Strituvad March Newsletter
Updated: Jan 12
Simulations to test tuberculosis therapies, created the first 15 virtual patients
The first 15 virtual patients have been modeled by partners from the University of Catania based on the data received from the CRO that manages the clinical trial in India.
These digital patients have been also used for the initial tuning phase of the UISS-TB in silico platform which has already performed very well in terms of predictivity.
UISS-TB is a computational platform based on a sophisticated model capable of predicting the progression and dynamics of the tuberculosis disease treated with specific therapeutic approaches. The platform is customized on real data from patients recruited in the phase IIb clinical trial officially launched last October at AIIMS, in India.
The computational model will expand the data from real patients with data from virtual (simulated) patients, through advanced modeling approaches and adaptive Bayesian methodologies. Thanks to the contribution of virtual patients, it will be possible to predict the effects of long-term combined therapy and to promptly detect any adverse or low-efficacy effects, thus suggesting appropriate corrective maneuvers. Read full article here
World Tuberculosis Day 2022
On 24 March 1882, Dr Robert Koch announced that he had discovered the bacterium that causes Tuberculosis. 140 years later, TB remains one of the world’s deadliest infectious killers, and the COVID-19 pandemic has reversed years of progress made in the fight to end TB. For the first time in over a decade, TB deaths increased in 2020.
The theme of World TB Day 2022 - ‘Invest to End TB. Save Lives.’ – conveys the urgent need to invest resources to ramp up the fight against TB and achieve the commitments to end TB made by global leaders. This is especially critical in the context of the COVID-19 pandemic that has put End TB progress at risk, and to ensure equitable access to prevention and care in line with WHO’s drive towards achieving Universal Health Coverage.
Source: World Health Organization
Verification of an agent-based disease model: interview to Dr Cristina Curreli
In her latest paper "Verification of an agent-based disease model of human Mycobacterium tuberculosis infection" co-authored with other partners from the University of Catania and University of Sheffield, biomedical engineer Cristina Curreli discusses the issue of UISS-TB model credibility assessment. In particular, she describes a new verification methodology that can be used to identify, quantify and reduce the numerical errors associated with the model.
We took the opportunity to talk with her about her work and role in the STriTuVaD project.
"Before my current appointment at the University of Bologna, I received my PhD in Biomechanics at the University of Pisa, Italy. My main interest is computer modeling and simulation for clinical applications and in the STriTuVaD project, together with the partners University of Catania and University of Sheffield, I work on the in silico trial definition and UISS-TB model credibility assessment. We recently developed a new verification strategy that can be used to identify and remove possible numerical implementation errors in our agent-based models."
What is your expertise with in silico trials?
My research activities mainly focus on the definition of verification and validation methods that can be used to assess the credibility of computation models. I always liked spotting mistakes and working towards the prevention of errors! I also worked on the regulatory activities for other in silico trials applications. For example, in silico trials for new joint replacements solutions and in silico trials used to evaluate the efficacy of new treatments against osteoporosis.
Since you mentioned your involvement in regulatory activities, what are, in your opinion, the challenges associated with the use of predictive models in the regulatory evaluation of new medical products?
The greatest challenge is to show that the dream of predicting human health can be reality. I think that we need to work hard to define rigorous methods that can be used to test our models and...Read the full interview on our blog
New FDA draft guidance on assessing the Credibility of Computational Modeling and Simulation in Medical Device submissions
The guidance will help improve the consistency and transparency of the review of CM&S evidence, ultimately increasing the confidence in the use of CM&S in regulatory submissions.
Bayesian Augmented Clinical Trials in TB Therapeutic Vaccination
The goal of this strategy is to reduce the number of real patients needed to test the efficacy of the adjuvant vaccine. Read the full article.
State of inequality: HIV, tuberculosis and malaria - A visual summary
Although remarkable progress has been made in reducing the overall burden of each disease, certain groups still have persistently higher disease mortality and morbidity, and lower access to life-saving interventions.
Interview to Prof F. Pappalardo from University of Catania
"STriTuVaD uses an in silico trial platform to predict the outcome of a real, randomized clinical trial that is testing new therapeutic vaccines against tuberculosis"
Interview to Dr Giulia Russo, Chief Research Officer of MIMESIS
"Modeling and simulation can accelerate the conventional pipeline for the development and regulatory assessment of medicines and medical devices.."
TBVI annual meeting - 5-7 April 2022, Les Diablerets (Switzerland)
TBVI symposium will bring together scientists from research institutes, universities, industry, funding agencies, technical agencies to share knowledge and hear from key global stakeholders about their current activities in the field. Theme of this year’s symposium will be Innovating and Delivering TB Vaccines and Biomarkers. More info
VPH SUMMER SCHOOL- 23-27 May 2022, Barcelona (Spain)
It provides junior engineers, early researchers and medical doctors with an integrative view of state-of-the-art research for in silico medicine, following a complete pipeline from basic science and clinical needs, to model application. More info