Clinical Transparency & Disclosure

New FDA Commissioner Endorses Use of M&S to Advance Drug Development

Suzanne Minton

With the swearing in of Dr. Scott Gottlieb as Commissioner of Food and Drugs in May, many have wondered as to the climate he will set for the US FDA. Certara’s mission and business thesis aligns with the FDA’s July 7 announcement regarding the steps it is taking to implement the 21st Century Cures Act. […]

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Topics: Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing

Modeling PK/PD Systems with Distributed Delays

Suzanne Minton

Many biological systems exhibit time delays. For instance, there is a delay between the time that a virus infects a cell and the onset of viral production. Mathematical models that incorporate these temporal delays are often used to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of drugs. In this blog post, I’ll discuss some examples of biological systems […]

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Topics: PK/PD Modeling & Simulation

Expanding the Use of Pharmacometrics in Japan with Yusuke Tanigawara

Suzanne Minton

Science is a global endeavor. Indeed, one of the most exciting things about drug development is working with scientists doing important research all over the globe. The use of modeling and simulation (M&S) to support drug development has been embraced by pharmaceutical researchers in some parts of the world and is still gaining traction in […]

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Topics: PK/PD Modeling & Simulation

Nurturing the Pharmacometricians of the Future

Suzanne Minton

As a scientist, you always remember your first conference. The ability to share your research and learn from your peers is an invaluable part of any scientist’s training. That’s why I’m so proud that Certara helps support the travel and accommodation expenses for a selected number of students wishing to attend the Population Approach Group […]

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

Predicting Drug Exposure During Pregnancy Using PBPK Models

Suzanne Minton

Moms want the best for their kids even before they’re born. When I was pregnant with my son and daughter, I watched my diet and tried to stay active. During both of my pregnancies, I had to take medications several times. And I was always concerned about whether the medications could impact my unborn children. […]

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Topics: PBPK Modeling & Simulation

The Model-informed Precision Dosing Revolution Is Coming

Suzanne Minton

Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global regulatory agencies. However, its implementation in clinical care has been modest to date. Model-based approaches are essential to realize the goal of precision dosing—providing the right drug dose to maximize therapeutic benefit, while reducing risk for each individual patient. The […]

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

How Model-informed Drug Development Will Increase R&D Productivity

Suzanne Minton

Will 2017 finally be the year that we overcome the blight of late-stage attrition of promising drug candidates? In a recent commentary, “Improving the Tools of Clinical Pharmacology: Goals for 2017 and Beyond,” in Clinical Pharmacology & Therapeutics, Issam Zineh and colleagues describe several areas where clinical pharmacology approaches can help reduce late-stage attrition and […]

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Topics: Clinical Pharmacology Strategy, Systems Pharmacology

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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Optimizing Drug Development Decisions: Looking Back at 2016

Suzanne Minton

Was it just me or did 2016 just seem to fly by? Reflecting on the events of the past year, I stumbled across this quote which seemed appropriate: There are years that ask questions and years that answer. [Zora Neale Hurston, Their Eyes Were Watching God] Our mission at Certara is helping our clients optimize […]

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Topics: PK/PD Modeling & Simulation

How PBTK Models Support Toxicological Triage

Suzanne Minton

Did you know that only a small fraction of the tens of thousands of commercially-used chemicals have undergone toxicological assessment? Time and cost constraints, not to mention the ethical impossibility of studying these chemicals in human trials, hamper large-scale toxicological assessment. Physiologically-based toxicokinetic (PBTK) models can be leveraged to predict TK from in vitro measurements […]

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Topics: PBPK Modeling & Simulation

The Impact of Genetic Polymorphisms and DDIs on Exposure

Suzanne Minton

Physiologically-based pharmacokinetic (PBPK) modeling and simulation is increasingly accepted due to the enormous cost and time saving benefits that can be realized through its ability to address regulatory concerns without always defaulting to clinical study — particularly relating to assessing complex drug-drug interactions (DDIs). Independent validation of simulations against clinical data provides confidence in the […]

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Topics: PBPK Modeling & Simulation

How PBPK Can Help Solve Fatal Poisonings

Suzanne Minton

My mom― a clinician scientist herself― would often say this about the power of pharmacology: Every medicine has its price. While most patients benefit from their medications, cases of fatal drug poisonings are tragedies wherein patients pay the ultimate price. Forensic toxicology probes cases of fatal poisonings where the cause of death is unknown. This […]

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Topics: PBPK Modeling & Simulation

6 Real-life Lessons About PBPK Modeling

Suzanne Minton

I recently had the pleasure of attending a 1.5 day Certara forum for management on the applications of physiologically-based pharmacokinetic (PBPK) modeling and simulation in Chicago, IL. Our CSO Dr. Amin Rostami and Certara consulting scientist, Dr. Alice Ke aptly led the forum. The highlight of the meeting was discussing the latest challenges and trends […]

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Topics: PBPK Modeling & Simulation

Informing Pediatric Drug Development: A Selection from Certara’s Best of Blogs

A selection of short essays by Certara’s pediatric drug development experts. Learn about our technologies and strategies for pediatric drug development to inform dose selection, including PK/PD simulations using sparse data analysis and our Simcyp Pediatric Simulator. Certara’s regulatory writing consultancy, Synchrogenix, also offer regulatory strategy for pediatrics.

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Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation 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.

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Effective Communication for Pharmacometricians with Joga Gobburu

Suzanne Minton

The modeling and simulation revolution is transforming our approach to drug development. Quantitative pharmacology models can yield valuable insights that help sponsors make better decisions regarding their drug programs. For pharmacometricians to influence decision making, they must be able to effectively communicate. Dr. Joga Gobburu is a Professor at the University of Maryland Schools of […]

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Topics: PK/PD Modeling & Simulation

Learning from Failure: Leveraging Biosimulation for Pediatric Drug Development Success

The high rate of trial failures, increasing regulatory demands, and ethical imperatives all require a reexamination of the current approach to pediatric drug development. Biosimulation is a proven approach that will help optimize trial design and inform the drug label. This approach can support global regulatory strategies that increase the likelihood of success for pediatric drug development programs.

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Conducting Virtual Trials Using PBPK to Drive More Precise Label Claims

Biosimulation technology is revolutionizing the way in which the pharmaceutical industry does business and how the regulators are reviewing new drug approvals. Biosimulation leverages both empirical analysis of clinical data and mechanistic in silico approaches. The latter approach encompasses both in vitro-in vivo extrapolation (IVIVE) and physiologically-based pharmacokinetic modeling and simulation (PBPK M&S).

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Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland

Suzanne Minton

Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation of a mechanistic understanding of pharmacokinetics since the 1960s. So you might think that he’d be ready for quieter pursuits. But this professor emeritus at the University of Manchester has no plans to stop actively teaching and guiding the pharmaceutical industry’s […]

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Topics: PBPK Modeling & Simulation

Insights on Quantitative Systems Pharmacology with Piet van der Graaf

Suzanne Minton

Quantitative systems pharmacology (QSP) is an emerging biosimulation technology that is going to increase pharmaceutical R&D productivity. This week at the Roundtable, we’re talking with Dr. Piet van der Graaf, PharmD, PhD about QSP and his vision for how it supports meeting the goal of precision medicine. Dr. van der Graaf is a professor of […]

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Topics: Systems Pharmacology
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