Building the Foundations for Proactive Drug Safety in 2026

PharmTech recently spoke with Beena Wood, chief product officer, Qinecsa Solutions, to get her perspective on trends that shaped pharmaceutical development and manufacturing in 2025 and where things are headed in 2026. In this part 3 of our three-part interview, Wood outlines how 2026 will mark a pivotal year for pharmacovigilance (PV), translational safety, and regulatory innovation, driven by a shift from reactive compliance to proactive, data-enabled decision making. She emphasizes that the industry’s biggest near-term priority is not deploying advanced AI use cases, but building the foundational infrastructure and governance required to make proactive PV viable at scale.

Wood argues that organizations that are willing to invest early—despite delayed returns—will be best positioned to lead. “Building the foundation… I think is going to be the most important thing that's going to happen in 2026,” she says, noting that meaningful transformation requires patience and long-term commitment.

A major theme is the evolution of translational safety, which Wood describes as connecting safety signals earlier in development rather than relying solely on post-market surveillance. She explains that development teams often stall not because of missing science, but because fragmented data systems make decisions unclear. “Teams rarely get stuck because the science is unclear; they get stuck because the decisions are unclear,” Wood says. Integrating mechanism data, toxicology, pharmacokinetics/pharmacodynamics, and real-world evidence earlier could fundamentally change how uncertainty is managed.

Wood also points to continued regulatory innovation in 2026, citing initiatives such as the FDA Commissioner’s National Priority Voucher program, expanded real-world evidence efforts, new FDA guidance, EMA reflection papers, and upcoming obligations tied to global frameworks like CIOMS and the EU AI Act. These developments, she notes, introduce guardrails that support innovation while maintaining trust and safety.

Finally, Wood highlights the growing importance of ecosystem-based collaboration. She predicts a move away from bilateral partnerships toward orchestrated networks involving pharma companies, AI-native biotechs, technology hyperscalers, regulators, and patient organizations. This collaborative model, she suggests, will be essential for advancing AI-enabled safety, accelerating development, and navigating increasingly complex regulatory and scientific landscapes.

Access Part 1 and Part 2 of this interview!

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

So, if I take PV itself as an example, how do we get it to have that infrastructure and governance so that the proactive PV can become real? And building the foundation in 2026, I think, is going to be the most important thing that's going to happen in 2026. The organization that commits to building that proactive infrastructure, even though the use cases might take years to implement.

The second thing, again, is translational safety, which is to connect the dots earlier. So proactive shift isn't just about—and that ties to the FDA [Commissioner’s] National [Priority] Voucher program, etc.—post-market surveillance alone; it's starting much earlier, the safety in development.

What I'm seeing and what I think will continue in 2026 is a fundamental shift of the translational safety leaders, fundamentally rethinking how we make decisions under uncertainty. So, a colleague of mine framed it this way: teams rarely get stuck because the science is unclear; they get stuck because the decisions are unclear. And the pattern, for example, is like we have the mechanism data, tox findings, the PK/PD data, real-world evidence. However, these are different systems, different competence levels and functions. So, when the decision comes, then I think it's about we don't have enough data. I think to connect the data earlier and upstream, that would be the trend I would see—that translation safety going and fundamentally thinking of that.

I think the regulatory innovations and guidances will continue with important guardrails. We are already seeing the trends as I explained earlier. The [Commissioner’s] National [Priority] Voucher program is one example. The center is setting up of that real-world evidence center is another example by FDA, the FDA guidance document, for example, and then, of course, the EMA reflection paper and they're starting to work on annex 11 and 22, if I'm remembering the numbers correctly. And also the CIOMS working group and the EU AI Act will add another layer in 2026 where there are some deadlines coming up because of that. Also the precision medicines, moving from oncology to mainstream, like we've seen the GLP-1 and how that's extended into other areas like cardiovascular, NASH, etc. I think that will continue.

And lastly, to keep to number five, is the ecosystem collaborations. It's not any more going to be like a one-on-one or one-on-two kind of collaborations, bilateral, but it has to become orchestrated ecosystems for, for example, AI. Do we have tech hyperscalers? Do we have AI-native biotechs? Do we have patient organizations participating, regulatory collaborations, all with pharma and industry?