News overview

Clinical Trial Simulations: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions, by Per Olsson and Alberto Russu.
Europe: Tuesday 19/09 at 3pm CEST.
US: Thursday 28/09 at 9am CDT.

Importing parameter estimates in Simulo: a video tutorial

Jul 05, 2017

We created a video tutorial, showing you how to import parameter estimates from Nonmem into Simulo.

Defining a model in Simulo: video tutorial

Jul 05, 2017

We created a video tutorial, showing you how to implement a basic model in Simulo.

Defining the trial protocol in Simulo: video tutorial

Jul 05, 2017

Philippe Jacqmin

We created a video tutorial, showing you how to define the trial protocol in Simulo

Can early phase ECG assessment serve as an alternative for thorough QT studies? A review of the literature

Jul 04, 2017

Thorough QT (TQT)-studies are recommended according to the 2005 ICH E14 guidelines to assess the potential of novel drugs to prolong QT interval. These stand-alone studies are expensive due to the large amount of subjects and typically carried out in Later Phase drug development. Replacing TQTstudies by incorporating QT-effect measurements in Early Phase SAD/MAD trials with an Exposure-Response (ER) QT-analysis could be an alternative enhancing cost-efficiency.

SGS Exprimo is sponsoring the DDMoRe Model Repository Challenge and works on a PharmML SO importer embedded in Simulo

Jun 19, 2017

SGS Exprimo decided to support the DDMoRe Model Repository Challenge and, consequently, to promote model sharing.

Two-day Clinical Trial Simulation course at PAGE 2017

Jun 05, 2017

Quentin Leirens

In the context of the PAGE meeting, SGS Exprimo ran a two-day satellite course on Monday and Tuesday 5-6 June.

Angela Äbelö joining !

May 24, 2017

We are delighted to welcome Angela Äbelö to our team of consultants. She will start at SGS Exprimo on June 1.

How can modelling and simulation optimize the clinical development of adalimumab biosimilar candidates?

May 18, 2017

Quentin Leirens

Bernardo de Miguel Lillo

In the context of the 7th European Biosimilars Congress, held in Munich 15-16 May 2017, Bernardo de Miguel Lillo presented an abstract and a poster about how we optimized the clinical development of an Adalimumab biosimilar candidate thanks to modelling and simulation.

Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis

May 15, 2017

Same Stats, Different Graphs

May 03, 2017

Justin Matejka and George Fitzmaurice show a convincing example of the value of data visualization. In this short paper, the authors transform the "Datasaurus" dataset into 12 different datasets, all with the same mean and standard deviation.
This makes a very convincing argument to present more than only summary statistics, and it is an entertaining read as well!

Top selling pharma drugs in 2016

Apr 28, 2017

Bernardo de Miguel Lillo

PharmaCompass provided an interesting overview of the top selling drugs in 2016. Abbvie's Humira generated record sales of US $16.078 billion in 2016, followed by Gilead's Harvoni (US $9.081 billion) and Amgen/Pfizer's Enbrel (US $8.875 billion).

Time-to-Seizure Modeling of Lacosamide Used in Monotherapy in Patients with Newly Diagnosed Epilepsy

Apr 04, 2017

Baseline disease severity was the most important predictor of seizure probability. Simulations suggest that an initial target dose >200 mg/day could potentially benefit patients with greater disease severity.

TDM Example in R Shiny

Mar 25, 2017

In this article, we demonstrate a TDM approach for dosing beta-lactams.

Simulo training for KULeuven

Mar 24, 2017

Quentin Leirens

Professors Pieter Annaert and Thomas Bouillon from the KULeuven (Belgium) attended a Simulo training session.

PK-Sim and Mobi now opensource

Mar 24, 2017

The PK-Sim and MoBi software suite, originally developed by Bayer Technology Services, has now become open-source under GPLv2.

SGS Early Phase Drug Development Course, 9 May 2017, Antwerp

Mar 13, 2017

On May 9th 2017, SGS Life Sciences is organizing a course in early phase drug development for clinical team members of start-ups and interested academics.
Next to regulatory and clinical protocol consultancy, SGS Exprimo will present PK/PD M&S methods to optimize drug development.

ISO9001:2015 certification for Exprimo datacenter

Mar 10, 2017

IT is considered a 'key risk area' for R&D Consultancy companies like SGS Exprimo. Our datacenter vendor has now achieved ISO9001:2015 compliance, further proving the quality Exprimo provides to its clients in all areas of project execution.

Simulo in the media

Mar 08, 2017

Several media outlets are writing about Simulo!

How can modelling and simulation optimize the clinical development of biosimilars?

Mar 01, 2017

Bernardo de Miguel Lillo

Bernardo de Miguel Lillo explores the competitive advantages SGS Exprimo can offer in the development of biosimilars

Simulo Press Release

Feb 23, 2017

SGS Exprimo officially launches Simulo platform to provide modeling and simulation solutions for clinical trial design optimization.

Population pharmacokinetics of ticagrelor and AR-C124910XX in patients with prior myocardial infarction.

Jan 30, 2017

Simulo: technical information

Jan 27, 2017

Simulo is complex software. In this article, we explore how it was developed.

The Simulo Expert library: an overview

Jan 27, 2017

Philippe Jacqmin

Simulo Expert is delivered with a wide library of demonstration models. Explore them in this article.

Enrica and Belén on board

Jan 17, 2017

SGS Exprimo is pleased to welcome Enrica Mezzalana and Belén Valenzuela in its team of consultants.

Evidence of NI-0101 pharmacological activity, an anti-TLR4 antibody, in a randomized phase 1 dose escalation study in healthy volunteers receiving LPS.

Jan 01, 2017

Philippe Jacqmin

Using Model-Based "Learn and Confirm" to Reveal the Pharmacokinetics-Pharmacodynamics Relationship of Pembrolizumab in the KEYNOTE-001 Trial

Jan 01, 2017

Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Size Dynamics in Pembrolizumab-Treated Advanced Melanoma

Jan 01, 2017

Simulo training at University of Lyon

Dec 13, 2016

To support the University of Lyon (prof. Michel Tod) in their research efforts wrt cancer treatment optimization, SGS Exprimo provided a 1-day webinar training in Simulo.

Simulo training at University of Navarra

Dec 01, 2016

SGS Exprimo gave a course about "Simulo" at the research group of prof. Iñaki F. Trocóniz at the University of Navarra. At the end of the two days, all 10 attendees were confident to use Simulo in subsequent research and teaching activities.

How modeling and simulation (M&S) supported the development of the immuno-oncology drug pembrolizumab

Nov 25, 2016

During his time at Merck (MSD) our consultant Andreas Lindauer participated in the modeling and simulation team that worked on numerous model-informed approaches to support the development of pembrolizumab (KEYTRUDA), a new monoclonal antibody approved for the treatment of melanoma and other cancer types. Check out a series of recently published articles by this M&S team.

Clinical Trial Simulation training at University of Lyon

Nov 24, 2016

In collaboration with the University of Lyon, we presented a 2-hour session in Clinical Trial Simulation. This session fitted nicely within the Master's program curated by Emilie Henin (Calvagone).
The 10 students managed to explore the PK model for Sunitinib. 4 students struck gold at the end, managing to create an efficient design that proved biosimilarity.

An abstract for Simulo

Nov 23, 2016

Simulo – a platform for advanced model based simulations using R

Exposure-response analyses supporting ticagrelor dosing recommendation in patients with prior myocardial infarction.

Nov 18, 2016

Trip to PKUK 2016

Nov 11, 2016

Per Olsson Gisleskog and Daniel Röshammar went recently to PKUK conference in London (9th to 11th November). They summarize their trip with a selection of presentations.

SGS BioPharm Day 2016

Oct 25, 2016