DIA 2023 Recap: Q&A with DIA President and Global Chief Executive, Marwan Fathallah

Marwan Fathallah, President and Global Chief Executive, DIA

Following the DIA 2023 Global Annual Meeting in Boston, MA, Applied Clinical Trials caught up with DIA’s President and Global Chief Executive, Marwan Fathallah to discuss his insights from another successful event.

Applied Clinical Trials: How many people attended DIA?

Marwan Fathallah: The DIA 2023 Global Annual Meeting welcomed more than 5,000 participants and 360 exhibitors from 40 countries and across six continents, who attended over 220 unique sessions, roundtables, or interactive discussion groups.

ACT: What were your overall impressions of the sessions?

Fathallah: I was truly in awe of the passion and enthusiasm demonstrated by our panelists, speakers, patients, and attendees throughout the entire event.This year, we extended the major themes from the Opening Plenary into three additional comprehensive DIAmond Session discussions: Navigating the Constellation of Efforts to Increase Representation in Clinical Research; Full Exposure: Artificial Intelligence to Advance, Replace, and Add Efficiency for Patient Benefit; and then a more focused Case Study for Illumined Therapeutic Development: Shining the Light on ALS; all of which continued the conversation about how generative technologies such as ChatGPT and other large language models are driving the future of clinical research and care. These DIAmond sessions sustained the energy (and engagement) of the Opening Plenary throughout the entire meeting.

ACT: Do you have any takeaways from the regulatory-related sessions or town halls?

Fathallah: The FDA Town Hall is always one of our most popular sessions, and this year it was again “standing room only.” It was inspiring to hear all the updates from various FDA representatives on what they have accomplished over the years. FDA mentioned how proud they were in handling the pandemic and kept standards high despite heavy workloads and pressures on their reviewers. They also continue to recognize the importance of trials that are reflective of the diversity of the US, which prompted the release of their draft guidance on diversity plans for industry in 2022. They noted continued progress in their enhanced equity initiative, and the impact and mandate of the Food and Drug Omnibus Reform Act (FDORA) on their efforts. Lastly, FDA created two discussion papers on artificial intelligence in drug development and manufacturing to showcase FDA’s thinking on those topics and to get feedback from stakeholders on what they should know and be concerned about in this space. In addition to the topic of AI, they are also looking at the role of digital health technologies (DHTs) and their role in clinical trials along with the release of their 2023 draft guidance on decentralized clinical trials (DCTs).

New to DIA 2023 was our inclusion of ANVISA, Brazil’s regulatory authority, and the room was packed full of attendees interested in learning more about their regulatory priorities and updates from that region. As a Regulatory Authority of Regional Reference (NRArr) by the Pan American Health Organization (PAHO), attendees were curious to know what was at the top of ANVISA’s mind. A few items included the implementation of eCTD in 2023, IDMP for 2024, and the evaluating the impact of new technologies as they currently do not have a formal policy on the topic and have been studying how public and private institutions are looking at it.

ACT: What was the response to the opening plenary/keynote? What kind of insights or feedback did you receive?

Fathallah: The theme of DIA 2023 was “Illuminate,” and I think we helped to shine a light on the future at this event. The Opening Plenary, which was centered around AI’s transformative potential to swiftly revolutionize patient care and the landscape of pharmaceutical research and development, was very well received. Innovation, diversity, and artificial intelligence are accelerating the future of patient care, and embracing AI’s potential is necessary as life sciences and industry evolve. DIA is committed to fostering developments in innovation, as well as providing a neutral global platform for key stakeholders to collaborate, share insights, and continue this important dialogue about AI’s impact on the future of healthcare.

ACT: What topics or sessions do you feel resonated the most with DIA’s audience this year?

Fathallah: The sessions on artificial intelligence, ChatGPT, and related technologies were of great importance and interest to our audience, and we’re looking forward to expanding our reach into these areas as they continue to develop. Our meeting is also officially designated as a “Patients Included” offering, which means that DIA 2023 meets a list of qualifications which ensure that patients or caregivers with experience relevant to the meeting's central theme actively participate in the design and planning of our event, including the selection of themes, topics, and speakers, and the creation of a dedicated Patient Engagement Track.

ACT: What are your goals or objectives for DIA for the remainder of the year?

Fathallah: We aim high: Our mission is to improve health and well-being worldwide by fostering innovation. We do that by nurturing collaborative relationships and knowledge sharing.

Our goals going forward remain rooted in our mission to foster innovation to improve health and well-being worldwide. For instance, among our current imperatives, we want to:

• Build on our solid foundation. There are great opportunities to grow our core globally—along with our products and conferences.
• Strengthen industry collaborations. We’re uniquely positioned to convene beneficial partnerships among industry, thought leaders, regulators, policymakers, academia, and others worldwide. We believe collaboration is an essential ingredient for solving significant healthcare challenges.
• Connect with adjacent areas such as diagnostics, devices, and digital. Increasingly, the realms of therapeutics, devices, and diagnostics are converging. Therefore, it’s only natural to bring them under one umbrella, so we can continue to help industry overcome big challenges with bold, innovative solutions and services.

At its heart, DIA is an independent, global organization that enables the industry to make connections and unleash the spirit of innovation to advance healthcare.

For nearly six decades, DIA has dedicated itself to being a transparent international platform for highly relevant forums and learning experiences. Our Global Annual Meeting, for example, brings together people from all parts of the life sciences ecosystem for an incredibly thoughtful and dynamic information exchange.

2024 marks our 60^th anniversary and will be including DIA’s nearly 12,000 world-wide members along with our sponsors and partners in a yearlong celebration of this important milestone.

ACT: Reflecting on DIA 2023 in Boston, how do you think DIA can make the biggest industry impact?

Fathallah: Unquestionably, AI poses the most exciting—and most challenging—opportunity for biopharma in the coming years. That’s why we kicked off DIA 2023 with an in-depth discussion of AI and weaving the topic into many sessions throughout the meeting.

Right now, we’re entering an era like the introduction of the Internet. We could communicate before that era, of course, but the Internet changed everything about it. We truly believe AI will do the same thing; it will take us to the next level.

ACT: On a personal level, what do you think is having the biggest impact on the industry and what is DIA’s view of that impact?

Fathallah: We’re at a pivotal stage of human innovation. We hope that DIA’s unique status as a neutral, global association can help ensure everyone comes together to figure out how to evolve AI so that, ultimately, it is useful for all humankind.

Already we’re starting to see reports of teams who’ve used AI to home in on more effective therapies for certain diseases. So, it’s exciting in that sense. On the flip side, however, AI’s potential uses are moving so fast that regulators and the industry don’t yet know how to harness its exhilarating energy properly. Regulators must figure out how to control it without reducing its effectiveness. Academia and industry must figure out how to take advantage of it safely.