How MBMA Can Help You Make Smarter Drug Development Decisions

Leon Bax

Successful drug development depends on making wise decisions about portfolios, clinical trials, marketing, etc. We’re continuously faced with the challenge of deciding whether to continue development or stop it. To support those decisions, we gather data, typically through clinical trials. We analyze the data from those clinical trials, and then we use these analyses to […]

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

Leveraging Dissolution Testing to Meet Regulatory Guidelines

Jean-Michel Cardot

Dissolution testing is a standard tool in a formulation scientist’s arsenal. When companies make changes to drug products (particle size, excipients, manufacturing process, equipment, etc), health authorities often require comparing dissolution profiles to determine if the reference and test products are equivalent. Generic drug developers are also required to show bioequivalence between the branded drug […]

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

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 event’s 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 […]

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

Revolutionizing Drug Development— d3 Medicine Joins the Certara Family

Craig Rayner

Thinking Without BordersTM Developing Medicines that MatterTM These guiding principles fueled the creation of d3 Medicine. With a goal of revolutionizing the pharmaceutical paradigm to accelerate developing medicines that benefit society, combining d3 and Certara was a ‘no brainer.’ Delivering on our clients’ mission The d3 Medicine staff join Certara’s Strategic Consulting (CSC) division, which […]

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

The Ultimate Cheat Sheet on CDISC-SEND

Chris Lovejoy

On December 18, 2016, numerous regulatory agencies will require electronic submission of non-clinical data using CDISC’s standard format. What exactly are CDISC data standards and how will they impact drug developers? In this blog post, I will provide an overview of the CDISC SEND data standard, review some of the requirements for implementing SEND, and […]

Read More
Topics: Model-based Drug Development, PK/PD 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 […]

Read More
Topics: Clinical Trial Design, Model-based Drug Development, PBPK Modeling and Simulation

Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug

Karen Rowland Yeo

Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety and efficacy. These factors include intrinsic variability― CYP metabolizer status, age, sex, renal/hepatic impairment― as well as external variables― co-medications, food effects, smoker status, etc. Clinical trials alone […]

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

Annual Report – Simcyp Consortium Meeting

Ellen Leinfuss

It may be 2016, but we just held the 17th annual Simcyp Consortium meeting in Sheffield, UK. This year’s gathering had >120 attendees with representatives from all but one of the 34 consortium member companies joining. The opening session reviewed the progress made by the Simcyp staff toward the field of regulatory science, physiologically-based pharmacokinetic […]

Read More
Topics: Drug Safety, 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 […]

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

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 […]

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

Arming Adherence-Based Drug Development with Pharmacometrics

Jonathan Knights

The time is right to explore how sensor-enabled digital adherence monitoring systems can benefit patients, sponsors, and payers. Non-adherence to prescribed medications is a key issue facing our healthcare industry, costing the US healthcare economy between $100-300 billion annually, representing between 3-10% of total healthcare costs [1, 2]. Further, non-adherence also decreases our ability to […]

Read More
Topics: Clinical Trial Design, Model-based Drug Development, PK/PD 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 […]

Read More
Topics: Clinical Trial Design, Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation

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. […]

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

How to Expedite FDA Approvals of Orphan Drugs

Thomas Peyret

350 million patients worldwide suffer from 7,000 rare diseases, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of rare disease patients, represents a huge unmet medical need. Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patients are difficult to identify […]

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

FDA’s PDUFA VI Goals Highlight Model-Informed Drug Development

Ellen Leinfuss

On July 15, the US FDA published its goals and commitment letters for the re-authorization of its Prescription Drug User Fee Act (PDUFA) for fiscal years 2018-2022, known as PDUFA VI.  The document reflects the agency’s performance and procedural goals to expedite bringing safer therapies to patients.  It also reflects and incorporates the advances in […]

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

Assessing Drug-Smoking Interactions Using PBPK Modeling

Theresa Cain

The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn’t good for your health. But, did you know that smoking can affect the metabolism of other drugs and even cause serious drug interactions? In this blog post, I’ll discuss the mechanisms by which smoking can impact pharmacokinetics, how physiologically-based pharmacokinetic […]

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

Using PBPK Models to Optimize Antiviral Dosing at the Point of Care

Manoranjenni Chetty

The use of physiologically-based pharmacokinetic (PBPK) modeling for drug development is well-established and is now routinely used by the pharmaceutical industry, regulators, and researchers. In this blog post, I’ll discuss a novel application that combined PBPK and Bayesian modeling to help clinicians optimize dosing at the point of patient care. This application was used to […]

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

Predicting Variations in Drug Clearance in Obese Patients Using Modeling and Simulation

Trevor Johnson

Many physiological changes are associated with obesity and can potentially impact pharmacokinetics (PK). This can require adjustments to be made to the standard doses for normal weight patients in order to ensure safety and efficacy of drug therapy. Dosing of specific drugs in this population is dependent on their physico-chemistry as well as changes in body […]

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

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 efficacy1, 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 […]

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

Highlights of the Quebec “Drug Discovery to Development” Symposium

Mark Reimer

In today’s drug development climate, we’re encouraged to “think global, act local.” I have had the privilege of supporting the development of important new therapies for clients around the globe. But sometimes, it is helpful to take a step back and look at the exciting science going on in your own backyard. With that spirit […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation
Learn More
LinkedIn