Turning Complexity Into Strategy: Regulatory Alignment Through NAMs

Grace Patlewicz, Ph.D., Senior Science Advisor at ToxStrategies, brings uncommon clarity to one of the most complex challenges in modern toxicology: aligning New Approach Methodologies (NAMs) with evolving regulatory expectations. With over two decades of experience spanning industry, policy, and government research, Grace doesn’t just apply guidance, she’s helped write it.

That experience provides her with a deep understanding of not just what regulatory guidance says, but why it was written the way it was. As a result, she helps organizations move beyond simple compliance and toward strategic alignment by interpreting regulatory intent, anticipating reviewer expectations, and positioning scientific data for stronger acceptance.

Systemizing the PFAS Problem: A Practical Application

One of Grace’s proudest achievements demonstrates how NAMs can be leveraged not only for assessment, but also for large-scale prioritization. At the EPA, she helped develop a structured approach to triage more than 15,000 PFAS substances, a task that would have been unmanageable using traditional methods alone.

By grouping chemicals and analyzing patterns of data availability, exposure, and mechanistic similarity, her team created a clear roadmap for identifying high-priority substances and closing critical data gaps. “It was quite novel,” she reflects. “We used a NAM-based grouping strategy to move from chaos to clarity.”

This approach wasn’t just regulatory. It was strategic. It allowed the agency to focus limited resources on the most relevant risks and revealed how in silico tools, like QSAR models, can accelerate early-stage screening and decision-making.

From Theory to Practice: The Guidance Gap

Despite these successes, Grace is candid about the disconnect between regulatory theory and real-world execution. “It sounded like a good idea in the technical guidance,” she says. “But when it comes to implementing it in practice, it’s not quite as easy to do.”

Many challenges that surfaced in the early days of NAMs persist today. Mixtures, polymers, and certain classes of substances still defy simple solutions. What’s more, the lack of clear regulatory thresholds continues to frustrate progress. Agencies may say they’ll “know success when they see it,” but without defined criteria, it’s difficult for organizations to know how much evidence is enough.

Grace’s experience has shown that success lies not in checking boxes, but in deeply understanding regulatory intent, and anticipating the questions that will be asked.

Aligning With What’s Ahead

Grace advises companies to start building their NAMs strategy before regulators force the issue. “If you're not thinking about it, the agencies will be ahead of you,” she warns. Her recommendation: assess your substances using the same tools regulators are already using, especially for submissions like the EPA’s Pre-Manufacture Notification (PMN). That foresight empowers organizations to avoid surprises and respond with confidence.

From Insight to Action

Grace’s work underscores a core principle: successful NAMs adoption isn’t just about technology. It’s about strategy, foresight, and regulatory fluency. At BlueRidge Life Sciences, we help clients navigate these complexities with tools grounded in science and informed by real-world experience. Whether you're working through a PFAS portfolio or preparing your next submission, we’re here to guide the path forward.

Contact us to talk through how to move from regulatory uncertainty to strategic clarity.