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Certara’s Synchrogenix Division Collaborates with Hedera Hashgraph to Offer Data Flow and Transparent Collaboration Solutions for the Life Sciences Industry

October 15, 2018 – Certara today announced that it has formed a strategic collaboration with Hedera Hashgraph. Synchrogenix®, Certara’s regulatory sciences division, has been building distributed applications in the life sciences and healthcare markets that will expand its reach in the areas of transparency and disclosure, regulatory reporting and data sharing, and collaboration/communications from drug development through market access.

Solution: Regulatory & Medical Writing
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Managing Immunogenicity Using Quantitative Systems Pharmacology

Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.

Author(s): Piet van der Graaf, Andrzej Kierzek, Timothy Hickling
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
Therapeutic Area: Cardiovascular, Central Nervous System, Dermatology, Endocrinology, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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Application of Tracer Kinetics in Drug Development: A Valuable but Underused Tool in Clinical Pharmacology

In this webinar, Pau Aceves, Associate Director of Consulting Services at Certara, presented case studies on how tracer kinetics were used to inform development of new drugs for lung, CNS, and liver diseases. By watching this webinar, you will learn how tracer kinetics can leveraged for PK, PD, and in silico modeling applications.

Speaker(s): Pau Aceves
Solution: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System
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Certara Experts Highlight Quantitative Systems Pharmacology’s Role in First-in-human Clinical Trials

PRINCETON, NJ – July 26, 2018 – Certara announced today that Clinical Pharmacology & Therapeutics has published its “Letter to the Editor” describing the important role that quantitative systems pharmacology can play in defining dosing criteria for first-in-human clinical trials, together with the European Medicines Agency’s response.

Solution: Systems Pharmacology
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Real Patients & Their Virtual Twins: A New Paradigm for Personalized Drug Safety Assessment

In this webinar, Sebastian Polak, Nikunj Patel, and Mark Holbrook introduced the Cardiac Safety Simulator (CSS) platform and explained how they developed a QSTS model for citalopram to serve as a “virtual twin” and help predict the likely occurrence of cardiotoxic events in real patients under different clinical conditions.

Speaker(s): Mark Holbrook, Nikunj Patel, Sebastian Polak
Solution: PBPK Modeling & Simulation
Therapeutic Area: Central Nervous System
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