The field of regulated bioanalysis has steadily evolved since its inception, marked by key milestones—from the early Crystal City AAPS/FDA meetings to the current ICH M10 bioanalytical method validation (BMV) guidance. Over the years, we’ve witnessed shifts in drug modalities, technological platforms, and expectations for assay performance. Business models have cycled between in-house resourcing and outsourcing, both within organizations and across the industry.
Yet, it feels like we are now at a unique inflection point—a convergence of transformative forces that could reshape our field more profoundly than ever before. This change, initially driven by advances in disease treatment, is now being accelerated by the rise of artificial intelligence (AI) and a fluctuating geopolitical landscape that is difficult to predict or control.
While we pride ourselves on being adaptable, the pace of change in our industry has traditionally been incremental, governed by the rigor and caution of a regulated discipline. This controlled evolution has served us well, and I remain proud of the high-caliber, defendable science we produce as bioanalysts. But the question now is: what comes next?
Have we reached a point where we must break from our historical progression curve? What lessons from the past should guide us forward—and where must we embrace radical change to meet the demands of a rapidly evolving world?
AI and the Future of Bioanalysis
AI has become a staple topic at every bioanalytical conference in 2025. We’re increasingly comfortable envisioning how new tools and strategies can enhance our efficiency and capabilities. AI is already influencing drug discovery, particularly in areas involving large datasets—take AlphaFold, for example, which has revolutionized protein structure prediction.
As AI continues to make its way into bioanalytical labs, we must remain vigilant about accuracy and validation. Importantly, we must not lose sight of the fact that bioanalytical method development and validation are highly customized processes. Each assay is unique, and skilled bioanalysts know that every new method presents an opportunity to learn and adapt.
Integrating AI into this environment will require flexibility—from scientists, regulators, and organizations alike. The tools are powerful, but they must be guided by human expertise.
New Approach Methodologies (NAMs) and the Shift from Animal Testing
Another major development is the growing adoption of new approach methodologies (NAMs), aligned with the FDA’s roadmap to reduce animal testing in preclinical safety studies. These innovations—ranging from AI-driven modeling to organ-on-a-chip technologies—are opening new frontiers in how we assess safety and efficacy.
It’s fascinating to consider how bioanalytical techniques will evolve to support these methods. The convergence of high-sensitivity technologies, microfluidics, and chip-based human organ simulations presents exciting opportunities. For example, I’m particularly encouraged with our investments in microsampling devices and their application extension to this area (see upcoming webinar). But again, success will depend on our ability to think flexibly and collaborate across disciplines.
A Call for Flexibility and Innovation
From small molecules to biotherapeutics, from cell and gene therapies to vaccines, and from xenobiotic pharmacokinetics to biomarker pharmacodynamics—bioanalysis remains a cornerstone of drug development and disease treatment.
Historically, we’ve built on the foundations laid by previous generations. But today, we must look at our field and our individual laboratories and ask: “Where and how do we add flexibility?”
New tools—such as electronic lab notebooks, automation, and AI—are helping us improve both efficiency and compliance. Let’s leverage these innovations alongside our deep scientific training to meet the needs of a changing world.
And let’s not forget: our training as bioanalysts has always conditioned us to treat every assay as a custom challenge. We are used to thinking on our feet, reaching into our vast toolbox, and finding a way forward.
Yes, we are a heavily regulated discipline. But we are also problem solvers. And in this moment, flexibility is not just a strategy—it’s our superpower.