More than a decade ago, a group of pharma R&D heads gathered for an annual meeting focused on addressing common industry challenges. They had a running joke: With an average tenure of just three years, if they wanted to see each other at more than one of these gatherings, they’d better figure out how to extend their survival odds.

The joke masked an underlying problem. Drug development timelines stretched to 15 years or more. Every company wrestled with the same operational hurdles—regulatory complexity, site engagement challenges, mounting procedural weight. And the public perception of the industry wasn’t exactly favorable, with criticisms centered on speed, cost, and efficiency. At a certain point, even strong organizations felt pressure from an environment that was evolving around them.

“It’s no good being the leading dinosaur,” one executive noted. “All dinosaurs perish.”

That realization sparked something unexpected. What if the problem wasn’t that pharma organizations couldn’t innovate, but that they were trying to solve systemic challenges in isolation? What if the operational friction slowing everyone down didn’t belong to any single organization, but to the system itself?

TransCelerate BioPharma emerged from that insight. Over the past decade, we’ve learned what it really takes to build collaboration across organizations at scale, and what that collaboration can accomplish when the foundation is solid.

Why the industry needed a new way of working

Those early conversations surfaced a pattern many people inside the industry recognized: much of the effort required to run trials came from the natural complexity that had accumulated over time. As science advanced, processes expanded to keep pace. Each organization refined its own methods and adapted its own way of working with regulators. All of this evolution made sense locally, yet collectively it created a landscape where even routine steps were harder than they needed to be.

No single organization could simplify that environment on its own. Even the most disciplined internal transformation eventually met the same external constraints, including data definitions that varied study to study, expectations that differed by regulator, and operational practices built in parallel rather than around a common center of gravity.

Once you see the system that way, a larger truth becomes clear. Scientific strategy is where companies differentiate. But the operational foundation that supports clinical development—how data moves, how processes interact, how sites experience their work—touches everyone. When that foundation gains strength, the entire ecosystem becomes more capable of serving patients and delivering the breakthroughs that good science makes possible.

What began as a pragmatic experiment grew into something sturdier, a collaborative mechanism capable of addressing system-scale challenges that are difficult for any single organization to resolve.

What we learned about working side by side

Collaboration endures when grounded in shared experience solving problems together, rather than isolated moments of cooperation. Over time, several approaches shaped how the work evolved, and why it was able to support more patient-focused ways of designing and running trials.

• Goals focused on shared lift: Progress accelerated when the group concentrated on challenges common to every trial—processes, expectations, and operational pathways that influence the entire ecosystem. Addressing these shared constraints created more room for innovation at the study level, including designs that reduce unnecessary burden on patients and sites.
• A working environment built for candid problem-solving: Thoughtful facilitation and space to explore emerging ideas made it easier to move past guarded exchanges, toward practical discussion. That environment proved especially important as trial models began to evolve. Conversations about flexible visit schedules and remote data capture are more productive when teams can also discuss alternative ways of engaging participants and speak openly about what works, what falls short, and how operational realities need to evolve to deliver better patient-centric results.
• Follow-through that matched the ambition: Ideas gained momentum when paired with steady execution in the form of clear priorities, practical milestones, and the flexibility to adjust when a path wasn’t yet meeting the needs of patients, sites, or sponsors. That discipline helped translate concepts such as decentralized elements and patient-friendly design from aspiration into repeatable practice.

These practices didn’t feel dramatic in the moment, but over time they reshaped how people approached each challenge. They helped transform collaboration from an experiment into a practice that continued to work as conditions changed.

Digital transformation demands a new foundation

As digital approaches have moved from novel to necessary, the industry has encountered a reality that has little to do with technology itself, because digital tools succeed only when the environment is prepared for them.

Digital approaches depend on a stable foundation, one where core data is expressed consistently and can travel through systems without continual adjustment. Yet much of clinical research still reflects decades of divergent evolution. Study artifacts are structured differently from sponsor to sponsor.

Data isn’t always expressed in ways that systems can easily interpret. Handoffs across the ecosystem remain heavily manual.

This is the point at which collaboration starts to have a real impact. Once essential components such as study definitions and core data structures take on dependable, predictable forms, the work becomes easier to execute across teams and systems. Companies retain what makes them unique, while spending less energy on the same operational hurdles that repeat throughout the ecosystem.

Digitally structured protocols offer one example. When essential components are organized in ways that downstream systems can interpret, trial build becomes smoother, and updates require less rework. That kind of progress delivers more than operational gains. It opens the door to trial designs that better reflect how patients receive care—allowing some procedures to happen close to home, enabling remote data capture when appropriate, and giving sites a clearer, more intuitive framework to work within.

Cross-industry collaborations ease the kinds of friction that have accumulated over many years, allowing organizations to devote more of their creativity to the scientific and operational issues that have real impact.

The culture that keeps collaboration moving

Programs endure when the people behind them establish ways of working that can absorb change without losing momentum. Collaboration is no different. As more companies joined TransCelerate and expectations grew, the challenge was to preserve and strengthen the environment that enabled progress in the first place.

Steady growth helped. New participants entered at a pace that allowed them to experience the culture rather than overwhelm it. Behaviors that supported the work—clarity of mission, openness to constructive disagreement, respect for the perspectives of patients and sites—were reaffirmed routinely. Change was expected. What mattered was guiding that change so the collaboration stayed effective as the organization evolved.

Leadership transitions became another proving ground. A collaboration built around particular personalities can become fragile when those individuals move on. What we saw instead was continuity, as new leaders carried forward the same expectations for how TransCelerate makes decisions, how challenges are explored, and how shared problems are approached. That steadiness is a sign of cultural maturity and one of the reasons the collaboration has continued to hold its shape.

The less visible advantages and why they matter

Not all benefits of shared work appear in formal outputs. Some are less visible but often more consequential.

More than a decade of working across companies has created a network of people who understand how to move quickly when circumstances shift. The relationships forged through repeated problem-solving make difficult conversations easier to begin. Ideas that once took months to vet can now be shaped in a fraction of the time. When unexpected challenges emerge, the group has a way of gathering insight rapidly and determining what the ecosystem needs next. A great example of this was during the emergence of the COVID-19 pandemic when member companies shared best practices and new ways of working to enable all sponsors to maintain clinical trial continuity for the good of patients.

These advantages rarely receive public attention, but they influence how swiftly new opportunities can be explored and how effectively the industry can respond to uncertainty.

What the next decade will ask of us

Biopharma is approaching a period when scientific discovery will continue to accelerate, while the operational machinery supporting it will face unprecedented pressure to adapt. To maintain momentum, collaboration itself will need to evolve, taking on the work of strengthening automation and interoperability, bringing patients and clinicians more directly into the process, and reducing long-standing sources of friction across the system.

This doesn’t mean everyone needs to operate identically. Different organizations have different strengths. The goal is to create an environment where those strengths can actually reach the patients who need them—where it’s easier to share what matters and easier to move quickly when it counts.

A decade of shared effort has shown that when competitors come together with purpose and discipline to solve problems that no one company can solve alone, the industry becomes more capable of pushing for progress. The next chapter of clinical development will require that same commitment, directed toward the opportunities that hold the greatest promise for patients and for the future of the field.

Andy Lee is Founding Member and Janice Chang is CEO, both of TransCelerate BioPharma Inc.