Tackling Mega-Scale Project Execution Challenges in the U.S. Pharmaceutical Sector
Complimentary
Learning Level: Basic
Session Length: 1.5 hours
The pharmaceutical industry is experiencing unprecedented growth in capital investment, particularly in large-scale manufacturing facilities driven by innovations in cell and gene therapies, mRNA platforms, and advanced biologics. However, executing mega-scale capital projects in the U.S. presents a unique set of challenges—from cost estimation and skilled labor shortages to navigating complex regulatory environments and integrating emerging technologies. To address these pressing issues, Pathfinder, LLC, in collaboration with the International Society for Pharmaceutical Engineers (ISPE), proposes a 90-minute interactive virtual workshop titled “Tackling Mega-Scale Project Execution Challenges in the U.S.”
The workshop concept would begin with a membership-wide survey designed to identify and prioritize the most critical execution challenges faced by ISPE members. Topics may include cost estimating accuracy in GMP environments, availability of specialized labor, execution strategies to reduce cost and time, and the integration of digital tools such as digital twins and automated validation systems.
The session will feature expert framing of the top three survey-identified topics, live polling, open discussion, and real-time sharing of strategies among participants. The format is designed to foster peer-to-peer learning and practical knowledge exchange, with a strong emphasis on Owner company participation.
Outcomes of the workshop will include a comprehensive Summary Report capturing key insights, shared strategies, and actionable recommendations. Participants will also receive an exclusive post-event report and be invited to engage in follow-up sessions focused on specific pain points identified during the workshop.
This initiative aims to elevate industry dialogue, promote collaborative problem-solving, and contribute to the development of best practices for executing large-scale pharmaceutical projects. By engaging stakeholders across the ISPE community, the workshop will serve as a catalyst for innovation, efficiency, and resilience in capital project delivery.
Learning Objectives
Identify and Prioritize Execution Challenges in Mega-Scale Pharma Projects
Participants will gain a clear understanding of the most critical issues impacting large-scale pharmaceutical capital projects in the U.S., as identified through a pre-workshop industry survey. These may include cost estimating in GMP environments, skilled labor shortages, and supply chain disruptions. Attendees will learn how these challenges manifest in real-world scenarios and how peers are addressing them.
Explore Practical Strategies and Peer Solutions
Through expert framing, live polling, and open discussion, participants will explore proven strategies and innovative approaches used by industry professionals to overcome execution hurdles. The workshop will foster peer-to-peer learning, allowing attendees to share and compare methods for improving project delivery, managing scope changes, and integrating digital tools into execution workflows.
Contribute to Industry-Wide Knowledge and Future Standards
Attendees will actively contribute to a collaborative dialogue that informs a post-event summary report. This report will compile shared insights, strategies, and recommendations, helping shape future best practices and standards for mega-scale pharmaceutical project execution. Participants will also have the opportunity to engage in follow-up sessions for deeper dives into specific pain points.
Download Presentation
For viewing, use password: ISPE1234567
Speakers
Copyright Disclaimer
This copyright notice applies to all proprietary pages, images, text, programs, and other material available throughout this Internet site (collectively, this “Publication”). All materials posted on the website are subject to copyrights owned by the International Society for Pharmaceutical Engineering (“ISPE”) and other individuals or entities. Any reproduction, retransmission or republication of all or part of any documents found on this site is expressly prohibited, unless ISPE or the copyright owner of the material has expressly granted its prior written consent to reproduce, retransmit or republish the material. All other rights reserved. View entire copyright policy.
& Click the bell for notifications.