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Real World Evidence Marches Forward in Drug Development

The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm on real-world evidence (RWE) and its adoption in the drug development process. While the collection of real-world data (RWD) and use of RWE is not new, they are now poised to have a profound impact on our industry.  Today, it […]

Author(s): Ulrich Neumann
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Building an MBMA Framework to Support Developing New Neuropathic Pain Drugs

Model-Based Meta-Analysis (MBMA) is a growing methodology that leverages literature based and often external data to provide a quantitative framework to enable strategic drug development decisions. MBMA comparator models often include valuable pieces of information such as time, covariates, clinical trial efficacy and safety information.

Speaker(s): Leticia Arrington, Richard C. Franzese
Solution: Model-based Meta-analysis, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System
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Certara Scientists Advance ASCPT Agenda: From Molecule to Patient

PRINCETON, NJ – Mar. 13, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its pharmacokinetic/pharmacodynamic (PK/PD), quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modeling experts will participate in 21 sessions at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2019 […]

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Certara Showcases Multi-faceted Approach to Improving Drug Safety Assessments at the Society of Toxicology Annual Meeting

PRINCETON, NJ – Mar. 8, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that it will be showcasing its multi-faceted – technology, service and regulatory science – approach to improving new drug safety assessments at the Society of Toxicology (SOT) Annual Meeting and […]

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Benefits of Apocalyptic Clinical Pharmacology During Regulatory Review

When developing a drug, pharmaceutical companies need to answer many questions to successfully undergo regulatory review and bring the drug to market. Apocalyptic clinical pharmacology is a framework that drug developers can use to uncover essential relationships between the drug dose and response or outcome. In other recent blog posts, I have covered what the […]

Author(s): Graham Scott
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Centers for Disease Control and Prevention (CDC) Selects Certara to Develop Technology Platform to Strengthen the Agency’s Death Investigation and Surveillance Systems

PRINCETON, NJ – March 5, 2019 – Certara will partner with CDC to create OpenMDI (Open Medicolegal Death Investigation), a national system that will collect and share mortality data efficiently, allowing CDC to respond rapidly to critical public health priorities, such as tracking and understanding the toxicology behind drug overdoses from opioids.

Solution: Regulatory & Medical Writing
Therapeutic Area: Central Nervous System
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Simulating Viral Dynamics in the New Trial Simulator

Watch this webinar to learn how to use simulation to anticipate risks and preview the range of possible trial results before millions of R&D dollars are spent exposing subjects to experimental therapies.

Speaker(s): Bill Poland
Solution: Clinical Trials Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease
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Managing Immunogenicity Using Quantitative Systems Pharmacology

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and […]

Author(s): Piet van der Graaf
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
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