How Front-End Planning Cuts Costs and Speeds Up Project Delivery

Balancing cost controls with accelerated timelines remains a significant challenge for pharmaceutical manufacturing projects. While speed to market has always been a concern for drug developers, the pandemic brought forth new expectations for fast-track projects.

A rapid drug manufacturing pace has redefined expectations for drug development and manufacturing timelines. In recent years, this momentum has evolved to address a broader range of health challenges. While this urgency drives innovation, it also necessitates navigating a delicate balance between accelerated schedules and the stringent quality and safety standards required by regulatory agencies. This shift is exemplified by the FDA’s Center for Biologics Evaluation and Research (CBER) launching Operation Warp Speed for Rare Diseases in 2023, designed to accelerate drug development and approval for over 7,000 rare diseases affecting more than 30 million Americans.

Front-end planning (FEP) plays a crucial role in preparing capital projects for success. As the third phase of the stage gate process (FEP 3), FEP builds on the foundation laid by conceptual and feasibility studies to create a robust framework for project execution. Key FEP objectives to consider are: 

• Developing detailed engineering scoping packages that guide subsequent phases. 

• Exploring potential design options to improve return on investment. 

• Conducting hazardous operations reviews to enhance safety outcomes. 

• Supporting internal funding processes with accurate cost estimates and risk assessments earlier in the design. 

• Providing a road map for project scope, budget and timeline that can be referenced throughout the engineering and construction phases. 

Benefits of Strategic FEP and EPC Delivery

Investing in FEP reduces project risks and uncertainties while creating long-term value. According to the Construction Industry Institute, FEP will return on average 10% cost savings and 7% shorter schedule delivery. FEP deliverables vary by project but typically include: 

• Comprehensive engineering designs and specifications. 

• Refined scope, schedule and cost estimates. 

• Risk identification and mitigation plans. 

• Health, safety and environmental strategies. 

These deliverables retain value throughout the project life cycle, enabling faster startup, commissioning and turnover while minimizing technical and financial risks.  The engineer-procure-construct (EPC) approach enhances efficiency by enabling concurrent engineering and construction activities. It also allows for adaptive design changes to meet evolving regulatory requirements, with early equipment procurement yielding smoother execution. To balance speed and quality, the EPC approach allows for innovative strategies, tools and methodologies to be applied to meet accelerated timelines, including: 

• Flexible, scalable designs that enable faster construction and validation compared to traditional single-process plants. 

• Real-time project management and supply chain optimization that improves speed and efficiency. 

• Pre-commissioning of components off site that helps increase consistency and reduce on-site installation risks. 

• Early selection of manufacturing processes and technologies that reduce development timelines. 

• Engaging with regulatory professionals early, streamlining approvals and avoiding costly delays. 

• Ordering critical or long-lead equipment early to prevent bottlenecks. 

Using FEP to Build Better Drug Pathways for the Future

The pharmaceutical industry has immense capacity for innovation and adaptation. When combining rigorous FEP, strategic partnerships and innovative technologies, pharmaceutical companies can achieve the agility needed to meet aggressive timelines without compromising quality or safety. This way, manufacturers can bring lifesaving treatments to the market faster, allowing patients to receive critical therapies without delay, while maintaining robust cost control and compliance with regulatory standards. 

With the proper front-end planning, the future of pharmaceutical manufacturing is brimming with potential driven by cutting-edge, efficient facility construction and development solutions.