Certara’s Best of Blogs 2016

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.

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The Special Opportunities for Modeling and Simulation in Oncology Drug Development

Rik de Greef and Ellen Leinfuss

In his most recent New York Times Magazine piece, “The Improvisational Oncologist,” Dr. Siddhartha Mukherjee, author of The Emperor of All Maladies: A Biography of Cancer, wrote, “In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.”

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Topics: Clinical Trial Design, Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation

How Biosimulation Can Bring New Immuno-Oncology Treatments to Patients

Rik de Greef

Immuno-oncology, which harnesses the patient’s own immune system to fight cancer, is one of the hottest areas in drug development today. In recent years, the FDA has granted breakthrough therapy designations to multiple immuno-oncology drugs for a variety of oncology indications including advanced non-small cell lung cancer and melanoma. Over the last two decades, PK/PD modeling and simulation (M&S) has played a growing role in oncology drug development. In this blog post, I’ll discuss how M&S (also known as biosimulation) can help support some of the unique challenges that immuno-oncology programs face.

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Topics: PK/PD Modeling and Simulation

Immunotherapy in Oncology

One of the biggest recent advances in cancer therapy has been the arrival of novel immunotherapies, such as anti-PD1 antibodies, which have demonstrated remarkable efficacy in multiple tumor types. In many instances supported by the ‘Breakthrough’ status granted by the FDA, many pharmaceutical companies are making huge efforts to bring these promising treatments to cancer […]

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