A COO’s Insights: Perspectives from the DIA 2024 Global Annual Meeting

History converged with the future at DIA’s 60th-anniversary Global Annual Meeting. The conference’s theme—Charting New Horizons—fit the mood perfectly. The palpable energy and high attendance levels were reminiscent of pre-pandemic times; it felt like we finally put COVID-19 behind us.

Still, underlying this return to “normal” was an eagerness not to forget the lessons of the past few years. I was struck by the collective resolve to build on the progress achieved as our industry embraced change during the pandemic.

From keynote presentations to informal conversations, the dominant question at DIA was, “How do we hardwire into the industry a continued willingness to innovate and take risks?” The message was clear—we must not backslide. Instead, we must leverage what we have learned to forge ahead. Chief among those learnings: Collaboration drives progress. 

Cultivating collaboration

As the COO of an industry consortium, I find it immensely gratifying when stakeholders join forces to solve common challenges for the greater good. Throughout the DIA conference, it was evident that others shared the same feeling. Session after session noted that the combined effort of sponsors, regulators, patient groups, and other stakeholders is necessary to improve drug development.

For instance, before sponsors can design better novel protocols, they must feel confident that regulators will support them. That’s why many of the best-attended DIA sessions included a regulatory perspective on clinical trial innovations. The panel discussion I participated in, Enhancing Adoption of Innovative Approaches in Clinical Trials, was one of them.

Among the panelists was Dr. Kevin Bugin, the head of the U.S. FDA’s new CDER Center for Clinical Trial Innovation (C3TI), who spoke alongside patient advocate Ella Balasa and Roche leader Michelle Rohrer. The opportunity for regulators, patients, and sponsors to share insights goes a long way toward providing clarity. Hopefully, collaborative discussions like this will help increase our confidence to forge ahead with more innovative and patient-centric trial designs.

2024 DIA Global Annual Meeting Session: Allison Cuff Shimooka with panelists Michelle Rohrer, Meghana Chalasani, Kevin Bugin, and Ella Balasa

Among the panelists was Dr. Kevin Bugin, the head of the U.S. FDA’s new CDER Center for Clinical Trial Innovation (C3TI), who spoke alongside patient advocate Ella Balasa and Roche leader Michelle Rohrer. The opportunity for regulators, patients, and sponsors to share insights goes a long way toward providing clarity. Hopefully, collaborative discussions like this will help increase our confidence to forge ahead with more innovative and patient-centric trial designs.

Expanding patient-centricity

DIA’s annual gathering also reinforced how much the industry has learned about the importance of designing truly patient-centric studies. During my panel session, for example, there was a lot of interest in preserving recent gains around decentralized clinical trials, pragmatic clinical trials, and other patient-focused novel trial designs.

However, as the focus on patient-centricity has evolved, so have the conversations around it. Gone are the days of talking about why patient-centered trials are beneficial. The emphasis is shifting from theory to practice with the question, “How do we make patient-centricity a reality?”

Sponsors have some distance to go before meaningful, patient-centric approaches are hardwired into everything we do. Yet, the movement to give patients a seat at the protocol development table is growing. By working together with patients and patient advocates, practical patient-centered solutions are surfacing. 

Mastering change management

Change management also emerged during the meeting as a critical component of the path forward.

Given the rapid pace of societal change, organizations ranging from sponsor companies to regulatory agencies are likely experiencing a misalignment between their future vision and operational realities. Overcoming this misalignment requires sound change management.

Consider, for example, the hot topic of generative AI. What I enjoyed about many of the AI sessions at DIA was that they went beyond educating about the technology itself to ask both “Can we use AI?” and “Should we use AI?” Many talks advocated for employing AI only when it genuinely solves the challenge at hand. In other words, its potential benefits must be carefully weighed against its shortcomings and risks.

The drug development environment is well known for being risk-averse. Yet, as my colleague Rob DiCicco pointed out during a panel discussion, risk management is actually one of our core strengths. It’s an inherent part of running clinical trials; we excel at it!

However, we know the risks of the current ways of working. We’re comfortable with them because we have processes and systems for managing them. What we need to do now is figure out how to shift that comfort level to new methods of working.

That’s where change management comes into play. As an industry, we must change how we think about risk. More specifically, we must become more comfortable trying new things by remembering that we’re really quite good at managing risk.

Embracing the energy

I returned from DIA Global Annual 2024 with new learnings, ideas and relationships – and yes, a full inbox. Most of all, though, I returned uplifted by the collaborative spirit and action in evidence at this year’s conference. Bringing new medicines to patients faster, safer and more efficiently requires all of us, not one of us, and I’m optimistic about what we can achieve together.

This blog post was authored by TransCelerate COO, Allison Cuff Shimooka.