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 and 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: Clinical Trial Design, Model-based Drug Development, PBPK Modeling and 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: Model-based Drug Development, PBPK Modeling and 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: Clinical Trial Design, Drug Safety, Model-based Drug Development, PBPK Modeling and 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: Model-based Drug Development, PK/PD Modeling and 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 use of modeling and simulation. Here, we pick Prof. Rowland’s brain about the impact of pharmacometrics on drug development, the direction he sees the field going, and the secrets to his success as a scientist and teacher.

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Topics: Clinical Trial Design, Model-based Drug Development, PBPK Modeling and 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 systems pharmacology, chair of pharmacology, and director of the Leiden Academic Centre for Drug Research at Leiden University in the Netherlands. He is also a former director of XenoloqiQ, the UK-based QSP consultancy, which Certara just acquired. Dr. van der Graaf is now the vice president of QSP at Certara.

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

The Year in Review for Biosimulation and Regulatory Writing

Suzanne Minton

Happy New Year! 2015 was a year of huge growth— both personally and professionally— for our Certara® family. We’re so grateful for our clients who give us the privilege of supporting them in their work to bring safer and more effective treatments to patients. In this blog post, I’ll be looking back at the top 10 […]

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

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

Suzanne Minton

Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions between drugs and patients, including beneficial effects and adverse effects. I recently had the pleasure of talking to a thought leader, Dr. Lawrence Lesko, about the history of pharmacometrics and how it will continue to shape drug development in the future.

Dr. Lesko was Director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for 16 years until his retirement in July 2011. He currently serves as Clinical Professor and Director of the Center for Pharmacometrics and Systems Pharmacology in the University of Florida, College of Pharmacy at Lake Nona in Orlando, FL.

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

Using Biosimulation to Support Approvals for Orphan Drugs

Suzanne Minton

Rare diseases affect fewer than 1 in 2000 people. Each one affects only a small number of patients. Yet, there are over 7000 rare diseases. And, there are no treatments for 95 percent of them. Thus, many patients suffer from these diseases. The treatments for rare diseases are often referred to as “orphan drugs.” Orphan drug developers face distinct challenges with rare diseases including:

Heterogeneity in disease progress and treatment outcomes
Few patients to run new studies
Uncertain appropriate durations of treatment
Sparse existing data available from limited populations
Biosimulation methods— also known as model based drug development— include both top-down (empirical) and bottom-up (mechanistic) models. These methods use sparse data from small populations to inform dosing and trial designs. For example, population PK/PD models can test the influence of factors such as age, weight, and disease status on drug exposure and response. Likewise, combining drug and disease models can help distinguish between treatment effects on symptoms vs changes in disease processes. Model based approaches can support accelerated approval pathways that get treatments to patients faster.

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Topics: Drug Safety, Model-based Drug Development, PK/PD Modeling and Simulation

How Pharmacometric Analyses Can Add Value to Oncology Drug Programs

Suzanne Minton

We are standing on the precipice of a new era in oncology drug development. In his Pulitzer prize winning book, The Emperor of All Maladies: A Biography of Cancer, Dr. Siddhartha Mukherjee traces the evolution of the approach to treating cancer. He identifies four major paradigms in our understanding of this disease:

Ancient views of cancer: The oldest recorded description of cancer was found on a papyrus from about 1600 BCE. The ancient clinician described the probable case of breast cancer as “a bulging tumor . . . like touching a ball of wrappings.” As for treatment? The papyrus reads that there is none.
The dawn of modern treatment: In 1947, Dr. Sidney Farber developed the first chemotherapy wherein he achieves a brief remission in a toddler suffering from acute lymphoblastic leukemia by treating him with aminopterin.
If some is good, more is better: In an attempt to help patients, oncologists performed radical surgeries and gave massive doses of chemotherapy in combination with bone marrow transplants, to little avail.
The quest for targeted treatments: Instead of simply killing cancerous and normal cells with toxic drugs, the newest generation of oncology drugs more selectively inhibits hyperactive growth pathways in cancer cells.
The emergence of pharmacometric analyses is the latest leap forward in how we bring safer, more effective medications to cancer patients. It can bring great value to sponsors by helping them optimize dosing, inform the drug label, achieve regulatory compliance, and in some cases, waive clinical trials.

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

100 Articles That Will Help You Understand PBPK Modeling & Simulation

Suzanne Minton

As a company with a strong academic foundation, our scientists actively publish the results of their research in the form of conference abstracts and peer-reviewed papers. We’re proud to announce that our PBPK modeling and simulation group has hit a milestone of having published more than 100 papers since 2007. In this blog post, I’ll discuss some of the highlights of this research group and touch on how our Consortium members are using the Simcyp Simulator to accelerate the pace of drug development.

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

What You Need to Know about the Precision Medicine Initiative

Suzanne Minton

Last month, I was fortunate to be able to represent Certara® at the BIO International Conference in Philadelphia, PA. One of the most exciting sessions that I attended was the Personalized Medicine Plenary with Dr. Francis Collins, the director of the NIH. He discussed how the Precision Medicine Initiative (PMI) will revolutionize the approach to improving health and treating disease. In this blog post, I’ll discuss the goals of PMI and how this initiative aligns with our mission to use biosimulation and strategic regulatory writing to bring safer and more effective medications to patients.

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Topics: Clinical Trial Design, Drug Safety, Model-based Drug Development

How to Explain the Value of Biosimulation to Your Grandma

Suzanne Minton

As most scientists can attest, it’s not always easy to communicate the importance of your work to non-scientists. I personally experienced this when my fiercely intelligent grandmother, a former elementary school teacher, asked to read a copy of my dissertation. When I asked her what she thought of it, I realized that her understanding of the concepts I was trying to convey was much like that of a kid in a Charlie Brown cartoon listening to a teacher talk. She perceived my dissertation as though it was written in a foreign language and got little out of it.

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Topics: Model-based Drug Development, Regulatory Writing

Positive Stats about PK/PD Modeling in the Pharmaceutical Industry

Suzanne Minton

Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation (M&S) is an important tool that can help researchers gain a better understanding of their drug’s efficacy— especially at the early stages of drug development. In this blog post, I’ll discuss some positive statistics uncovered in a recent IQ Consortium survey that examined the current landscape for preclinical PK/PD modeling […]

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

The Highlights in Model Based Drug Development for 2014

Suzanne Minton

As the end of the year draws near, I want to thank all of our customers for letting us be your biosimulation and model based drug development solution provider. We feel honored to be able to play a small, but crucial role in your success in bringing safe and effective drugs to patients. 2014 has […]

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