Catching Up with Consulting — DIA 2024 Insights

This article is based on opinions and perceptions from the DIA 2024 Global Annual Meeting, in San Diego, June 2024. Many thanks to our contributors: April Purcell (Specialist) and Michelle Peter (Senior Specialist). The team sat down with Gail Winslow, Head of Marketing, after the conference to share their experiences.  

From start to finish, several key themes emerged. Artificial Intelligence in clinical trials dominated the agenda, mirroring its prominence in many industry events. International collaboration was also a major focus, highlighted by Japan’s PMDA taking a strong stance. Real-world data and real-world evidence were consistent undercurrents, alongside discussions on regulatory guidance and the urgent need to accelerate changes in clinical trials to bring new innovations to market faster and meet patient needs. 

Q: What were the most valuable insights or lessons you learned at the conference? 

Michelle: 

• I found the regulatory agency presence at DIA to be most valuable. We were able to hear directly from the FDA, EMA, and PMDA, which made the event worthwhile. Clearly, there is a focus on quality and regulations in clinical development, otherwise, these regulators would not attend DIA.  
• For the quality track sessions, which is where I spent most of my time, it was clear that quality is a major focus area for these regulatory agencies. The quality aspects are getting a lot of attention across the industry, which is a critical part of the drug development process, and it was vital that the regulators had presence. 

April: 

• One of the most valuable insights I gained at the conference was the importance of understanding and anticipating the evolving care delivery environment, which often changes at a different pace than the development and approval process. 
• There was a significant focus on how emerging technologies, such as AI, telemedicine, and electronic health records, are being integrated into everyday clinical practice. These technologies are transforming care delivery, making it more efficient, personalized, and data driven. Our industry must understand and anticipate these changes to ensure we are meeting needs and staying at the forefront of the field. 

Q: Was there a particular session or speaker that stood out to you? Why? 

Michelle: 

• There was a session on the implementation of ICH E6(R3), and this stood out because we heard directly from US, EU, and Japan regulatory agencies on their plans for training and implementing the new guideline. Because many are still struggling with R2, it was valuable to hear their training approach for R3. 
• I’m excited about the R3 approach because it is a training. The agencies emphasized that the underlying principles are the same, but many adopters over-engineer the interpretation of the guidance, and therefore, the agency wants to train adopters which they haven’t done previously. This is a very positive development. 

April:  

• The session with Tom and Emily Whitehead, titled “Whitehead Patient Experience with CAR-T Therapy,” stood out to me the most. Witnessing firsthand the incredible journey of Emily Whitehead, the pioneering pediatric patient who defied the odds and became the first in the world to undergo CAR T-cell therapy, was profoundly inspiring. Tom and Emily shared invaluable insights into the transformative power of CAR-T therapy, offering a unique perspective that captivated and inspired the audience. Their story reminded me why we do what we do every day and reinforced the importance of our work in making a real difference in patients’ lives. 

Q: Were there any surprising or unexpected topics covered that you found interesting? Or was there anything you thought would be covered and wasn’t? 

Michelle: 

• Most of the event was centered around AI, and while AI is important and emerging in our industry, it’s not everything to everyone. I was looking for more specific, applicable, and practical insights outside of AI, and while I discovered those insights in the quality track, I was hoping for more. 
• I also saw value in conversing with vendors because my current clients use these vendors, and there were many technology platforms present and I was able to get demonstrations applicable to my clients’ interests. I was pleasantly surprised because I went into DIA thinking the value would be all in the sessions, but there was also value in conversations with vendors. 

April: 

• Not really, as Michelle mentioned, the conference was dominated by discussions on AI, which I find incredibly interesting. However, one comment that stood out was from a presenter who compared AI to driving a car. They pointed out that, back in the day, we didn’t wait for seatbelts to be perfected before we started driving cars. Similarly, we shouldn’t wait until everything about AI is perfected before we start using it. It’s a process, and we should proceed with caution. This perspective resonated with me and highlighted the importance of embracing innovation while being mindful of its risks. 

Q: From what you learned, what is the best advice you would give to your clients having gone to this year’s DIA?  

Michelle: 

Three essential pieces of advice include: 

• AI is not going away. It will be important for clients to keep listening for trends and challenges, and to embrace the technology as best they can. 
• The regulatory agencies are working to roll-out training on ICH E6(R3) implementation. It will be important for sponsors to not over-engineer the changes to the agency’s related guidance. 
• There are many companies working to solve technology problems for clinical trials. Look beyond the big flashy expensive systems to find affordable compliant solutions. There are options available to stay compliant and inspection ready without breaking the bank or hiring an entire IT team. Explore what’s available before storing your data in a non-compliant system. 

April: 

• I advise clients to stay informed and anticipate and adapt to changes in the care delivery environment to ensure that products and services remain relevant and practical. 
• Additionally, adopt the mindset that innovation is a process. Proceed with caution, stay informed, and be adaptable. This approach will help you stay at the forefront of the industry and continue to make a meaningful difference in patient care. 

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