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Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

Author(s): Alice Ke, Andrzej Kierzek, Angela Colbers, Barry Mangum, Behtash Bahador, David Turner, Ellen Leinfuss, Graham Scott, Iain Gardner, Julie Bullock, Leon Bax, Lora Killian, Maria Saluta, Nathan Teuscher, Nirpal Singh Virdee, Oliver Hatley, Peter Bonate, Rob Connelly, Ronette Gehring, Shriram Pathak, Shuhua Hu, Stacey Tannenbaum, Steve Sibley, Suzanne Minton, Tom Snowden
Solution: Clinical Pharmacology Strategy, Clinical Transparency & Disclosure, Clinical Trials Simulation, Drug Development & Regulatory Strategy, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Scientific Informatics, Systems Pharmacology
Therapeutic Area: Central Nervous System, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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Changing the Game in Drug Development

At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and unlock millions of dollars in R&D savings.

Solution: Drug Development & Regulatory Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
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D360 Partner

D360 Partner is an affordable add-on product for D360 for external partners that allows for seamless, secure sharing of data and analysis while advancing communication and collaboration.

Solution: Scientific Informatics
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Investigational Drug Gap Analysis

As the process of drug development has increased in cost and complexity, Certara has developed a service offering to assess a sponsors’ development program across multiple domains, and to craft a strategy to address each.

Solution: Clinical Pharmacology Strategy
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Simcyp Consultancy: Bespoke PBPK Modeling and Simulation

Physiologically-based Pharmacokinetic (PBPK) models describe and predict the handling of drugs by the body in a realistic way based on demography, physiology, biochemistry, and genetics. We integrate this information with in vitro drug absorption, metabolism, and transport data to simulate and predict in vivo pharmacokinetics in virtual patient populations.

Solution: PBPK Modeling & Simulation
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Certara Nurture

Recognizing the great importance of serving pediatrics balanced against the inherent hurdles, Certara Nurture offers comprehensive pediatric drug development services.

Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, PBPK Modeling & Simulation, Regulatory & Medical Writing
Therapeutic Area: Pediatrics
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Burstable Compute Grid

Certara’s Compute Grid allows you to access up to 1,800 cores in the cloud with just one click, significantly accelerating model runs. Projects that took days can now be completed in hours or even minutes, affordably and without IT support.

Solution: PBPK Modeling & Simulation
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