Certara’s Best of the Blog 2017

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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Using Model-informed Drug Development Approaches to Accelerate Orphan Drug Development

Maria Saluta

Orphan drugs are used to treat rare diseases and disorders. This year marks the 35th anniversary of both the landmark Orphan Drug Act, a law passed by the US FDA that created legal and financial incentives for pharma and biotech to pursue rare disease R&D, and the formation of the National Organization for Rare Disorders […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation

A Practical Approach to the Challenges of Pediatric Drug Development

Barry Mangum

Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges regarding trial planning, design, and conduct. In this blog post, I’ll […]

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Topics: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation

The European Regulatory Landscape for Pediatric Drug Development

Barry Mangum

In my 35 years of working to develop safer, more effective medications for children, I’ve often been asked about how to navigate the regulatory landscape in the US and Europe. In a previous blog post, I discussed the latest FDA trends regarding pediatric drug development. In this blog, I’ll focus on the path for achieving […]

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Topics: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation

What the FDA Expects from Your Pediatric Drug Program

Barry Mangum

Historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. To address this market failure, regulatory legislation for drug development in pediatric patients was passed worldwide over the past decade. The number of drugs tested in and labeled for children has increased dramatically as a result. In […]

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Topics: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation

Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs

In this webinar, Dr. Barry Mangum from Paidion Research and Dr. JF Marier from Certara discussed how pediatric considerations fit into the overall drug development program. They also made recommendations for addressing issues from both a practical and scientific perspective. Anonymized case studies were presented with a review of historical issues with a focus on solutions for today (ie, licensed comparators differences in US and EU, importation issues, and endpoint selection).

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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

Leveraging PBPK Modeling and Simulation for Neonatal and Infant Drug Development

Alice Ke

Despite increased regulatory support for pediatric drug development, sponsors still face ethical, economic and practical constraints. Indeed, while children represent about 40% of the world’s population, only 10% of the drugs on the market have been approved for pediatrics. Children are not small adults, and all children are not the same. In particular, children under […]

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Topics: PBPK Modeling & Simulation

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 the Timing of Maternal Influenza Vaccination

April 19, 2018 – Infants face a gap in protection against influenza between birth and the time of vaccination. Thus, maternal immunization is the only way to prevent flu infection in pregnant women and newborns. Our current understanding of the optimal timing of vaccination is rudimentary. Join this webinar with Dr. Michael Dodds to learn how modeling and simulation (M&S) offers an alternate approach to dedicated clinical studies to determine the best time to vaccine pregnant women against influenza.

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Quantitative Pharmacology Strategies for Pediatric Drug Development

Patrick Smith

Pediatric patients are not simply small adults. Children differ from adults in both disease pathophysiology and pharmacokinetics/pharmacodynamics (PK/PD). Yet historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. In this blog post, I’ll discuss the challenges of developing drugs for children and explain how quantitative pharmacology […]

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Topics: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation
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