New Approach Methodologies
Exploring the Future of Toxicology and Risk Assessment
Altasciences is actively engaged in the ongoing dialogue and scientific exploration surrounding New Approach Methodologies (NAMs) in toxicology and risk assessment. As the field of drug development continues to evolve, NAMs offer promising potential to complement or enhance traditional preclinical safety testing approaches through the use of innovative technologies, such as in vitro assays, in silico modeling, organ-on-a-chip platforms, and high-throughput screening.
These emerging tools are slowly gaining attention from regulatory authorities and industry alike, as they aim to improve efficiency, ethical standards, and the predictive value of preclinical safety data. Altasciences recognizes the importance of staying aligned with these developments and remains attentive to their growing role in shaping the future of toxicology.
Staying Aligned With Scientific
and Regulatory Progress
As regulatory agencies continue to evaluate and support the application of NAMs — through initiatives such as the FDA Modernization Act 2.0 and global efforts to reduce animal use — Altasciences is closely following these trends and participating in the broader scientific discussions.
Our teams are monitoring advancements in the field and assessing opportunities where NAMs may align with sponsor needs and evolving regulatory expectations. Areas of interest include:
- In vitro systems and human-relevant models
- Computational toxicology and predictive modeling
- Mechanistic- and pathway-based approaches to risk assessment
- Ethical frameworks supporting the 3Rs (Replace, Reduce, Refine)
Positioning for the Future
As interest in NAMs grows, Altasciences is committed to understanding how these methodologies can potentially fit within the broader context of nonclinical development. While traditional in vivo testing remains central to many regulatory programs today, the industry’s momentum toward more integrated and human-relevant approaches is accelerating.
Altasciences is actively engaging with thought leaders, regulatory updates, and scientific consortia to better understand how NAMs may impact drug development pathways in the years ahead.
Partnering Toward Progress
Through close collaboration with sponsors and a strong focus on adaptability, Altasciences continues to explore innovative approaches that may help optimize study design, improve decision-making, and support regulatory success. Our involvement in the conversation around NAMs reflects our broader commitment to advancing science while remaining responsive to the evolving needs of our industry and clients.
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Connect with our experts to learn more about how the evolving role of New Approach Methodologies may impact the future of toxicology and risk assessment. |
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