'Now Is the Time': At DIA 2024, Biopharmaceutical Industry Insists It's Ready for Convergence

DIA's Global Annual Meeting recently concluded, leaving attendees with a wealth of insight into the future of healthcare. Tamei Elliott , DIA's Associate Director of Scientific Programs, and Radha Goolabsingh , DIA's Global Regulatory Strategy and Engagement Leader, spoke in an on-site interview immediately after the final session ended on the most compelling topics and thought-provoking ideas that emerged from the event's four intensive days.

Another successful Global Annual Meeting is in the books. We've heard from several industry experts, government regulators, academics, and patient advocates. What do you think are some of the biggest takeaways from the event?

Radha Goolabsingh: AI is foremost on everyone’s mind. New technology in the space of cell and gene therapy, collaboration, and convergence were also hot topics. My big takeaway is that convergence is happening. Convergence is necessary: It is beneficial to industry and regulators and most importantly, it ultimately benefits the patient. Now is the time, especially in the space of cell and gene therapy, and in AI, since these are new technologies, and everyone is still learning. Why not put our collective minds together to develop some of these guidance documents, and have a consensus of what the requirements are? I believe now is the time for global regulatory collaboration and convergence. Those are my big takeaways.

Tamei Elliott: Radha, I think you covered a lot of the hot topics that were on everyone’s mind at our meeting. There were three other topics that I heard a lot about over these four days, and they were diversity in clinical trials, reliance, and real-world evidence. When attendees were polled in the FDA-EMA question time session on the most important topics emerging over the next five years that would benefit from transatlantic coordination, real-world data and real-world evidence, along with reliance pathways, rose to the top.

Goolabsingh: And to that end, devices are ahead of pharmaceuticals, and pharmaceuticals need to get quickly on board to catch up to where devices are regarding implementing AI and real-world evidence as these technologies are moving very quickly.

When you talk about collaboration, convergence, and globalization, do you think there's now more of an effort to leave nobody behind?

Elliott: I think there is. And the speakers in one of the sessions mentioned understanding who's missing in the conversations as well, including low- and middle-income countries and regulators.

Goolabsingh: Yes. The smaller countries or smaller agencies have an impact collectively.

Elliott: In addition, I have been excited about the progress of the African Medicines Agency (AMA) — it's waiting for the appointment of the director general who will lead the agency, which I think should be coming soon. It's exciting. The EMA has been helpful in supporting its efforts, and I know, as we heard at the FDA town hall, the FDA is waiting for the head director general to be established. However, these regulators have already begun efforts to increase harmonization and health care access in Africa and make sure they're not left behind.

There seems to be more action than ever. For example, the FDA's Center for Drug Evaluation and Research set up the Center for Clinical Trial Innovation, and after talking about some of its upcoming pilot programs at this event a year ago, its leadership shared some early results. What do you think will happen in the next six to 12 months as a result of some of the conversations that took place here?

Goolabsingh: There's a lot of discussions with the agencies — with EMA and FDA. A lot of collaboration is already taking place.

Elliott: But we're seeing results.

Goolabsingh: I am more encouraged. And coming to DIA this year, with the many exciting and innovative topics and hearing all the regulators, hearing from industry, I feel more encouraged that there's collaboration and there's a move towards convergence.

Elliott: And I think it's this route of, as you said, it's just education and understanding what industry is doing, what regulators are doing, and understanding how they can collaborate. To your point, Radha, how that collaboration can happen and the opportunities that actually exist for that, especially for demonstration programs and projects that allow regulators to test new approaches in a controlled environment, gather data to support regulatory decision-making, and train and build capacity in new areas of science and regulation is very important.

Do you believe it's a good thing that there's more alignment among regulators?

Elliott: Yes, and during the COVID-19 pandemic, we witnessed so much progress that bolstered unprecedented collaboration to strengthen regulatory systems globally that will ultimately lead to more supportive efforts for future public health emergencies.

Goolabsingh: Yes. What I would like to see more of, though, is the regulatory bodies from some of those smaller countries or agencies being brought to the table, because historically it's been mostly the EU and U.S., as they're the biggest players. More recently, though, there has been involvement of Canada, Australia, Singapore, Switzerland, and the U.K. as part of the Access Consortium with the goal of promoting regulatory collaboration and alignment. In addition, there is a partnership of several global regulators as part of Project Orbis, which is an FDA-led initiative that provides a framework for collaboration in the review of oncology products among these regulatory partners.    

That was one of the messages Dr. Anthony Lawler, from Australia's Therapeutic Goods Administration, mentioned in his panel appearances all week. There's this idea of asserting yourself on the global stage but also recognizing, "Look, if this product has been approved by these agencies, it's probably good enough for us."

Elliott: Yes, as I mentioned earlier, reliance is a hot topic not only at this meeting, but also at many of our smaller DIA meetings around the world. For instance, at our Latin America Annual Meeting, happening on Sept. 25-26 in Brasília, Brazil, our goal is to engage more lower- and middle-income countries. These are countries where regulatory systems may not be as strong, and we aim to foster knowledge sharing from countries designated as national regulatory authorities of regional reference (NRAr) by the PAHO and the WHO to address gaps in the Americas. Additionally, DIA’s Southeastern Europe Region Conference engaged regulators outside of the EMA and the MHRA, ensuring we hear about the progress being made in their respective countries and the challenges they face.

And we'll certainly hear some of that at the Latin America Annual Meeting, the first of its kind, in Brasília in September. Thank you both for your time, and congratulations on a very productive week.