cash flows, costs and impact of changes
- Resolve cost issues
- Avoid unnecessary redesign
- Optimize return on capital investment
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Centralized Project and Cost Management
Pharmatech’s methodology utilizes software which allows projects being initiated globally to be tracked and managed through a single centralized secure web portal. The program enables program managers, general contractors, specialty subcontractors, and financial professionals to review the progress of all projects at any time. This ensures that all parties are looking at the same, up-to-date information and affords the opportunity to synchronize scheduling, cost, resources, technical and quality issues through a single point of entry. Project- or person-specific access can be established so all participants can have access to the information pertaining to their project anywhere in the world. Similarly, managers running multiple projects can view all of their projects through a single portal, eliminating the error factor associated with multiple reports and schedules.
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Risk Management Impact
The current reality of the industry’s regulatory environment is one embracing an integrated approach to risk management. The FDA’s guidance on “cGMPs for the 21st Century: A Risk Based Approach” and the ICH guidances for Q8, Q9 and Q10 all advocate a wholesale conversion of the current product development quality system to one driven by the thoughtful, measured assessment of risk. This methodology is a critical component in PAT implementation as it allows visibility to the risk to GMP operations that a lack of specific resources imposes on the process as a whole if they are not fulfilled. The application of Pharmatech’s methodology is an integral part of an organization’s commitment to PQAS, positioning the organization to support not only financial and project development milestones, but also regulatory and quality milestones in the most efficient and synchronous manner.
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