Speaker: Professor Alejandro F Frangi
Title: Computational Medicine: AI-enabled Digital Twins and Pro-Innovation Regulatory Science
Time and Location: 11am, 19th July, Kilburn Lecture Theatre 1.4
Abstract:
Traditional medical device product development life cycle begins with pre-clinical development. In laboratories, bench/in-vitro experiments establish plausibility for treatment efficacy. Then in-vivo animal models with different species provide guidance on medical device efficacy/safety for humans. With success in both in-vitro/in-vivo studies, products are tested on clinical trials assessing use in humans. Testing on many people is costly, lengthy, and sometimes implausible (e.g., paediatric patients, rare diseases, and underrepresented ethnic groups). When medical devices fail at later stages, financial losses can be catastrophic. Predicting low-frequency side effects has been difficult because such side effects may not become apparent until many patients adopt the treatment. In recent years, medical devices also failed because of a lack of efficacy rather than safety. Success rates are declining, clinical trial costs are rising, innovation is stagnating, clinical trials in US/UK are moving abroad where costs are lower, and patient profiles may differ. One reason for failure is that traditional trials aim to establish efficacy/safety for *most* subjects rather than for *individual* subjects, so efficacy is determined by a statistic of central tendency for the trial. Traditional trials do not adapt treatment to covariates of subjects. Many reports have pointed to this broken/slow innovation system and its impact on societal costs and suboptimal healthcare. However, radical changes to this innovation process are still to be developed.
Computational Medicine uses methods from computer science, engineering and mathematics to advance healthcare by developing computational models of disease, personalizing these models using data from patients, and applying these models to improve the diagnosis and treatment of disease as well as using digital evidence to accelerate the development and performance of novel treatment options. Computational Regulatory Science is the science of developing new computational methods and digital representations to deliver tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all medical regulated products. These two areas require considerable underpinning on solid computer science, machine learning and scientific computing foundations alongside with a commitment to interdisciplinary collaboration and mission-driven discovery science.
In this talk, I will overview our progress in the INSILEX Programme funded by the Royal Academy of Engineering. We envision a paradigm shift in medical device innovation where quantitative sciences are exploited to carefully engineer medical device designs, explicitly optimise clinical outcomes, and thoroughly test side effects before being marketed. In-silico trials (IST) are essentially computer-based medical device trials performed on populations of virtual patients. They use computer models/simulations to conceive, develop and assess devices with the intended clinical outcome explicitly optimised from the outset (a-priori) instead of tested on humans (a-posteriori). This will include testing for potential risks to patients (side effects) and exhaustively exploring in-silico for medical device failure modes and operational uncertainties before being tested in human clinical trials. Advanced computer modelling will prove useful to predict how a device behaves when deployed across the general population or when used in new scenarios outreaching the primary prescriptions (device repurposing), helping to help the widest possible target patient group without unintended consequences of side effects and device interactions.
Selected References
Frangi AF, Taylor ZA, Gooya A. Precision Imaging: more descriptive, predictive and integrative imaging. Med Image Anal. 2016 Oct;33:27-32.
Sarrami-Foroushani A, Lassila T, MacRaild M, Asquith J, Roes KCB, Byrne JV, Frangi AF. In-silico trial of intracranial flow diverters replicates and expands insights from conventional clinical trials. Nat Commun. 2021 Jun 23;12(1):3861.
Bio:
Professor Alejandro F Frangi, FIEEE FSPIE FMICCAI FAAIA
Bicentennial Turing Chair in Computational Medicine at the University of Manchester and KU Leuven
RAEng Chair in Emerging Technologies, University of Manchester
http://www.cistib.org/afrangi/
Professor Frangi is Bicentennial Turing Chair in Computational Medicine and Royal Academy of Engineering Chair in Emerging Technologies at the University of Manchester, UK, with joint appointments at the Schools of Computer Science and Health Sciences. He directs the CISTIB Center for Computational Imaging and Simulation Technologies in Biomedicine. He is a Turing Fellow of the Alan Turing Institute. Previously, Prof Frangi was Scientific Director of the Leeds Centre for HealthTech Innovation and Director of Research and Innovation of the Leeds Institute for Data Analytics. He holds an Honorary Chair at KU Leuven in the Departments of Electrical Engineering (ESAT) and Cardiovascular Science. He holds a BSc/MSc in Telecommunications Engineering from UPC Barcelona (1996) and a PhD in Imaging Science from Utrecht University (2001). He also coordinates the InSilicoUK Innovation Network (www.insilicouk.org).
Professor Frangi’s main research interests lie at the crossroads of medical image analysis and modelling, emphasising machine learning (phenomenological models) and computational physiology (mechanistic models). He is particularly interested in statistical methods applied to population imaging and in silico clinical trials. His highly interdisciplinary work has been translated into cardiovascular, musculoskeletal and neurosciences.