Following the FDA’s announcement to phase out animal testing for monoclonal antibodies and other drugs, preclinical development is entering a new era. A fundamental change in drug development has started and the best prepared companies must ‘future-proof’ their portfolios to gain competitive advantage from timeline acceleration, cost reduction and more predictive evidence generation via biosimulation. AI- and in vitro-based toxicity models, predictive biosimulation, and other new approach methodologies (NAMs) will play a critical role. With thousands of mAbs currently in preclinical development, drug developers face major opportunities—and regulatory shifts—as they move beyond traditional animal studies. Certara’s Non-Animal Navigator™ solution helps companies adapt by selecting and optimizing the best-fit NAM strategies. We do this by first conducting a gap analysis. Based on this assessment, we then tailor a bespoke software and services solution for the particular asset. Using this approach helps our clients accelerate development, manage costs, and ensure regulatory alignment.
Non-Animal Navigator™
Expert strategy and AI-enabled biosimulation to reduce, refine, or replace animal studies
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Hone your regulatory strategy
The FDA roadmap creates new opportunities to design non-clinical safety programs that leverage new approach methodologies instead of in vivo studies. In the near term, companies with mAbs in preclinical or early clinical development must quickly reassess their regulatory strategies. Early clinical-stage companies should explore how NAMs could reduce chronic toxicology requirements, while pre-IND sponsors must design a NAM-based data package. In both cases, strategies must be scientifically sound and aligned with regulatory expectations, with early FDA engagement critical to securing an agreed path forward.
Evaluate opportunities and risks
Alternative approaches to animal toxicology studies can lower costs, shorten timelines, and reduce animal use, especially for studies using scarce non-human primates. However, skipping key studies carries serious risks if participant safety is compromised. Success requires an integrated, weight-of-evidence strategy combining in vitro, in vivo, and modeling data—with expert toxicology input to avoid pitfalls and ensure regulatory alignment.
Design an optimal IND enabling program
Design a smarter path to first-in-human studies with Certara. By integrating clinical trial and real-world data from sources including our proprietary CODEX database, biosimulation, and regulatory expertise, we help sponsors identify when human experience can supplement or replace animal studies. Our approach optimizes enabling studies, reduces timelines and costs, and secures regulatory alignment early.
Leverage AI-enabled modeling and simulation techniques
Quantitative systems pharmacology (QSP) and physiologically based pharmacokinetic (PBPK) modeling enable mechanistic simulation of human and preclinical pharmacokinetics (PK), pharmacodynamics (PD), drug-drug interactions (DDIs), toxicity, and anti-drug antibody (ADA) responses across species including mouse, rat, dog, monkey, and human. These models integrate physiological, biochemical, and molecular data to support species translation, optimize study design, and significantly reduce reliance on animal testing in line with evolving regulatory guidance.
Meet our experts on alternative approaches to animal studies
Fran Brown, PhD
Senior Vice President, Certara Drug Development Solutions
从药物早期发现到报批和上市后，Fran 在全球战略性和运营性药物开发方面拥有超过 25 年的经验。她在战略性药物发现和开发方面拥有广泛的知识，尤其侧重于发展策略和模型引导的药物开发 (MIDD) 的应用。
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Geoff Fatzinger
Vice President, Regulatory Strategy, Certara
Geoff 拥有 20 多年的专业经验，在美国、欧洲、亚太地区（在日本、中国和韩国有深入的经验）和中东地区的监管和业务成就有目共睹。
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Hannah Jones, PhD
SVP, Head of Simcyp PBPK Modeling Services
Hannah 在跨国药企深耕逾 20 年，尤其在 PBPK 和 PKPD 建模方面拥有深厚的背景。She has over 70 publications in PBPK/PKPD modeling and other DMPK related topics, and considerable experience influencing drug research and development programs through modeling and simulation.<...
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Patrick F. Smith
SVP, Translational Science, Certara
Dr. Patrick F. Smith is SVP, Translational Science, Certara, where he leads a global team of drug development scientists and regulatory strategy that creates value for clients across the entire life cycle and ultimately accelerates patient access to medicines. 凭借逾 20 年的药物开发经验，Patrick 拥有药物开发各个阶段的工作经验，在传染病、肿瘤学和炎症，以及新颖的早期开发方案设计，乃至应用建模和模拟来解决关键开发问...
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Piet van der Graaf, PharmD, PhD
Senior Vice President and Head of Quantitative Systems Pharmacology
Piet van der Graaf 现任 Certara 高级副总裁兼 QSP 负责人，同时也是莱顿大学系统药理学教授。Piet 是 2013 - 2016 年莱顿药物研究学术中心的研究主任。1999 年至 2013 年，Piet 在 Pfizer 发现生物学领域担任多个领导职务...
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Tong Zhu, PhD, FCP
VP, Global Head, Clinical Pharmacology & Translational Medicine Certara Drug Development Solutions
Dr. Tong Zhu 拥有超过 25 年专注于转化医学、早期开发及临床药理学的丰富经验，对药物研发领域有着深厚的专业知识。对药物研发领域有着深厚的专业知识。她曾负责领导安斯泰来 Astellas 线粒体生物学主要聚焦战略，通过全球协作帮助识别和开发创新疗法...
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查看全部Our offerings for navigating animal alternatives
Simulate and predict drug exposure
The Simcyp PBPK Simulator is the industry leader and most widely adopted platform for PBPK modeling in drug development. Developed through the expertise of a 25 year-long consortium involving 37 leading global pharmaceutical companies, the Simcyp PBPK Simulator is recognized and licensed by 11 regulatory agencies worldwide. Our Simcyp offerings are backed by a dedicated research and development team as well as a team of global PBPK consultants, ensuring comprehensive support for clients.
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常见问题解答
What role does Certara play in helping sponsors navigate the transition away from animal studies?
Certara’s regulatory experts partner with sponsors to design innovative development strategies that leverage validated in silico and in vitro data, engage proactively with regulators, and prepare submissions that meet FDA expectations while minimizing or eliminating animal use.
Can Certara help obtain regulatory acceptance for alternative methods?
Yes. Certara has a proven track record of gaining regulatory buy-in for non-animal approaches by generating compelling scientific justifications, participating in pre-submission meetings, and guiding the development of data packages that demonstrate human relevance and regulatory compliance.
Are regulatory agencies accepting modeling data in place of animal studies?
Yes. Regulatory agencies worldwide increasingly support the use of validated modeling approaches—such as PBPK and QSP—to inform decisions, reduce reliance on animal data, and align with emerging guidance aimed at modernizing nonclinical testing strategies.
What types of questions can modeling and simulation answer without using animals?
Modeling can address species differences, predict human drug exposure, simulate drug-drug interactions, assess organ-level toxicity, and evaluate immunogenicity risks (e.g., ADA formation)—helping reduce or avoid animal studies while improving translational relevance.
How does Certara’s regulatory strategy align with the FDA’s goal to reduce animal testing?
Certara integrates advanced modeling and simulation tools—such as PBPK, QSP, and in vitro to in vivo extrapolation (IVIVE)—into regulatory submissions, providing scientifically robust alternatives to traditional animal studies and supporting alignment with the FDA’s evolving nonclinical guidance.
