Do You Compute?

Candidate drugs emerging from discovery await in vivo PK evaluation prior to moving to late-stage development. Facing ever-increasing clinical development costs, drug companies are performing elaborate and intensive evaluations of PK/PD at earlier stages. The US Food and Drug Administration (FDA) Critical Path Initiative is calling for more use of PK/PD modeling.

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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 Trial Design, Model-based Drug Development

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 of getting safe and effective medications to patients while containing or reducing the burgeoning costs and time lines that pharma is currently incurring.
Biosimulation— the use of modeling and simulation for drug development— is a radical solution for an industry that still largely relies on empiricism.
Realizing the benefits of biosimulation will require the use of breakthrough technologies that integrate our understanding of biological systems with the power of computer modeling.

In this blog post, I will discuss the human and economic investments required to develop the field of quantitative systems pharmacology (QSP) to the point that it becomes an integral part of pharma R&D.

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Topics: Model-based Drug Development, PBPK Modeling and Simulation

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 financial information on a regular basis both internally and externally. Yet, many of the benefits of leveraging biosimulation technology are “strategic benefits.” These benefits are not readily captured by accounting systems. Thus, the default system for measuring business value gives only a partial view, at best, of the value of this technology-enabled solution. In this blog post, I’ll explain why focusing solely on value as captured by your accounting departments could cause you to miss out on some very valuable strategic benefits.

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Topics: Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and 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 average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is $2.5 billion. When so much is at stake—time, money, and the needs of our patients — having a solid drug development strategy is critical. Yet, I frequently see sponsors make the same mistakes over and over again. In this blog post, I’ll discuss these common strategic blunders and provide suggestions of how to address them.

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Topics: Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation, Regulatory Writing
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