Certara Launches Non-Animal Navigator鈩� Solution to Help Drug Developers Reduce Reliance on Animal Testing
Certara (Nasdaq: CERT) has launched its Non-Animal Navigator鈩� 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庐 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鈩� 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庐 e modelli di farmacologia sistemica quantitativa per mAb
L'iniziativa mira ad aiutare le aziende a raggiungere tempi di sviluppo pi霉 rapidi, costi inferiori e prove predittive pi霉 solide, garantendo al contempo la conformit脿 normativa.
Certara (Nasdaq: CERT) ha lanzado su soluci贸n Non-Animal Navigator鈩� para ayudar a las empresas biofarmac茅uticas a reducir las pruebas en animales en el desarrollo de f谩rmacos, aline谩ndose con la nueva hoja de ruta de la FDA para los estudios de seguridad precl铆nicos. La soluci贸n se centra particularmente en los anticuerpos monoclonales y los conjugados anticuerpo-f谩rmaco (ADCs), donde los modelos de biosimulaci贸n pueden predecir los resultados humanos con la misma eficacia que los estudios tradicionales en animales.
La oferta incluye tres componentes clave:
- Asesor铆a regulatoria estrat茅gica para presentaciones IND a prueba de futuro
- Plan de desarrollo precl铆nico integrado que combina diversas fuentes de datos
- Kit de herramientas de modelado optimizado habilitado por IA que incluye el Simcyp Simulator庐 y modelos de farmacolog铆a sistem谩tica cuantitativa para mAb
La iniciativa tiene como objetivo ayudar a las empresas a lograr plazos de desarrollo m谩s r谩pidos, costos m谩s bajos y evidencia predictiva m谩s s贸lida, asegurando al mismo tiempo el cumplimiento regulatorio.
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- 氙鸽灅 歆�頄レ爜鞚� IND 鞝滌稖鞚� 鞙勴暅 鞝勲灥鞝� 攴滌牅 臁办柛
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Certara (Nasdaq: CERT) a lanc茅 sa solution Non-Animal Navigator鈩� pour aider les entreprises biopharmaceutiques 脿 r茅duire les tests sur les animaux dans le d茅veloppement de m茅dicaments, en accord avec la nouvelle feuille de route de la FDA pour les 茅tudes de s茅curit茅 pr茅cliniques. La solution se concentre particuli猫rement sur les anticorps monoclonaux et les conjugu茅s anticorps-m茅dicament (ADCs), o霉 les mod猫les de biosimulation peuvent souvent pr茅dire les r茅sultats humains aussi efficacement que les 茅tudes traditionnelles sur les animaux.
L'offre comprend trois composants cl茅s :
- Conseils r茅glementaires strat茅giques pour des soumissions IND 脿 l'茅preuve du temps
- Plan de d茅veloppement pr茅clinique int茅gr茅 combinant diverses sources de donn茅es
- Bo卯te 脿 outils de mod茅lisation optimis茅e avec IA comprenant le Simcyp Simulator庐 et des mod猫les de pharmacologie syst茅mique quantitative pour mAb
L'initiative vise 脿 aider les entreprises 脿 atteindre des d茅lais de d茅veloppement plus rapides, des co没ts plus bas et des preuves pr茅dictives plus solides tout en garantissant la conformit茅 r茅glementaire.
Certara (Nasdaq: CERT) hat seine Non-Animal Navigator鈩� L枚sung eingef眉hrt, um biopharmazeutischen Unternehmen zu helfen, Tierversuche in der Arzneimittelentwicklung zu reduzieren, und damit dem neuen Fahrplan der FDA f眉r pr盲klinische Sicherheitsstudien zu entsprechen. Die L枚sung konzentriert sich insbesondere auf monoklonale Antik枚rper und Antik枚rper-Wirkstoff-Konjugate (ADCs), bei denen Biosimulationsmodelle oft menschliche Ergebnisse genauso effektiv vorhersagen k枚nnen wie traditionelle Tierversuche.
Das Angebot umfasst drei Hauptkomponenten:
- Strategische regulatorische Beratung f眉r zukunftssichere IND-Einreichungen
- Integrierter pr盲klinischer Entwicklungsplan, der verschiedene Datenquellen kombiniert
- Optimiertes KI-gest眉tztes Modellierungs-Toolkit mit dem Simcyp Simulator庐 und quantitativen Systempharmakologie-Modellen f眉r mAb
Die Initiative zielt darauf ab, Unternehmen zu schnelleren Entwicklungszeiten, niedrigeren Kosten und st盲rkeren pr盲diktiven 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鈩� solution represents a strategic market positioning that aligns perfectly with the FDA's recent regulatory shift. This isn't merely a new product 鈥� 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 鈥� 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鈩� 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鈥檚 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 鈩� solution designed to help biopharmaceutical companies lead the transition ignited by the 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.
鈥淭he FDA announcement and roadmap pave the way for more model-informed drug development approaches that are predictive, efficient, and ethical,鈥� said William F. Feehery, Chief Executive Officer. 鈥淚t 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.鈥�
鈥淣avigating this paradigm shift requires deep regulatory insight, cross-functional expertise and modeling and simulation technology,鈥� said Patrick Smith, Senior Vice President of Translational Medicine. 鈥淐lients have begun reaching out about how to best lead their organizations through this major regulatory and scientific inflection point.鈥�
Based on Certara鈥檚 extensive experience working with聽FDA, EMA, and other major health authorities, the Non-Animal Navigator is a flexible solution that ensures each client鈥檚 development program is compliant, agile, and future ready. It offers clients:
- Strategic Regulatory Advice 鈥� Design preclinical programs that future-proof your INDs and include the appropriate use of NAMs while ensuring regulatory alignment.
- Integrated Preclinical Development Plan 鈥� 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 鈥� Accelerate timelines with access to the most widely adopted platform for PBPK modeling, the Simcyp Simulator庐, and ready-to-use mAb Quantitative Systems Pharmacology models.
To learn more about how Certara鈥檚 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 .
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
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Media Contact:
Alyssa Horowitz
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1 Based on global pipeline analysis from GlobalData's鈸� 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?
