Clinical Pharmacology Strategy

What is Model-based Drug Development Worth?

Mark Hovde

If you have ever argued, as we have, for the resources and time needed for model-based drug development (MBDD), you have likely encountered that irritating accountant in the room who says, “Sure, this modeling stuff sounds interesting, but how much MONEY will this save us?” My answer: $97M of savings per New Drug Application (NDA). […]

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Topics: Clinical Pharmacology Strategy

Is the Maturation of Quantitative Systems Pharmacology a Moonshot?

Mark Hovde

At Certara, we are not afraid to think big. In fact, solving the hardest problems in pharmaceutical R&D is our passion. You might say that some of our ambitions could be described as “moonshots.” After all, they meet the criteria put forth by the Google X moonshot program. We seek to address the huge problem […]

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Topics: Systems Pharmacology

Seeing the Strategic Value of Biosimulation Technology

Mark Hovde

They say beauty is in the eye of the beholder. One could also say that the benefits of biosimulation are in the eye of the beholder. How does the beholder, in this case, a drug developer, see the benefits of these approaches? All reputable businesses use “generally accepted accounting principles” to manage, measure, and communicate […]

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

7 Horrible Mistakes You’re Making with Your Drug Development Strategy

Mark Hovde

In thinking about the complex nature of drug development, I’m often reminded of a Dwight Eisenhower quote: “In preparing for battle, I’ve always found that plans are useless, but planning is essential,” Drug development is a risky business. According to a 2014 study from the Tufts Center for the Study of Drug Development, “the estimated […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing
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