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Optimizing the Timing of Maternal Influenza Vaccination

Infants face a gap in protection against influenza between birth and the time of vaccination. Thus, maternal immunization is the only way to prevent flu infection in pregnant women and newborns. Our current understanding of the optimal timing of vaccination is rudimentary. Watch this webinar with Dr. Michael Dodds to learn how modeling and simulation (M&S) offers an alternate approach to dedicated clinical studies to determine the best time to vaccine pregnant women against influenza.

Speaker(s): Michael Dodds
Solution: PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease, Pediatrics
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Using M&S to Evaluate Oncology Drug Dosing

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk […]

Author(s): Maria Saluta
Solution: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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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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Using a Pharmacology to Payer Framework to Support Product Development

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, […]

Author(s): Carl Kirkpatrick, Craig Rayner
Solution: Clinical Pharmacology Strategy
Therapeutic Area: Infectious Disease
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Certara and Faculty from UNC Eshelman School of Pharmacy to Launch New Pharmacometrics Skills Competition at ASCPT 2018 Annual Meeting

PRINCETON, NJ – Mar. 12, 2018 – Certara today announced that it is partnering with faculty at the UNC Eshelman School of Pharmacy to launch the Model-informed Drug Development (MIDD) Gran Prix at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.

Solution: Clinical Pharmacology Strategy, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology
Therapeutic Area: Infectious Disease, Pediatrics
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