From June 16 to June 20, the Drug Information Association (DIA) held its 60th global annual meeting, bringing leaders from across the life sciences industry together to drive innovation.  

This year's meeting was centered around the theme "Charting New Horizons," aiming to facilitate stakeholder collaboration on overcoming challenges to developing next generation therapies. Here are our four biggest takeaways from the conference.  

1. It's more important than ever to anticipate how the care delivery environment will change.

It's easy to overlook the pace of change in care delivery when comparing it to the pace of change in pharmaceutical products. However, many of the same technologies facilitating innovation in the latter, such as artificial intelligence (AI) and remote patient monitoring (RPM), are also changing the care delivery environment.  

Now more than ever, commercial success depends on stakeholders' ability to anticipate this change. In addition, it's important for stakeholders to anticipate the data and evidence that patients, physicians, plans, and providers will need to make decisions. This will require stakeholders in the pharma value chain to: 

• Anticipate and plan for a dramatically different care delivery environment where care is "everywhere" and no longer concentrated in the hospital or traditional care sites.

• Ensure that you understand and are catering to the needs of clinical and non-clinical stakeholders, such as IT, influencing patient care in a world of technology-enabled decision-making and more structured patient journeys.

• Stay current on the cost-containment strategies being used by public and private purchasers as they grapple with the strategic and financial implications of the drug pipeline. 

2. AI was featured heavily in trial innovation — but so was representativeness.  

You seemingly can't attend a healthcare conference today without discussing AI. DIA 2024 featured many vendors focused on how various AI applications could support everything from trial data integrity and human workloads to patient discovery.  

However, we were pleased to learn that vendors and speakers alike recognize how important inputs are to success — specifically the need to ensure that clinical trials represent future patients. As one panelist noted, "I was part of the problem as a sponsor, and I know I can be part of the solution as well." For both opportunities, the necessary work of purposeful design from the ground up will determine if these solutions and investments prove fit-for-purpose.  

3. We're past the tipping point for real-world evidence, but questions remain on how to collect and value it. 

In our survey of health system pharmacy and therapeutics committee leaders, 60% of respondents said they want to see more real-world evidence (RWE) as they evaluate products in coming years. The need to gather this type of data was on full display at DIA. It seemed that every other session touched on providers' desire to consume RWE. But two questions remained unanswered: how do we generate this data, and how do we communicate its value?

While demand for RWE is exploding, articulating its value is still a work in progress. Commercial and medical affairs leaders still need to identify the right use cases for RWE, assure end users of the data's quality, and balance RWE with other efficacy, safety, and financial data to persuade prescribers and formulary decision-makers.  

From an evidence generation perspective, Phase IV confirmatory trials were a common suggestion from leaders. However, there was an uneasy acceptance that the long timeline associated with this method will prevent it from becoming an industry norm. Organizations must innovate on clinical trial design and recruitment to generate real-world data earlier in asset development, instead of after the commercial launch.  

4. Partnerships are going to be essential to commercialize innovative products and evidence. 

It's clear that pharmaceutical manufacturers are looking for innovative ways to improve the traditional clinical trial process to generate new types of evidence or speed products to market — but any change in clinical trials comes with risk. Will the FDA take issue with innovation in trial design? Will efforts to decentralize clinical trials still pose barriers to underserved populations? However, as one presenter noted, "the clinical trial process is no stranger to risk."  

Even industry standard ways to develop assets, like randomized controlled trials, come with risks that manufacturers have learned to accept and manage. Today, the aversion to clinical trial innovation stems from a fear of the unknown nature of new risks that threaten manufacturers' abilities to commercialize products that leverage innovative clinical trials.  

The good news is that managing these new, potentially unknown risks had an almost unanimous solution: partnerships. The right partnerships can help organizations be confident that their innovative methods will pay off. At DIA, three partnerships came up:  

• Internal partnerships with sales, marketing, and medical affairs: These teams must coordinate with product development early to ensure that evidence they generate reflects demands that commercial teams hear from customers.  

• FDA and other regulatory agencies: Representatives from these organizations continuously stressed that they want to partner with sponsors and contract research organizations (CROs) to inform trial design. They want to ensure trials will meet their standards before any data is generated for their review.  

• Patients, especially those from underrepresented communities: Advocacy groups were clear that sponsors and CROs cannot make assumptions on how to reach historically underrepresented groups on their own. They need feedback from patients to understand how cultural norms and structural barriers to accessing trials can impact patients' abilities to participate in clinical trials. 

(DIA 2024 promotional brochure, accessed 6/24; About DIA 2024; accessed 6/24) 

Want to learn more? We compiled a list of resources to help life sciences leaders navigate industry challenges and drive innovation:  

• 3 major trends shaping the infusion care market 
• How clinicians will use evidence in 2032 
• Harnessing the power of AI in drug development and testing 
• 4 imperatives for the future of healthcare innovation 
• An ecosystem approach to achieving diversity in clinical trials