FDA releases guidance for dose optimization in oncology trials
Following the 2021 launch of Project Optimus by the Oncology Center of Excellence and an extensive workshop on the topic, in January 2023 the FDA released a draft guidance for industry entitled “Optimizing the Dosage of Human Prescription Drugs and … Read More
Successes and Opportunities in Modeling & Simulation for FDA
The use of in silico trials is expected to play an increasingly important role in the development and regulatory evaluation of new drugs and medical devices. One of the advantages that in silico approaches offer is the possibility to test … Read More
An interview with Manuel Ottaviano
Manuel Ottaviano has a M.Sc. Computer Science Engineering and a PhD in Bioengineering. He works as senior researcher in digital health and wellbeing at the University of Madrid UPM. He studies human factors implied in the design of digital technologies for health. He explores different … Read More
An interview with Prof. Christine Le Maitre
Our conversations on in silico methods in medicine are becoming more and more interesting. Christine Le Maitre, Professor of Cell Biology and Tissue Regeneration at Sheffield Hallam University, England, is the Head of the Tissue Engineering and Biomechanics Research Group … Read More
An interview with Prof. Mariano Vázquez
Modeling the human body is certainly one of the most extraordinary applications of computational simulation. We talked about this with Mariano Vázquez, a PhD in Physics, currently CTO/CSO at ELEM Biotech, a spinoff company of the Barcelona Supercomputing Center (BSC), … Read More
Simulation to help fight cardiovascular disease
Simulation to help fight cardiovascular disease. As we all know, cardiovascular disease (CVD) is the leading cause of death worldwide, with 18 million deaths each year according to WHO estimates. Currently, 15 million people in Europe live with heart failure. You can see why we were so … Read More
An interview with Prof. Javier Saiz
We met Javier Saiz – Professor of Biomedical Engineering at the Polytechnic University of Valencia, Spain – who led the research group that created the computational model which is at the core of our QT/TdP Risk Screen product, available on our cloud-based platform. Our objective was to … Read More
An interview with Prof. Stefano Severi
We met Stefano Severi – Assistant Professor of Biomedical Engineering department of Electronics, Computer Science and Systems of the University of Bologna, Italy – who created a computational model which is at the core of STrhiPS: a web-based tool that helps perform in … Read More
How to accelerate safety and performance assessments of 3D-printed PPE at POC
New simulation standards can accelerate safety and performance assessments of 3D-printed personal protective equipment (PPE), especially during global emergencies: this was the starting point of our participation in the ASTM Workshop on Fast-Tracking Standards Development to Address PPR Shortages due … Read More
Towards Good Simulation Practice
During the 2020 Avicenna Day, many experts from all over the world talking about the need for Good Simulation Practice, a term coined by the Avicenna Alliance taking inspiration from the Good Clinical Practice typical of the clinical world to … Read More