FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Ellen Leinfuss

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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

7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

Tom Snowden

Modeling and simulation has become an indispensable part of drug development. Historically, the type of modeling employed changes as a drug moves through the stages of drug development—from discovery to pre-clinical testing to clinical trials. At the early stages of drug discovery, we may use systems biology models to identify drug targets and possible compounds, […]

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Topics: Systems Pharmacology

Taming Complex Quantitative Systems Pharmacology Models with Model Reduction

Tom Snowden

Quantitative systems pharmacology (QSP) combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. This emerging discipline integrates quantitative drug data with knowledge of its mechanism of action. QSP models predict how drugs modify cellular networks in space and time and how they impact and […]

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Topics: Systems Pharmacology

Quantitative Systems Toxicology—Taking the Cue from Aristotle

Maria Saluta

“The whole is greater than the sum of its parts” -Aristotle This quote from the great 4th century BCE Greek philosopher and scientist has become the mantra for many endeavors, sectors, organizations, and disciplines. From biology, chemistry, and physics to agriculture, engineering, and business, it is the foundation for synergy. What is the connection between […]

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Topics: Systems Pharmacology

Using Model Reduction to Bridge the QSP-Pharmacometrics Divide

Tom Snowden

Quantitative systems pharmacology (QSP) models are generally too large to be validated or fit in a traditional sense and they can become intractable to standard methods of analysis or even to the modeler’s own intuition. Model reduction can alleviate these issues of complexity by eliminating portions of a system that have minimal effect upon the […]

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Topics: Systems Pharmacology

Mechanistic Modeling of Genome Scale Molecular Interaction Networks

Andrzej Kierzek

Upon the completion of the Human Genome Project, the lead investigator, Dr. Francis Collins remarked: Science is a voyage of exploration into the unknown. We are here today to celebrate a milestone along a truly unprecedented voyage, this one into ourselves. Alexander Pope wrote, “Know then thyself. Presume not God to scan. The proper study […]

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Topics: PBPK Modeling & Simulation, Systems Pharmacology

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 Launches First Global Quantitative Systems Pharmacology Consortium

PRINCETON, NJ – Jan. 25, 2017 – Certara today announced that it is launching a Quantitative Systems Pharmacology (QSP) Immunogenicity Consortium. Modeled after Certara’s highly successful Simcyp Consortium, the QSP Immunogenicity Consortium brings together leading biopharmaceutical companies in a pre-competitive environment to cooperatively develop an Immunogenicity Simulator.

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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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Can QSP Save Lives? Lessons from a Trial Debacle

Neil Benson

The notion that volunteers could be harmed in a clinical trial is every drug developer’s worst nightmare. Earlier this year, the drug company, Bial, investigated inhibitors of the enzyme fatty acid amide hydrolase (FAAH) in clinical trials as a treatment for pain. Tragically, one person in the volunteer group died, and six patients were hospitalized. […]

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Topics: Systems Pharmacology

Status of QSP Modeling in the Pharmaceutical Industry

Steve Toon

A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to lack of efficacy,1 suggesting inadequate understanding in therapeutic targets’ biology and their relevance to disease progression or modulation. Quantitative systems pharmacology (QSP) has the promise of increasing the probability of success in R&D by bridging scientific gaps between disciplines to enable […]

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Topics: Systems Pharmacology

How Does the In Vivo Biliary Elimination of Drugs Change with Age? Evidence from In Vitro and Clinical Data Using a Systems Pharmacology Approach

Information on the developmental changes in biliary excretion (BE) of drugs is sparse. The aims of this study were to collate literature data on the pharmacokinetics of biliary excretion of drugs used in pediatrics and to apply a physiologically-based pharmacokinetic (PBPK) model to predict their systemic clearance (CL) with a view to elucidating age-related changes […]

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Status of Quantitative Systems Pharmacology Modeling in the Pharmaceutical Industry: A Consortium Survey of the What, When and How

A primary cause of failures in pharmaceutical research and development (R&D) was attributed to lack of efficacy (Hay et al. 2014), suggesting a lack of understanding in therapeutic targets biology and their relevance to disease progression or modulation. Quantitative systems pharmacology (QSP) has the promise of increasing probability of success in R&D by bridging scientific […]

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Can QSP Save Lives? Lessons from the Bial Trial Debacle

One of the biggest challenges for the pharmaceutical industry is the high rate of drug attrition in Phase 2 clinical trials, which wastes significant amounts of money and time. The major reasons for this attrition are that either candidate drugs do not show efficacy or have unexpected toxicity, in turn implying that we did not fully understand the complexity of the biology the candidate drugs were designed to modulate.

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A Six-stage Workflow for Robust Application of Systems Pharmacology

Quantitative and systems pharmacology (QSP) is increasingly being applied in pharmaceutical research and development. One factor critical to the ultimate success of QSP is the establishment of commonly accepted language, technical criteria, and workflows. We propose an integrated workflow that bridges conceptual objectives with underlying technical detail to support the execution, communication, and evaluation of […]

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