Welcoming Faye Vazvaei-Smith to the Bioanalysis Editorial Board

The Bioanalysis Editorial Board plays a critical role in shaping the journal’s content, editorial policies and strategy, leveraging the expertise and experience of its members. Our newest addition to the Bioanalysis Editorial Board is Faye Vazvaei-Smith, Executive Director at Merck & Co. (NJ, USA), who brings a wealth of knowledge in regulated PK and ADA bioanalysis to the board. Faye has also served on the AAPS board as a Member at Large.

Find out how you could become involved with the Bioanalysis Editorial Board here.

1. You recently joined the Bioanalysis Editorial Board – congratulations! Can you share what motivated you to take on this role and the experience you hope to bring?

Thank you— it’s truly an honor. I come to this with a deep belief that regulated bioanalysis is where science is translated into confident decisions — it is the point in development where rigor, interpretability, and execution quality directly influence program direction, regulatory confidence, and most importantly, patient access to medicines. Over the course of my career, I’ve seen the power of bioanalysis when it is positioned early, thoughtfully, and strategically—not just as a downstream activity, but as a full partner in shaping development strategy.

I’m particularly passionate about advancing a mindset that equips bioanalytical scientists with deep technical expertise and a broad understanding of drug development, enabling them to influence decisions, anticipate risks, and contribute meaningfully beyond simple data generation. What I hope to bring to the Editorial Board is a practical, regulator‑aware perspective, grounded in real development experience across modalities and lifecycle stages. Equally important to me is helping elevate work that supports people development — building strong science should work hand in hand with building confident, empowered scientists who are prepared to proactively lead in an increasingly complex landscape.

2. Are there any specific areas of bioanalysis that you are particularly passionate about and would like to see highlighted in the journal?

There are several areas of bioanalysis that I’m particularly passionate about, all connected by a common theme: enabling high‑quality, interpretable science, all while modalities and datasets become increasingly complex. One area I care deeply about is the evolution of bioanalytical strategy for new and complex modalities—such as ADCs, PDCs, engineered peptides, T‑cell engagers, and multispecific antibodies. These modalities don’t fit neatly into traditional paradigms and rarely lend themselves to a single platform or a standard approach. These challenges require deeper scientific understanding and broader skill sets, closer integration between ligand‑binding and LC–MS technologies, and—most importantly—intentional assay strategies, developed in close collaboration with project teams, that are aligned with the scientific and regulatory questions a program truly needs to answer.

I’m also very interested in seeing greater emphasis on data interpretability and decision‑making, not just technical assay performance. Bioanalysis ultimately informs safety, efficacy, and labeling, and I believe the journal can play an important role in showcasing work that explains not just what but why certain strategies were chosen, revealing in which ways the resulting data were used to guide development decisions.

That’s also where I see real opportunity for the responsible application of AI and advanced data analytics—particularly for data review, visualization, and integration across platforms. When used thoughtfully, AI can help improve consistency, transparency, and insight generation, allowing scientists to spend more time on interpretation and scientific judgment, all the while maintaining regulatory rigor and traceability.

Finally, I’m excited about innovation that strengthens rigor rather than replacing rigor—whether through robotics, automation, smarter workflows, or emerging analytical and digital approaches that improve robustness, reproducibility, and turnaround time. When applied deliberately, these tools help teams move faster while maintaining confidence in the data and the decisions such data supports.

3. Your perspective on antibody–drug conjugate pharmacokinetic assay strategy was published in February 2026 in Bioanalysis. Can you walk us through the paper and highlight the main conclusions?

The paper was motivated by a clear and widely shared challenge in the field: ADC pharmacokinetic evaluation has historically required measuring multiple constituent analytes, including total antibody, conjugated antibody or conjugated payload, free payload, and potential metabolites. While comprehensive, this approach has resulted in a significantly higher bioanalytical burden, increased patient blood volume requirements, and substantially greater resource demands than monoclonal antibodies or small molecules.

In this perspective, we discuss how this paradigm is beginning to shift. In 2024, the U.S. FDA issued guidance encouraging a more streamlined, data‑driven approach to ADC PK assessment, including the possibility of omitting certain analytes when appropriate scientific justification exists. While this represents an important regulatory inflection point, the paper notes that industry adoption has been slow, and few concrete examples of successful assay reduction have been publicly shared.

A central contribution of the paper is the proposal of a pragmatic framework for reducing ADC PK assays, grounded in three core principles explicitly discussed in the manuscript: clinical relevance, early‑phase data, and platform knowledge. The intent is not to reduce measurements indiscriminately, but to ensure that each assay included continues to provide meaningful information for pharmacokinetic interpretation, safety assessment, and development decisions.

The key conclusion is that ADC PK strategies can be simplified in a scientifically and regulatorily responsible way, provided decisions are supported by data and aligned with regulatory expectations. When done thoughtfully, assay streamlining can reduce complexity and resource burden, and this without compromising patient safety or data integrity, which is the guiding principle emphasized throughout the paper.

4. As someone familiar with writing and submitting journal articles, do you have advice for those looking to publish in the future?

My advice is simple: start with purpose and know what it is you are writing before it is written. Be clear about the question your work is answering and why it matters — to the program, to regulators, and to patients.

I also encourage authors to focus on interpretability, not pedantic perfection. Share the rationale behind key decisions, be transparent about limitations, and explain how challenges were addressed. Especially for new modalities, these insights have been, are, and will be invaluable to the broader community. Another important point is to write with both peers and future scientists in mind: who is your audience, know them like you want them to know what you are saying. Publishing is one of the most effective ways to transfer knowledge, raise standards, and help the next generation navigate complexity with confidence. Finally, I would encourage scientists to be brave, bold, and to contribute. Our field advances when we share not only successes, but also thoughtful lessons learned.

5. Closing thought

At its core, bioanalysis is about trust — trust in the data, trust in the decisions they inform, and trust that the science will hold when push comes to shove. As pipelines become more complex and timelines more compressed, the role of the bioanalytical scientist is expanding in exciting ways. This is a moment for our community to step forward — to combine rigor with innovation, to think proactively, and to intentionally develop the next generation of leaders. When we do that well, bioanalysis doesn’t just support drug development — it helps shape it, ensuring that strong science translates into meaningful outcomes for patients.

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The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of Bioanalysis Zone or Taylor & Francis Group.