On Demand Webinars Page
Browse our free, educational webinars— covering topics including clinical pharmacology, pharmacometrics, PBPK modeling and simulation, regulatory writing, real world evidence, and market access, all available on-demand.
PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Case Study
Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating advanced melanoma. As in the best practice case of ibrutinib, we generally perform physiologically-based pharmacokinetic (PBPK) simulations with model verification based on CYP3A4 strong inhibitor...
Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Case Study
Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October 2015 at monthly and 6-week dosing options. Although aripiprazole was not a new drug, Aristada was a new, long-acting injectable formulation to combat this challenging...
Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations Blog Post
The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc. received FDA approval of voretigene neparvovec-rzyl (Luxturna™), a recombinant adeno-associated...
How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline Press Coverage
Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the FDA’s new guidance Project Optimus, which addresses issues relating to dose optimization in clinical trials assessing oncology drugs.
FDA’s Digital Transformation Journey White Paper
Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Case Study
In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for adults with type 1 Gaucher disease. Eliglustat is an oral inhibitor of glucosylceramide synthase. It is metabolized primarily by CYP2D6, and to a lesser extent...
Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates Case Study
Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures in ages 2 and older. Unlike many other therapies for treating TSC-associated seizures, everolimus addresses the underlying pathophysiology of TSC. As TSC-associated seizures can also...
