Model-based Meta-analysis

The Expanding Role of Natural History Studies in Drug Development

Sumeet Bakshi & Artak Khachatryan

Natural history studies follow a group of people over time who have or are at risk of developing a specific disease. This type of study is an important tool in modern drug development and in assessing new health technologies by payers. This is especially true for rare diseases or diseases with high, unmet medical need […]

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Topics: Evidence and Market Access

Do Rigorous Science, Benefit the Patients & Have Fun: Insights from Regulatory Expert Eva Berglund

Suzanne Minton

Drug development is a global enterprise. One of the great things about working at Certara is the ability to learn from fantastic colleagues living around the world. My Swedish colleague, Dr. Eva Berglund, is a clinical pharmacologist who is now a Senior Director of Regulatory Strategy at Certara after spending a long and distinguished career […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

Piet van der Graaf and Andrzej Kierzek

Immuno-oncology – The Breakthrough in Cancer Therapeutics Cancer immuno-oncology (IO) uses the body’s natural defenses to combat cancer. These therapies stimulate an individual’s immune system and restore its ability to identify and destroy cancer cells. Anti-cancer immune responses are often inhibited during the spread of cancer. Ultimately, IO therapy expedites long term responses against cancer […]

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Topics: Systems Pharmacology

Simulating Viral Dynamics in the New Trial Simulator

Suzanne Minton, Bill Poland

Antiviral drug development presents a unique set of challenges. First, viruses are constantly mutating, and drug-resistant viruses emerge easily. Therefore, combination therapies are typically required to maintain a sustained virologic response. In addition, successful treatment requires high medication adherence, which is often a challenge for patients with chronic viral infections such as hepatitis or HIV. […]

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Topics: PK/PD Modeling & Simulation

Real World Evidence Marches Forward in Drug Development

Ulrich Neumann

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 […]

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Topics: Evidence and Market Access

Benefits of Apocalyptic Clinical Pharmacology During Regulatory Review

Graham Scott

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 […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Managing Immunogenicity Using Quantitative Systems Pharmacology

Piet van der Graaf

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 […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology