Rasmus Kidmose, European Business Development Director at CRB explores the benefits of working with global partners, no matter your location.
Project owners in the life sciences industry are uniquely familiar with that old adage, “The only constant is change.” Facing the pressures of Covid-19 and ignited by new technologies and research advances, the industry has undergone immense transformation over the last eighteen months. Cell and gene therapy innovators are particularly notable agents of change; they raised $19.9 billion in 2020, exceeding 2019’s investment by more than 200%. The European Commission recognised this momentum in its recent EU Pharmaceutical Strategy, which aims to drive further competitiveness and innovation in the industry. Change isn’t coming—it’s already here, and it’s transforming life science research in the EU.
To keep up with this pace, the industry’s assumptions about capital project delivery must change. In particular, the notion that working with a regional Architecture, Engineering and Construction (AEC) partner is the most effective way to balance cost, quality, and speed when developing the facilities to support the industry’s continuous growth.
This perception is self-limiting, particularly in the era of Pharma 4.0, when organisational silos are giving way to seamless collaboration supported by advanced digital tools. For those working towards a new generation of commercial-scale therapeutics, success starts by finding the right partners at the right time. It’s never been easier to build a choice team of process architects, engineers, and technologists from around the world—and it’s never been more necessary to maintain a competitive position.
Prioritise Experience Over Location
Within the EU’s life sciences sector runs an abundant current of AEC experience and innovation. The industry must eradicate the notion of “elsewhere” altogether—that instead of considering borders when looking for project delivery solutions, drug developers consider skills, qualifications, and experience.
This isn’t an either/or scenario. It’s both/and. The best team is a hybrid team, combining the borderless specialisations needed to accelerate a project forward and the in-country expertise that will ensure a smooth launch. For example, developing a robust and quality-driven compliance strategy takes local regulatory experience. But a capital project’s success story is far bigger than its regulatory strategy—from early feasibility studies through process scale-up, these projects require a diverse and integrated team of highly skilled experts, and where they live shouldn’t matter.
This is especially true in novel areas of drug development, where new challenges in capital project delivery need innovative solutions, quickly. According to a CRB report that surveyed 150 leaders from the cell and gene therapy industry, process optimisation is the biggest challenge in scaling towards commercial manufacturing. We must acknowledge and understand this challenge, and address it with the right combination of emerging solutions. Is your project a candidate for the dense efficiency of multimodal manufacturing? Are you effectively managing your risks and preparing for future scale-up with closed and automated processes? How will you design flexibility into your facility to stay competitive as new opportunities arise? These and other pressing questions will determine which manufacturers of tomorrow’s advanced therapeutics will succeed, and which will fall behind. The right experts, with the right answers, are out there—some may be close to home and some may be on the other side of the world.
Right-size Your Partnership To Fit The Problem
Within the perception that local procurement is better lies another perilous belief: you need to be big to be borderless. Or, a smaller-scale innovator is not suited to partner with a large, international AEC entity. Maybe you’ve been oversold and under-serviced in the past. Maybe you’ve worked with a global company who reduced your upfront investment by outsourcing their drawings to a third party, then charged you for fixing those drawings when they arrived full of errors. These costly experiences chisel away at your willingness to look farther afield for a suitable partner. That’s understandable, but not necessary.
Smaller-scale drug developers don’t need to limit themselves to smaller-scale vendors. The right AEC partner, regardless of size, will adapt their approach to suit your project’s objectives and deliver results within the target value. A large-scale AEC partner has the advantage of a diverse, broad talent pool. They can tailor-build a lean and integrated team that’s perfectly suited to a project and its CAPEX budget. In the hands of a true partner with the skill and experience to deliver what you need, quality-driven and cost-effective solutions are part of the service package.
Harness The Flexibility and Speed of Digital Tools
A “borderless” partnering approach offers practical and lasting benefits. For one thing, working across time zones—a nuisance in the pre-digital era— is now a competitive advantage, particularly for companies focused on improving speed to market. If your hybrid team extends from California to Switzerland, for example, then an eight-hour working day is extended, doubling or tripling efficiency without adding a single night shift to the team.
The now-ubiquitous video conference has usurped the traditional boardroom. More sophisticated platforms have joined the global team’s digital toolkit. Artificial reality makes design-build activities like site walkthroughs or factory acceptance tests, possible from anywhere in the world. Even the well-established “workhorse” tools of AEC project delivery, like 3D building information modeling platforms, are helping to collapse the distance between global partners by providing a centralized superhighway for moving design packages through the review process.
Global Is The New Local
Limiting capital project delivery teams to local partners is like limiting your diet to the backyard garden: the quality may be excellent, but it lacks the variety needed to thrive.
A robust capital project strategy requires the right resources, not only those close at hand. That’s where the hybrid team becomes invaluable: local and international experts with complementary skills and experience are jet fuel for your capital project, accelerating it from concept to commercialisation with the best solutions and technologies available. This is how the EU’s pharmaceutical industry will continue its remarkable pace of change, and how we will address the unmet needs of patients at home and all around the world.