Certara Launches Non-Animal Navigator™ Solution to Help Drug Developers Reduce Reliance on Animal Testing
Certara (Nasdaq: CERT) has launched its Non-Animal Navigator™ solution to help biopharmaceutical companies reduce animal testing in drug development, aligning with FDA's new roadmap for preclinical safety studies. The solution focuses particularly on monoclonal antibodies and antibody-drug conjugates (ADCs), where biosimulation models can often predict human outcomes as effectively as traditional animal studies.
The offering includes three key components:
- Strategic Regulatory Advice for future-proof IND submissions
- Integrated Preclinical Development Plan combining various data sources
- Optimized AI-Enabled Modeling Toolkit featuring the Simcyp Simulator® and mAb Quantitative Systems Pharmacology models
The initiative aims to help companies achieve faster development timelines, lower costs, and stronger predictive evidence while ensuring regulatory compliance.
Certara (Nasdaq: CERT) ha lanciato la sua soluzione Non-Animal Navigator™ per aiutare le aziende biopharmaceutical a ridurre i test sugli animali nello sviluppo dei farmaci, in linea con il nuovo piano dell'FDA per gli studi di sicurezza preclinici. La soluzione si concentra in particolare sugli anticorpi monoclonali e sui coniugati anticorpo-farmaco (ADCs), dove i modelli di biosimulazione possono spesso prevedere gli esiti umani con la stessa efficacia degli studi tradizionali sugli animali.
Offre tre componenti chiave:
- Consulenza strategica regolatoria per sottomissioni IND a prova di futuro
- Piano di sviluppo preclinico integrato che combina varie fonti di dati
- Toolkit di modellazione ottimizzato abilitato all'IA con il Simcyp Simulator® e modelli di farmacologia sistemica quantitativa per mAb
L'iniziativa mira ad aiutare le aziende a raggiungere tempi di sviluppo più rapidi, costi inferiori e prove predittive più solide, garantendo al contempo la conformità normativa.
Certara (Nasdaq: CERT) ha lanzado su solución Non-Animal Navigator™ para ayudar a las empresas biofarmacéuticas a reducir las pruebas en animales en el desarrollo de fármacos, alineándose con la nueva hoja de ruta de la FDA para los estudios de seguridad preclínicos. La solución se centra particularmente en los anticuerpos monoclonales y los conjugados anticuerpo-fármaco (ADCs), donde los modelos de biosimulación pueden predecir los resultados humanos con la misma eficacia que los estudios tradicionales en animales.
La oferta incluye tres componentes clave:
- Asesoría regulatoria estratégica para presentaciones IND a prueba de futuro
- Plan de desarrollo preclínico integrado que combina diversas fuentes de datos
- Kit de herramientas de modelado optimizado habilitado por IA que incluye el Simcyp Simulator® y modelos de farmacología sistemática cuantitativa para mAb
La iniciativa tiene como objetivo ayudar a las empresas a lograr plazos de desarrollo más rápidos, costos más bajos y evidencia predictiva más sólida, asegurando al mismo tiempo el cumplimiento regulatorio.
Certara (Nasdaq: CERT)는 생물제약 회사들이 약물 개발에서 동물 실험을 줄일 수 있도록 돕기 위해 Non-Animal Navigator™ 솔루션을 출시했습니다. 이는 FDA의 새로운 전임상 안전 연구 로드맵과 일치합니다. 이 솔루션은 특히 단클론 항체 및 항체-약물 접합체(ADCs)에 중점을 두며, 생물 시뮬레이션 모델이 전통적인 동물 연구만큼 효과적으로 인간 결과를 예측할 수 있습니다.
이 제공물에는 세 가지 주요 구성 요소가 포함됩니다:
- 미래 지향적인 IND 제출을 위한 전략적 규제 조언
- 다양한 데이터 출처를 통합한 전임상 개발 계획
- Simcyp Simulator® 및 mAb 정량적 시스템 약리학 모델을 포함한 최적화된 AI 지원 모델링 도구 키트
이 이니셔티브는 기업들이 더 빠른 개발 일정, 더 낮은 비용 및 더 강력한 예측 증거를 달성하도록 돕는 동시에 규제 준수를 보장하는 것을 목표로 합니다.
Certara (Nasdaq: CERT) a lancé sa solution Non-Animal Navigator™ pour aider les entreprises biopharmaceutiques à réduire les tests sur les animaux dans le développement de médicaments, en accord avec la nouvelle feuille de route de la FDA pour les études de sécurité précliniques. La solution se concentre particulièrement sur les anticorps monoclonaux et les conjugués anticorps-médicament (ADCs), où les modèles de biosimulation peuvent souvent prédire les résultats humains aussi efficacement que les études traditionnelles sur les animaux.
L'offre comprend trois composants clés :
- Conseils réglementaires stratégiques pour des soumissions IND à l'épreuve du temps
- Plan de développement préclinique intégré combinant diverses sources de données
- Boîte à outils de modélisation optimisée avec IA comprenant le Simcyp Simulator® et des modèles de pharmacologie systémique quantitative pour mAb
L'initiative vise à aider les entreprises à atteindre des délais de développement plus rapides, des coûts plus bas et des preuves prédictives plus solides tout en garantissant la conformité réglementaire.
Certara (Nasdaq: CERT) hat seine Non-Animal Navigator™ Lösung eingeführt, um biopharmazeutischen Unternehmen zu helfen, Tierversuche in der Arzneimittelentwicklung zu reduzieren, und damit dem neuen Fahrplan der FDA für präklinische Sicherheitsstudien zu entsprechen. Die Lösung konzentriert sich insbesondere auf monoklonale Antikörper und Antikörper-Wirkstoff-Konjugate (ADCs), bei denen Biosimulationsmodelle oft menschliche Ergebnisse genauso effektiv vorhersagen können wie traditionelle Tierversuche.
Das Angebot umfasst drei Hauptkomponenten:
- Strategische regulatorische Beratung für zukunftssichere IND-Einreichungen
- Integrierter präklinischer Entwicklungsplan, der verschiedene Datenquellen kombiniert
- Optimiertes KI-gestütztes Modellierungs-Toolkit mit dem Simcyp Simulator® und quantitativen Systempharmakologie-Modellen für mAb
Die Initiative zielt darauf ab, Unternehmen zu schnelleren Entwicklungszeiten, niedrigeren Kosten und stärkeren prädiktiven Beweisen zu verhelfen und gleichzeitig die regulatorische Compliance sicherzustellen.
- Launch of innovative solution positions CERT as a leader in FDA's initiative to reduce animal testing
- Product targets thousands of mAbs and ADCs in preclinical development, representing significant market opportunity
- Solution can potentially reduce development costs and accelerate timelines for pharmaceutical companies
- Success depends on regulatory acceptance of non-animal testing methods
- Implementation requires significant changes to established drug development processes
Insights
Certara's launch of its Non-Animal Navigator™ solution represents a strategic market positioning that aligns perfectly with the FDA's recent regulatory shift. This isn't merely a new product – it's a comprehensive solution addressing a major industry inflection point in drug development methodology.
The company is targeting a significant opportunity in monoclonal antibody development, with thousands of candidates currently in preclinical phases across multiple therapeutic areas. This market focus is astute as mAbs represent both high-value assets for pharma companies and an area where computational approaches have demonstrated superior predictive power compared to traditional animal models.
What makes this offering particularly compelling is its three-pronged approach combining regulatory strategy, integrated development planning, and AI-enabled modeling tools. This holistic package addresses the complete challenge pharmaceutical companies face – not just technical execution but regulatory navigation of this paradigm shift.
Most significantly, Certara isn't starting from scratch but leveraging its established Simcyp Simulator platform, which already enjoys widespread industry adoption. This approach allows them to extend their existing technological advantage into an emerging market segment while creating a differentiated offering through their regulatory expertise.
The timing is excellent as companies that adapt early to these regulatory changes stand to gain competitive advantages in development speed and cost efficiency. Certara is positioning itself as the expert guide through this transition, potentially cementing long-term relationships with biopharma clients navigating unfamiliar regulatory territory.
This product launch represents a strategic expansion of Certara's service portfolio that builds upon their core modeling and simulation expertise while opening new revenue opportunities. The Non-Animal Navigator™ solution is particularly well-timed to capitalize on regulatory shifts in the industry.
From a financial perspective, this offering has several attractive characteristics. First, it builds upon Certara's existing Simcyp Simulator platform, suggesting favorable margins by leveraging already-developed technology. Second, it creates a bundled offering combining software with high-value consulting services, potentially increasing average deal size and customer retention.
The targeting of monoclonal antibody development is financially sound given this represents one of the highest-growth segments in drug development. With thousands of such candidates in preclinical phases, Certara is addressing a substantial market need at precisely the point where development decisions significantly impact ultimate commercial success.
The product structure itself suggests potential for recurring revenue as clients will likely need ongoing support navigating evolving regulatory frameworks rather than one-time implementations. By positioning as a strategic partner rather than just a technology provider, Certara may increase both customer lifetime value and switching costs.
This launch demonstrates management's ability to identify and rapidly respond to regulatory catalysts that create new market opportunities. While the immediate revenue impact isn't quantified, the solution leverages Certara's existing strengths in biosimulation and regulatory expertise to address emerging client needs, representing a logical extension of their business model.
New offering provides strategic guidance and AI-enabled biosimulation to navigate FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies
RADNOR, Pa., April 14, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the launch of its Non-Animal Navigator™ solution designed to help biopharmaceutical companies lead the transition ignited by the FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. The Roadmap marks a pivotal moment in drug development. Companies that act now can future-proof their portfolios, gaining competitive advantage through faster timelines, lower costs, and stronger predictive evidence.
Globally, there are thousands of monoclonal antibodies and antibody-drug conjugates (ADCs) currently in the preclinical phase of development1 across a broad range of therapeutic areas. Monoclonal antibodies are a key area in efforts to reduce animal testing, as biosimulation models often predict human outcomes as well as or better than, traditional animal studies. For over two decades, Certara has partnered with biopharmaceutical sponsors and regulatory agencies to integrate predictive, mechanistic models into the development and regulatory evaluation of biologics, including monoclonal antibodies.
“The FDA announcement and roadmap pave the way for more model-informed drug development approaches that are predictive, efficient, and ethical,” said William F. Feehery, Chief Executive Officer. “It is part of a growing industry adoption trend to use scientifically robust new approach methodologies (NAMs) like AI-enabled biosimulation to improve strategic decision-making and success rates at every phase of drug development.”
“Navigating this paradigm shift requires deep regulatory insight, cross-functional expertise and modeling and simulation technology,” said Patrick Smith, Senior Vice President of Translational Medicine. “Clients have begun reaching out about how to best lead their organizations through this major regulatory and scientific inflection point.”
Based on Certara’s extensive experience working with FDA, EMA, and other major health authorities, the Non-Animal Navigator is a flexible solution that ensures each client’s development program is compliant, agile, and future ready. It offers clients:
- Strategic Regulatory Advice – Design preclinical programs that future-proof your INDs and include the appropriate use of NAMs while ensuring regulatory alignment.
- Integrated Preclinical Development Plan – Build an integrated, weight-of-evidence strategy combining in vitro, in vivo, real-world evidence, and biosimulation data with expert toxicology input.
- Optimized AI Enabled Modeling Toolkit – Accelerate timelines with access to the most widely adopted platform for PBPK modeling, the Simcyp Simulator®, and ready-to-use mAb Quantitative Systems Pharmacology models.
To learn more about how Certara’s Non-Animal Navigator supports preclinical development, visit https://www.certara.com/solutions/non-animal-navigator/. For more insights on the impact of the FDA Roadmap and how to prepare for this new regulatory era, join Certara scientists on April 30 at 11 AM ET for an exclusive webinar.
About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com.
Certara Contact:
Sheila Rocchio
sheila.rocchio@certara.com
Media Contact:
Alyssa Horowitz
certara@pancomm.com
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1 Based on global pipeline analysis from GlobalData'sⓒ Intelligence Center
FAQ
What is Certara's Non-Animal Navigator solution and how does it reduce animal testing?
How will CERT's new solution impact drug development timelines and costs?
What specific tools does Certara's Non-Animal Navigator include for drug development?
How does Certara's solution align with FDA's new animal testing reduction roadmap?
